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HARVARD MEDICAL SCHOOL

'.

GRETCHEN BRODNICKI, J.D.

: .

DEAN FOR FACULTY AND RESEARCH INTEGRITY

'

(b) (7)(A)

25 SHATTUCK STREET
BOSTON, MAsSACHUSETTS 02115

TEL: (617) 432-2496


FAX: (617) 432-7462
GRETCHEN_BRODNICICI@HMS:HARVARD.EDU

CONFIDENTIAL

June S, 2012
John E. Dahlberg, Ph.D., Director
Division of Investigative Oversight
Office for Research Integrity
1101 Wootton Parkway
Suite 750
Rockville, MD 20852
Re:

DIO:
Matter of (b) (6), (b)(7)(C)
(b) (6), (b)(7)(C)

Dear Dr. Dahlberg:


Enclosed please find the fmal determination, final reports and documentary record in the
above-referenced investigation. As you will see, there was a fmding of research misconduct.
Please do not hesitate to contact me at 617-432-2496 or
Gretchen Brodnicki@hms.harvard.edu if you have any questions or need any additional
information.
Sincerely,

/:J~6~-

Gretchen Brodnicki
Dean for Faculty and
Research Integrity
Enclosures
cc:

Kristin Bittinger (w/o enclosures)


Ellen Berkman, J.D. (w/o enclosures)

(b) (6), (b)(7)(C)

HHS-PSC000001

HHS-PSC000002

MASSACHUSEITS GENERAL HOSPITAL~ HARVARD MEDICAL SCHOOL


PAUL S. RUSSELL, MD

John Homans Professor of Surgery


Harvard
Visiting Surgeon and Chief, Transplantation Unil
Massachusetts General Hospital, Boslon, MA 02114
(617) 726-2801

\@V

May 22, 2012


Jeffrey Flier, M.D.
Dean of the Faculty of Medicine
Harvard Medical School
25 Shattuck Street
Boston, MA 02115
Dear Dr. Flier:

On behalf of the Harvard Medical School Standing Committee on Facility Conduct, I am


writing to convey to you the recommendation of the Standing Committee relating to an investigation
into allegations that
(b) (6), (b)(7)(C)
in the laboratory of
(b) (6), (b)(7)(C) , might
have conimitted research misconduct
(b) (7)(A)

(b) (6), (b)(7)(C)

This matter commenced in October 2007, when Margaret Dale, J.D., former Research
Integrity Officer and Dean for Faculty and Research Integrity at HMS, was notified by Gerianne
Sands, J.D., Associate General Counsel at Fred Hutchinson Cancer Research Center (FHCRC)
that (b) (6), (b)(7)(C) might
(b) (7)(A) . The research
reported in (b) (6), (b)(7)(C) was conducted at HMS while
(b) (6), (b)(7)(C) in
laboratory.
(b) (6), (b)(7)(C) , where
in the Division of Basic Sciences.

(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)

The allegations against(b) (6), (b)(7)(C) were first brought forward by another former fellow in
(b) (6), (b)(7)(C) (b) (6), (b)(7)(C) prepared a detailed
laboratory at FHCRC,
report setting forth
(b) (7)(A) allegations against (b) (6), (b)(7)(C) related to (b) (6), (b)(7)(C) . In
addition, (b) provided a series of PowerPoint presentations supporting (b) allegations.

(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)

(6)
(6),
,
(b)
(b)
(7)
After
policies and federal
(7) an initial assessment, and in accordance with institutional (C)
regulations,
(C a joint inquiry panel was appointed to look into the matter and to report its findings and
)

HHS-PSC000003

PAUL S. RUSSELL, M.D.


conclusions to the Chair of the Standing Committee on Faculty Conduct. The inquiry panel,
comprised of
(b) (6), (b)(7)(C) Professor (b) (6), (b)(7)(C) ,
(b) (6), (b)(7)(C)
Professor
(b) (6), (b)(7)(C) and
(b) (6), (b)(7)(C) Professor (b) (6), (b)(7)(C)
(b) (6), (b)(7)(C)
, reviewed the matter and recommended that it proceed to investigation in accordance
with institutional policies, Public Health Service regulations and the Department of Defense
directive. The Chair of the Standing Committee on Faculty Conduct, Paul S. Russell, M.D.,
John Romans Distinguished Professor of Surgery, accepted the recommendations of the inquiry
panel and his recommendations were accepted by you. The final determinations of the inquiry
panel were then forwarded to the respondent, the federal Office of Research Integrity and the
Department of Defense.
The members of the inquiry panel agreed to serve as members of an investigative panel.
The investigative panel was charged with applying the standard for review set forth in 42 CFR
1
Sec. 50.102 to determine whether (b) (6), (b)(7)(C) committed research misconduct. As detailed in the
attached investigation report, the panel met three times at the end of 2010 and early 2011 to review
the written submissions of the respondent and complainant, to interview (b) (6), (b)
and (b) (6),
(b) (6), (b)(7)(C)
(7)(C)
(b)(7)
and to consider the evidence
While the panel reached
(b) (7)(A) against
preliminary conclusions
(b) (7)(A) in March 2011, it held issuance of its draft (C)
report pending its formal inquiry into (b) (6), (b)(7)(C) allegations against a second respondent.
The conclusions of that review did not ultimately alter the findings of the investigative panel.
Consequently, on (b) (6), (b)(7)(C) , a draft report was shared with (b) (6), (b)(7)(C) (b) (6), (b)(7)(C) declined
to comment in (b) (6), (b)(7)(C) .
(b) (6), (b)(7)(C)
(b) (6), (b)(7)(C)

The panel issued its final report on (b) (6), (b)(7)(C) They concluded that (b) (6), (b)(7)(C)
Specifically, the panel concluded that
(b) (6), (b)(7)(C) .

(b) (6), (b)(7)(C)


(b) (6), (b)(7)(C)
(b) (6), (b)(7)(C)
(b) (6), (b)(7)(C)

The Standing Committee met on March 22,2012 to consider the matter. At the meeting, we
reviewed the investigative panel's report and the accompanying documentation, met with the
investigation staff, and interviewed (b) (6), (b)(7)(C) , a representative on behalf of the investigative paneL

42 CFR Sec. 50.102 was the regulation in effect when the alleged misconduct occurred. "Misconduct" or
"Misconduct in Science" is defined as fabrication, falsification, plagiarism or other practices that seriously deviate
from those that are commonly accepted within the scientific community for proposing, conducting or reporting
research. It does not include honest error or honest differences in interpretations or judgments of data. The
investigation was conducted in compliance with that standard, but the procedural requirements of 42 CFR Part 93,
the revised regulation covering misconduct, were followed with respect to the panel's investigative process.
1

HHS-PSC000004

PAUL S. RUSSELL, M.D.


/

Conclusions
Having reviewed and considered carefully the final report of the investigative panel,
including the accompanying documentation, we conclude that the work of the investigative panel
was thorough and fair.

(b) (6), (b)(7)(C)

We agree with the conclusion of the investigative panel tha


(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)

Although we find
appear from the record that (b) (6), (b)(7)(C) exercised

In particular, it does not

(b) (6), (b)(7)(C) primary data


(b) (6), (b)(7)(C) results were

preliminary. (See investigation report, exhibit 8, p. 11). A careful review of all primary data
(b) (6), (b)(7)(C)
(b) (6), (b)(7)(C)
supporting the
paper before submission might have
showing the reported
inspired a more careful review of the

(b) (6), (b)(7)(C) This might have


(b) (6), (b)(7)(C)

Recommendations
We agree with the recommendation of the investigative panel that the Office for Research
Integrity, Department of Defense and appropriate institutional officials at HMS be notified of the
(b) (6), (b)(7)(C)
outcome of this investigation.
We also agree with the panel that FHCRC, (b) (6), (b) and (b) (6), (b) be notified in writing
(7)(C)
(7)(C)
of the conclusion of this matter.
These are the conclusions and recommendations of the Standing Committee on Faculty
Conduct. Please feel free to call on us if we can be of further assistance.
SjJerely ,

()

r(Jul g~ ~~u/rUJ,- ~

Paul S. Russell, M.D.


Chairperson
Enclosures

HHS-PSC000005

HHS-PSC000006

HARVARD MEDICAL SCHOOL

JEFFREY

S.

FUER,

MD

DEAN OF THE FACULTY OF MEDICINE


HARVARD MEDICAL SCHOOL
25 SHATTUCK ST.
BOSTON,

MA 02II5

CONFIDENTIAL

May 29, 2012

(b) (6)
Via Email: (
b
Dear(b) (6), (b)(7)(C))
(
6
I am writing to inform you of the determinations Harvard Medical School has reached after reviewing and
)
considering the
final conclusions and recommendations of the HMS Standing Committee on Faculty Conduct, as
set forth in their letter to me of(b) (6), (b)(7)(C) as well as the Investigation Panel's report, and the rest of
documentary record in this case.

After careful consideration, I have accepted the findings, conclusions, and recommendations of the Standing
Committee and the Investigation Panel.
(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)


I also agree with the panel that FHCRC, (b) (6), (b)(7)(C) and (b) (6), (b)(7)(C) be notified in writing of the conclusion of this
matter.

(b) (6), (b)(7)(C)

If you have any further questions conceming this matter, including any questions about the implementation of the
Standing Committee's recommendations, please contact Gretchen Brodnicki, the HMS Dean for Faculty and
Research Integrity, at Gretchen Brodnicki@hms.harvard.edu, or at 617-432-2496.
Sincerely,

~~

Dean of the Faculty of Medicine

cc:

Gretchen Brodnicki
Kristin Bittinger

(b) (6), (b)(7)(C)


Ellen Berkman, J.D. (Office of the General Counsel)
Enclosures

HHS-PSC000007

HHS-PSC000008

HARVARD MEDICAL SCHOOL

CONFIDENTIAL MEMORANDUM

To:

Paul Russell, M.D., Chair, Faculty of Medicine Standing Committee on Faculty Conduct

(b) (6), (b)(7)(C) Professor (b) (6), (b)(7)(C)


(b) (6), (b)(7)(C) Professor
(b) (6), (b)(7)(C)
(b) (6), (b)(7)(C) Professor of
(b) (6), (b)(7)(C)

From:

Re:

Report of the Investigative Panel Concerning Allegations of Research Misconduct against


(b) (6), (b)(7)(C) former Harvard Medical School (HMS) (b) (6), (b)(7)(C)

Date: March 13,2011


INTRODUCTION

Following is the report of an Investigation Panel established to examine allegations that


(b) (6), (b)(7)(C)
(b) (6), (b)(7)(C) former Harvard Medical School (HMS)
(b) (6), (b)(7)(C)
(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)


This panel was originally appointed in March 2008 as members of an ad hoc inquiry
panel. The inquiry panel was charged with determining whether or not sufficient evidence of
research misconduct existed to warrant an investigation of this matter. Our inquiry report dated
May 5, 2010, including exhibits and other supporting materials, is attached to this investigation
report. The inquiry report provides a factual summary of the matter and our conclusions
following initial inquiry, including our recommendation that the matter proceed to investigation.
We briefly summarize the inquiry process and outcome below.
SUMMARY OF THE INQUIRY PROCESS

In October 2007, Margaret Dale, J.D., former Research Integrity Officer and Dean for
Faculty and Research Integrity at HMS, was notified by Gerianne Sands, J.D., Associate General
(b) (6), at Fred Hutchinson Cancer Research Center (FHCRC), regarding allegations that
(b) (6), (b)(7)(C)

(b)(7)(C)

(b) (6), (b)(7)(C)


HHS-PSC000009

CONFIDENTIAL

(b) (6), (b)(7)(C) .

(b) (6), (b)(7)(C)


(b) (6), (b)(7)(C)

. Because the research in


question was conducted while
(b) (6), (b)(7)(C) , the HMS Office for Professional
Standards and Integrity (OPSI) took the administrative lead in staffing the matter? The
(b) (6), (b)(7)(C) in
complainant in this matter is
(b) (6), (b)(7)(C) . (b) (6), (b) prepared a very detailed report dated November
(7)(C) and provided these materials to the FHCRC panel
(b) (6), (b)(7)(C)
in the course of its related review. In addition,
(b) (6), (b)(7)(C)
FHCRC secured and sequestered all available
primary data relevant to the inquiry and, in view of the jurisdiction ofHMS over the allegations
discussed in this report, provided these data and submissions to HMS.
(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)

In compliance with institutional policy and federal regulation,3 (b) (6), (b)(7)(C) was notified of
commencement of the inquiry and provided with our names as proposed members of the review
panel.
raised no objection to our service on the inquiry panel or to our continued service on
this investigation panel. We are
(b) (6), (b)(7)(C) Professor (b) (6), (b)(7)(C) ,
(b) (6), (b)(7)(C) Professor
(b) (6), (b)(7)(C) , and
(b) (6), (b)(7)(C)
Professor
(b) (6), (b)(7)(C) Gretchen Brodnicki, J.D., Research Integrity Officer and
Dean for Faculty and Research Integrity,4 Mortimer Litt, M.D., HMS Senior Scientific
Investigator, Kristin Bittinger, HMS Director of Scientific Integrity,s and (b)(6),(b)(7)(C) of the
OPSI also served as staffto the panel. In addition, a representative ofthe Harvard University
Office of General Counsel (Ellen Berkman, J.D.) was available to advise us throughout the
proceedings and attended both inquiry and investigative panel meetings.
(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)


The inquiry and subsequent investigation were conducted in accordance with the HMS Principles and Procedures
for Dealing with Allegations of Faculty Misconduct and the Public Health Services Rule, 42 CFR Part 93, and the
(b) (6), (b)(7)(C)
Department of Defense INSTRUCTION 3210.7 (May 14,2004), which implements Dodd DIRECTIVE 3216.2.
3

(b) (6), (b)(7)(C)

Dean Brodnicki arrived at HMS in July 2008.

Ms. Bittinger arrived at HMS in April 2009.

2
HHS-PSC000010

CONFIDENTIAL

Although we initially met in April 2008 for orientation and document review, the bulk of
the inquiry was conducted through the end of2009 and early 2010.6 This panel convened two
meetings on March 20,2009 and March 30,2009 to further discuss the allegations, the
documentation,
(b) (6), (b)(7)(C) and the available primary image data. Following these
meetings, we requested that
(b) (6), (b)(7)(C)
(b)
(6),
(b)(7)(C)
On July 29, 2009, we met in the
laboratory of(b) (6), (b)(7)(C) to
7
review relevant original slides. Following our review of the available slides, we posed followup questions
(b) (6), (b)(7)(C) with an additional opportunity to respond
that he had not previously addressed. Through
counsel,
(b) (6), (b)(7)(C)
(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)


The allegations under review relate to (b) (6), (b)(7)(C) paper, which reported on the (b) (6),
(b) (6), (b)(7)(C)

(b)(7)
(b) (6), (b)(7)(C)

(C)
(b) (6), (b)(7)(C)
; (ii) (b) (6),
(b)(7)(C)

; (iii)

(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)


(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)


3
HHS-PSC000011

CONFIDENTIAL

(b) (6), (b)(7)(C) expressed by

(b) (6), (b)(7)


(b) (6), (b)(7)(C) (C)
(b) (6), (b)(7)(C) .8 They observed
(b) (6), (b)(7)(C)

In a previous paper, using the


that the
.

(b) (6), (b)(7)(C)

Based on experience derived from this paper,

(b)
(6),
(b)
(b) (6), (b)(7)(C)
(7)
(b) (6), (b)(7)(C)
(C)

(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)

The authors reported, as expected, that

Furthermore, (b) (6),

(b)(7) .
(b) (6), (b)(7)(C)
(C)

(b) (6), (b)(7)(C)


.

Upon joining (b) (6), (b)(7)(C)

group,

(b) (6), (b)(7)(C)


(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)

4
HHS-PSC000012

CONFIDENTIAL

(b) (6), (b)(7)(C) . 9 (See Inquiry Report, Exhibit 8, p. 8).

(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)


(b) (6), (b)(7)(C)

efforts to gather insight from (b) (6), (b)(7)(C) regarding potential causes for
difficulty with
(b) (6), (b)(7)(C)
the
protocol,
(b) (6), (b)(7)(C)
r. Following
(b) (6), (b)(7)(C) regarding the discrepancies and the
challenges he encountered in his attempt to follow the (b) (6), (b)(7)(C) protocol, including a trip by
concerns to the attention of
(b) (6), (b)(7)(C) , (b) (6), (b)(7)(C) brought
(b) (6), (b)(7)(C)
immediately notified institutional officials at FRCRC .
(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)


(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)


(b) (6), (b)(7)(C) ,

(b) (6), (b)(7)(C) that had been


(b) (6), (b)(7)(C) . According to
(b) (6), (b)(7)(C)

alleges that

the real data did not demonstrate

(b) (6), (b)(7)(C)

set forth (b) (6), (b)(7)(C)


one allegation with numerous subparts identifying specific
manipulations
alleged
(b) (6), (b)(7)(C) on the figures in (b) (6), (b)(7)(C) At the
conclusion of the inquiry, we found
(b) (6), (b)(7)(C)
(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C) .

The final inquiry report was provided to Paul Russell, M.D., Chair of the Standing
Committee on Faculty Conduct, for review and approval. Dr. Russell concurred with the
conclusions ofthis panel's inquiry and recommended to Jeffrey Flier, M.D., Dean ofthe Faculty
of Medicine,
(b) (6), (b)(7)(C) Dr. Flier
concurred with Dr. Russell's recommendation
(b) (6), (b)(7)(C) (Exhibit 4).

(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)


(b) (6), (b)(7)(C)
5
HHS-PSC000013

CONFIDENTIAL

In addition, because the research in question was funded, in part, by federal grants, the Office of
Research Integrity (ORl) and the Department of Defense (DoD) were notified. (Exhibits 5 and
6).

INVESTIGATION STANDARD FOR REVIEW


As members of the investigation panel, we were charged with determining (b) (7)(A)
Under 42 CFR 50.102 , the regulation in effect when the alleged misconduct
occurred, "Misconduct" or "Mis<2onduct in Science" is defined as fabrication, falsification,
plagiarism, or other practices that seriously deviate from those that are commonly accepted
within the scientific community for proposing, conducting, or reporting research. It does not
include honest error or honest differences in interpretations or judgments of data. We conducted
our investigation in accordance with this standard. The procedural requirements that this panel
followed, however, were governed by 42 CFR Part 93.

INVESTIGATION PROCESS
We first met as an investigation panel on October 5, 2010 to review our charge and
additional documentation
(b) (7)(A)

(b) (7)(A)

We met a final time (b) (6), (b)(7)(C) to interview


(b) (6), (b)(7)(C)
(b)
(6),
(b)(7)(C)
(b)
(6),
(b)(7)(C)
in
laboratory and the complainant in this matter.
interview was
(b)
(6),
(b)(7)(C)
recorded, transcribed, and provided to him for his review.
Prior to this meeting,
.
This panel's review (b) (6), (b)(7)(C) is the subject of a second formal report and is not
discussed in this report. We did, however, hold the issuance of this report as a result of the
pendency of the related inquiry to ensure that its findings would not impact our conclusions with
respect to the allegations (b) (6), (b)(7)(C) The second inquiry ended (b) (6), (b)(7)(C) The
outcome of our review
(b) (6), (b)(7)(C) ultimately did not alter the findings and
recommendations we made (b) (6), (b)(7)(C) with (b) (6), (b)(7)(C) each of which is set forth
below.

(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)

also given a final opportunity to comment on this report.


comment on the report (b) (6), (b)(7)(C)

declined to

(b) (6), (b)(7)(C)

12
The Office for Research Integrity has advised that the procedural requirements set forth in the new regulation,
42 CFR Part 93, are applicable to proceedings that commence after the new regulation went into effect. However,
the defmition of research misconduct that was in effect at the time the alleged misconduct occured continues to
apply.

6
HHS-PSC000014

CONFIDENTIAL
ALLEGATIONS AND FINDINGS
The facts and findings set forth in the inquiry report regarding each allegation are
incorporated by reference into this report. We focus here on the additional information provided
by
(b) (6), (b)(7)(C) as each relates to the pending allegations.

(b) (6), (b)(7)(C)


however,
experimental basis one must consider
explore the
(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C) , to fully understand their


(b) (6), (b)(7)(C) to
(b) (6), (b)(7)(C)

Briefly, the method is supposed to consist of the following steps:

(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)


(b) (6), (b)(7)(C)
(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)

13

7
HHS-PSC000015

CONFIDENTIAL

(b) (6), (b)(7)(C)

A review of the literature


(b) (6), (b)(7)(C) among members
of this investigation panelled to the following conclusions as
(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)

14

(b) (6), (b)(7)(C)

15

8
HHS-PSC000016

(b) (6), (b)(7)(C)

CONFIDENTIAL

(b) (6), (b)(7)(C)


(b) (6), (b)(7)(C) to answer the
(b) (6), (b)(7)(C) This contributed (i) (b) (6), (b)(7)(C)
, (ii)
(b) (6), (b)(7)(C)

In summary,
questions asked

(b) (6), (b)(7)(C)

and (iii)

It must be emphasized that the above reconstruction describes potential sources of human
error, and does not, alone, describe events that fall within the definition of research misconduct.
It is very common for scientific assays to detect a combination of genuine signal and background
noise; this paper's use of a method that included background labeling does not constitute
scientific misconduct. Scientific research is always limited to the use of techniques that are
available at the time: a technique may initially seem promising yet difficult, and remedies may be
attempted that generate artifacts.

(b) (6), (b)(7)(C)

16

9
HHS-PSC000017

CONFIDENTIAL

(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)


10
HHS-PSC000018

CONFIDENTIAL

(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)

11
HHS-PSC000019

(b) (6), (b)(7)(C)

CONFIDENTIAL

(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)


12
HHS-PSC000020

(b) (6), (b)(7)(C)


CONFIDENTIAL

(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)


(b) (6), (b)(7)(C)
13
HHS-PSC000021

CONFIDENTIAL

(b) (6), (b)(7)(C)


(b) (6), (b)(7)(C)
(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)

(A)

(b) (6), (b)(7)(C)


(b) (6), (b)(7)(C)

14
HHS-PSC000022

CONFIDENTIAL

(b) (6), (b)(7)(C)


(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)


(b) (6), (b)(7)(C)
(b) (6), (b)(7)(C)
IS
HHS-PSC000023

CONFIDENTIAL
In view of our review ofthe original sections,

(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)


Our review of the original slide that produced figure 21, however, revealed (b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)


(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)


(b) (6), (b)(7)(C)
(b) (6), (b)(7)(C) By simply comparing the

A review of

16
HHS-PSC000024

CONFIDENTIAL
two figures,

(b) (6), (b)(7)(C)


(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)

We were not able to locate the original slide that produced this figure. (b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)


(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)

17
HHS-PSC000025

CONFIDENTIAL

(b) (6), (b)(7)(C)


.

(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)


(b) (6), (b)(7)(C)
(b) (6), (b)(7)(C)

CONCLUSIONS

We have reviewed the documentary record relating to (b) (6), (b)(7)(C) against (b) (6), (b)(7)(C)
(b) (6), (b)(7)(C)
(b) (6), (b)(7)(C) the numerous submissions from (b) (6), (b)(7)(C) ,
(b) (6), (b)(7)(C)
throughout this process, the
slides that we were able to locate and review, and the
(b) (6), (b)(7)(C)
,
and (b) (6), (b)(7)(C) In reviewing these materials, we
(b) (6), (b)(7)(C) of
have been mindful of our charge as an Investigation Panel. Mindful of that charge, we have
determined that
(b) (6), (b)(7)(C)
(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)

18
HHS-PSC000026

CONFIDENTIAL

(b) (7)(A)

RECOMMENDATIONS
In accordance with the applicable institutional policies and federal regulations and for the
reasons stated above, we recommend this matter be referred to HMS officials with such finding
and a recommendation that OR! and DoD be notified.

19
HHS-PSC000027

List of Zou Exhibits

(b) (6), (b)(7)(C)

Exhibit 1:

Exhibit 2:

(b) (6), (b)(7)(C) .

Exhibit 3: Letter of Dr. Paul Russell, Chair of the Standing Committee on Faculty Conduct,
affinning the decision of the Inquiry panel.
Exhibit 4: Deciding Official Letter, signed by Jeffrey Flier, M.D., Dean ofthe Faculty of
Medicine, following inquiry.
Exhibit 5: Notification to the Office of Research Integrity (ORI) of decision of Inquiry
Panel to proceed to investigation.
Exhibit 6: Notification to the Department of Defense (DoD) of decision of Inquiry Panel
to proceed to investigation.
Exhibit 7: Transcript of testimony of

(b) (6), (b)(7)(C)

Exhibit 8: Transcript of testimony of

(b) (6), (b)(7)(C)

Exhibit 9: Transcript of testimony of


Exhibit 10:

(b) (6), (b)(7)(C)


(b) (6), (b)(7)(C)

HHS-PSC000028

HHS-PSC000029

articles

(b) (6), (b)(7)(C)

HHS-PSC000030

articles

(b) (6), (b)(7)(C)

HHS-PSC000031

articles

(b) (6), (b)(7)(C)

HHS-PSC000032

articles

(b) (6), (b)(7)(C)

HHS-PSC000033

(b) (6), (b)(7)(C)


articles

HHS-PSC000034

articles

(b) (6), (b)(7)(C)

HHS-PSC000035

articles

(b) (6), (b)(7)(C)

HHS-PSC000036

HHS-PSC000037

(b) (6), (b)(7)(C)


RETRACTION

(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)


(b) (6), (b)(7)(C)

HHS-PSC000038

HHS-PSC000039

MASSACHUSETTS GENERAL HOSPITAL ~ HARVARD MEDICAL SCHOOL


PAULS.RUSSELL,M.D.

John Homans Distinguished Professor of Surgery

.~

Harvard
Senior Surgeon
Massachusetts General Hospital, Boston, MA 02114
(617) 726-2801

mWi

May 12,2010
Jeffrey S. Flier, M.D.
Dean of the Faculty of Medicine
Harvard Medical School
25 Shattuck Street
Boston, MA 02115
.Dear Dr. Flier:
On behalf of the Harvard Medical School StandilJ.g Committee on Faculty Conduct, I am
writing to convey to you my recommendation, as chair of the Standing Committee, relating to
(b) (6), (b)(7)(C) former Harvard Medical School (HMS)(b) (6), (b)(7)(C)
. allegations

(b) (6), (b)(7)(C) (b) (6), (b)(7)(C)

As the attached inquiry report details, the allegations in this matter were first to HMS's
(b) (6), (b)(7)(C) at Fred Hutchinson Cancer
attention by
(b)
(6),
(b)(7)(C)
Research Center (FHCRC)
conveyed to (b) (6), (b)(7)(C)
. fonner Research Integrity Officer and Dean for Facility and Research Integrity at HMS that
in the _
(b) (6), (b)(7)(C) (b) (6), (b)(7)(C)
laboratory of
laboratory moved to FHCRC in 2002. After an initial assessment and in accordance with
institutional policies, a joint inqUlly panel was appointed to look into the matter. The inquiry panel
(b) (6), (b)(7)(C) Professor (b) (6), (b)(7)(C) (b) (6), (b)(7)(C)
was comprised of
(b) (6), (b)(7)(C) and
(b) (6), (b)(7)(C) Professor of
Professor
(b) (6), (b)(7)(C) The inquiry panel was charged with determining whether or not the
matter warranted a further investigative process. It was detennined that (b) (6), (b)(7)(C)
National Institute of Health and the Department of Defense
and, therefore the matter was subject to the Public Health Services Rule, 42 CFR Part 93 and the
Department of Defense INSTRUCTION 3210.7 (May 14,2004).
(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)

1
I

The inquiry panel met in person on four occasions to review (b) (6), (b)(7)(C)
submitted in support (b) (6), (b)(7)(C) several written responses submitted by the
respondent and all available onginal source documentation, including original croscope slides
sequestered and provided through FHCRC. As indicated in their report, the inquiry panel members
concluded that there was sufficient evidence to wiimuit proceeding to investiga~on (b) (6), (b)(7)(C)

';

II
HHS-PSC000040

I
f

!
i

PAUL S. RUSSELL, MD.

(b) (6), (b)(7)(C)


The report of the inquiry panel was submitted to me, as chair of the Standing Committee, on
May 5, 2010 to consider the matter. I reviewed inquiry panel's report and the accompanying
documentation.

(b) (7)(A)
Conclusion

I
\

I
!
!

II

-\.
"j
)

I
i

"/
!

,!

"I

~II

HHS-PSC000041

HHS-PSC000042

(b) (7)(A)
PAUL S. RUSSELL, M.D.

'j.

HHS-PSC000043

(b) (7)(A)
PAUL S. RUSSELL, M.D.

Recommendations

(b) (7)(A)

I agree with:the inquiry ~el that

Because NIH and DOD fimding was involved, the Office of


Research Integrity (OR!) of the Public Health Service and the Department of Defense should be .
notified of the decision.
These are the conclusions and recommendations of the chair, on behalf of the Standing
Committee on Faculty Conduct
Sincerely,

PllliL S, Rw~ .

Paul Russell, M.D.


Chair

II
!

Enclosures

I
i
i

.,i

-i
I

HHS-PSC000044

Ii

HARVARD MEDICAL SCHOOL

JEFFREY

S. FLIER, MD

DI!AN 0[' THE

FACULTY OF MEDICINE

HARvARD MEDICAL ScHOOL

25 SHAITUCK ST.
BOSTON, W,A 02II5

CONFIDENTIAL

May 25, 2010


VIA ELECTRONIC DELIVERY

(b) (6), (b)(7)(C)


(b) (6), (b)(7)(C)

I am. writing to provide you with the final conclusions of the HMS Standing Committee on
. Faculty Conduct and to inform you of the determinations reached by the Harvard Medical School
after-reviewing the reports and the documentaIy record in this case, including your submissions.

After careful conside~tio~ HMS has accepted the findings, conclusions, and
recommendations of the Chair of the Standing Committee and the Inquiry Panel. We agree that
further investigation is warranted in this matter and, as required by institutioDal policy, we will be
commencing the investigative process.
Gretchen Brodnicki, J.D., Dean for Faculty arid Research Integrity at the Medical School,
will be in contact with you concerning the investigative process. Please let her know if you have
any questions.

J2JJ?~.
Sincerely,

Dean of the Faculty of Medicine

Enclosure
cc:

Gretchen Brodnicki, J.D.


Ellen Berlon~ J.D.

-~-~-----.-----~----

HHS-PSC000045

HHS-PSC000046

i
I

.I

I!

Harvard MedicalSchool .

25 Shattuck Street
Boston. Massachusetts 021 i 5
(617) 432-3191
FAX: (617) 432-0566
Office for Research Issues

CONFIDENTIAL

May 25, 2010


John E. Dahlberg, Ph.D., Director
Division of Investigative Oversight
Office for Research Integrity
.1101 Wootton Parkway
. Suite 750
Rockville, MD 20852
Re:

DIO:

(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C) '

Dear Dr. Dahlberg:


I enclose th~ full inquiry panel report, Standing Committee report, and determination letter
in the inquiry of the allegation
(b) (6), (b)(7)(C) As you will see, we will be proceeding to
. further investigation.
Please do not hesitate to contact me at 617-432-2496 or .
Gretchen Brodnicki(a),hms.harvard.edu if you have any questions or need any-additional .
information.
Sincerely?

'r\..

.,i
.

()

~A~

L.L)_~~-~

Gretchen A. Brodnicki
Dean for Faculty and
Research Integrity

!.
~

&

Enclosures
~

.:

cc:

Kristin Bittinger, J.D. (w/o enclosures)


Ellen Berkman, J.D. ("flo enclosures)

HHS-PSC000047

HHS-PSC000048

.--------_.... - ............. .

Harvard Medical. School

25 Shattuck street
..Boston. Massachusetts 02115
(617) 432-3191
FAX: (617) 432-0566
Office for Research Issues

CONFIDENTIAL

May 25, 2010


Mr. Jay Winchester
Office of the Staff Judge Advocate .
Medical Research and Development Command
United States Army
Department of Defense ..
504 Scott Street
Fort Detrick
Frederick, Maryland 21702-5012

,I

,-,

FAX: 301-619-5034
Re:

Research Misconduct Inquiry of Allegations

(b) (6), (b)(7)(C)

Dear Mr. Winchester:


I enclo'se the fujI inquiry panel report, Standing Committee report, and detennination letter
in the research misconduct inquiry of the allegation
(b) (6), (b)(7)(C) As you will see, we
will be proceeding to further investigation.
The data subject to the pending allegations were fimded, in part, through a Department of
(b) (6), (b)(7)(C)
Army Grant
) and two NllI grants (b) (6), (b)(7)(C) The Office for Research
Integrity (ORl) is simultaneously being notified of the results of this inquiry.
Please do not hesitate to contact me at 617-432-2496 or
. Gretchen Brodnicki@hrns.harvard.edu if you have any questions or need any additional
information.
.
.
Sincerely,

1
j
I

"--0"

I~~~g,~
Gretchen A. Brodnicki

i
I

!
HHS-PSC000049

Enclosures
cc:

Kristin Bittinger, lD. (w/o enclosures)


Ellen Berkman, J.D. (w/o enclosures)

I
I
I
i

"

-I

! .

":i

.1

I
I

'1j.

HHS-PSC000050

HHS-PSC000051

HARVARD

MEDl~AL

'SOHOOL

OFFICE FOR RESEARCH fSSUES

CO N FiDENTJ AL

1
I

(b) (6), (b)(7)(C)

HHS-PSC000052

HARVARD MEDICAL SCHOOL


Transcription of the Meeting with (b) (6), (b)(7)(C)
Conducted on October 5,2010
InquiIy Panel Members Present:
Staff Members Present: Gretchen Brodnicki (GB),
Pat Gilligan (PG), and Ellen Berkman (EB).
Witness, by telephone:

(b) (6), (b)(7)(C)


(b) (6), (b)(7)(C) Kristin Bittinger (KB),

(b) (6), (b)(7)(C)

(b) (6), (b)(7)(a), (b)(7)(c)

HHS-PSC000053

(b) (6), (b)(7)(a), (b)(7)(c)

(b) (6), (b)(7)(C)

2
HHS-PSC000054

(b) (6), (b)(7)(a), (b)(7)(c)

3
HHS-PSC000055

(b) (6), (b)(7)(a), (b)(7)(c)

4
HHS-PSC000056

(b) (6), (b)(7)(a), (b)(7)(c)

5
HHS-PSC000057

(b) (6), (b)(7)(a), (b)(7)(c)

6
HHS-PSC000058

(b) (6), (b)(7)(a), (b)(7)(c)

7
HHS-PSC000059

(b) (6), (b)(7)(a), (b)(7)(c)

8
HHS-PSC000060

(b) (6), (b)(7)(a), (b)(7)(c)

HHS-PSC000061

(b) (6), (b)(7)(a), (b)(7)(c)

10
HHS-PSC000062

(b) (6), (b)(7)(a), (b)(7)(c)

11
HHS-PSC000063

(b) (6), (b)(7)(a), (b)(7)(c)

12
HHS-PSC000064

(b) (6), (b)(7)(a), (b)(7)(c)

13
HHS-PSC000065

(b) (6), (b)(7)(a), (b)(7)(c)

14
HHS-PSC000066

(b) (6), (b)(7)(a), (b)(7)(c)

15
HHS-PSC000067

(b) (6), (b)(7)(a), (b)(7)(c)

16

HHS-PSC000068

(b) (6), (b)(7)(a), (b)(7)(c)

17

HHS-PSC000069

HHS-PSC000070

HARVARD MEDICAL SCHOOL


Transcription of the Meeting with (b) (6), (b)(7)(C)
Conducted on December 17, 2010
InquirY Panel Members Present:
Staff Members Present: Gretchen Brodnicki (GB),
Pat Gilligan (PG), and Ellen Berkman (EB).
Witness, by telephone:

(b) (6), (b)(7)(C)


(b) (6), (b)(7)(C) Kristin Bittinger (KB),

(b) (6), (b)(7)(C)

(b) (6), (b)(7)(a), (b)(7)(c)

HHS-PSC000071

(b) (6), (b)(7)(a), (b)(7)(c)

2
HHS-PSC000072

(b) (6), (b)(7)(a), (b)(7)(c)

3
HHS-PSC000073

(b) (6), (b)(7)(a), (b)(7)(c)

4
HHS-PSC000074

(b) (6), (b)(7)(a), (b)(7)(c)

5
HHS-PSC000075

(b) (6), (b)(7)(a), (b)(7)(c)

6
HHS-PSC000076

(b) (6), (b)(7)(a), (b)(7)(c)

7
HHS-PSC000077

(b) (6), (b)(7)(a), (b)(7)(c)

HHS-PSC000078

(b) (6), (b)(7)(a), (b)(7)(c)

9
HHS-PSC000079

(b) (6), (b)(7)(a), (b)(7)(c)

10
HHS-PSC000080

(b) (6), (b)(7)(a), (b)(7)(c)

11
HHS-PSC000081

(b) (6), (b)(7)(a), (b)(7)(c)

12
HHS-PSC000082

HHS-PSC000083

HARVARD MEDICAL SCHOOL


Transcription of the Meeting with (b) (6), (b)(7)(C)
Conducted on March 29, 2011

(b) (6), (b)(7)(C)

Inquiry Panel Members Present:

Staff Members Present: Kristin Bittinger, (b) (6), (b)(7)(C) , Ellen Berkman, and Patrick Gilligan.
Witness. by web conference:

(b) (6), (b)(7)(C)

(b) (6), (b)(7)(a), (b)(7)(c)

1
HHS-PSC000084

(b) (6), (b)(7)(a), (b)(7)(c)

2
HHS-PSC000085

(b) (6), (b)(7)(a), (b)(7)(c)

3
HHS-PSC000086

(b) (6), (b)(7)(a), (b)(7)(c)

HHS-PSC000087

(b) (6), (b)(7)(a), (b)(7)(c)

5
HHS-PSC000088

(b) (6), (b)(7)(a), (b)(7)(c)

6
HHS-PSC000089

(b) (6), (b)(7)(a), (b)(7)(c)

7
HHS-PSC000090

(b) (6), (b)(7)(a), (b)(7)(c)

8
HHS-PSC000091

(b) (6), (b)(7)(a), (b)(7)(c)

9
HHS-PSC000092

(b) (6), (b)(7)(a), (b)(7)(c)

10
HHS-PSC000093

(b) (6), (b)(7)(a), (b)(7)(c)

11
HHS-PSC000094

(b) (6), (b)(7)(a), (b)(7)(c)

12
HHS-PSC000095

(b) (6), (b)(7)(a), (b)(7)(c)

13
HHS-PSC000096

(b) (6), (b)(7)(a), (b)(7)(c)

14
HHS-PSC000097

(b) (6), (b)(7)(a), (b)(7)(c)

15
HHS-PSC000098

(b) (6), (b)(7)(a), (b)(7)(c)

16
HHS-PSC000099

(b) (6), (b)(7)(a), (b)(7)(c)

17
HHS-PSC000100

(b) (6), (b)(7)(a), (b)(7)(c)

18
HHS-PSC000101

(b) (6), (b)(7)(a), (b)(7)(c)

19
HHS-PSC000102

(b) (6), (b)(7)(a), (b)(7)(c)

20
HHS-PSC000103

(b) (6), (b)(7)(a), (b)(7)(c)

21
HHS-PSC000104

(b) (6), (b)(7)(a), (b)(7)(c)

22
HHS-PSC000105

(b) (6), (b)(7)(a), (b)(7)(c)

23
HHS-PSC000106

(b) (6), (b)(7)(a), (b)(7)(c)

24
HHS-PSC000107

(b) (6), (b)(7)(a), (b)(7)(c)

25
HHS-PSC000108

(b) (6), (b)(7)(a), (b)(7)(c)

26
HHS-PSC000109

(b) (6), (b)(7)(a), (b)(7)(c)

27
HHS-PSC000110

HHS-PSC000111

Page 1 of 1

(b) (6), (b)(7)(C)


(b) (6), (b)(7)(C)

From:
Sent:

Tuesday, January 24, 2012 2:44 PM

To:

Bittinger, Kristin L.

Subject: RE: Confidential: Draft report from HMS panel


Dear Kristin,
Thank you for giving me the opportunity to see the draft report. I do not have any comment as I have stated my
viewes in all previous responses. I deeply apologize for the precious time spent on this by the committee
members.
Sincerely,

(b) (6), (b)(7)(C)

> From: Kristin_Bittinger@hms.harvard.edu


> To:
(b) (6), (b)(7)(C)
> CC: Gretchen_Brodnicki@hms.harvard.edu; ellen_berkman@harvard.edu; (b)(6),(b)(7)(C)

patrick_gilligan@hms.harvard.edu
> Date: Thu, 22 Dec 2011 17:22:21 -0500
> Subject: Confidential: Draft report from HMS panel

>
> (b) (6), (b)(7)(C) ,
>
> Attached please find a copy of a draft report of the Harvard Medical School Investigation Panel regarding the

allegations (b) (6), (b)(7)(C) I believe that you are familiar with many of the documents referenced within this report,
however, we. are happy to provide you with copies of all of the documents. Harvard Medical School is on break
until January 3rd, however, and the hard copy materials will not be sent until that time. In view of this, we will
extend your time for review of this draft report.

>
> We invite you to comment and/or respond to the enclosed draft prior to February 3, 2012. Your response

and/or comments will be shared with the Investigation Panel, who may revise the report based on such additional
information. Regardless, all comments will be attached to the report when it is finalized and submitted to the
Standing Committee on Faculty Conduct for final recommendation regarding this matter. The Standing
Committee's final recommendations will go to Dean Flier, as the deciding official in this matter. You will have an
opportunity to speak directly with the Standing Committee if you desire.

>
> Please let me know if you have any questions. I am happy to discuss the process directly with you.
>
> Thank you again for your continued cooperation.
>
> Regards,
> Kristin
>
> Kristin L. Bittinger, M.S., J.D.
> Director of Scientific Integrity
> Office for Professional Standards and Integrity
> Harvard Medical School

> 25 Shattuck Street


> Gordon Hall, Suite 210C
> Boston, Massachusetts 02115
> (617) 432-7769
3/13/2012

HHS-PSC000112

I f/

Case Tracking System - (b) (7)(A)

Page 1 of 10

FOIA 12-0452; Appeal 13-0118


Index of ORI Case l

j and 2011-29 - CONFIDENTIAL FOR FOIA USE ONLY

72 Case Indexes found.

TO

FROM

TYPE OF
DOCUMENTATION

ATTACHMENTS

SUMMARY OF DOCUMENTATION

10102/2007

DALHBERG

DALE

CONVERSATION
DOCUMENT

NONE

(b) (7)(A)

02/1612008

KRUEGER

PRICE

EMAIL

NONE

03/06/2008

KRUEGER

PRICE

EMAIL

PUBLICATION
RETRACTION AND
PUBLICATION
ARTICLE

12/10/2008

BRODNICKI

LlPSHULTZ

EMAIL

NONE

12/10/2008

LlPSHULTZ

BRODNICKI

EMAIL

NONE

04/28/2009

BRODNICKI

LlPSHULTZ

EMAIL

NONE

04/28/2009

LlPSHULTZ

BRODNICKI

EMAIL

NONE

08/20/2009

BRODNICKI

LlPSHULTZ

EMAIL

NONE

DATE

FILE
DESIGNATION

(b) (7)(A)

HHS-PSC000113

https:llori.hhs.gov/intranet/CaseTracking/caseindex_rpt. php

3/2312013

Case Tracking System - (b) (7)(A)

DATE

FILE
DESIGNATION

Page 2 of 10

TO

FROM

TYPE OF
DOCUMENTATION

ATTACHMENTS

(b) (7)(A)
08/27/2009

LlPSHULTZ

BRODNICKI

EMAIL

NONE

11/18/2009

BRODNICKI

HOHMANN

EMAIL

NONE

01/12/2010

BRODNICKI

LlPSHULTZ

EMAIL

NONE

01/14/2010

LlPSHULTZ CC:BITTINGER

BRODNICKI

EMAIL

NONE

01/19/2010

BRODNICKI

LlPSHULTZ

EMAIL

NONE

03/30/2010

BRODNICKI

LlPSHULTZ

EMAIL

NONE

04/13/2010

BRODNICKI

LlPSHULTZ

EMAIL

NONE

04/14/2010

LlPSHULTZ

BRODNICKI

EMAIL

NONE

LETTER

WI ATTCHMNTS &

SUMMARY OF DOCUMENTATION

(b) (7)(A)

"

05/25/2010

DAHLBERG CC:BITTINGER,
BERKMAN

BRODNICKI

INQUIRY REPORT
DETERMINATION

HHS-PSC000114

https:llori.hhs.gov/intranet/CaseTracking/caseindexJPt.php

3/2312013

Case Tracking System - (b) (7)(A)

DATE

FILE
DESIGNATION

Page 3 of 10

FROM

TO

TYPE OF
DOCUMENTATION

(b) (7)(A)

ATTACHMENTS

SUMMARY OF DOCUMENTATION

LETTER

(b) (7)(A)

10107/2010

BRODNICKI

LlPSHULTZ

EMAIL

NONE

10/21/2010

BRODNICKI

LlPSHULTZ

EMAIL

NONE

10/21/2010

LlPSHULTZ

BRODNICKI

EMAIL

NONE

10/22/2010

BRODNICKI

DAHLBERG

EMAIL

NONE

EMAIL

NONE

EMAIL

NONE

(b) (6), (b)(7)(C)


11/19/2010

DAHLBERG

11/24/2010

LlPSHULTZ

BRODNICKI

(b) (6), (b)(7)(C)


01/27/2011

ASKORI

EMAIL

NONE

01/27/2011

ASKORI/MAHLER/ROCHEZITAYMAN

EMAIL

NONE

01/2712011

ASKORIIDAH LBERG

EMAIL

NONE

HHS-PSC000115

https:llori.hhs.gov/intranet/CaseTracking/caseindex_rpt.php

3/2312013

Case Tracking System - (b) (7)(A)

DATE

01/30/2011

FILE
DESIGNATION

Page 4 of 10

FROM

TYPE OF
DOCUMENTATION

ATTACHMENTS

DAHLBERG

EMAIL

NONE

TO

(b) (7)(A)(b)

(6), (b)(7)(C)

SUMMARY OF DOCUMENTATION

(b) (7)(A)

(b) (6), (b)(7)(C)


01/30/2011

DAHLBERG

EMAIL

NONE

02/24/2011

DAHLBERG CC:SPRUNG/PRICE

EMAIL

NONE

03/21/2011

DAHLBERG

EMAIL

NONE

04/11/2011

DAHLBERG CC: EAST

SWEM(US
DOJ
ATTRNY)

EMAIL

NONE

04/11/2011

SWEM CC:DAHLBERG, ROCHEZ

DAHLBERG

EMAIL

NONE

06/08/2011

BRODNICKI

LlPSHULTZ

EMAIL

NONE

07/06/2011

LlPSHULTZ

BRODNICKI

EMAIL

NONE

07/06/2011

BRODNICKI

LlPSHULTZ

EMAIL

NONE

HHS-PSC000116

https://ori.hhs.gov/intranet/Case Tracking/caseindex_rpt. php

312312013

Case Tracking System - (b) (7)(A)

FILE
DESIGNATION

Page 5 of 10

TO

FROM

TYPE OF
DOCUMENTATION

ATTACHMENTS

SUMMARY OF DOCUMENTATION

LlPSHULTZ

BRODNICKI

EMAIL

NONE

(b) (7)(A)

10/19/2011

KABAK

BRODNICKI

EMAIL

NONE

10/19/2011

BRODNICKI

LlPSHULTZ

EMAIL

NONE

10/19/2011

BRODNICKI

KABAK

EMAIL

NONE

10/19/2011

KABAK

BRODNICKI

EMAIL

NONE

10/24/2011

TABAK, ROCKEY, BAR

DAHLBERG

EMAIL

NONE

10/25/2011

TABAK/ROCKEY/BAR

DIO/ORI

MEMO

NONE

01/24/2012

BRODNICKI

KABAK

EMAIL

NONE

02/01/2012

Brodnicki

Kabak

Email

none

02/01/2012

Kabak

Brodnicki

Email

none

DATE

10/19/2011

(b) (7)(A)

HHS-PSC000117

https:llori.hhs.gov/intranet/CaseTracking/caseindexJPt.php

3/23/2013

Case Tracking System - (b) (7)(A)

FILE
DESIGNATION

Page 6 of 10

TO

FROM

TYPE OF
DOCUMENTATION

ATTACHMENTS

Brodnicki

Kabak

Email

none

02/01/2012

Kabak

Brodnicki

Email

none

02/01/2012

SynanlFisher

Kabak

Email

none

02/27/2012

Rochez, East Cc: Dahlberg

Dahlberg

Email

None

02127/2012

Brodnicki; Bittinger Cc; Dahlberg

Dahlberg

Email

NONE

02/27/2012

Dahlberg; Bittinger

Brodnicki

Email

NONE

02/27/2012

Brodnicki Cc: Dahlberg

Dahlberg

Email

NONE

05/17/2012

Dahlberg Cc:Swem/Puyce

East

Email

none

05/17/2012

East Cc:Fleming/Morgan

Dahlberg

Email

none

DATE

02/01/2012

(b) (7)(A)

SUMMARY OF DOCUMENTATION

(b) (7)(A)

HHS-PSC000118

https:llori.hhs.gov/intranet/CaseTracking/caseindex_rpt. php

3/23/2013

Case Tracking System - (b) (7)(A)

TO

FROM

TYPE OF
DOCUMENTATION

ATTACHMENTS

Dahlberg
Cc: Flem ing/Morgan/Swem/Buyce

East

Email

none

06105/2012

Dahlberg
Cc: Bittinger/Berkman/Godin/Kell

Brodnicki

Letter

Investigation Report
and Exhibits

06/07/2012

East Cc: Dahlberg

Dahlberg

Email

Investigation Report
( NOT Attached to
FILE COPY)

06/07/2012

Dahlberg Cc: Swem

East

Email

NONE

06/07/2012

East Cc: Dahlberg

Dahlberg

Email

NONE

DATE

05/17/2012

FILE
DESIGNATION

Page 7 of 10

(b) (7)(A)

SUMMARY OF DOCUMENTATION

(b) (7)(A)

HHS-PSC000119

https:llori.hhs.govlintranetlCaseTracking/caseindex_rpt. php

3123/2013

Case Tracking System - (b) (7)(A)

TO

FROM

TYPE OF
DOCUMENTATION

ATTACHMENTS

06/08/2012

Brodnicki

Kabak

Email

NONE

06/08/2012

Kabak

Brodnicki

Email

NONE

06/08/2012

Brodnicki

Kabak

Letter

NONE

DATE

FILE
DESIGNATION

Page 8 of 10

(b) (7)(A)

SUMMARY OF DOCUMENTATION

(b) (7)(A)

(b) (6), (b)(7)(C)

07/17/2012

Dahlberg

Email

Jan.27 and Jan.


30,2011 email
exchange between
DIO Director and
Complaint

08/24/2012

Dahlberg

Email

(b) (7)(A)
HHS-PSC000120

https://ori.hhs.gov/intranet/CaseTracking/caseindexJPt.php

3123/2013

Case Tracking System - (b) (7)(A)

DATE

FILE
DESIGNATION

Page 9 of 10

TO

FROM

TYPE OF
DOCUMENTATION

(b) (7)(A)

ATTACHMENTS

SUMMARY OF DOCUMENTATION

082012.pdf

(b) (7)(A)

08/27/2012

(b) (6), (b)(7)(C)

05/25/2010

DAHLBERG CC:BITTINGER,
BERKMAN

BRODNICKI

06/05/2012

Dahlberg
Cc:Bittinger/Berkman/Godin/Kell

Brodnicki

Letter

Investigation Report
and Exhibits

04/02/2012

Taymen Cc: Rochez

Schwendinger

Email

NONE

04/10/2012

Dahlberg Cc: Mahler;Rochez; Szakaly

Taymen

Email

NONE

Dahlberg

Email

none

INQUIRY REPORT

WI ATTACHMENTS

& DETERMINATION
LTR

LETTER

HHS-PSC000121

https:llori.hhs.gov/intranet/CaseTracking/caseindexJpt. php

3/23/2013

Case Tracking System - (b) (7)(A)

DATE

FILE
DESIGNATION

Page 10 of 10

TO

FROM

TYPE OF
DOCUMENTATION

ATTACHMENTS

(b) (7)(A)
04/10/2012

Taymen; Cc:Mahler, Rochez, Szakaly,


JD

Dahlberg

Email

NONE

08/20/2012

Bradley\Kabak\Wright\Dahlberg

Garfinkel

Email

None

08/20/2012

Bradley, et al

Garfinkel

Email

None

SUMMARY OF DOCUMENTATION

(b) (7)(A)

HHS-PSC000122

https:llori.hhs.govlintranetICaseTracking/caseindex_rpt.php

312312013

(b) (7)(A)
Dahlberg, John E (HHS/OASH)
From:
Sent:
To:
Cc:
Subject:

(b) (7)(A)

Dahlberg, John E (HHS/OASH)


Monday, August 27,2012 11:42 AM

(b) (6), (b)(7)(C)

Dahlberg, John E (HHS/OASH)


RE: HMS review panel decision

(b) (6), (b)(7)(C)


With the receipt of the Harvard report, DIO has initiated its separate oversight review of the investigation. During this
review, the records are not available to others. DIO staff may wish to discuss this matter with you as either a witness or
as the complain!'lnt, but we are not at a point where this has yet been discussed. Thank you for your offer to assist.
Sincerely,
John Dahlberg, Ph.D.
Director, Division of Investigative Oversight
Office of Research Integrity

240-453-8800

From

(b) (6), (b)(7)(C)

Sent: Friday, August 24, 2012 2:30 PM


To: Dahlberg, John E (HHSjOASH)
Subject: HMS review panel decision

Dear Dr. Dahlberg,

(b) (6), (b)(7)(C)

I received a note from the HMS review panel

I would like
to request to see the final report from the HMS review panel regarding the investigation in order to comment on
it and help OR! conduct a thorough review process.
Regards,

(b) (6), (b)(7)(C)


Begin forwarded message:

From: "Brodnicki, Gretchen A. <Gretchen Brodnicki@hms.haNard.edu>


Subject: Confidential
Date: August 20, 2012 1:13:05 PM GMT-05:00
To:
II

(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)


1

HHS-PSC000123

I attach confidential correspondence to you for your review.


Thank you,
Gretchen Brodnicki, J.D.
Dean for Faculty and Research Integrity
Harvard Medical School
25 Shattuck Street, Suite 108
Boston, MA 02115
(t) (617) 432-2496
(f) (617) 432-0566
Gretchen Brodnicki@hms.harvard.edu

HHS-PSC000124

(b) (7)(A)

Dahlberg. John E (HHS/OASH)


From:
Sent:
To:
Subject:
Attachments:

(b) (6), (b)(7)(C)

Friday, August 24,20122:30 PM


Dahlberg, John E (HHS/OASH)
HMS review panel decision

(b) (6), (b)(7)(a), (b)(7)(c)

Dear Dr. Dahlberg,

(b) (6), (b)(7)(C)

I received a note from the HMS review panel

I would like
to request to see the fmal report from the HMS review panel regarding the investigation in order to comment on
it and help OR! conduct a thorough review process.
Regards,

(b) (6), (b)(7)(C)


Begin forwarded message:

From: "Brodnicki, Gretchen A." <Gretchen Brodnicki@hms.harvard.edu>


Subject: Confidential
Date: August 20, 2012 1 :13:05 PM GMT-05:00
To:
(b) (6), (b)(7)(C)
(b) (6), (b)(7)(C) ,
I attach confidential correspondence to you for your review.
Thank you,
Gretchen Brodnicki, J.D.
Dean for Faculty and Research Integrity
Harvard Medical School
25 Shattuck Street, Suite 108
Boston, MA 02115
(t) (617) 432-2496
(f) (617) 432-0566
Gretchen Brodnicki@hms.harvard.edu

1
HHS-PSC000125

(b) (7)(A)

GRETCH~N BRODNICKI.

HARVARD MEDICAL SCHOOL

DEAN FOR FAcul:n' AND

"

J.D.

RESEARCH

INTEGnm'

2) SHATTUCK STREET
BOSTON. l\1ASSACHI1SF,nS 02115

Tn: (617) 432-2496


FAX: (617) 432-7462
GRETCHEN_BRODNICKI@IIMS.IIARVARI>.EI>ll

August 20, 20 12

(b) (6), (b)(7)(C)

I am writing to let you know the resolution of the concerns you raised to Harvard Medical
School (HMS) regarding possible research misconduct
(b) (6), (b)(7)(C)

A thorough investigation ofyolll' allegations (b) (6), (b)(7)(C) was conducted by an HMS

(b) (6), (b)(7)(C)


The same HMS faculty panel also conducted a formal inquiry into yoUI' allegations against

(b) (6), (b)(7)(C)


Confidentiality requirements preclude me ti'OI11 giving you more information about ollr
findings, but I want to assure you that this was a thorough, fail' and objective process.
Thank you for bringing this matter to our attention and for your cooperation with the detailed
review.
Sincerely,

~ X" ).v_~(t~ 6ru7J.-G-~k

Gl'etcnen Brodnicki
Dean for Faculty
and Research Integrity

HHS-PSC000126

(b) (7)(A)

Garfinkel, Susan J (HHS!OASH)


From:

Sent:
To:
Cc:

Subject:

Garfinkel, Susan J (HHS/OASH)


Monday, August 20, 2012 2:24 PM
Bradley, Ann (HHS/OASH)
Kabak, Shara (HHS/OPHS/ORI); Wright, David E. (OS/OASH); Dahlberg,
John E (HHS/OASH)
Confidential:

(b) (7)(A)

FYI on case (b) (7)(A)


I got a call from Gretchen Brodnicki at Harvard regarding this case. HMS has finished the investigation

(b) (6), (b)(7)(a), (b)(7)(c)


The usual HMS process at the closure of a case is to inform the complainant of the outcome, very simply
that findings were made or not. Gretchen called because they are ready to send the complainant this
letter and wanted ORI to know that there may be a public backlash from complainant.
Susan
Susan Garfinkel, Ph.D.
Office of Research Integrity
Division of Investigative Oversight
Phone: 240-453-8421

HHS-PSC000127

(b) (7)(A)

Dahlberg. John E (HHS/OASH)


From:
Sent:
To:
Subject:

(b) (6), (b)(7)(C)

Tuesday, July 17, 20121 :31 PM


Dahlberg, John E (HHS/OASH)
(b) (6), (b)(7)(a), (b)(7)(c)
misconduct case

Dear Dr. Dahlberg,


I am in contact with the

(b) (7)(A) d am aware that the Harvard investigation has a final report
(b) (6), (b)(7)(a), (b)(7)(c)

I would also like to see the report from Harvard as soon as possible and offer comments
that may be useful for OR! in the oversight review and final report. I hope that all the issues ofthis case in
particular
(b) (7)(A) are discussed with all relevant parties,
including the (b) (7)(A)
Regards,

(b) (6), (b)(7)(C)


On Jan 30,2011, at 11 :59 AM, Dahlberg, John E (HHS/OASH) wrote:

(b) (6), (b)(7)(C)


I will attempt to answer your questions for all of the recipients of this email, as quite likely I would have been
asked to do so in any event. I am sympathetic to your concerns as the complaint in these two cases that the
process has been protracted, and has not reached closure. However, 42 C.F.F .. Part 93 is pretty clear that once
allegations are made and considered to meet the definition of research misconduct, the inquiry and investigation
process should be overseen by neutral unbiased institutional officials and scientists comprising the committees.
The complainant mayor may not be a useful fact witness, depending on circumstances, but has no special
status beyond being a possible fact witness. If you fell you have identified additional evidence of possible value
to an ongoing process, the institution is expected to consider it, and if not, OR! would do so during its oversight
review that begins after receipt of the final investigation report.
You correctly note that the regulation does not require that the complainant be provided all of portions of either
the inquiry or investiqation report for review. It is not a complainant's responsibility to judge the merits of the
evidence for or against findings of misconduct. Such decisions are quite complex and based on far more that
simply demonstrating that a figure or statement is wrong or falsified.
(b) (6), (b)(7)(C)

Sincerely,
1

HHS-PSC000128

John Dahlberg, Ph.D


Director, Divison oflnvestigative Oversight
Office of Research Integrity

(b) (6), (b)(7)(C)


Sent: Thursday, January 27, 2011 4:32 PM
To: OS OPHS askORI (HHS/OPHS)
Subject: to Dr. John Dahlberg
This email is directed to the following individual:
John Dahlberg, Ph.D., Director of Division oflnvestigative Oversight,
I am writing to ask your opinion regarding PHS Policies on Research Misconduct, 42 CFR Part 93. It states that
a requirement of an institution that accepts PHS funds for research includes: "A thorough, competent, objective,
and fair response to allegations of research misconduct consistent with, and within the time limits of the final
rule, including precautions to ensure that individuals responsible for carrying out any part of the research
misconduct proceeding do not have unresolved personal, professional, or financial conflicts of interest with the
complainant, respondent, or witnesses."
I have two questions regarding this policy and would like to hear your opinion.

(b) (6), (b)(7)(C)


The underlying presumption is that an institution is inherently biased against making determinations of research
misconduct against its members (or former members) and thus may not want to review all the evidence that
implicates that member. The institution therefore may do what it can to avoid consideration of additional
evidence that it becomes aware of, and also attempt to prevent the complainant from seeing the draft report.
Regards,

(b) (6), (b)(7)(C)


2

HHS-PSC000129

CASE SUMMARY (no names):

(b) (7)(A)

HHS-PSC000130

(b) (7)(A)

HHS-PSC000131

(. "4

DEPARTMENT OF IlliALTII &- HUMAN SERVICES

"+~",.::::l.

Office of the Assistant Secretary for Health


Office of Research Integrity
1101 Wootton Parkway, Suite 750
Rockville, MD 20852
Phone: 240-453-8800
FAX: 301-594-0043
Email: shara.kabak@hhs.gov

CONFIDENTIAL
June 8, 2012
Gretchen Brodnicki, ill
Dean for Faculty Research and Research Integrity
Harvard Medical School
25 Shattuck Street
Boston, MA 02115
RE:

(b) (7)(A)

Dear Ms_ Brodnicki:


The Division of Investigative Oversight (DIO), Office of Research Integrity (ORl), has
received the report of the investigation with attachments, by Harvard Medical School

(b) (6), (b)(7)(a), (b)(7)(c)

HHS-PSC000132

Kabak, Shara (HHS/OPHS/ORI)


From:
. Sent:
To:
Subjec,:

Brodnicki, Gretchen A. [Gretchen_Brodnicki@hms.harvard.edu]


Friday, June 08, 2012 1:07 PM
Kabak, Shara (HHS/OPHS/ORI)
RE: (b) (7)(A)CONFIDENTIAL

Shara,

My apologies - my letter indicated our internal account numbers, not the official NIH-assigned grant numbers. The two
NIH grants are as follows:

(b) (6), (b)(7)(C)


Please do not hesitate to contact me with any further questions.
Thanks,
Gretchen

From: Kabak, Shara (HHS/OPHS/ORI) [mailto:Shara.Kabak@hhs.gov]

Sent: Friday, June 08, 2012 11:22 AM

To: Brodnicki, Gretchen A.


Subject (b) (7)(A) CONFIDENTIAL
Gretchen,

(b) (6), (b)(7)(C)


Thank you.
Regards,
Shara
Shara Kabak, PhD
Office of Research Integrity
Division of Investigative Oversight
Phone: 240-453-8800

HHS-PSC000133

Dahlberg, John E (HHS/OASH)


From:
Sent:
To:
Cc:
Subject:

Dahlberg, John E (HHS/OASH)


Thursday, June 07, 2012 12:24 PM
East, David (USAWAW)
Dahlberg, John E (HHS/OASH)
RE: Scanned document from Fisher, Raymond (HHS/OPHS) (raymond.fisher.os)

David,
with regard to ORI's system of records notice, the report can only be release following the
completion of ORI's oversight review and case closure. At that point, if the FOIA office (or
ORI) receives a request, a suitably redacted copy can be sent. For example, if we concur
that only one finding was made, all references to the other allegations, analyses, and
findings would be redacted. This is not to day that other legal issues might trump our
privacy issues, but aside from your interest, that is how we would handle a direct request.
And Harvard could choose to share part or all of the report with the complainant (but is
unlikely to do so).
John

-----Original Message----From: East, David (USAWAW) [mailto:David.East@usdoj.gov]


sent: Thursday, June 87, 2812 12:89 PM
To: Dahlberg, John E (HHS/OASH)
Cc: Swem, Judy (USAWAW)
Subject: Re: Scanned document from Fisher, Raymond (HHS/OPHS) (raymond.fisher.os)

(b) (6), (b)(7)(C)


Original Message ----From: Dahlberg, John E (HHS/OASH) [mailto:John.Dahlberg@hhs.gov]
Sent: Thursday, June 87, 2812 11:59 AM
To: East, David (USAWAW)
Cc: Dahlberg, John E (HHS/OASH) <John.Dahlberg@hhs.gov>
Subject: FW: Scanned document from Fisher, Raymond (HHS/OPHS) (raymond.fisher.os)
Hello David,

(b) (6), (b)(7)(C)


Regards, John
John Dahlberg, Ph.D.
Director, Division of Investigative Oversight Office of Research Integrity 248-453-8888
248-453-8427 (direct)
1

HHS-PSC000134

Dahlberg. John E (HHS/OASH)


From:
Sent:
To:
Cc:

Subject:

East, David (USAWAW) [David.East@usdoj.gov]


Thursday, May 17, 2012 5:43 PM
Dahlberg, John E (HHS/OASH)
Fleming, Sheila P (HHS/OASH); Morgan, Tracy S (HHS/OASH); Swem, Judy (USAWAW);
Buyce, Pat (USAWAW)
RE: Harvard Investigation

Many thanks for the quick response.


From: Dahlberg, John E (HHSjOASH) [mailto:John.Dahlberg@hhs.gov]

Sent: Thursday, May 17, 20122:34 PM

To: East, David (USAWAW)


Cc: Fleming, Sheila P (HHSjOASH); Morgan, Tracy S (HHSjOASH)
Subject: RE: Harvard Investigation
Hello David,
I pinged Harvard after receiving your email, as the report was due May 1. I just heard that it should be sent early next
week. I will be on leave next week, but I will ask DIO staff to immediately forward a copy of the report and its
attachments as soon as it arrives.
This may be a time to be optimistic.
Regards, John
John Dahlberg, Ph.D.
Director, Division of Investigative Oversight
Office of Research Integrity
240-453-8800

From: East, David (USAWAW) [mailto:David.East@usdoj.gov]


20~2 2:33 PM
To: Dahlberg, John E (HHSjOASH)
Cc: Swem, Judy (USAWAW); Buyce, Pat (USAWAW)
Subject: Harvard Investigation

Sent: Thursday, May 17,

Hi Dr. Dahlberg,
Sorry to bother you again, but I wanted to see if you have any updates on the status of the Harvard investigation report.
Thanks.
David

David R. East
Assistant United States Attorney
United States Attorney's Office
Western District of Washington

700 Stewart Street I Suite 5220 I Seattle, Washington 98101-1271


206-553-1018 1,I;l, 206-553-4073 I [8J david.east@usdoj.gov

HHS-PSC000135

Confidentiality Notice: E-mails from the United States Attorney's Office normally contain confidential and privileged material, and are for the sole
use of the intended recipient. Use or distribution by an unintended recipient is prohibited, and may be a violation of law. If you believe that you
received this e-mail in error, please do not read this e-mail or any attached items. Please delete the e-mail and all attachments, including any
copies thereof, and inform the sender that you have deleted the e-mail, all attachments and any copies thereof. Thank you.

HHS-PSC000136

Fisher, Raymond (HHS/OPHS)


From:
Sent:
To:
Subject:

Kabak, Shara (HHS/OPHS/ORI)


Wednesday, February 01,20123:19 PM
Synan, Kyle C (HHS/OASH); Fisher, Raymond (HHS/OPHS)
FW: (b) (7)(A)

(b) (7)(A)
From: Brodnicki, Gretchen A. [mailto:Gretchen Brodnicki@hms.harvard.edul

Sent: Wednesday, February 01, 2012 10:29 AM

To: Kabak, Shara (HHS/OPHS/ORI)


Subject: RE: (b) (7)(A)
Thanks so much.

From: Kabak, Shara (HHS/OPHS/ORI) [mailto:Shara.Kabak@hhs.govl

Sent: Wednesday, February 01, 2012 10:28 AM

To: Brodnicki, Gretchen A.


Subject: RE: (b) (7)(A)
Gretchen,

Your request for an extension is reasonable and we will expect the report on May 1, 2012.
Shara

From: Brodnicki, Gretchen A. [mailto:Gretchen Brodnicki@hms.harvard.edul

Sent: Wednesday, February 01, 2012 10: 18 AM

To: Kabak, Shara (HHS/OPHS/ORI)


Subject: RE: (b) (7)(A)
Shara,

My apologies - I mis-calendared the due date for our update, and thought it wasn't due until February 20

th

(b) (7)(A)
Please do not hesitate to contact me with any questions.
Thanks,
Gretchen

From: Kabak, Shara (HHS/OPHS/ORI) [mailto:Shara.Kabak@hhs.govl

Sent: Wednesday, February 01, 20129:11 AM

To: Brodnicki, Gretchen A.

Subject:

(b) (7)(A)
1

HHS-PSC000137

Hi Gretchen,

(b) (7)(A)
Regards,
Shara

Shara Kabak, PhD


Office of Research Integrity
Division of Investigative Oversight
Phone: 240-453-8428

2
HHS-PSC000138

(b) (7)(A)

Kabak, Shara (HHS/OPHS/ORI)


From:
Sent:
To:
Subject:

Kabak, Shara (HHS/OPHS/ORI)


Tuesday, January 24, 2012 9:52 AM
'Brodnicki, Gretchen A.'
RE:
(b) (7)(A)

Gretchen,
The investigation report for
regarding the case?

(b) (7)(A) Can you please provide a status update

Thank you.
Regards,
Shara

From: Brodnicki, Gretchen A. [mailto:Gretchen Brodnicki@hms.harvard.edul


Sent: Wednesday, October 19, 2011 2:55 PM
To: Kabak, Shara (HHSjOPHSjORI)
Subject: RE:
(b) (7)(A)
Shara,
Thank you for the extension, and for your advice with respect to the need for two reports. We will handle accordingly.
Thanks,
Gretchen

From: Kabak, Shara (HHSjOPHSjORI) [mailto:Shara.Kabak@hhs.govl


Sent: Wednesday, October 19, 2011 2:32 PM
To: Brodnicki, Gretchen A.
Subject: RE:
(b) (7)(A)
Gretchen,
Thank you for the update. I appreciate the extra work you had to do after interviewing the complainant, and grant you a
90 day extension. We will expect the investigation report around January 16, 2012.

(b) (7)(A)
Please feel free to contact me with any questions.
Regards,
Shara

From: Brodnicki, Gretchen A. [mailto:Gretchen Brodnicki@hms.harvard.edul


Sent: Wednesday, October 19, 2011 1:01 PM
To: Kabak, Shara (HHSjOPHSjORI)
Subject: RE:
(b) (7)(A)
1

HHS-PSC000139

Kabak, Shara (HHS/OPHS/ORI)


From:
Sent:
To:
Subject:

Brodnicki, Gretchen A. [Gretchen_Brodnicki@hms.harvard.edu]


Wednesday, October 19, 2011 2:55 PM
Kabak, Shara (HHS/OPHS/ORI)
RE:
(b) (7)(A)

Shara,
Thank you for the extension, and for your advice with respect to the need for two reports. We will handle accordingly.
Thanks,
Gretchen

From: Kabak, Shara (HHS/OPHS/ORI) [mailto:Shara.Kabak@hhs.gov]


Sent: Wednesday, October 19, 2011 2:32 PM
To: Brodnicki, Gretchen A.
Subject: RE: (b) (7)(A)
Gretchen,
Thank you for the update. I appreciate the extra work you had to do after interviewing the complainant, and grant you a
90 day extension. We will expect the investigation report around January 16, 2012.

(b) (7)(A)
Please feel free to contact me with any questions.
Regards,
Shara

From: Brodnicki, Gretchen A. [mailto:Gretchen Brodnicki@hms.harvard.edu]


Sent: Wednesday, October 19, 2011 1:01 PM
To: Kabak, Shara (HHS/OPHS/ORI)
Subject: RE: (b) (7)(A)
Dear Shara,

(b) (7)(A)
1

HHS-PSC000140

Thanks,
Gretchen

From: Kabak, Shara (HHS/OPHS/ORI) [mailto:Shara.Kabak@hhs.gov]


Sent: Wednesday, October 19, 2011 12:38 PM
To: Brodnicki, Gretchen A.
Subject:
(b) (7)(A)

Hi Gretchen,

(b) (7)(A)
Thank you,
Shara
Shara Kabak, PhD
Office of Research Integrity
Division of Investigative Oversight
Phone: 240-453-8428

HHS-PSC000141

(b) (7)(A)
Lipshultz, Gary (HHS/OASH)
From:
Sent:
To:
Subject:

Lipshultz, Gary (HHS/OASH)


Wednesday, October 19, 2011 1:39 PM
'8rodnicki, Gretchen A.'
RE: Request for status of 010 Cases

Gretchen,
Thank you for your prompt reply. The extensions you requested have been granted.(b) (7)(A) is listed as an unknown
were allegations of
respondent which stemmed from a telephone call with Dr. Dahlberg and Ms. Bittinge
plagiarism; falsification and fabrication in a presentation. The phone call took place on August 2, 2011.
Gary
From: Brodnicki, Gretchen A. [mailto:Gretchen Brodnicki@hms.harvard.edul
Sent: Wednesday, October 19, 20111:15 PM
To: Lipshultz, Gary (HHS/OASH)
Cc: Dahlberg, John E (HHS/OASH)
Subject: RE: Request for status of 010 Cases

Gary and John,


I sincerely apologize. In reviewing the case files, I thought I had responded to John about case number NR Instead,
however, I mistakenly updated Dr. Ambalavanar on case (b) (7)(A) with data about the status of NR I apologize and will
be correcting that immediately. In the meantime, here is information our status on these matters, and our requests for
extensions where necessary:

Non-responsive

(b) (7)(A)
1

HHS-PSC000142

Thanks,
Gretchen

Non-responsive
Thanks,
Gretchen

From: Lipshultz, Gary (HHSjOASH) [mailto:Gary.LiDshultz@hhs.gov]


Sent: Wednesday, October 19, 201111:39 AM
To: Brodnicki, Gretchen A.
Subject: Request for status of DIO Cases
Gretchen,
Can you please give us the status of the following cases:

Non-responsive
Thank you for your prompt response to our request.

/s/
Gary Lipshultz
Program Analyst
Division of Investigative Oversight
Office of Research Integrity
240-453-8800

2
HHS-PSC000143

(b) (7)(A)
Dahlberg. John E (HHS/OASH)
From:
Sent:
To:
Subject:

(b) (6), (b)(7)(C)


Monday, March 21,20113:16 PM
Dahlberg, John E (HHS/OASH)
request

Dear Mr. Dahlberg,

(b) (6), (b)(7)(C)


Thanks,

(b) (6), (b)(7)(C)

HHS-PSC000144

(b) (7)(A)

Dahlberg. John E (HHS/OASH)


From:
Sent:

To:
Cc:

Subject:

(b) (6), (b)(7)(C)


Thursday, February 24, 2011 3:52 PM
Dahlberg, John E (HHS/OASH)
Jeff Sprung; Alan - Price

(b) (6), (b)(7)(C)

Dear Dr. Dahlberg,


I would like to know whether Fred Hutchinson Cancer Research Center submitted to ORI (or another
government agency) the results of their preliminary assessment of
(b) (6), (b)(7)(C)

Regards,

(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)


On 30 Jan 2011, at 08:59, Dahlberg, John E (HHS/OASH) wrote:

(b) (6), (b)(7)(C)


I will attempt to answer your questions for all of the recipients of this email, as quite likely I would have been
asked to do so in any event. I am sympathetic to your concerns as the complaint in these two cases that the
process has been protracted, and has not reached closure. However,42 C.F.F .. Part 93 is pretty clear that once
allegations are made and considered to meet the definition of research misconduct, the inquiry and investigation
process should be overseen by neutral unbiased institutional officials and scientists comprising the committees.
The complainant mayor may not be a useful fact witness, depending on circumstances, but has no special status
beyond being a possible fact witness. If you fell you have identified additional evidence of possible value to an
ongoing process, the institution is expected to consider it, and if not, ORI would do so during its oversight
review that begins after receipt of the final investigation report.
You correctly note that the regulation does not require that the complainant be provided all of portions of either
the inquiry or investiqation report for review. It is not a complainant's responsibility to judge the merits of the
evidence for or against findings of misconduct. Such decisions are quite complex and based on far more that
1

HHS-PSC000145

simply demonstrating that a figure or statement is wrong or falsified. I

(b) (6), (b)(7)(C)

Sincerely,
John Dahlberg, Ph.D
Director, Divison of Investigative Oversight
Office of Research Integrity

(b) (6), (b)(7)(C)


Sent: Thursday, January 27,2011 4:32 PM
To: OS OPHS askORI (HHS/OPHS)
Subject: to Dr. John Dahlberg
This email is directed to the following individual:
John Dahlberg, Ph.D., Director of Division oflnvestigative Oversight,
I am writing to ask your opinion regarding PHS Policies on Research Misconduct, 42 CFR Part 93. It states that
a requirement of an institution that accepts PHS funds for research includes: "A thorough, competent, objective,
and fair response to allegations of research misconduct consistent with, and within the time limits of the final
rule, including precautions to ensure that individuals responsible for carrying out any part of the research
misconduct proceeding do not have unresolved personal, professional, or financial conflicts of interest with the
complainant, respondent, or witnesses."

(b) (6), (b)(7)(C)

Regards,
2

HHS-PSC000146

(b) (6), (b)(7)(C)


CASE SUMMARY (no names):

(b) (7)(A)

HHS-PSC000147

(b) (7)(A)
(b) (6), (b)(7)(C)

4
HHS-PSC000148

(b) (7)(A)

Dahlberg. John E (HHS/OASH)


From:
Sent:
To:
Subject:

(b) (6), (b)(7)(C)


Sunday, January 30,2011 12:57 PM
Dahlberg, John E (HHS/OASH)
Re: to Dr. John Dahlberg

Hi John,

(b) (6), (b)(7)(a), (b)(7)(c)

Regards,

(b) (6), (b)(7)(C)

On 30 Jan 2011, at 08:59, Dahlberg, John E (RRS/OASH) wrote:

(b) (6), (b)(7)(C)

HHS-PSC000149

I will attempt to answer your questions for all of the recipients of this email, ~3 quite likely I would have been
asked to do so in any event. I am sympathetic to your concerns as the complaint in these two cases that the
process has been protracted, and has not reached closure. However, 42 C.F.F .. Part 93 is pretty clear that once
allegations are made and considered to meet the definition of research misconduct, the inquiry and investigation
process should be overseen by neutral unbiased institutional officials and scientists comprising the committees.
The complainant mayor may not be a useful fact witness, depending on circumstances, but has no special status
beyond being a possible fact witness. If you fell you have identified additional evidence of possible value to an
ongoing process, the institution is expected to consider it, and if not, ORI would do so during its oversight
review that begins after receipt ofthe final investigation report.
You correctly note that the regulation does not require that the complainant be provided all of portions of either
the inquiry or investiqation report for review. It is not a complainant's responsibility to judge the merits of the
evidence for or against findings of misconduct. Such decisions are quite complex and based on far more that
simply demonstrating that a figure or statement is wrong or falsified.
(b) (6), (b)(7)(C)

Sincerely,
John Dahlberg, Ph.D
Director, Divison of Investigative Oversight
Office of Research Integrity

(b) (6), (b)(7)(C)


From
Sent: Thursday, January 27, 20114:32 PM
To: OS OPHS askORI (HHS/OPHS)
Subject: to Dr. John Dahlberg
This email is directed to the following individual:
John Dahlberg, Ph.D., Director of Division of Investigative Oversight,
I am writing to ask your opinion regarding PHS Policies on Research Misconduct, 42 CFR Part 93. It states that
a requirement of an institution that accepts PHS funds for research includes: "A thorough, competent, objective,
and fair response to allegations of research misconduct consistent with, and within the time limits of the final
rule, including precautions to ensure that individuals responsible for carrying out any part of the research
misconduct proceeding do not have unresolved personal, professional, or financial conflicts of interest with the
complainant, respondent, or witnesses."
I have two questions regarding this policy and would like to hear your opinion.

(b) (6), (b)(7)(C)


2

HHS-PSC000150

(b) (6), (b)(7)(C)


Regards,

(b) (6), (b)(7)(C)


CASE SUMMARY (no names):

(b) (7)(A)
3

HHS-PSC000151

(b) (7)(A)
(b) (6), (b)(7)(C)

HHS-PSC000152

Dahlberg, John E (HHS/OASH)


From:
Sent:

Dahlberg, John E (HHS/OASH)


Sunday, January 30, 2011 12:00 PM

(b) (6), (b)(7)(C)

To:

Cc:

Subject:

Dahlberg, John E (HHS/OASH)


RE: to Dr. John Dahlberg

(b) (6), (b)(7)(C)


I will attempt to answer your questions for all of the recipients of this email, as
quite likely I would have been asked to do so in any event. I am sympathetic to your
concerns as the complaint in these two cases that the process has been protracted, and
has not reached closure. However, 42 C.F.F:. Part 93 is pretty clear that once
allegations are made and considered to meet the definition of research misconduct, the
inquiry and investigation process should be overseen by neutral unbiased institutional
officials and scientists comprising the committees. The complainant mayor may not be
a useful fact witness, depending on circumstances, but has no special status beyond
being a possible fact witness. If you fell you have identified additional evidence of
possible value to an ongoing process, the institution is expected to consider it, and
if not, ORI would do so during its oversight review that begins after receipt of the
final investigation report.
You correctly note that the regulation does not require that the complainant be
provided all of portions of either the inquiry or investiqation report for review. It
is not a complainant's responsibility to judge the merits of the evidence for or
against findings of misconduct. Such decisions are quite complex and based on far more
that simply demonstrating that a figure or statement is wrong or falsified. (b) (6), (b)(7)(C)

Sincerely,
John Dahlberg, Ph.D
Director, Divison of Investigative Oversight Office of Research Integrity
From:
(b) (6), (b)(7)(C)
Sent: Thursday, January 27, 2011 4:32 PM
To: OS OPHS askORI (HHS/OPHS)
Subject: to Dr. John Dahlberg
This email is directed to the following individual:
John Dahlberg, Ph.D., Director of Division of Investigative Oversight,
I am writing to ask your opinion regarding PHS Policies on Research Misconduct, 42 CFR
Part 93. It states that a requirement of an institution that accepts PHS funds for
research includes: "A thorough, competent, objective, and fair response to allegations
of research misconduct consistent with, and within the time limits of the final rule,
including precautions to ensure that individuals responsible for carrying out any part
of the research misconduct proceeding do not have unresolved personal, professional, or
financial conflicts of interest with the complainant, respondent, or witnesses."
I have two questions regarding this policy and would like to hear your opinion.
1

HHS-PSC000153

(b) (6), (b)(7)(C)

Regards,

(b) (6), (b)(7)(C)


CASE SUMMARY (no names):

(b) (7)(A)
2

HHS-PSC000154

(b) (7)(A)

HHS-PSC000155

(b) (7)(A)

Dahlberg. John E (HHS/OASH)


From:
Sent:
To:
Subject:

(b) (6), (b)(7)(C)

Friday, November 19, 2010 5:24 PM


Dahlberg, John E (HHS/OASH)
(b) (6), (b)(7)(C)

Hi John,

(b) (6), (b)(7)(C)


Regards,

(b) (6), (b)(7)(C)

HHS-PSC000156

Fleming, Sheila P (HHS/OASH)


From:
Sent:
To:
Cc:
Subject:

Dahlberg, John E (HHS/OASH)


Friday, October 22,20102:28 PM
'Gretchen_Brodnicki@hms.harvard.edu'
Dahlberg, John E (HHS/OASH); Fleming, Sheila P (HHS/OASH); Garfinkel, Susan J
(HHS/OASH)
RE: (b) (7)(A)

Hello Gretchen,
We appreciate your update on this investigation,
(b) (6), (b)(7)(a), (b)(7)(c)
Your update suggests that the process may be
complete within a few months.
(b) (6), (b)(7)(a), (b)(7)(c)
010 is willing to grant
the additional 90 days to complete the investigation and provide a report, and therefore
will expect that report on or about January 24, 2011.
Regards, John
John Dahlberg, Ph.D.
Director, Division of Investigative Oversight Office of Research Integrity 240-453-8800

From: Brodnicki, Gretchen A. [Gretchen Brodnicki@hms.harvard.edu]


Sent: Thursday, October 21, 2010 3:34 PM
To: Lipshultz, Gary (HHS/OASH)
Subject: RE: (b) (7)(A)
Gary,
I apologize for the delay in responding. As we notified ORIon May 25, 2010,HMS has
moved forward with the investigation of this matter.

(b) (6), (b)(7)(a), (b)(7)(c)


We respectfully request an additional 90 days to complete the interview of the respondent,
obtain any other information the panel deems necessary, and complete the investigative
report in this matter.
Thanks,
Gretchen
From: Lipshultz, Gary (HHS/OPHS) [mailto:Gary.Lipshultz@hhs.gov]
Sent: Thursday, October 07, 2010 11:04 AM
To: Brodnicki, Gretchen A.
Subject: (b) (7)(A)
Gretchen,

(b) (6), (b)(7)(C) .


1

HHS-PSC000157

Page 1 of 1

Lipshultz, Gary (HHS/OPHS)


From:

Brodnicki, Gretchen A. [Gretchen_Brodnicki@hms.harvard.edu]

Sent:

Wednesday, April 14, 2010 9:21 PM

To:

Lip~tiultz, Gary (HHS/OPHS)

Subject: RE: (b) (7)(A)


Gary,
My apologies for the delay in responding. The inquiry panel finalized its report, and it was sent to

(b) (6), (b)(7)(a), (b)(7)(c)

(b) (6), (b)(7)(a), (b)(7)(c)


Thanks,
Gretchen

From: Lipshultz, Gary (HHSjOPHS) [mailto:Gary.Lipshultz@hhs.gov]

Sent: Tuesday, April 13, 2010 1:22 PM

To: Brodnicki, Gretchen A.

Subject: (b) (7)(A)


Gretchen,

I'm following up for Dr. Hohmann regarding the above captioned case. Our last correspondence reflects an
extension until March 1, 2010. Can you please update our office as to the status of this case.
Thank you.

Gary l. Lipshultz
Program Analyst
Office of Research Integrity
Division of Investigative Oversight
1101 Wootton Parkway
Suite 750
Rockville, Maryland 20852
240-453-8800

HHS-PSC000158

Lt./1

~/?O1

Page 1 of3
Morgan, Tracy S (HHS/OPHS)
From:

Lipshultz, Gary (HHS/OPHS)

Sent:

Friday, January 15, 201010:07 AM

To:

Fleming, Sheila P (HHS/OPHS); Morgan, Tracy S (HHS/OPHS)

Subject: FW: Request for status of cases


Sheila or Tracy,
Can you please pass this along to the file room and give a copy to Nancy. Thanks and have a great weekend.
Gary

From: Brodnicki, Gretchen A. [mailto:Gretchen_Brodnicki@hms.harvard.edu]


Sent: Thu 1/14/20104:04 PM
To: Lipshultz, Gary (HHS/OPHS)
Cc: Bittinger, Kristin L.
Subject: RE: Request for status of cases
Hi Gary,
Happy New Year! I hope you had a wonderful and restful holiday.

Non-responsive

1 /1 "1')(\ 1 {\

Page 2 of3

Non-responsive

(b) (6), (b)(7)(a), (b)(7)(c)

HHS-PSC000160

1115/2010

Page 3 of3

Non-responsive
I hope all is well.
Thanks,
Gretchen

From: Lipshultz, Gary (HHSjOPHS) [mailto:Gary.Lipshultz@hhs.gov]


Sent: Tuesday, January 12, 2010 9:44 AM
To: Brodnicki, Gretchen A.
Subject: Request for status of cases
Gretchen,
Happy New Year. Can you please give us the status of the following cases:

Non-responsive
(b) (6), (b)(7)(a), (b)(7)(c)
Non-responsive
Thank you.
Gary L. Lipshultz
Program Analyst
Office of Research Integrity
Division of Investigative Oversight
1101 Wootton Parkway
Suite 750
Rockville, Maryland 20852
240-453-8800

HHS-PSC000161

111512010

Hohmann, Ann (HHS/OPHS)

From:
Sent:
To:
Subject:

Hohmann, Ann (HHS/OPHS)


Wednesday, November 18, 200910:30 AM
'gretchen_brodnicki@hms.harvard.edu'

(b) (7)(A)

Good Morni ng!


I have been assigned as lead investigator for the above named accession.

(b) (7)(A)
We look forward to hearing from you.
Thanks.

Ann

HHS-PSC000162

Page 1 of2

Lipshultz, Gary (HHS/OPHS)


From:

Brodnicki, Gretchen A [Gretchen_Brodnicki@hms.harvard.edu]

Sent:

Thursday, August 27,200910:21 AM

To:

Lipshultz, Gary (HHS/OPHS)

Subject:

(b) (7)(A)

Gary,
I hope all is well with you and I apologize for the delay in my report on these two matters:

Non-responsive
(b) (6), (b)(7)(a), (b)(7)(c)
If you need any additional information, please do not hesitate to contact me. I will calendar an update for you 90
days from now in the event, which I hope to be unlikely, that these cases have not completed the inquiry portion
of the investigation.
Thanks,
Gretchen

From: Upshultz, Gary (HHSjOPHS) [mailto:Gary.Lipshultz@hhs.gov]

Sent: Thursday, August 27,20099:27 AM

To: Brodnicki, Gretchen A

Subject:

(b) (7)(A)

Gretchen,

(b) (7)(A)
Gary L. Lipshultz
Program Analyst
Office of Research Integrity
Division of Investigative Oversight
1101 Wootton Parkway
HHS-PSC000163

812712009

Page 2 of2
Suite 750
Rockville, Maryland 20852
240-453-8800

HHS-PSC000164

'80,12712009

Page 1 of 1

Lipshultz, Gary (HHS/OPHS)


From:

Lipshultz, Gary (HHS/OPHS)

Sent:

Thursday, August 20, 2009 10:28 AM

To:

'Brodnicki, Gretchen A'

Subject:

(b) (7)(A)

Gretchen,
Can you please update us as to the current status of the captioned cases.

(b) (7)(A)

Gary L. Lipshultz
Program Analyst
OffiCe of Research Integrity
Division of Investigative Oversight
1101 Wootton Parkway
Suite 750
Rockville, Maryland 20852
240-453-8800

HHS-PSC000165

R12012009

Page 1 of 1

Lipshultz, Gary (HHS/OPHS)


From:

Brodnicki, Gretchen A [Gretchen_Brodnicki@hms.harvard.edu]

Sent:

Tuesday, April 28, 200910:49 AM

To:

Lipshultz, Gary (HHS/OPHS)

Subject:

(b) (7)(A)

Hi Gary,

(b) (6), (b)(7)(a), (b)(7)(c)


Gretchen

From: Lipshultz, Gary (HHS/OPHS) [mailto:Gary.Lipshultz@hhs.gov]

Sent: Tuesday, April 28, 200910:10 AM

To: Brodnicki, Gretchen A

Subject:

(b) (7)(A)

Gretchen,

(b) (6), (b)(7)(a), (b)(7)(c)


Gary L.. Lipshultz
Program Analyst
Office of Research Integrity
Division of Investigative Oversight
1101 Wootton Parkway
Suite 750
Rockville, Maryland 20852
240-453-8800

HHS-PSC000166

4/28/2009

Page 1 of 1

Lipshultz, Gary (HHS/OPHS)


From:

Lipshultz, Gary (HHS/OPHS)

Sent:

Tuesday, April 28, 200910:10 AM

To:

'gretchen_Brodnicki@hms.harvard.edu'

Subject: (b) (7)(A)

Gretchen,

(b) (6), (b)(7)(a), (b)(7)(c)


Gary L. Lipshultz
Program Analyst
Office of Research Integrity
Division of Investigative Oversight
1101 Wootton Parkway
Suite 750
Rockville, Maryland 20852
240-453-8800

HHS-PSC000167

4/2812009

Page 1 of 1

Lipshultz, Gary (HHS/OPHS)


From:

Brodnicki, Gretchen A [Gretchen_Brodnicki@hms.harvard.edu]

Sent:

Wednesday, December 10, 2008 10:33 AM

To:

Lipshultz, Gary (HHS/OPHS)

Subject:

(b) (7)(A)

Gary,

(b) (6), (b)(7)(a), (b)(7)(c)


Thank you,
Gretchen

From: Lipshultz, Gary (HHSjOPHS) [mailto:Gary.Lipshultz@hhs.gov]

Sent: Wednesday, December 10, 2008 10:29 AM

To: Brodnicki, Gretchen A

Subject:

(b) (7)(A)

Ms. Brodnicki,

(b) (6), (b)(7)(a), (b)(7)(c)


Thank you.

lsI

Gary L. Lipshultz
Program Analyst
Office of Research Integrity
Division of Investigative Oversight
1101 Wootton Parkway
Suite 750
Rockville, Maryland 20852

240-453-8800

HHS-PSC000168

12110/2008

Page 1 of 1

Lipshultz, Gary (HHS/OPHS)


From:

Lipshultz, Gary (HHS/OPHS)

Sent:

Wednesday, December 10, 200810:29 AM

To:

'gretchen_brodnicki@hms.harvard.edu'

Subject:

(b) (7)(A)

Ms. Brodnicki,

(b) (6), (b)(7)(a), (b)(7)(c)


Thank you.

lsI
Gary L. Lipshultz
Program Analyst
Office of Research Integrity
Division of Investigative Oversight
1101 Wootton Parkway
Suite 750
Rockville, Maryland 20852
240-453-8800

HHS-PSC000169

12/10/2008

Page 1 of5

(b) (6), (b)(7)(C)


Krueger, John (HHS/OPHS)

(b) (6), (b)(7)(C)

From:

Sent:

Thursday, March 06, 20084:34 PM

To:

Krueger, John (HHS/OPHS); Dahlberg, John E (HHS/OPHS)

Subject:

(b) (6), (b)(7)(C)

John,

a;.J)

(b) (6), (b)(7)(C)

Did the complainant in CA call you on this? I referred him to you.


The retracted paper cites NIH grant support. HMS is doing the "inquiry"
following the COH inquiry (the paper was published from HMS, before
their move to CA. Lots of image and data falsifications that he can document.

(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)

HHS-PSC000170

3/6/2008

Page 2 of5

(b) (6), (b)(7)(C)

HHS-PSC000171

3/6/2008

Page 3 of5

(b) (6), (b)(7)(C)

HHS-PSC000172

3/6/2008

Page 4 of5

(b) (6), (b)(7)(C)

HHS-PSC000173

3/6/2008

Page 5 of 5

(b) (6), (b)(7)(C)

3/612008

HHS-PSC000174

t'age

Krueger, John (HHS/OPHS)

(b) (6), (b)(7)(C)

Subject:

(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)

2/20/2008

HHS-PSC000175

or

Harvard Medicql Scbool

25 Shattuck Street
Boston, Massachusetts 02115
(617) 432-3191
FAX: (617) 432-0566

(b) (6), (b)(7)(C)

Office for Research Issues

CONFIDENTIAL

May 25,2010
John E. Dahlberg, Ph.D., Director
Division of Investigative Oversight
Office for Research Integrity
1101 Wootton Parkway
Suite 750
Rockville, MD 20852
Re:

(b) (6), (b)(7)(C)

Dear Dr. Dahlberg:


I enclose the full inquiry panel report, Standing Committee report, and determination letter
(b) (6), (b)(7)(C) As you will see, we will be proceeding to
further investigation.
Please do not hesitate to contact me at 617-432-2496 or
Gretchen Brodnicki@hms.harvard.edu if you have any questions or need any additional
information.
Sincerely,

()

L..'!j.~ ~~-b/~~~
Gretchen A. Brodnicki
Dean for Faculty and
Research Integrity

Enclosures
cc:

Kristin Bittinger, J.D. (w/o enclosures)


Ellen Berkman, J.D. (w/o enclosures)

HHS-PSC000176

HARVARD MEDICAL SCHOOL

JEFFREY

S. FUER, MD

DEAN OF THE FACULTY OF MEDICINE


HARVARD MEDICAL SCHOOL
25 SHATI1.lCK ST.
BOSTON,

MA 02rI5

CONFIDENTIAL
May 25, 2010

VIA ELECTROl\'1C DELIVERY

(b) (6), (b)(7)(C)


Dear

(b) (6), (b)(7)(C)

I am writing to provide you with the final conclusions of the HMS Standing Committee on
Faculty Conduct and to inform you of the determinations reached by the Harvard Medical School
after-reviewing the reports and the documentary record in this case, including your submissions.

(b) (6), (b)(7)(C)


Gretchen Brodnicki, J.D., Dean for Faculty arid Research Integrity at the Medical School,
will be in contact with you concerning the investigative process. Please let her know if you have
any questions.
Sincerely,

J~.

Ir.,an of the Faculty of Medicine

Enclosure
cc:

Gretchen Brodnicki, J.D.


Ellen Berkman, J.D.

HHS-PSC000177

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MASSACHUSETIS GENERAL HOSPITAL ~ HARVARD MEDICAL SCHOOL

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PAULS. RUSSELL,M.D.

John Homans Distinguished Professor of Surgery

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Senior Surgeon
Massachusetts General Hospital. Boston. MA 02114
(617) 726-2801

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May 12,2010
Jeffrey S. Flier, M.D.
Dean of the Faculty of Medicine
Harvard Medical School
25 Shattuck Street
Boston, MA 02115
.Dear Dr. Flier:

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On behalf of the Harvard Medical School Standing Committee on Faculty Conduct, I am


writing to convey to you my recommendation, as chair of the -Standing Committee, relating to
allegations that
(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)

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HHS-PSC000178

PAUL S. RUSSELL, M.D.

(b) (6), (b)(7)(C)


The report of the inquiry panel was submitted to me, as chair of the Standing Committee, on
May 5, 20 I0 to consider the matter. I reviewed inquiry panel's report and the accompanying
documentation.
Conclusion

(b) (6), (b)(7)(C)

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HHS-PSC000179

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PAUL S. RUSSRL, M.D.

(b) (6), (b)(7)(C)

HHS-PSC000180

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(b) (6), (b)(7)(C)


Recommendations

(b) (6), (b)(7)(C)


These are the conclusions and recommendations of the chair, on behalf ofthe Standing
Committee on Faculty Conduct.
Sincerely,

Pllil" S. /L/WJL "

",

Paul Russell, M.D.


Chair

Enclosures

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HHS-PSC000181

HARVARD MEDICAL SCHOOL

CONFIDENTIAL MEMORANDUM

To:
From:

Re:

Paul Russell, M.D., Chair, Faculty of Medicine Standing Committee on Faculty Conduct

(b) (6), (b)(7)(C)


Report of the Inquiry Panel Concerning Allegations of Research Misconduct
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BACKGROUND AND INQUIRY ,PROCESS


In October 2007, Margaret.Dale, J;D.,,fopnerReseararIntegrity Offim and Deanfor
Faculty and Research Integrity at HM8- met with Gerianne Sands, J.D., Associate General
Counsel at Fred Hutchinson Cancer.Research Center (FReRC) regarding allegations, that

(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)

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HHS-PSC000182

CONFIDENTIAL

(b) (6), (b)(7)(C)

Allegations of research misconduct were originally brought to

(b) (6), (b)(7)(C)

The FRCRC panel met on several


occasions and, in September 2007, concluded that, because the research was conducted while
allegations discussed herein should be referred to RMS for inquiry.
Ms. Sands provided former Dean Dale with the most current version of(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)

This inquiry was conducted in accordance with the HMS Principles and Procedures for
Dealing with Allegations ofFaculty Misconduct, and-the Public Realth Services Rule, 42 CFR
Part 93 4 and the Department of Defense INSTRUCTION 3210.7 (May 14, 2004) which
implements DoD DIRECTIVE 32il6.2. (Exhibits 3, 4 and 5). The inquiry process was
administratively staffed by theHMS Office for Research Issues.
Pursuant to institutional policies, we were appointed as'members of the Inquiry Panel. We

(b) (6), (b)(7)(C)

are

Gretchen Brodnicki, J.D., current


.Research. Integrity Officer and -Dean,for F.aC1:llty and R.esearch.-Integrilf,Mortimer Litt, M.D.,
HMS Senior Scientific Investigator, Kristin Bittinger,HMS'DirectorofScientific Integrity6 and
-Patrick-Gilligan oftheHMS OfficeforResearchlssues a1so'servedas~staffto the Panel. In

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5 Dean Brodnicki arrived.at HMS
6 Ms.

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in July 2008.

Bittinger arrived at HMS in April 2009 .

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HHS-PSC000183

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CONFIDENTIAL
addition, a representative of the Harvard University Office of General Counsel (Ellen Berkman,
J.D.) was available to advise the Inquiry Panel throughout the proceedings and attended Inquiry
Panel meetings.
On December 13,2007, Ms. Dale notified

(b) (6), (b)(7)(C)

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(b) (6), (b)(7)(C)

Having been previously provided with

Due-to the complexity of the allegations and the length of elapsed-time between the
(b) (6), (b)(7)(C)
original-experimentation and commenGement -of this proceeding,

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HHS-PSC000184

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CONFIDENTIAL
to review the original requested slides.lO At the end of the meeting, we requested that

(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)

THE (b) (6), (b)(7)(C) PAPER

(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)


4

HHS-PSC000185

CONFIDENTIAL
Similarly, Figure 2 showed that

(b) (6), (b)(7)(C)

Role of Other Authors


The complainant and respondent agree that

(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)


ALLEGATIONS AND'RESPONSE

(b) (6), (b)(7)(C)


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HHS-PSC000186

CONFIDENTIAL

(b) (6), (b)(7)(C)

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HHS-PSC000187

CONFIDENTIAL

(b) (6), (b)(7)(C)

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CONFIDENTIAL

(b) (6), (b)(7)(C)


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CONFIDENTIAL

(b) (6), (b)(7)(C)

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(b) (6), (b)(7)(C)

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(b) (6), (b)(7)(C)

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HHS-PSC000193

(b) (6), (b)(7)(C)

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HHS-PSC000194

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(b) (6), (b)(7)(C)

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CONCLUSIONS

(b) (6), (b)(7)(C)

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HHS-PSC000195

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CONFIDENTIAL

(b) (6), (b)(7)(C)

RECOMMENDATIONS

(b) (6), (b)(7)(C)

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HHS-PSC000196

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List of Zou Exhibits

(b) (6), (b)(7)(C)

Exhibit 1:

Exhibit 2:

(b) (6), (b)(7)(C)


(b) (6), (b)(7)(C)

Exhibit 3:

Exhibit 4: Public Health Services Rule, 42 CFR Part 93


Exhibit 5: Department of Defense INSTRUCTION 3210.7 (May 14, 2004) which
implements DoD DIRECTIVE 3216.2.
Exhibit 6: Notification letter (December 13, 2007) to (b) (6), (b)(7)(C)
Exhibit 7: Notification letter (December 13,2007) to (b) (6), (b)(7)(C)
Exhibit 8:

(b) (6), (b)(7)(C)


(b) (6), (b)(7)(C)

Exhibit 9: Memorandum to panel re:

(b) (6), (b)(7)(C)

Exhibit 10:

(b) (6), (b)(7)(C)

Exhibit 11:
.'

Exhibit 12: Supplemental response of

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(b) (6), (b)(7)(C)

Exhibit 13:

(b) (6), (b)(7)(C)

Exhibit 14:

(b) (6), (b)(7)(C)


(b) (6), (b)(7)(C)

Exhibit 15:

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(b) (6), (b)(7)(C)

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articles

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HHS-PSC000204

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(b) (6), (b)(7)(C)

HHS-PSC000205

HHS-PSC000206

(b) (6), (b)(7)(C)

HHS-PSC000207

HHS-PSC000208

PRINCIPLES
The integrity of the teaching, research and clinical programs ofthe Faculty of Medicine requires that the
Faculty pay careful attention to and resolve in an equitable manner allegations of misconduct of faculty
appointees and fellows.
Because of variations in such factors as the kind of misconduct alleged, the seriousness of the
allegations, the nature of the dispute over the facts, and the interests and involvement of other private or .
public institutions and agencies, the course of action that will enable the Faculty to fulfill this
responsibility in the best possible manner is likely to vary from case to case. Accordingly, the
procedures set forth below permit flexibility and are designed to provide a framework that should enable
equitable resolution of allegations of misconduct in a wide variety of circumstances. When applying
these procedures to a specific case, persons acting on behalf of the Faculty and others involved in the
proceedings should keep in mind the following concerns:
The importance of the Faculty's maintaining standards consistent with the highest traditions of
teaching, patient care, and research ill medicine and with the lawful obligations ofthe Faculty.
The responsibility of the Faculty to the public and the scientific community and to,the private and
public institutions and agencies with which the Faculty is affiliated or has contractual or other
arrangements.
The necessity ofthe Faculty's protecting the rights and reputations of all individuals, including the
person who is alleged to have engaged in-misconduct and the person who has made the allegation.
The necessity of the Faculty'sresolving allegations with care and objectivity, with ample
opportunity.for.allinterestedparties to beheard, and as.promptly as the circumstances penmt.

PROCEDURES

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1. The Office ofllie Dean shall have principal responsibility for assessing a proper response to
allegationsill of misconductconceming.faculty appointees and fellows. To enable the Office of
the'Dean to meet this responsibility, all allegations of misconduct, whether initially received by a
.Department Head or other person, shall be promptly brought to the attention of the Office of-the
,Dean (and where appropriate, the ChiefExecutive Officer of an affiliated institution) unless they
are clearly frivolous or otherwise lacking in substance.
2. Upon receipt of an allegation of misconduct, the OfficeoftheDean and, in those instances where
the faculty member has a dual appointment, the Chief Executive Officer of the otherinstitution
shall determine~ after such consultation as may seem appropriate, whether primary responsibility
for resolving the aliegation rests with the Faculty or with anotherinstitution. For example, primary
responsibility forresolving an allegation of misconduct in connection with care ofa patient would
ordinarily reside in a hospital. In the case of an allegation pertaining-toextemallyfiInded research,
primary responsibility ordinarily rests with the institution that has admiriistered the research grant
Or contract. An affiliated institution that has received support for research by a Harvard appointee
.may request, however, that allegations related to research by such appointees be dealt with by the

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515/2010

HHS-PSC000209

Medical School. In any case, where the interests of two or more institutions are significantly
implicated, it is expected that such inquiry and any investigation will proceed with the
simultaneous participation of all concerned institutions, with agreement regarding which
institution bears primary responsibility.
3. Ifprimary responsibility rests with the Faculty, the Office of the Dean shall detennine whether,
taking into account the nature ofthe allegation, it is appropriate to attempt to resolve the matter
through infonnal processes and discussions. The affected Department Head shall ordinarily have
the responsibility for such efforts. Final resolution through infonnal means shall require the
approval ofthe Office of the Dean. When primary responsibility rests with an affiliated institution,
notice of resolution should be transmitted to the Office of the Dean.
4. If the matter is not resolved under paragraph 3, and ifiil the view of the Office oftJ:te Dean further
proceedings are required, the Office of the Dean shall, in the absence of any specific Faculty
procedure designed to cover the subject matter of the Committee on Faculty Conduct m with the
request that the Committee make such factual inquiry, investigation, findings and
recommendations to the Office of the Dean as seem appropriate to the circumstances. If there is a
dispute over facts or for other good cause, the Office of the Dean, after consultation with the
Chairperson of the Committee and other appropriate people, may first create one or more panels
of inquiry of one or more individuals, who need not be members of the Committee, to inquire into
the facts and submit the result of its inquiry to the Committee. In deciding upon the size and
composition of the Panel, the Office of the Dean, to help insure competence and objectivity, shall
take into account such factors as:
a.the subject matter of the inquiry, including the desirability of the panel's possessing
competence in a specialized area or investigative skills,
b. the desirability of including on the panel persons associated with another affiliated hospital
or individuals who are not members of the Faculty or not associated with Harvard
University, and
c. the importance of selecting ,people who have had no prior involvement in the subject matter
of the inquiry.
The Committee, with the benefit of a report from the panel ofinquiry, if one is created, and after
such further investigation, deliberations and proceedings as it deems appropriate or necessary,
taking into account any applicable govenunental regulations, shall submit its report to the Office
ofthe Dean. The Committee will submit conclusions and, ordinarily, comments on gravity of
offense, possible. sanctions, and prevention of future misconduct.
5. The Office oftheDeall;.after receiving comments on the report from such other people as may
seem appropriate, shaH decide the matter and take such action or make such recommendations as
may be required. In casesJnvolving another itistitution, the Dean-will confer with the Chief
.. Executive Officer of such institution in reaching a final resolution and. applying appropriate
sanctions. Sanctions may range, for example, from a letter of censure, to probation and
monitoring, to termination of appointment.
6. The Office of the Dean, in carrying outits responsibilities under these procedures, shall bear in .
mind the concerns of the Faculty as. set forth in the preamble and in particular:

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HHS-PSC000210
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a. the importance of care, fairness and objectivity, and of the appearance of these attributes,
b. the necessity of informing at the appropriate time other Faculty and University officers,
including the Chairperson of the Committee on Faculty Conduct, the Head of the
Department(s) involved, and the General Counsel to the University, of the existence of
allegations, and of consulting with these and other Faculty and University officers as
resolution of allegations progresses,
c. the responsibility of informing and consulting with officers of affiliated institutions and of
other private and public institutions and agencies to the extent necessary to meet in good
faith the obligations of the Faculty to others, and of coordinating the Faculty's proceedings
with those of affected institutions and agencies,
d. the importance of protecting the reputations of individuals and to that end ordinarily
maintaining confidentiality to the extent practicable and to the extent consistent with other
obligations of the Faculty during the course of and at the conclusion of proceedings,
e. the need to protect the rights of the person alleged to have engaged in misconduct, including
the right to be informed with specificity at the appropriate time of the allegations and the
evidence in support ofthe allegations, and the need to discuss with that person the
procedures to be followed,
f. the need to protect the rights ofindividuals who, in good faith, make allegations,

g. the importance of using the staff resources of the Faculty and the' University to aid in any
inquiry and of broadening the scope of any inquiry, when indicated, to make certain that the
full obligations of the Faculty are met, and
h. theneed to .make certain that the President of the University is informed when allegations
may constitute grave misconduct under the Third Statute of the University and that
resolution of the-matter proceeds.with this fact in mind.

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7. The Office of the Dean and the Committee ()n Faculty Conduct shall maintain records of any
. proceedings in which they are involved.

Adopted by the Faculty Council (Harvard University Faculty ofMedicine) on December 14, 1989.

Footnotes:
I An allegation will ordinarily be made by a written statement describing the misconduct in sufficient
detail to form the basis ofan inquiry. (go back to source)

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2The Committee on Faculty Conduct, appointed by the Dean, shall consist ofnine faculty members with
overlapping three-year terms. (go back to source)
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ADDENDUM

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When an allegation of misconduct by a Faculty appointee or fellow pertains to biomedical or behavioral

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5/5/2010
HHS-PSC000211

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research, research training, or other activities related to that research or research training for which
Public Health SeIVice (PHS) funds have been provided or requested, the following additional principles
and procedures shall be obseIVed in accordance with applicable governmental requirements:
1. Where the Office of the Dean determines that there is an allegation or other evidence of possible
misconduct that would be subject to the Final Rule of the PHS entitled "Public Health Service
policies on Resrach Misconduct," or any successor document ("PHS Rule"), ill the Office of the
Dean, after consultation with the Chair ofthe Committee and other appropriate people, shall
create one or more panels of inquiry as described in the "Principles and Procedures for Dealing
with Allegations ofFaculty Misconduct." The panel(s) shall conduct an inquiry in accordance
with the requirements of the PHS Rule. At the conclusion of the inquiry, the panel(s) shall present
a written report of the findings to the Committee on Faculty Conduct, along with any written
comments on the report that may be provided by the respondent. Such inquiry shall be concluded
within sixty days unless circumstances warrant a longer period (in which case the panel's report
shall document the reasons for exceeding the the sixty day period).
2. Within thirty days after receiving the report of the panel of inquiry, the Committee shall determine
whether the findings of that inquiry provide sufficient basis for conducting an investigation. If
deemed to be necessary, such investigation shall be commenced within thirty days after such
setermination is made and shall be conducted in accordance with the requirements of the PHS
Rule and with such additional assistance from the members of the panel of inquiry as the
Committee shall deem necessary and appropriate.
3. In the event the Committee concludes that an investigation is warranted, the Office of the Dean
shall, within thirty days after reaching that conclusion, report this decision in writing to the
Director, Office of Research Integrity of the Department of Health and Human Services (ORl), in
-the manner required by the PHS Rule, and shall take any other actions required by the PHS Rule.
4. The Committee shall submit a report of its investigation, including any recommended sanctions, '
to the Office-of the Dean upon its completion. Unless an extension oftime has been granted by
OR! in accordance with the requirements of the PHS Rule, such report shall be submitted to the
Office of the Dean within one hundred and twenty days of the initiation of such investigation.
5. After receiving-the final report and such-<:ommentsfrom other persons as may seem appropriate,
:the Office of the Dean shall decide the matter and take such action or make such
recommendations as may be deemed fitting, including submission of the final report to theORI
,and any other actions required by the PHS Rule. In cases involving another institution, the Dean
will confer with the Chief Executive Officer of such institution in reaching a final resolution.
.6. This Addendum is intended to include, and hereby incorporates by reference, all of the specific
mandatory requirements of the PHS Rule pertaining to the conduct and reporting of research
misconduct proceedings that are subject to that rule.

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Footnote on Addendum:
I"Research Misconduct" means fabrication, falsification, orplagiarism in proposing, performing, or
reviewing research, or. in reporting research results.
(a) Fabrication is making up data or results and recording or reporting them.

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HHS-PSC000212
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(b) Falsification is manipulating research materials, equipment, or processes, or changing or omitting


data or results such that the research is not accurately represented in the research record.
(c) Plagiarism is the appropriation of another person's ideas, processes, results, or words without giving
appropriate credit.
(d) Research misconduct does not include honest error or differences in opinion. (go back to source)

Adopted by the Faculty Council (Harvard University Faculty o/Medicine) on December 14. 1989.
Revisions adopted by the Faculty Council (Harvard University Faculty o/Medicine) on June 1. 2005.
,AJ;:'

fable of ,contents

1996 President and Fellows 0/Harvard College. All rights reserved. Materials adapted from the

paper version o/Faculty Policies on Integrity in Science. available/rom the Office/or Research Issues.
Harvard Medical School. 25 Shattuck Street. Boston. MA 02115. (617) 432-3191.

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HHS-PSC000213

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Tuesday,
May 17, 2005

Part ill

Department of
Health and Human
.Services
42 CFR Parts 50 and 93
Public Health Service Policies on
Research Misconduct; Final Rule

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HHS-PSC000215

HHS-PSC000216

Department of Defense

INSTRUCTION
NUMBER 3210.7
May 14,2004

USD{AT&L)

SUBJECT: Research Integrity and Misconduct

References: (a) DoD Directive 3216.2, "Protection of Human Subjects and Adherence to
Ethical Standards in DoD-Supported Research," March 25,2002
(b) Federal Register, Volume 65, page 76262, December 6, 2000, "Federal
Policy on Research Misconduct" current edition
(c) Title 32, Code of Federal Regulations, Part 22, "DoD Grant and
Agreement Regulations (DoDGARs)," current edition
(d) Title 48, Code of Federal Regulations, Chapter 2, "Defense Federal
Acquisition Regulation Supplement (DFARS)," current edition
(e) through (g), see enclosure 1

1. PURPOSE

This Instruction supplements the:policy established by paragraph 4.8. of reference (a) and
implements subparagraph 5.1.5.ofreference (a) by specifying detailed procedures and
standards for the Department of Defense for the prevention: of research misconduct. This
Instruction is consistent with the "Federal Policy on Research Misconduct" (reference
(b, which calls upon .those Federal Agencies that support or conduct research on an
. intramural or extramural basis to is~ue policies and procedures that conform to the
Federal policy.

2. APPLICABILITY AND SCOPE

This Instruction applies to:


2.1. The Office of the Secretary of Defense, the Military Departments, the
Chainnanofthe Joint Chiefs of Staff, the Combatant Commands, the Defense Agencies,
the DoD Field Activities and all other organizational entities in the Department of
Defense .(hereafter referred to collectively as "the DoD Components") ..

HHS-PSC000217

DoD! 3210.7, May 14, 2004

2.2. All allegations of research misconduct (as defmed in enclosure 2) by


perfonners or reviewers of research (also as defined in enclosure 2) or advanced
technology development activities that use DoD resources, including:

2.2.1. Civilian and military employees of the DoD Components;


2.2.2. Employees of non-Federal entities that receive DoD funding through
procurement contracts, grants, cooperative agreements, or other funding instruments,
under the tenns of those instruments;
2.2.3. Individual consultants, under the tenns of their appointments; and
2.2.4. Individuals other than DoD employees participating in research
activities conducted by the DoD Components or under their auspices, including proposal
reviewers not covered under subpara~phs 2.2.2. or 2.2.3., individuals under special
personnel appointments, and visiting sci~ntists, under the tenns of the instruments that
establish their relationship with the Department of Defense.

3. DEFINITIONS
Terms used in this Instruction are defined in enclosure 2.

4. POLICY
Consistent with the objective of reference (b) to ensure public trust in the research
enterprise, the DoD Components shaUpromote the integrity of research conducted under
their purview. The DoD Components shall establish procedures to foster integrity in .
research activities and to respond- to -allegations of research misconduct consistent with
applicable laws and regulations.

s.

PROCEDURES

Guidance for implementation of this Instruction by the DoD Components is provided in


enclosure 3; The guidance addresses requirements that pertain to research institutions in
general, as well as specific requirements for intramural research institutions. Enclosure 4
specifies the requirements to be implemented in the DoD Grant and Agreement
Regulations and the Defense Federal Acquisition Regulation Supplement (references (c)
and (d for inclusion in applicable contracts, other acquisition instruments, grants, and
agreements.

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HHS-PSC000218

DoD! 3210.7, May 14,2004

6. RESPONSIBILITIES
6.1. The Director, Defense Research and Engineering (DDR&E), under the Under
Secretary of Defense (Acquisition, Technology, and Logistics) (USD(AT&L:
6.1.1. Shall amend reference (c) to implement the requirements of this
Instruction for extramural research institutions. Amendments to reference (c) shall be
proposed in the Federal Register for public comment within 270 days of the effective date
of this Instruction.
6.1.2. Shall be the central point of contact within the Department of Defense
for policy matters relating to research misconduct and interpretation of this Instruction.
6.1.3. Shall act as the principal DoD liaison with Federal Agencies outside the
Department of Defense on matters pertaining to research misconduct.
6.1.4. Shall establish a committee consisting of representatives from the DoD
Components to assist in the implementation and maintenance of this Instruction.
6.1.5. May issue DoD instructions or other guidance necessary to implement
this Instruction.
6.1.6. May,grant exceptions to requirements of this Instruction, if they are
consistent with law and justified by special circumstances.
6.1.7. May specify periodic or ad hoc reporting requirements, including any
required to obtain information to respond to inquiries by the Office of Science and
Technology Policy.

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6.1.8. Shall coordinate with the Director ofDefense Procurement and


Acquisition'Policy (DDPAP) in matters relating to contracts and other acquisition
instruments.
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6.1.9. In coordination with theDDPAP, shallpropo-se changes to reference (d)


to implement the requirements of this Instruction for contracts and other transactions with
extramur~l research institutions for presentation to the Defense Acquisition Regulation
Council.. Changes to reference (d) shall be proposed in the Federal Register for public
comment within 270 days of the effective date of this lilstruction.
6,2. The Heads of the DoD Components shall:
6.2.1. Develop, issue, and monitor implementing policies and procedures to
ensure.compliance with this Instruction and applicable DQDGARS and DFARS
requirements (references (c) and {d.

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HHS-PSC000219

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DoD! 3210.7, May 14,2004

6.2.2. Ensure that authorities and responsibilities under this Instruction are
delegated to levels of command or authority that allow responses to allegations of
research misconduct to be handled at an appropriate organizational level consistent with
the requirements of this Instruction.
6.2.3. For allegations of research misconduct that involve more than one DoD
Component or a DoD Component(s) and a non-DoD Federal entity, jointly determine and
assign executive responsibility for compliance.
6.2.4. Maintain adequate documentation of all responses to allegations of
research misconduct conducted by a headquarters-level DoD Component or by an
intramural research institution.
6.2.5. Establish procedures to ensure timely response to DDR&E reporting
requirements.

7. EFFECTIVE DATE
This Instruction is effective immediately.

. Enclosures - 4
El. References, continued
E2. Definitions
E3. Requirements for DoD Components' Research MisconductProcedures
E4. Requirements for Extrainural Research Institutions

HHS-PSC000220

DoD! 3210. 7, May 14, 2004

El. ENCLOSURE]
REFERENCES, continued

(e) Section 2409 of title 10, United States Code, "Contractor Employees: Protection
from Reprisal for Disclosure of Certain Infonnation"
(f) Section 552 of title 5, United States Code, "Freedom oflnfonnation Act"
(g) Section SS2a of title 5, United States Code, "Privacy Act"

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ENCLOSURE 1

HHS-PSC000221

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DoD! 3210.7, May 14,2004

E2. ENCLOSURE 2
DEFINITIONS

E2.1.1. Adjudication. The stage in the response to an allegation of research


misconduct when the outcome of the investigation is reviewed, and appropriate corrective
actions, if any, are determined. Corrective actions generally will be administrative in
nature (e.g., termination of an award(s), deba. . ment, special approvals, or correction of the
research record); however if there is an indication of violation of civil or criminal
statutes, civil or criminal sanctions may be pursued.
E2.1.2. Fabrication. Making up data or results and recording or reporting them.
E2.1.3. Falsification. Manipulating research materials, equipment, or processes, or
changing or omitting data or results such that the research is not accurately represented in
the research record.
E2.1.4. Finding of Research Misconduct. The conclusion proven by a
preponderance of the evidence that there was research misconduct and that such
misconduct represented a significant departure from accepted practices of the relevant
research community and has been committed intentionally, knowingly, or recklessly.
E2.1.S. Inquiry. The stage in the response to an allegation of research misconduct
when an assessment is made to determine whether the allegation has substance and an
investigation is warranted.
E2.1.6. Investigation. The stage in the response to an allegation of research
misconduct when the factual-record is formally developed and examined to determine
whether to dismiss the case, recommend for a finding of research misconduct, and/or take
other appropriate remedies.

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E2.1. 7. Plagiarism. The appropriation ofanother person's ideas, processes, results,


or words without giving appropriate credit.
E2.1.8. Research. _All basic, applied, and demonstration research in all fields of
science, engineering, and mathematics. This inclUdes, but is not limited to, research in
eeonomics,education, lingUistics, medicine, psychology, physical sciences, social
sciences, statistics, and research involving human subjects ot animals regardless of the
funding appropriation used to support it.

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ENCLOSURE 2

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HHS-PSC000222

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DoDI 3210.7. May 14.2004

E2.1.9. Research Institution. All organizations using DoD resources (including


funds, personnel, equipment, facilities, and other resources) for research. Research
institutions include, but are not limited to, DoD intramural research laboratories, federally
funded research and development centers affiliated with the Department of Defense,
colleges and universities, national user facilities, industrial laboratories, and other
research institutes, centers, or organizations.
E2.1.10. Research Misconduct. Fabrication, falsification, or plagiarism in
proposing, perfonning, or reviewing research, or in reporting research results. Research
misconduct does not include honest error or differences of opinion.
E2.1.l1. Research Record. The record of data or results that embodies the facts
resulting from scientific inquiry. It includes, but is not limited to, research proposals,
laboratory records, progress reports, abstracts, theses, oral presentations, internal reports,
and journal articles, whether in physical or electronic fOIiD.

ENCLOSURE 2

HHS-PSC000223

DoD! 3210.7. May 14.2004

E3. ENCLOSURE 3
REQUIREMENTS FOR DoD COMPONENTS' RESEARCH MISCONDUCT
PROCEDURES

E3.1.1. The DoD Components shall adopt implementing procedures that recognize
the role of the research institution in ensuring that research is conducted under the highest
ethical standards and in reviewing allegations of research misconduct. A copyofthe
implementing instructions (and any subsequent modifications) shall be provided to the
DDR&E.
E3.1.2. The authority to review and act on allegations of research misconduct by
DoD employees or others working in DoD facilities (other than contractor employees or
consultants) shall be placed at the lowest possible organizational level that allows an
independent, unbiased, and equitable process. However, implementing procedures may
retain for the headquarters-level of the DoD Component (parent command) the right to
exercise authorities that otherwise would be delegated to intramural research institutions.
E3.1.3. The DoD Components shall designate in their implementing procedures
responsible individuals and the process for reviewing and responding to research
misconduct-related information and documentation submitted by research institutions.
E3.1.4. Implementing procedures shall minimize disruption to research in process
unless the research misconduct could result in a threat to public health or safety.
E3.1.S. The DoD Components may use their existing procedures for intramural
research institutions as long as they comply with the minimum requirements of this
Instruction. Nothing in this Instruction is intended to supersede current civilian or
military personnel management authorities.
E3.1.6 .. For extramural research institutions, the DoD Components may continue to
follow existing requirements until they are superseded by changes to references (c) and
(d), as applicable. The DoD Components may not adopt new or changed research
'integrity/researchmisconduct policies for extramural institutions in advance of final
changes to references (c) and (d).
E3.1. 7. The DoD Components may use any available resources to respond to
allegations of misconduct, including their Office of the Inspector General, legal counsel,
and expert consultants.

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ENCLQSURE3

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HHS-PSC000224

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DoD! 3210.7, May 14, 2004

E3.l.8. The DoD Components may develop alternate or additional procedures to


address allegations of research misconduct that arise under classified research as long as
they comply with the minimum requirements of this Instruction and references (c) and
(d), as applicable.
E3.1.9. At a minimum, the DoD Components' procedures implementing this
Instruction for intramural research institutions shall include the following:
E3.l.9.1. Responsibilities for handling each phase of the response to an
allegation of research misconduct: inquiry, investigation, and adjudication. These
responsibilities shall be assigned to organizations and officials that understand the
research and the research environment, can ensure objectivity, can provide due process,
and reach a timely resolution. The responsibilities for adjudication shall be separate from
those for inquiry and investigation, but they can be assigned to an individual higher in the
chain of command ot to a part of the research institution other than that which conducted
the inquiry and investigation.
E3.l.9.2. Procedures for handling allegations of research misconduct made
directly to the headquarters level of the DoD Component (instead of the research
institution).
E3.1.9.3. The circumstances, ifany, under which the headquarters level of the
DoD Component may respond directly to an allegation (other than exercise of the _
authority provided in paragraph E3.1.2.). These include, but are not limited to, a
determination that the research institution is una~le to conduct a thorough and unbiased
inquiry and investigation; a detennination that it is in the public interest for the parent
command tq conduct the inquiry and investigation; or a determination that the allegation
involves a small organization or an individual that cannot reasonably be expected to
re~pond.

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E3.1.9A. Responsibilities for, and the form and timing of, notifying an
individual that an allegation of research misconduct involving him or her has been made
and its disposition.
E3.1.9.5. A requirement to provide the report of the inquiry to a designated
official in the DoD Component after completion ofthe inquiry phase, if the individual's
commander (military personnel) or supervisor or commander (civilian) determines there
is s~ffi.cient evidence to proceed to an investigation.
E3.L9.6. A requirement that the research institution immediately notify the
headquarters levei of the DoD Component and provide an explanation of the
circumstances if:
E3.1.9.6J. The public health orsafety is at risk.

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ENCLOSURE 3

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HHS-PSC000225

DoD! 3210.7, May 14, 2004

E3.1.9.6.2. The research institution's resources or interests are threatened


or at risk.
E3.1.9.6.3. Research activities are to be suspended because of the inquiry
into or investigation of the allegation.
E3.1.9.6.4. There is a possible violation of civil or criminal law.
E3.1.9.6.5. Action to protect the interests of those involved in the inquiry
into or investigation of the allegation is required from the parent command.
E3.1.9.6.6. A premature public disclosure of the inquiry into or
investigation of the allegation may compromise the process; or
E3 .1.9.6.7. The research community or public should be informed.
E3.1.9. 7. The notice and accompanying explanation provided by the intramural
research institution (pursuant to subparagraph E3.1.9.6.) shall be used by the
headquarters level of the DoD Component to determine whether it or the research
institution shall respond directly to the allegation (if that right is reserved as provided
. under paragraph E3.1.2.).
E3.l.9.8. In any instance where the authority to adjudicate the findings is not
delegated to the intramural research institution, a requirement that, after completing the
investigation, the research institution report the outcome of the investigation to the same
individual as under subparagraph E3.1.9.5. The rep0rt shall include a copy of the
evidentiary record, the investigative report, and any other materials that bear on the
allegation. If adjudicated by the research institution, a requirement that the research
institution report the outcome ofthe adjudication to this individual. The report shall
include a summary of the findings and any action taken.
E3.1.9.9. Required documentation for each phase of the response to an
allegation of misconduct and requirements related to document retention, storage,
handling, and dissemination (see subparagraph E3.1.9.12. for requirements for
confidentiality). At a minimum, the documentation should include the allegation; the
methods and procedures used to gather the information and evaluate the allegation; the
outcome of the investigation (ineludinR the findings and supporting evidence), if any;
and, for fmdings of research misc0nduct, any recOmmended or imposed institutional
sanctions, and any recommended corrective actions.
E3.l.9.l0. Procedures to protect the rights of those who make allegations of
research misconduct to promote a c1imatewh~re the informant does not fear retribution
(for example, section 2409 of title 10, United States Code, "Contractor
. Employees: ProteCtion from Reprisal for Disclosure of Certain lnformati0n" (reference
(e))):Protections fOi-those alleging research misconduct should include protection

10

ENCLOSURE 3

HHS-PSC000226

DoD! 3210.7, May /4,2004


against retaliation or harm to their positions or reputations for making a good faith
allegation and fair and objective procedures for the examination and resolution of
allegations.
E3.1.9.ll. Procedures to protect the rights of those who are alleged to have
engaged in research misconduct in order to instill confidence that individuals shall be
treated in an impartial and professional manner. Protections for subjects of allegations of
research misconduct should include providing them a description of substantial
allegations made against them; giving them reasonable access to the data and other
supporting evidence related to the allegation; and affording them the opportunity to
respond to the allegation, the evidence, and the findings.
E3.1.9.12. Procedures intended to ensure confidentiality during the inquiry,
investigation, and decision-making processes. To the extent possible, consistent with a
fair and thorough investigation and as allowed by law, the procedures shall limit
knowledge about the identity of subjects and informants to those who "need to know."
The procedures shall be in compliance with the Freedom oflnformation Act and the
Privacy Act (references (f) and (g.
E3.1.9.13. Time frames for completing each phase of the response to an
allegation of research misconduct.
E3.1.9.l4. Types of remedies available.
E3.1.9.15. Available appeal rights. The authority to which an appeal may be
made must not be an office or individual directly involv~ in the inquiry, investigation, or
adjudication of an allegation of research misconduct. "Office" means that organizational
component with formalresponsibility for one or more phases of the response to an
allegation of research misconduct. The organizational level may be defined by the DoD
Component as long as there is an adequate separation of responsibilities and there is no
.
appearance of bias, inequity, ~r conflict of interest.
E3 .1.9.16. If authority to respond to an allegation of research misconduct is
.delegated to a research institution, a requirement that a copy of the research institution's
implementing procedures be provided to the headquarters level of the DoD ComponeQ.t.
E3.1.1O. Relationship to Other Requirements. Some of the research covered by this
Instruction also may be subject to regulations of other governmental agencies (e.g., a
DoD research institution that receives funding under a grant from another Federal
. Agency). Research covered under this Instnlction that also is subject to requirements of
other Agencies or funding sources must be cOnducted in compliance with all applicable
requirements.

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. ENCLOSURE 3 .

HHS-PSC000227

DoD! 3210. 7, May 14, 2004


E3.l.ll. Non-compliance. Instances of any DoD Component or intramural research
institution failing to comply with the requirements of this Instruction shall be referred for
resolution to a management level that is at least one level above where the noncompliance is alleged to have occurred. DoD Components shall provide the DDR&E
reports of all actions taken under this paragraph. Issues related to non-compliance by
extramural research institutions with requirements related to research integrity and
misconduct shall be addressed, as provided in enclosure 4, paragraph E4.1.1O., and
implemented in references (c) and (d).

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ENCLOSURE 3

HHS-PSC000228

DoDI 3210.7, May 14, 2004

E4. ENCLOSURE 4
REQUIREMENTS FOR EXTRAMURAL RESEARCH INSTITUTIONS

E4. I. I. Extramural research institutions must foster an atmosphere conducive to


research integrity. They must develop procedures to respond to allegations ofresearch
misconduct that ensure:
E4. I. I. I. Appropriate separation of responsibilities for inquiry and
investigation, and adjudication. (See paragraph E4.I.3.)
E4.l.1.2. Objectivity.
E4.l.1.3. Due process.
E4.l.1.4. Whistleblower protection.
E4.1.1.5. Confidentiality; and
E4. I. 1.6. Timely resolution.
E4.l.2. Extramural research institutions may use existing procedures applicable to
all of their federally and non-federally funded activities as long as they meet the
requirements specified in this enclosure. These procedures are not required to be
submitted to the DoD awarding activity, but must be available for inspection at the
research institution.
E4~1.3 .. Except as provided paragraph E4.1.4., following an allegation of research

misconduct made directly to it, whether related to an ongoing award or to a proposal


submitted to the Department of Defense for funding consideration, the research
institution is responsible for response to the allegation. This includes conducting the
inquiIy, investigation, and, if applicable, adjudication of the allegation. The
responsibilities for adjudication must be separate from those for inquiIy and
investigation, but they can be assigned to an individual higher in the cham of command
or to a part of the research institution other than that which conducted the inquiIy and
investigation.
E4.1.4. The DoD awarding activity shall refer an allegation of research misconduct
made to the Department of D~fense to the cognizant extramural research institution for
response. However, the DoD awarding activity may respond to an allegation of research
misconduct made to it or to the research institution if the awarding activity determines
that:

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ENCLOSURE 4

HHS-PSC000229

DoD! 32/0.7. May 14.2004

E4 .1.4 .1. The research institution is unable to conduct a thorough and unbiased
inquiry and investigation;
E4.1.4.2. It is in the public interest for the Department of Defense to conduct
the inquiry and investigation; or
E4 .1.4.3. The allegation involves a small organization or an individual that
cannot reasonably be expected to respond.
.
E4.1.S. After completion of the inquiry phase, the research institution must notify

the individual specified in the award of any allegation of research misconduct for which
there is sufficient evidence to proceed to an investigation. Each applicable award shall
specify the official to whom such notices must be sent.
E4.1.6. The research institution is required to provide immediate notification at any
time if:
E4.1.6.1. The public health or safety is at risk.
E4.1.6.2. The research institution's resources or interests are threatened or at
risk.
E4.1.6.3. Research activities are to be suspended because of the inquiry into or
investigation of the allegation.
E4.1.6.4. There is a possible violation of civil or criminal law.

E4.1.6.5. Action to protect the interests of those involved in the inquiry into or
investigation of the allegation is required from the DoD Component.

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E4.1.6.6. A premature public disclosure of the inquiry into or investigation of


the allegation may compromise the. process; or

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E4.1.6.7. The broader research community or public should be informed.


E4.l.7. Following completion of the investigation, the research institution must
provide a copy of the evidentiary record, the report of the investigation, recommendations
made to the institution's adjudicating official, and the written response of the individual
that is the subject of the allegation to any recommendations. This information must be
provided to (insert name or title of the Contracting Officer (generally the Administrative
Contracting Officer), Grants Officer, Agreement Officer, or other designated official).
E4.l.8. The extramural researcllinstitution must maintain the following documents
related to an allegation of research misconduct:

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ENCLOSURE 4

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HHS-PSC000230

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DoD! 3210.7, May 14,2004


E4.1.8.1. Written statement of the original allegation.
E4.1.8.2. Fonnal notification to the subject of the allegation.
E4.1.8.3. Written outcome of the inquiry phase and supporting documentation.
E4.l.8.4. Written repor:t of the investigation, including the evidentiary record
and supporting documentation; and
E4.1.8.5. Ifapplicable, statement of recommended corrective actions and any
response thereto, including any corrective action plan.
E4.1.9. The documents specified in paragraph E4.1.8. are considered project-related
records that must be retained for 3 years after the [mal decision.
E4.1.1 O. In the event the extramural institution does not comply with the
requirements of the award, the DoD awarding activity may use any available
administrative or other appropriate remedy, including the termination ofaward(s) or
suspension and debannent of the institution. The DoD awarding activity also may
recommend Suspension or debarment of the individual that is the subject of the allegation
after a finding of research misconduct

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ENCLOSURE 4

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HHS-PSC000231

HHS-PSC000232

Harvard Medical School

25 Shattuck street
Boston. Massachusetts 02115
(617) 432-3191
FAX: (617) 432-0566

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Office for Research IssueS

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CONFIDENTIAL
December 13, 2007

(b) (6), (b)(7)(C)

.1
On behalf of Harvard Medical School (HMS), I am writing toinfonn you that we will be
conducting an inquiry into allegations of
(b) (6), (b)(7)(C)

The:purpose of the inquiry is to determine \\'hether sufficient evidence ofresearch


rilisconductexistsoto warrant fwtherinvestigation. At the time thewotk :was done-and published,
"scientific misconduct" was,definedby the;formerlIMS Pr;nc~lesand Procedures for Dealing
with Allegations ofFaculty Misconduct, and the former Public Health "Services:FinaLRule, 42
CFR~Part 93 as "fabrication, falsification, plagiarism, or otherpractioesthat-senously deviate
from,those that are commonly accepted within the scientific communityfor,proposing,
conducting,orreporling-research." Specifically excludedofromthedefinition were "honest error
or honest differences; inintetpretation orjudgments of data." The definition comes from the
,policy and regulations that were ineffectcatthetime that the:paper referenced-above was
:published. The inquiry wiIlbe conducted in-accordance with the current Public HealthServices
. Regulations, 42 CPR P!.li 93 and the currenHIMS Principles and Procedures for Dealing with
Allegations ofFaculty Misconduct, copies fwhichare enclosed.

(b) (6), (b)(7)(C)


(

HHS-PSC000233

\,

believe that any of the individuals selected are not appropriate for the panel, please let me know the
reasons by December 21, 2007. Please do not contact the proposed panel members directly.

My office will be staffing the inquiry panel. Consistent with federal requirements, steps

(b) (6), (b)(7)(C)


relevant original records or data relating to this matter which you have in your possession, please let
me know immediately. I can be reached at (617) 432-2496 or margaret_dale@luns.harvard.oou. In
no case, should any existing record be destroyed or altered.

.I

The' inquiry panel may interview you (by person or by telephone) and others who may have
relevant information. Any interviews will be tape recorded. and transcribed and you will be given
tbeopportunity to review and correct the transcript of your interview. You may have someone,
including an attorney or a faculty advisor, come with you to your interview to advise you if you
wish.

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At the conclusion of the inquiry, the panel will prepare a draft report with its
recommendation as-to whetherofiuther-investigation is warranted. You will be provided with a copy
of the draft report and. given the opportunity to review an~ make comments on it. As the result of
your comments-the draft report may be changed and at the very least yourconunents will be
appended to the final report.

Please. understand that you are to take no steps to retaliate against anyone who came
.forward with the allegations or against anyone who may participatem the inquiry process.

(b) (6), (b)(7)(C)

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. -_Please donofhesitate. to caB me if you have any questions.

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Sincerely,

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Enclosures
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HHS-PSC000234

HHS-PSC000235

.' .

Harvard Medical School

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25 Shatfuck Street
Boston, MassachuseHs 02115
(617) 432-3191
FAX: (617) 432{)566
Office for Research Issues

..

CONFIDENTIAL

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December 13, 2007

I!

(b) (6), (b)(7)(C)

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On behalf of Harvard Medical School (HMS), I am writing to infonn you that we will be
conducting an inquiIy into
(b) (6), (b)(7)(C)

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The pwpose of-the-inquiry,is to determine whether sufficient evidence ofreseareh


.misconduct exists to,warrant further investigation. At the time the work was done and published,
tlscientificmisconduct" _,was.:defined by the former.HMS Principles and Procedures for Dealing
wilhAliegations, ofFaculty Misconduct, and the fonner Public Health Services Final Rule. 42
CPR Part 93 as tlfabrication,.falsification"plagiarism,or other practices that seriously deviate
from those that are commonly accepted, within the scientific community for proposing,
conducting, Or reporting research~tI SpeCifically excluded from the definition weretlhonest error
or honest differences~ihinterpretation' ol'judgments of data. II The definition comes: from the
.policy and regulations that were in effect at-the. time' that the paper referenced above was
published. The inquiry will be conductectin accordance with the current Public Health services
:Regulations, 42CFRPart93 and the current HMS-Princip/es and Procedures for Dealing with
.. Allegations ofFaculty Misconduct, copies. f which are enclosed.
.

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HHS-PSC000236

(b) (6), (b)(7)(C)


My office will be staffing the inquiry panel. Consistent with federal requirements, steps

(b) (6), (b)(7)(C)


need. If there are further relevant original records or data relating to this matter which you have in
your possession, please let me know immediately. I can be reached at (617) 432-2496 or
margaret_dale@hnis.harvard.edu. In no case should any existing record be destroyed or altered.

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The inquiry panel may want to interview you (by person or by telephone) and others who
may have relevant information. Any interviews will be tape recorded and transcn'bed and you will
be,given the opportunity to review and correct the transcript of your interview.

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(b) (6), (b)(7)(C)

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We consider this to be a confidentiaLmatter and will make every effort to ensure that
confidentiality is maintained. Please be assured that we are committed to a fair, thorough and
objective process.

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Please do not hesitate to contact me ifyou.bave any questions.


Sincerely,

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Research Integrity

Harvard Medical School

.Enclosures

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TABLE OF CONTENTS

(b) (6), (b)(7)(C)

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TIMELINE OF THE PROJECT AND CONTRIBUTIONS

(b) (6), (b)(7)(C)

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(b) (6), (b)(7)(C)

HHS-PSC000245

(b) (6), (b)(7)(C)

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(b) (6), (b)(7)(C)

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(b) (6), (b)(7)(C)

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HHS-PSC000249
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REANALYSIS OF THE ORIGINAL DATA

(b) (6), (b)(7)(C)

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HHS-PSC000250

(b) (6), (b)(7)(C)

HHS-PSC000251

(b) (6), (b)(7)(C)

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(b) (6), (b)(7)(C)

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(b) (6), (b)(7)(C)

HHS-PSC000255

ALLEGATIONS OF MISCONDUCT

(b) (6), (b)(7)(C)

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(b) (6), (b)(7)(C)

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(b) (6), (b)(7)(C)

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(b) (6), (b)(7)(C)

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(b) (6), (b)(7)(C)

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(b) (6), (b)(7)(C)


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HHS-PSC000266

(b) (6), (b)(7)(C)


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(b) (6), (b)(7)(C)

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(b) (6), (b)(7)(C)

HHS-PSC000276

(b) (6), (b)(7)(C)

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(b) (6), (b)(7)(C)

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HHS-PSC000282

(b) (6), (b)(7)(C)

HHS-PSC000283

(b) (6), (b)(7)(C)

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HHS-PSC000284

ANCILLARY FILES

(b) (6), (b)(7)(C)

HHS-PSC000285

(b) (6), (b)(7)(C)

HHS-PSC000286

(b) (6), (b)(7)(C)

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(b) (6), (b)(7)(C)

HHS-PSC000290

(b) (6), (b)(7)(C)

HHS-PSC000291

HHS-PSC000292

CONFIDENTIAL

(b) (6), (b)(7)(C)

TO:

(b) (6), (b)(7)(C)

CC:
FROM:

(b) (6), (b)(7)(C)

DATE:

June 6, 2008

(b) (6), (b)(7)(C)

RE:

(b) (6), (b)(7)(a), (b)(7)(c)

In light of the (still) massive amount of material (b) (6), (b)(7)(C) supmitted, I suggest we take the
next two or three weeks to look over these files on our individual timetables. I'll then be in touch
with each of you for your thoughts about a realistic and sensible plan f<?r proceeding. If anyone
has immediate suggestions for a different approach, please let me know.

Turning to the files:

(b) (6), (b)(7)(a), (b)(7)(c)

HHS-PSC000293

(b) (6), (b)(7)(a), (b)(7)(c)

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November 13, 2008


Response to allegations of (b) (6), (b)(7)(C)
submitted (b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)


BACKGROUND ON THE EXPERIMENTS

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(b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)

Respectfully submitted,

(b) (6), (b)(7)(C)


November 13, 2008 .

Page 24 of 24

HHS-PSC000319

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Page 1 ofl

-Bittinger, Kristin L
From:

Brodnicki, Gretchen A. .

Sent:

Friday, November 06, 2009 4:00 PW!

To:

'Tom Watson'

Cc:
.SubJect:

Bittinger, Kristin l.

(b) (6), (b)(7)(C)

Attachments

Tom,

(b) (6), (b)(7)(C)


.
.
l.ast/y,:J:haVe,cbpjedJ<rlstin Blttinger~our-Directo:- of ScientifIC Integrity who will be our primary

oominislraUve~d:of.t'llS.case-from ouroffice. 'Please do not hesltateto contact either one of us with any

. questions.
Thanks,
Gretchen

Gretchen A Brodnickl, JiD.


:Deanfor Faculty'and,Research Integrity

./
1

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. Harvard-Medical'Schoot
Office for Researctl'issues
25 Shatt~Slreet,Sliite1 08

. Boston,Ml\ .02H5
. :(tH6Hl432-2496
:(f) '(617)432."'0566

:GretGhe.'J3rodnickt@hms;harvard~u

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HHS-PSC000353

REPLY TO "Additional Questions for(b) (6), (b)(7)(C) "


The scientific material in this response is provided by (b) (6), (b)(7)(C) . It has been necessary to clarify some
(b) (6), (b)(7)(C)
of
statements because, while
(b) (6), (b)(7)(C)
The clarifications and the other material,
particularly that applying the principles for determining what is and what is not scientific misconduct,
are provided by counsel.

(b) (6), (b)(7)(C)


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HHS-PSC000354

(b) (6), (b)(7)(C)


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Comments of(b) (6), (b)(7)(C) on draft Inquiry Committee Report

Apri130, 2010

(b) (6), (b)(7)(C)


All statements of fact and scientific material below are provided by (b) (6), (b)(7)(C) All
statements regarding the principles for detennining what is and is not scientific
misconduct are provided by counsel.

All textual materials of the paper, including all versions of the manuscript,
communications with editors, and responses to reviewers, and all figure legends, were
written entirely by (b) (6), (b)(7)(C)

(b) (6), (b)(7)(C)


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Friday. Augusl24, 2007 2:28 PM


Sands, Gerianne J
Fwd: about the OC paper

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(b) (6), (b)(7)(C)

HHS-PSC000369

E   $
Dahlberg. John E (HHS/OASH)
From:
Sent:
To:
Subject:

E    E  D  E  F

Monday, March 21,2011 3:16 PM


Dahlberg, John E (HHS/OASH)
request

Dear Mr. Dahlberg,


I am curious if you have given any more thought to my request to be apprised of whether and when OR! was
informed of my allegations of misconduct relating to
E    E  D  E  F . I thought that I sent
another request to you a week or two ago, but do not have a record of it. Could you please confirm that you
received it? I would like to reiterate that I have never received any solid confirmation that the allegations were
reported to the government.
Thanks,

E    E  D  E  F

HHS-PSC000370

E   $
Dahlberg. John E (HHS/OASH)
From:
Sent:
To:
Cc:
Subject:

Dahlberg, John E (HHS/OASH)


Monday, April 11 ,2011 1 :21 PM
'Swem, Judy (USAWAW)'
Dahlberg, John E (HHS/OASH); Rochez, Jo An (HHS\OGC)
RE: E    E  D  E  F

Ms. Swem,
The OR! contacts at FHCRC, Harvard, and Yale are:

Name: Lawrence Corey MD Title: President and Director Phone: (206) 667-6600
667-5268
Email: lcorey@thcrc.org

Ext:

Fax: (206)

Name: Gretchen A. Brodnicki Title: Director of Research & Faculty Integrtiy Phone: 617-432-2496
Ext:
Fax: 617-432-0566 Email: gretchen brodnicki@hms.harvard.edu
Name: Andrew Rudczynski Title: Associate Vice President for Research Administrati
Fax: 203-785-3510 Email: andrew.rudczynski@yale.edu
Phone: 203-785-3012
Ext:
Note: At Yale, I normally go to Robert Bienstock, Gneral Counsel's Office: robert.bienstock@yale.edu
Regarding your comment in your email about there not being issues at FCCRC, I tried to indicate that the issues
that had been identified regarding
E    E  D  E  F

John Dahlberg, Ph.D.


Director, Division of Investigative Oversight
Office of Research Integrity
240-453-8800

Fr~m: Swem, Judy (USAWAW) [mailto:Judy.Swem@usdoj.govl


Sent: Monday, April 11, 2011 12:07 PM
To: Dahlberg, John E (HHS/OASH)
Cc: East, David (USAWAW)
Subject: E    E  D  E  F

'Dr. Dahlberg:
Thank you for talking with me this morning.. As I advised, we are conducting an investigation of some grants
awarded to Fred Hutchinson Cancer Research Center (FHCRC), Harvard University, Yale University and
You indicated that you are awaiting reports of investigation from Harvard and FHCRC, but was
not aware ofthe
E    E  D  E  F You

E    E  D  E  F

HHS-PSC000371

indicated that the preliminary results you had received from

E    E  D  E  F

I do appreciate you sending us the contact information for the Research Integrity Officers at FHCRC, Harvard
and Yale, so we can reach out to them as well. As I indicated, we were just like everyone to be aware of our
ongoing investigation and do appreciate your offer for technical assistance on this matter.
As promised, AUSA David East's email address is shown above and his direct dial phone number is 206-5531018. My contact inforr:nation is listed below.
We are looking forward to working with you and appreciate any technical assistance you can provide.
Judy A. Swem
ACE Investigator
US Attorney's Office
Western District of Washington
office: 206-553-4623
cell: 206-718-4712
fax: 206-553-4067

HHS-PSC000372

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E    E  D  E  F
HHS-PSC000374

ofl

4/1112011 1:38PM

E   $
Dahlberg. John E (HHS/OASH)
From:

Sent:
To:

Cc:
Subject:

E    E  D  E  F
Thursday, February 24, 2011 3:52 PM
Dahlberg, John E (HHS/OASH)

E    E  D  E  F

Dear Dr. Dahlberg,


I would like to know whether Fred Hutchinson Cancer Research Center submitted to ORI (or another
E    E  D  E  F
government agency) the results of their preliminary assessment of misconduct allegations regarding
The assessment committee report was
completed on October 9,2007 and provided to me later. I am aware there is no requirement to submit such an
assessment report, but due to the formality of this particular review
E    E  D  E  F
regarding it, there may have been information submitted. Subsequently, the RIO at Harvard Medical School
(Margaret Dale) was contacted and the case was transferred there for a formal inquiry. I am aware (from Ms.
Gretchen Brodnicki, current RIO at Harvard) that an inquiry has concluded and therefore a report must have
been submitted to ORI. Could I find out the date of this submission as well? I have cc'd an attorney that I am
working with currently E    E  D  E  F and consultant who you may know E    E  D  E  F
may be in contact
with additional questions regarding this case.
E    E  D  E  F

Regards,

E    E  D  E  F
On 30 Jan 2011, at 08:59, Dahlberg, John E (HHS/OASH) wrote:
E    E  D  E  F

I will attempt to answer your questions for all of the recipients of this email, as quite likely I would have been
asked to do so in any event. I am sympathetic to your concerns as the complaint in these two cases that the
process has been protracted, and has not reached closure. However, 42 C.F.F .. Part 93 is pretty clear that once
allegations are made and considered to meet the definition of research misconduct, the inquiry and investigation
process should be overseen by neutral unbiased institutional. officials and scientists comprising the committees.
The complainant mayor may not be a useful fact witness, depending on circumstances, but has no special status
beyond being a possible fact witness. If you fell you have identified additional evidence of possible value to an
ongoing process, the institution is expected to consider it, and if not, ORI would do so during its oversight
review that begins after receipt of the fmal investigation report.
You correctly note that the regulation does not require that the complainant be provided all of portions of either
the inquiry or investiqation report for review. It is not a complainant's responsibility to judge the merits of the
evidence for or against findings of misconduct. Such decisions are quite complex and based on far more that
1

HHS-PSC000375

simply demonstrating that a figure or statement is wrong or falsified. I would add that both institutions dealing
with your allegations have been notably competent in many earlier cases that ORI has reviewed over the years,
and I am unaware of any bias towards protecting institutional interests at either University.
Sincerely,
John Dahlberg, Ph.D
Director, Divison ofInvestigative Oversight
Office of Research Integrity

E    E  D  E  F

Sent: Thursday, January 27, 2011 4:32 PM


To: OS OPHS askORI (HHS/OPHS)
Subject: to Dr. John Dahlberg

This email is directed to the following individual:


John Dahlberg, Ph.D., Director of Division ofInvestigative Oversight,
I am writing to ask your opinion regarding PHS Policies on Research Misconduct, 42 CFR Part 93. It states that
a requirement of an institution that accepts PHS funds for research includes: "A thorough, competent, objective,
and fair response to allegations of research misconduct consistent with, and within the time limits of the final
rule, including precautions to ensure that individuals responsible for carrying out any part of the research
misconduct proceeding do not have unresolved personal, professional, or financial conflicts of interest with the
complainant, respondent, or witnesses."
I have two questions regarding this policy and would like to hear your opinion.
QUESTION #1: Is it your opinion that if a review panel investigating allegations of research misconduct is
aware of additional evidence that may influence their decision regarding determinations of falsifications and
culpability, are they required to review this evidence as part of an "objective, and fair response to allegations of
research misconduct"?
QUESTION #2: The sample policy guidelines for an institution include a suggestion that the complainant be
given the opportunity to review any draft inquiry or investigation report, presumably as part of a fair response to
the allegations, though the
42 CFR Part 93
policy does not require an institution to do so. However, if the complainant requests to view the draft report due
to concerns that the investigation ("response") may not be conducted in a fair manner, and complainant has
additional evidence to present to support his original allegations and reputation that he suspects have been
challenged by respondents, should it be considered a breach of an "objective, fair response to allegations of
misconduct" if the complainant is denied the ability to review and comment on the draft report?
The underlying presumption is that an institution is inherently biased against making determinations of
research misconduct against its members (or former members) and thus may not want to review all the evidence
that implicates that member. The institution therefore may do what it can to avoid consideration of additional
evidence that it becomes aware of, and also attempt to prevent the complainant from seeing the draft report.
Regards,
2

HHS-PSC000376

E    E  D  E  F
CASE SUMMARY (no names):

E    E  D  E  F

HHS-PSC000377

E    E  D  E  F

HHS-PSC000378

E   $

Dahlberg. John E (HHS/OASH)


From:
Sent:

To:

Subject:

E    E  D  E  F

Sunday, January 30,2011 12:57 PM


Dahlberg, John E (HHS/OASH)
Re: to Dr. John Dahlberg

Hi John,

E    E  D  E  F

Regards,

E    E  D  E  F

On 30 Jan 2011, at 08:59, Dahlberg, John E (HHS/OASH) wrote:


E    E  D  E  F

HHS-PSC000379

I will attempt to answer your questions for all of the recipients of this email, as quite likely I would have been
asked to do so in any event. I am sympathetic to your concerns as the complaint in these two cases that the
process has been protracted, and has not reached closure. However, 42 C.F.F .. Part 93 is pretty clear that once
allegations are made and considered to meet the definition of research misconduct, the inquiry and investigation
process should be overseen by neutral unbiased institutional officials and scientists comprising the committees.
The complainant mayor may not be a useful fact witness, depending on circumstances, but has no special status
beyond being a possible fact witness. If you fell you have identified additional evidence of possible value to an
ongoing process, the institution is expected to consider it, and if not, OR! would do so during its oversight
review that begins after receipt of the final investigation report.
You correctly note that the regulation does not require that the complainant be provided all of portions of either
the inquiry or investiqation report for review. It is not a complainant's responsibility to judge the merits of the
evidence for or against findings of misconduct. Such decisions are quite complex and based on far more that
simply demonstrating that a figure or statement is wrong or falsified. I would add that both institutions dealing
with your allegations have been notably competent in many earlier cases that OR! has reviewed over the years,
and I am unaware of any bias towards protecting institutional interests at either University.
Sincerely,
John Dahlberg, Ph.D
Director, Divison of Investigative Oversight
Office of Research Integrity
From:
E    E  D  E  F
Sent: Thursday, January 27, 2011 4:32 PM
To: OS OPHS askOR! (HHS/OPHS)
Subject: to Dr. John Dahlberg
This email is directed to the following individual:
John Dahlberg, Ph.D., Director of Division ofInvestigative Oversight,
I am writing to ask your opinion regarding PHS Policies on Research Misconduct, 42 CFR Part 93. It states that
a requirement of an institution that accepts PHS funds for research includes: "A thorough, competent, objective,
and fair response to allegations of research misconduct consistent with, and within the time limits of the final
rule, including precautions to ensure that individuals responsible for carrying out any part of the research
misconduct proceeding do not have unresolved personal, professional, or financial conflicts of interest with the
complainant, respondent, or witnesses."
I have two questions regarding this policy and would like to hear your opinion.
QUESTION # 1: Is it your opinion that if a review panel investigating allegations of research misconduct is
aware of additional evidence that may influence their decision regarding determinations of falsifications and
culpability, are they required to review this evidence as part of an "objective, and fair response to allegations of
research misconduct"?
QUESTION #2: The sample policy guidelines for an institution include a suggestion that the complainant be
given the opportunity to review any draft inquiry or investigation report, presumably as part of a fair response to
the allegations, though the
42 CFR Part 93
2

HHS-PSC000380

policy does not require an institution to do so. However, if the complainant requests to view the draft report due
to concerns that the investigation ("response") may not be conducted in a fair manner, and complainant has
additional evidence to present to support his original allegations and reputation that he suspects have been
challenged by respondents, should it be considered a breach of an "objective, fair response to allegations of
misconduct" if the complainant is denied the ability to review and comment on the draft report?
The underlying presumption is that an institution is inherently biased against making determinations of
research misconduct against its members (or former members) and thus may not want to review all the evidence
that implicates that member. The institution therefore may do what it can to avoid consideration of additional
evidence that it becomes aware of, and also attempt to prevent the complainant from seeing the draft report.
Regards,

E    E  D  E  F
CASE SUMMARY (no names):

E    E  D  E  F

HHS-PSC000381

E    E  D  E  F

E    E  D  E  F

HHS-PSC000382

Dahlberg, John E (HHS/OASH)

Dahlberg, John E (HHS/OASH)


Sunday, January 30, 2011 12:00 PM

From:
Sent:

E    E  D  E  F

To:
Cc:

Subject:

Dahlberg, John E (HHS/OASH)


RE: to Dr. John Dahlberg

E    E  D  E  F

I will attempt to answer your questions for all of the recipients of this email~ as
quite likely I would have been asked to do so in any event. I am sympathetic to your
concerns as the complaint in these two cases that the process has been protracted~ and
has not reached closure. However~ 42 C.F.F;. Part 93 is pretty clear that once
allegations are made and considered to meet the definition of research misconduct~ the
inquiry and investigation process should be overseen by neutral unbiased institutional
officials and scientists comprising the committees. The complainant mayor may not be
a useful fact witness~ depending on circumstances, but has no special status beyond
being a possible fact witness. If you fell you have identified additional evidence of
possible value to an ongoing process, the institution is expected to consider it, and
if not, ORI would do so during its oversight review that begins after receipt of the
final investigation report.
You correctly note that the regulation does not require that the complainant be
provided all of portions of either the inquiry or investiqation report for review. It
is not a complainant's responsibility to judge the merits of the evidence for or
against findings of misconduct. Such decisions are quite complex and based on far more
that simply demonstrating that a figure or statement is wrong or falsified. I would
add that both institutions dealing with your allegations have been notably competent in
many earlier cases that ORI has reviewed over the years, and I am unaware of any bias
towards protecting institutional interests at either University.
Sincerely~

John Dahlberg, Ph.D


Director, Divison of Investigative Oversight Office of Research Integrity
E    E  D  E  F
From:
Sent: Thursday, January 27, 2011 4:32 PM
To: OS OPHS askORI (HHS/OPHS)
Subject: to Dr. John Dahlberg

This email is directed to the following individual:


John Dahlberg, Ph.D., Director of Division of Investigative Oversight,
I am writing to ask your opinion regarding PHS Policies on Research Misconduct, 42 CFR
Part 93. It states that a requirement of an institution that accepts PHS funds for
research includes: "A thorough, competent, objective, and fair response to allegations
of research misconduct consistent with, and within the time limits of the final rule,
including precautions to ensure that individuals responsible for carrying out any part
of the research misconduct proceeding do not have unresolved personal, professional, or
financial conflicts of interest with the complainant, respondent, or witnesses."
I have two questions regarding this policy and would like to hear your opinion.
1

HHS-PSC000383

QUESTION #1: Is it your opinion that if a review panel investigating allegations of


research misconduct is aware of additional evidence that may influence their decision
regarding determinations of falsifications and culpability~ are they required to review
this evidence as part of an "objective~ and fair response to allegations of research
misconduct"?
QUESTION #2: The sample policy guidelines for an institution include a suggestion that
the complainant be given the opportunity to review any draft inquiry or investigation
report~ presumably as part of a fair response to the allegations~ though the
42 CFR Part 93
policy does not require an institution to do so. However~ if the complainant reque.sts
to view the draft report due to concerns that the investigation ("response") may not be
conducted in a fair manner~ and complainant has additional evidence to present to
support his original allegations and reputation that he suspects have been challenged
by respondents~ should it be considered a breach of an "objective~ fair response to
allegations of misconduct" if the complainant is denied the ability to review and
comment on the draft report?
The underlying presumption is that an institution is inherently biased against making
determinations of research misconduct against its members (or former members) and thus
may not want to review all the evidence that implicates that member. The institution
therefore may do what it can to avoid consideration of additional evidence that it
becomes aware of~ and also attempt to prevent the complainant from seeing the draft
report.
Regards~

E    E  D  E  F
CASE SUMMARY (no names):

E    E  D  E  F

HHS-PSC000384

E    E  D  E  F

HHS-PSC000385

Dahlberg. John E (HHS/OASH)

E    E  D  E  F

From:

Sent:

To:

Subject:

Thursday, January 27, 2011 4:30 PM


OS OPHS askORI (HHS/OPHS)
opinion solicitation

This email is directed to the following individual:


Don Wright, M.D., Director of the Office of Research Integrity,
I am writing to ask your opinion regarding

PHS Policies on Research Misconduct, 42 CFR Part 93. It states that a requirement of an institution
that accepts PHS funds for research includes: "A thorough. competent. objective. ondfair response to allegations ofresearch misconduct consistent with. and within the time limits ofthe final

rule. including precautions to ensure that indiViduals responsible for carrying out any port ofthe research misconduct proceeding do not have unresolved personal. professional. or finoncial
conflicts ofinterest with the complainont. respondent. Or witnesses."

I have two questions regarding this policy and would like to hear your opinion.

QUESTION #1: Is it your opinion that if a review panel investigating allegations of research misconduct
is aware of additional evidence that may influence their decision regarding determinations of
falsifications and culpability, are they required to review this evidence as part of an "objective, and fair
response to allegations of research misconduct"?
QUESTION #2: The sample policy guidelines for an institution include a suggestion that
the complainant be given the opportunity to review any draft inquiry or investigation report, presumably
as part of a fair response to the allegations, though the
42 CFR Part 93

policy does not require an institution to do so. However, if the complainant requests to view the draft
report due to concerns that the investigation ("response") may not be conducted in a fair manner, and
complainant has additional evidence to present to support his original allegations and reputation that he
suspects have i?een challenged by respondents, should it be considered a breach of an "objective, fair
response to allegations of misconduct" if the complainant is denied the ability to review and comment on
the draft report?

E    E  D  E  F
Regards,

E    E  D  E  F

CASE SUMMARY (no names):

E    E  D  E  F
1

HHS-PSC000386

E    E  D  E  F

HHS-PSC000387

E    E  D  E  F

HHS-PSC000388

E   $

Dahlberg. John E (HHS/OASH)


From:
Sent:
To:
Subject:

E    E  D  E  F

Friday, November 19, 2010 5:24 PM


Dahlberg, John E (HHS/OASH)

E    E  D  E  F

Hi John,
We just talked on the phone. I was the complainant in the case involving
E    E  D  E  F at
Harvard and Fred Hutchinson Cancer Research Center. I have not been informed regarding what stage the
process is currently at from either institution. All I know is that a preliminary assessment went forward and I
provided my allegations to Harvard to do a formal inquiry.
I read under the regulations that an inquiry is to be completed within 60 days of allegations being made and
that the complainant is to be interviewed early in the process or an investigation. Is this true? I have not been
informed that the inquiry stage has ended or an investigation begun.
I am concerned that the investigation is not being thorough enough. Is there anything I can do about it at this
point?
Also, by the Freedom of Information Act, can I request the reports for this or other cases? At this point, I
would like to request the report related to
E    E  D  E  F Thanks for talking with me.
Regards,

E    E  D  E  F

HHS-PSC000389

E   $
Dahlberg, John E (HHSIOPHS)
From:

Sent:

To:

Subject:

Kabak, Shara (HHS/OPHS/ORI)


Thursday, September 16, 2010 1:00 PM
Dahlberg, John E (HHS/OPHS)
retractions

JohnHere is the information about E   $ , at Fred Hutchinson Cancer Center:


Two papers are being retracted:

E    E  D  E  F

Let me know if you want any further information. I spoke with Gerianne Sands about how to handle questions- they have
an "if ask media" release set up where they will say the investigation is ongoing and they can't comment on it.
Shara
Shara Kabak, PhD
Office of Research Integrity
Division of Investigative OverSight
Phone: 240-453-8428

HHS-PSC000390

E    E  D  E  F
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nytimes.com

Pr;!INTER.F'RIENDU FORM"AT

E    E  D  E  F

spo"""o BY I

NEVER LET
MEr-.n
.....
'-'

WATCH THE TRAILER

E    E  D  E  F

Copyright 2008 The New York Times Company


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HHS-PSC000391

1 of 1

9116/20101:25 PM

(...t!f.
~

...V1c....

DEPARTMENT OF HL._TII &. HUMAN SERVICES

~,~<~~~

Office of Public Health and Science


Office of Research Integrity
1101 Wootton Parkway, Suite, 750
Rockville MD 20852
Ph. 240-453-8800
FAX 301-594-0043
e-mail: john.dahlberg@hhs.gov
Web: http://ori.dhhs.gov/

CONFIDENTIAL
March 10,2010
Gerianne J. Sands, Esq.
Associate General Counsel
Fred Hutchinson Cancer Research Center
1100 Fairview Avenue N.
J6-205
PO Box 19024
Seattle, W A 98109-1024
RE:

E   $

Dear Ms. Sands:


The Division of Investigative Oversight (DIO) of the Office of Research Integrity (OR!) has
received your letter of February 24,2010, requesting an extension to complete the investigation
of allegations of possible research misconduct on the part of E    E  D  E  F You noted that
E    E  D  E  F

would normally be the case. DIO much prefers a careful thorough review and analysis of
allegations to a hasty one, and gladly grants an extension to June 1,2010, to complete the
investigation and provide a report to OR!.
If you have any questions or additional concerns please do not hesitate to contact me.

ohn E. Dahlberg, Ph.D.


Director
Division of Investigative Oversight
Office of Research Integrity

HHS-PSC000392

FRED HUTCHINSON

CANCER RESEARCH CENTER


A LIFE OF SCIENCE

E   $

Office of the General Counsel

CONFIDENTIAL
John E. Dahlberg, Ph.D.
Director, Division of Investigative Oversight
Office of Research Integrity
U.S. Department of Health and Human Services
1101 Wootton Parkway, Suite 750
Rockville, Maryland 20852

RE:

Request for Extension of Misconduct Investigation

E    E  D  E  F

Dear Dr. Dahlberg:


I am writing on behalf of Fred Hutchinson Cancer Research Center (the "Center") to request an
extension from March 6, 2010 to June 1, 2010 for completion of the Investigation in the abovementioned matter.

E    E  D  E  F
Due to the challenges of communicating with the Respondent,
the Investigation Committee needs additional time in order
to conduct a thorough Investigation.
Thank you for your consideration of an extension to June 1, 2010 for completion of the
Investigation in the above-mentioned matter. Please contact me at (206) 667-1224 should you
have any questions.
Sincerely,

Gerianne J. Sands
Associate General Counsel

cc:

Dr. Leland H. Hartwell, President and Director of the Center


Dr. Jonathan Cooper, Investigation Committee Member
Dr. Julio Vazquez-Lopez, Investigation Committee Member

HHS-PSC000393

DEPARTMENT OF HEtu..TH &. HUMAN SERVICES


Office of Public Health and Science
Office of Research Integrity
1101 Wootton Parkway, Suite, 750
Rockville MD 20852

Ph. 240-453-8800
FAX 301-594-0043

e-mail: john.dahlberg@hhs.gov
Web: http://ori.dhhs.gov/

CONFIDENTIAL
February 25, 2010
Gerianne J. Sands, Esq.
Associate General Counsel
Fred Hutchinson Cancer Research Center
1100 Fairview Avenue N .
205
PO Box 19204
. Seattle, WA 98109-1024

.:ro-

RE: E   $
Dear Ms. Sands:
The Division of Investigative Oversight (DIO) of the Office of Research Integrity (ORI) has
received your letter of February 24, 2010, requesting an extension to complete the investigation
of allegations of possible research misconduct on the part of E    E  D  E  F . You noted that
because of
E    E  D  E  F
would normally be the case. DIO much prefers a careful thorough review and analysis of
allegations to a hasty one, and gladly grants an extension to June 1,2010, to complete the
investigation and provide a report to ORl.
If you have any questions or additional concerns please do not hesitate to contact me.

}rY'
John E. Dahlberg, Ph.D.
Director
Division of Investigative Oversight
Office of Research Integrity

HHS-PSC000394

E   $
FRED HUTCHINSON
Ci\NC1+;

F:r~Ji\i\Cll

CENTER

February 24,2010
Office of the General Counsel

CONFIDENTIAL
John E. Dahlberg, Ph.D.
Director, Division of Investigative Oversight
Office of Research Integrity
U.S. Department of Health and Human Services
1101 Wootton Parkway, Suite 750
Rockville, Maryland 20852
RE:

Request for Extension of Misconduct Investigation

E    E  D  E  F

Dear Dr. Dahlberg:


I am writing on behalf of Fred Hutchinson Cancer Research Center (the "Center") to request an
extension from March 6,2010 to June 1,2010 for completion of the Investigation in the abovementioned matter.
Due to the challenges of communicating with the Respondent,
E    E  D  E  F
the Investigation Committee needs additional time in order
to conduct a thorough Investigation.
Thank you for your consideration of an extension to June 1, 2010 for completion of the
Investigation in the above-mentioned matter. Please contact me at (206) 667-1224 should you
have any questions.
Sincerely,

Gerianne J. Sands
Associate General Counsel

cc:

Dr. Leland H. Hartwell, President and Director of the Center


Dr. Jonathan Cooper, Investigation Committee Member
Dr. Julio Vazquez-Lopez, Investigation Committee Member

HHS-PSC000395

Dahlberg, John E (HHS/OPHS)


From:
Sent:
To:
Cc:
Subject:
Attachments:

Chapman, Claire [cchapman@fhcrc.org]


Wednesday, February 24, 2010 5:54 PM
Dahlberg, John E (HHS/OPHS)
Sands, Gerianne J
E   $
Request for Extension
022410 Letter to ORI from Gerianne Sands re Extension of
nvestigation (final}.pdf

Sensitivity:

Confidential

Dear Dr. Dahlberg:


I attach a letter from Gerianne Sands, Associate General Counsel at Fred Hutchinson Cancer Research Center,
concerning a request for an extension for an Investigation. I have also sent a copy by U.S. Mail in case that is easier for
you.
Thank you for your consideration.
Claire

Claire Chapman

Office of the General Counsel


Fred Hutchinson Cancer Research Center
1100 Fairview Avenue North, J6-205
Seattle, WA 98109-1024
(206) 667-1227; (206) 605-0336 - cell
(206) 667-6590 - fax
This electronic message transmission contains information which may be confidential or privileged. The information is intended to be for the use of the individual
or entity named above. If you are not the intended recipient, be aware that any disclosure, copying, distribution or use of the contents of this information is
prohibited. If you have received this electronic transmission in error. please notify us by telephone at (206) 667-6458 or by electronic reply, and delete this
message.

HHS-PSC000396

Page 1 of 1

E   $
Fleming, Sheila P (HHS/OPHS)
From:

Synan, Kyle C (HHS/OPHS)

Sent:

Friday, October 02, 2009 1:47 PM

To:

Fleming, Sheila P (HHS/OPHS)

Subject: AccessnDB update 4141 & 4177


Sheila,
Dr. Davidian called Gerianne Sands, Fred Hutchinson Cancer Center General Counsel on Friday Oct 2 to
discuss E   $ and 15 They came to the conclusion that
E    E  D  E  F

15

I put Dr. Garfinkels' 9/25/09 phone conversation document fromlinto the existing E   $ . I let Dr. Dahlberg
know of Gerianne Sands call to Dr. Garfinkel and that Dr. 0 th~n called her back and had determined that the 2
calls were related.

HHS-PSC000397
1 1/1 ":;;/')(1(10

CONVERSATION DOCUMENT - CONFIDENTIAL


Division of Investigative Oversight - Office of Research Integrity
Date: 09-25-09
Time: 2:00 p.m.
Est. Dur. 10 min.
ORI Staff: S. Garftnkel
Person Calling / Called (Degree): Gerianne Sands
Affiliation/Address: Fred Hutchinson Cancer Research Center

ORIc

E   $

Office of General Counsel

Email: gisands@fhcrc.org
Phone: 206-667-6590

Fax:

Call Initiated By: Sands

SUBJECT - REASON FOR CALL: advice on ongoing case


SUMMARY OF CONVERSATION:

E    E  D  E  F

TO DO: Wait for inquiry report.


HHS-PSC000398

,. ~ ... -

.'--

.. -

'.

.. '-

E   $
May 19,2010

FRED HUTCHINSON

{i\i'-iCEK RESEARCH CENTER


'\

i Iff

() i

> i, II :',' \ !

lee Hartwell. Ph.D.


President & Director
PO Box: 19024; D1.()6{)
Seattle. WA 9811J9.1024
Tel: 206-6675670 Fax: 206-6675268
E:mail: Ihar1we!@fhClC.org

CONFIDENTIAL, VIA EMAIL <iohn.dahlberg@hhs.gov)


John E. Dahlberg, Ph.D.
U.S. Department of Health and Human Services
Office of Research Integrity
1101 Wootton Parkway, Suite 750
Rockville, Maryland 20852
RE:

Investigation Report

E    E  D  E  F

Dear Dr. Dahlberg:


This letter is sent in accordance with 42 CFR 93.315 to advise you that Fred Hutchinson Cancer
Research Center ("Center") has completed an Investigation of alleged research misconduct in
relation to the above-referenced research funded, in part, by the NIH.
As the Center's President and Director, 1 have reviewed the Center's Investigation Report
("Report") prepared by the Investigation Committee in the above-reference matter. Based on my
review and consideration of the Report, I have
E    E  D  E  F

I enclose a copy of the Report, along with Exhibits A through 1\1, for ORI review in accordance with
42 CFR Part 50. With regard to the Respondent's hard drive, we have included the evidence relied
upon by the Investigation Committee as Exhibits to the Report. We can provide you with any other
evidence that you request.
In the interest of saving some time and paper, I am having the Report and Exhibits sent to you
electronicaLLy. If a hard-copy of the Report and Exhibits would facilitate your review, then please let
Gerianne Sands (the Center's Associate General Counsel and Research Integrity Officer, 206-6671224) know and she can provide that to you.
A considerable amount of data was sequestered at the start of this matter. The Inventory, attached as
Exhibit M to the Report, only includes the evidence considered by the Investigation Committee.
The Inventory does not include evidence sequestered and sent to Harvard Medical School. On April
9, 20lO, Claire Chapman, from the Center's General Counsel's office, spoke with Ann Hohmann,
Ph.D., M.P.H, of your office, who confirmed this was an appropriate approach for the Inventory, and
she suggested that we note that we discussed this with her.

E    E  D  E  F
1100 Fairview Avenue North

P.O. Box 19024

Seattle. WA 98109-1024

Phone: 206 667-5000

www.fhcrc.org
HHS-PSC000399

Please note that ORt granted to the Center an extension of the deadline to complete the Investigation
to June 1,2010.
The Center is notifying Respondent by way of copy of this letter, and is notifying the other funding
agenci<;?s,
1RQ5HVSRQVLYH
by separate correspondence.
If you have any questions or concerns, please contact Ms. Sands at (206) 667-1224.

Leland H. Hartwell, Ph.D.


President and Director
Enclosures (Report and Exhibits A through M)
cc w/encls.:

E    E  D  E  F
Ms. Sands, Associate General Counsel and Research Integrity Officer

E    E  D  E  F

HHS-PSC000400

CONFIDENTIAL

FRED HUTCHINSON CANCER RESEARCH CENTER


INVESTIGATION REPORT
MAY 19,2010
Allegations of Research Misconduct

E   $

CONFIDENTIAL

INVESTIGATION REPORT

Page 1 of16

HHS-PSC000401

TABLE OF CONTENTS

CONFIDENTIAL .......................................................................................................................................................... 3
I.
BACKGROUND ................................................................................................................................................. 3
A.
Factual History ................................................................................................................................................ 3
B.
Data Sequestration .......................................................................................................................................... 4
C.
Pre-Inquiry Preliminary Assessment ............................................................................................................... 4
D.
Inquiry ............................................................................................................................................................. 4
E.
Investigation .................................................................................................................................................... 4
PHS SUPPORT ................................................................................................................................................... 5
II.
III.
INVESTIGATION PROCESS ........................................................................................................................ 6
IV .
ALLEGATION ............................................................................................................................................... 6
V.
INVESTIGATION COMMITTEE FINDINGS/ANALYSIS OF ALLEGATIONS ........................................... 7
VI.
RESPONDENT'S APRIL 1,2010 COMMENTS ON DRAFT INVESTIGATION REPORT .................... 12
See Exhibit J ................................................................................................................................................................ 12
VII.
COMPLAINANT'S APRIL 1,20 I0 AND MAY 6, 20 10 COMMENTS ON DRAFT INVESTIGATION
REPORT See Exhibit K........................................................................................ ;.................................................... 12
VIII.
CONCLUSION ............................................................................................................................................. 12
IX.
CENTER'S PRESIDENT AND DIRECTOR'S DECISION REGARDING INVESTIGATlON ................ 14
X.
E    E  D  E  F

XIII.
XIV.
XV.
XVI.

Exhibit D: December 2, 2008 "Report of Allegations" (J 8 pages) ........................................................... 15


Exhibit E: January 16,2009 Comments from Respondent re Allegations (5 pages) .................................. 15
Exhibit F: May 18,2009 Comments from Respondent re Draft Inquiry Report (2 pages) ......................... 15
Exhibit G: May 18,2009 Comments from Complainant re Draft Inquiry Report (9 pages) ....................... 15
Exhibit H: September 30, 2009 Final Inquiry Report (9 pages)................................................................... 15
Please note, in the interest of consolidating exhibits, the Exhibits A-G to the Inquiry Report are the same as the
Investigation Report above, with one exception. The correspondence on and after November 4, 20 lOin Exhibit C
only apply to the Investigation Report ........................................................................................................................ 15
XVJ1I.
Exhibit I: January 20, 2010 Responses from Complainant to Investigation Committee's Questions (3
pages)
.................................................................................................................................................................. 15
XIX.
Exhibit J: April], 20 I 0 Comments from Respondent re Draft Investigation Report (2 pages) ................. 15
XX.
Exhibit K: April 4, 2010 and May 6, 20 I 0 Comments from Complainant re Draft Investigation Report (32
pages) ................... :.................................................................................................................................................. 15
XXI.
Exhibit L: 2003 Manuscript (unpublished) (19 pages) ............................................................................... 15
XXII. Exhibit M: Inventory (43 pages) ................................................................................................................. 15
XXIII.
Endnotes: .................................................................................................................................................. ] 6

xvn.

CONFIDENTIAL

INVESTIGATION REPORT

Page 2 of 16

HHS-PSC000402

CONFIDENTIAL

MEMORANDUM

DATE:
TO:

May 19,2010
Dr. Lee Hartwell, President and Director
Dr. Mark Groudine, Executive Vice President and Deputy Director

FROM:

Dr. Jonathan Cooper, Investigation Committee Member


Dr. Julio Vazquez-Lopez, Investigation Committee Member

Re:

Investigation Report
Allegations of Research Misconduct Investigation, Case E   $
Respondent E    E  D  E  F

I. BACKGROUND

A. Factual History
In early August of 2007, Fred Hutchinson Cancer Research Center ("Center") management
received a report of suspected research misconduct ("Case E   $ related to a E    E  D  E  F
The first author of the article is E    E  D  E  F
("Respondent"), who was principally responsible for the research and manuscript as a

E    E  D  E  F

E    E  D  E  F

CONFIDENTIAL

INVESTIGATION REPORT

Page 3 of 16

HHS-PSC000403

that article will be necessary because E    E  D  E  F confirmed that Respondent only


contributed a minor piece of confirmatory data to that article.
B. Data Sequestration

E    E  D  E  F
c.

Pre-Inquiry Preliminary Assessment

On March 18, 2008.


E    E  D  E  F
to review Respondent's work while at the Center. On July 29. 2008, we concluded in the
PreJiminary Assessment Committee Report that an Inquiry should proceed E    E  D  E  F
D. Inquiry
On November 10. 2008. Dr. Hartwell appointed us to serve as the Inquiry Committee and
charged us with conducting a preliminary review of the allegations of research misconduct
("Inquiry") under the Center's "RC?search Misconduct Policy and Procedures" ("Policy"), a copy
of which is attached as Exhibit BVl. and to make findings and recommendations to Dr. Hartwell,
President and Director of the Center, for appropriate action. On September 17, 2009, we
submitted our final Inquiry Report to Dr. Hat1well.
E    E  D  E  F
E. Investigation
On November 4. 2009 Dr. Hartwell sent to Respondent a letter notifying
of the
Investigation, attached as Exhibit C. On November 7, 2009, the Investigation commenced upon
the Center receiving Respondent's email that he had received Dr. Hartwell's letter notifying him
of the Investigation. On November 12,2009, Dr. Hartwell sent to Respondent a letter notifying
him of the allegation of research misconduct, attached as Exhibit C.
E    E  D  E  F

On November 9, 2009, Dr. Hartwell appointed us to serve as the Investigation Committee and
charged us with conducting a review of the allegation of research misconduct ("Investigation")
under the Center's Policy, and to make findings and recommendations to Dr. Hartwell. President
and Director of the Center, for appropriate action.
This is the Investigation RepOlt that makes those findings and recommendations. As
Investigation Committee' members. we agreed to conduct the Investigation in an objective
manner free of bias. conflicts of interest (personal. professional or financial) or conflicts of

CONFIDENTIAL

INVESTIGATION REPORT

Page 40f16

HHS-PSC000404

commitment. Respondent did not object to our appointment to the Investigation Committee.
(See Exhibit C).
The Investigation Committee's contact with Respondent,

E    E  D  E  F

In a November 12, 2009 letter sent by email, and again, in a December email, Respondent was
offered the opportunity to be interviewed by the Investigation Committee. (See Exhibit C). On
December 7,2009, in an email, Respondent declined the opportunity to be interviewed bythe
Investigation Committee by phone or in person. (See Exhibit C).
On December 16, 2009, we met as the Investigation Committee to discuss the matter.
On December 18, 2009, in lieu of an interview, we submitted questions for written answers to

E    E  D  E  F

On January 20, 2010,

E    E  D  E  F

responded in writing to our questions. (See Exhibit I),

On January 28, 2010, we sent E    E  D  E  F responses to Respondent, and on January 28, 2010,
Respondent declined to comment. (See Exhibit C).
On February 8, 2010, we met as the Investigation Committee to discuss E    E  D  E  F
and our findings.
On March 4, 2010, a draft of this Investigation Report was shared with Respondent and
Complainant. On April I, 2010, Respondent sent to us
comments to the draft Investigation
Report. On April 4, 2010 and May 6, 2010, Complainant sent to us
comments to the draft
Investigation Report. Their comments on the draft are attached as Exhibit J and Exhibit K,
respectively.
E    E  D  E  F

E    E  D  E  F

On May 12,2010, a final, draft Investigation Report was sent to Dr. Hartwell. On May 19,2010,

II.

E    E  D  E  F

E    E  D  E  F

E    E  D  E  F
CONFIDENTIAL

INVESTIGATION REPORT

Page 5 of 16

HHS-PSC000405

III. INVESTIGATION PROCESS


The purpose of the Investigation is to provide a finding as to whether, by a preponderance of
evidence (i.e. more likely than not, 50+%), research misconduct did or did not occur for each
separate Allegation of research misconduct identified during the Investigation. At the time the
work was done and the 2005 Manuscript was published, "scientific misconduct," which we will
refer to as "research misconduct," was defined by the former Center "Policy For Dealing With
And Reporting Possible Scientific Misconduct in Research," and the former PHS Final Rule, 42
CFR Part 93 as intentional or knowing "fabrication, falsification, plagiarism, or other practices
that seriously deviate from those that are commonly accepted within the scientific community for
proposing, conducting, or reporting research." Although the fonner Center policy did not
specifically define "fabrication" or "falsification," federal policy defined these terms as foIloW:
"fabrication" means "making up data or results and recording or reporting them;"
and
"falsification" means "manipulating research materials, equipment, or processes
or changing or omitting data or results such that the research is not accurately
represented in the research record."
See Office of Science and Technology Policy (65 FR 76260, December 6, 2000). The phrase "or
other practices that seriously deviate from those that are commonly accepted within the scientific
community" is not defined by law or regulation and remains a matter of interpretation.
Specifically excluded from the definition are "honest error or honest differences in interpretation
or judgments of data." These definitions come from the policy and regulations that were in
effect at the time that the
E    E  D  E  F , so we have been advised by the RIO
that this is the standard that is applicable to our review of this matter. The procedures used in the
Investigation were consistent with the current PHS Regulations, 42 CFR Part 93 and the current
Center Policy.

IV. ALLEGATION

E    E  D  E  F

CONFIDENTIAL

INVESTIGATION REPORT

Page 6 of 16

HHS-PSC000406

V. INVESTIGATION COMMITTEE FINDINGS/ANALYSIS OF ALLEGATIONS


The Investigation Committee addressed whether the following two-part test for research
misconduct was met:

E    E  D  E  F

~ONFIDENTIAL

INVESTIGATION REPORT

Page 7 of 16

HHS-PSC000407

E    E  D  E  F
Basis for findings

E    E  D  E  F

CONFIDENTIAL

INVESTIGATION REPORT

Page 8 of16

HHS-PSC000408

E    E  D  E  F

CONFIDENTIAL

INVESTIGATION REPORT

Page 9 of 16

HHS-PSC000409

E    E  D  E  F

CONFIDENTIAL

INVESTIGATION REPORT

Page 10 of 16

HHS-PSC000410

E    E  D  E  F

CONFIDENTIAL

INVESTIGATION REPORT

Page 11 of16
HHS-PSC000411

E    E  D  E  F
VI. RESPONDENT'S APRIL I. 2010 COMMENTS ON DRAFT INVESTIGATION
REPORT
See Exhibit J.
VII. COMPLAINANT'S APRIL I. 2010 AND MAY 6, 2010 COMMENTS ON DRAFT
INVESTIGATION REPORT
See Exhibit K.
VIII. CONCLUSION

E    E  D  E  F

E    E  D  E  F
CONFIDENTIAL

INVESTIGATION REPORT

Page 12 of16

HHS-PSC000412

E    E  D  E  F

CONFIDENTIAL

INVESTIGATION REPORT

Page 13 of 16

HHS-PSC000413

IX. CENTER'S PRESIDENT


INVESTIGATION

AND

DIRECTOR'S

DECISION

REGARDING

E    E  D  E  F
Dr. Leland Hartwell, President and Director

CONFIDENTIAL

May 19,2010

INVESTIGATION REPORT

Page 14 of 16

HHS-PSC000414

E    E  D  E  F

X. Exhibit A:

XI. Exhibit B: Center Research Misconduct Policy ("Policy") (8 pages)


XII.

Exhibit C: Center Correspondence with Respondent

A. November 10, 2008 Letter from Dr. Hartwell to Respondent re Notification of Allegations and
Initiation ofInquiry
B. December 5, 2008 Letter from the RIO to Respondent re Inquiry Committee's December 2, 2008
Report of Allegations
C. December 12 and 17,2008 Letters from the RIO to Respondent, re: Inquiry Committee's December 2,
2008 Report of Allegations
D. November 4,2009 Letter from RIO to Respondent re: Notification of Commencement of Misconduct
Investigation
E. November 12,2009 Letter from the RIO to Respondent re: Commencement of Research Misconduct
Investigation
F. December 7, 2009 Email response from Respondent re: Commencement of Research Misconduct
Investigation (No objections to Investigation Committee Members and Respondent's right to be
interviewed)
G. January E    E  D  E  F
28,2010 Email to Respondent and from Respondent re: Investigation Committee'S Written
Questions to
H. Mal'ch 4, 2010 Letter from the RIO to Respondent re: Draft Investigation Report

XIII.

Exhibit D: December 2, 2008 "Report of Allegations" (18 pages)

XIV.

Exhibit E: January 16, 2009 Comments from Respondent re Allegations (5 pages)

XV.

Exhibit F: May 18,2009 Comments from Respondent re Draft Inquiry Report (2 pages)

XVI.

Exhibit G: May 18, 2009 Comments from Complainant re Draft Inguity Report (9

XVII. Exhibit H: September 30, 2009 Final Inquiry Report (9 pages)

E    E  D  E  F
XVIII. Exhibit I: January 20,2010 Res,ponses from Complainant to Investigation Committee's
Questions (3 pages)
XIX.

Exhibit J: April I, 20) 0 Comments from Respondent re Draft Investigation Report (2

XX. Exhibit K: April 4, 2010 and May 6, 2010 Comments from Complainant re Draft
Investigation Report (32 pages)
XXI.

Exhibit L:

E    E  D  E  F

XXII. Exhibit M: Inventory (43 pages)

CONFIDENTIAL

INVESTIGATION REPORT

Page 15 of 16

HHS-PSC000415

XXllI.Endnotes!

E    E  D  E  F

CONFIDENTIAL

INVESTIGATION REPORT

Page 16 of 16

HHS-PSC000416

E    E  D  E  F

HHS-PSC000417

E    E  D  E  F

HHS-PSC000418

E    E  D  E  F

--"'

HHS-PSC000419

E    E  D  E  F

HHS-PSC000420

E    E  D  E  F

HHS-PSC000421

E    E  D  E  F

HHS-PSC000422

FRED HUTCHINSON CANCER RESEARCH CENTER


RESEARCH MISCONDUCT POLICY AND PROCEDURES
RESTATED 3114107

In all of its research activities, Fred Hutchinson Cancer Research Center (the "Center") expects the highest
standards of professional conduct. The enterprise of scientific research relies upon the trust and confidence
of both the scientific community and the public at large. Unethical behavior undermines confidence in the
reliability of science and the integrity of the Center. For these reasons, the Center considers misconduct in
science a betrayal of fundamental scientific principles and shall deal with all instances of possible research
misconduct firmly in accordance with the Center's Research Misconduct Policy and Procedures ("Policy").
Situations that do not constitute research misconduct may be reviewed under the Center's other policies,
including but not limited to the Center's Research Integrity Policy and Procedures. In some cases, the
alleged conduct under review may be subject to both this Policy and the Center's Research Integrity Policy.

This Policy is developed to prevent, detect and deal with possible research misconduct in the Center's
research programs. It is designed to balance the need to deal firmly and effectively with allegations of
possible research misconduct with the need for openness and creativity in the scientific enterprise. In
responding to allegations of research misconduct, the Center also must comply with all applicable laws and
regulatory requirements of federal agencies supporting the research in question, as well as Center policies
and procedures. In cases involving research funded by the U.S. Department of Health and Human Services
("HHS"), the Office of Research Integrity ("OR!") oversees the Center's compliance with HHS research
misconduct regulations (~ Exhibit "AD). In cases involving research funded by the National Science
Foundation rNSF") ~ Exhibit "B") and other federal agencies, the Office of the Inspector General ("OIG")
generally carries out enforcement of research misconduct regulations. This Policy will refer throughout simply
to ORI except in those instances In which the procedures mandated by NSF regulations differ from those
imposed by HHS.
The Center's President and Director ("Director"} has the final authority and responsibility for defining the
ethical standards for the Center.
This Policy replaces in its entirety the Center's prior policy dated September 24, 2003.

The Center expects intellectual honesty in all of its endeavors. All employees should maintain open
communication, submit work for peer review, disclose and cooperate in the management of conflicts of
interest, commit to self-regulation. and comply with Center processes for the disclosure and management of
conflicts of interest. (See: http://www.fhcrc.org/intranetlgeneral counsel/conflict interest 2002.pdf)
The Center shall educate and inform all employees regarding Its ethical standards, its guidelines for
conducting and reporting research, its philosophy and policy of dealing with and reporting possible research
misconduct and the importance of complying with the relevant policies and procedures.
As a regular element of its policy of maintaining the highest possible standard of scientific productivity, the
Center will continue to maintain a regular and rigorous system of review of the quality of the scientific
programs of its investigators.

HHS-PSC000423

RESEARCH MISCONDUCT POLICY AND PROCEDURES


The Center's Director shall appoint a Research Integrity Officer to (I) assist with the education of all staff and
employees regarding the Center policies and procedures relating to research misconduct; (ii) provide
clarification and information to Individuals with concerns regarding potential incidents of misconduct; (iii) assist
Individuals in understanding the Center's policies and procedures In this area; (Iv) assist with the
administration of this Policy including Inquiries and Investigations conducted pursuant to this Policy; and (v)
provide mediation services where Indicated.
The Center shall periodically evaluate its policy and procedures for educating its staff about the proper
conduct of research and assess whether additional efforts are necessary.

Research misconduct means fabrication, falsification, or plagiarism in proposing, performing, or reviewing


research, or In reporting research results.
Fabrication means making up data or results and recording or reporting them.
Falsification means manipulating research materials, equipment, or processes, or changing or omitting data or
results such that the research Is not accurately represented in the research record.
Plagiarism means the appropriation of another person's ideas, processes, results, or words without giving
appropriate credit.
Research misconduct does not include honest error or honest differences in interpretations or judgments of
data.
A finding of research misconduct requires that (i) there is a significant departure from accepted practices of
the relevant research community; (Ii) the misconduct is committed intentionally, knowingly, or recklessly; and
(iii) the allegation of research misconduct is proven by a preponderance of the evidence. There may be a
different standard of proof for misconduct under other Center policies.

The procedures described in this Policy represent the general approach to be employed by the Center In
instances of possible research misconduct, since no policy and procedures can anticipate every possible
issue that might arise in the course of an inquiry or investigation. The Center's Director is responsible for
implementing these procedures and modifying them as necessary to ensure adherence to the Policy.
I.

CONFIDENTIALITY

To the extent allowed by law, the Center shall maintain the identity of the individual(s) against whom the
allegation of research misconduct is made ("respondents") and the individual(s) bringing forward the allegation
(complainants~) securely and confidentially and shall not disclose any Identifying information, except to:
A. those who need to know in order to carry out a thorough, competent, objective and fair research
--misconduct llroceeding;and
B. ORI as it conducts its review of the research misconduct proceeding and any subsequent
proceedings.
To the extent allowed by law, any information obtained during the research misconduct proceeding that might
identify the subjects of research shall be maintained securely and confidentially and shall not be disclosed,
except to those who need to know in order to carry out the research misconduct proceeding.
The Center prohibits retaliation of any kind against a person who, acting in good faith, reports or provides
Information about suspected misconduct.

HHS-PSC000424

RESEARCH MISCONDUCT POLICY AND PROCEDURES


II. RESEARCH MISCONDUCT PROCEEDINGS-CRITERIA. REPORTS. ANP TIME LlMITATIONS1

A. Preliminary Assessment
Disclosures of possible research misconduct received by the Center through any means of
communication ("Allegation") shall be promptly referred to the director of the division In which the
alleged research misconduct occurred ("Division Director"). The Division Director shall assess the
Allegation to determine if:
1. It meets the definition of research mlsconduct2;
2. It involves Public Health Service ("PHS") supported research, applications for PHS
research support, or research records 3 ;
3. it is sufficiently credible and specifiC so that potential evidence of research misconduct
may be identified; and
4. it Is tlmely.4
If the Division Director determines that these criteria have not been met, then the matter will not
proceed to inquiry and may be reviewed under the Center's other policies, including but not limited to
the Center's Research Integrity Policy and Procedures. If the Center's Division Director determines
that these criteria have been met, then the matter will proceed to inquiry.
B. Inquiry5.
An Inquiry is an initial review of the evidence to determine if the criteria for conducting an investigation
have been met. The criteria for determining whether or not an investigation may be required Include a
finding that:
1. There is a reasonable basis for concluding that the Allegation falls within this Policy's
definition of research misconduct; and
2. The preliminary review of the facts indicates that the Allegation has substance.
The Center shall complete the inquiry, including preparation of the inquiry report and giving the
respondent a reasonable opportunity to comment on it, within sixty (60) calendar days of its initiation,
unless the circumstances warrant a longer period. If the inquiry takes longer than sixty (60) days to
complete, the Center shall include documentation of the reasons for the delay In the inquiry record.
The Inquiry report shall contain the following information:
1. The name and position of the respondent;
2. A description of the Allegation of research misconduct;
3. The PHS support Involved, including, for example, grant numbers, grant applications.
contracts, and publications listing PHS support;
4. The basis for recommending that the alleged actions warrant an investigation; and
5. Any comments on the report by the respondent or the complainant.
The Center's Director will make a written determination of whether an Investigation Is warranted. If the
Center's Director determines that an investigation is not warranted, 1henthe matter maybe reviewed
1 NSF proceeding requirements can be found in 45 CFR Section 689.4 and Section 689.6 (See Exhibit B). In
absence of any specific requirements, the Center may follow the HHS requirements.
2 The definition of research misconduct can be found above and in 42 CFR Section 93.1 03 ~ Exhibit A)
and/or in 45 CFR Section 689.1 ~ Exhibit B).
3 HHS describes research In 42 CFR Section 93.1 02(b) ~ Exhibit A}. NSF describes research in 45 CFR
Section 689.1 ~ Exhibit B).
" In cases involving PHS supported research, the time limitations can be found in 42 CFR Section 93.103 (See
Exhibit A).
5NSF time limitations and extensions for an Inquiry can be found In 45 CFR Section 689.4 (See Exhibit B).

HHS-PSC000425

RESEARCH MISCONDUCT POLICY AND PROCEDURES


under the Center's other policies, Including but not limited to the Centers Research Integrity Policy
and Procedures, if warranted in the sole discretion of the Center's Director.
C. InvestigatlonB
If the Center's Director determines that an investigation is warranted, then the Center shall begin the
Investigation within thirty (30) calendar days of that determination and, on or before the date on which
the investigation begins, send the inquiry report and the written determination to ORI. The Center
shall use its best efforts to complete the investigation within one hundred and twenty (120) calendar
days of the date on which it began, including conducting the investigation, preparing the report of
findings, providing the draft report for comment, and sending the final report to ORI. If it becomes
apparent that the Center cannot complete the investigation within that period, the Center shall
promptly request an extension in writing from ORI.
In conducting all investigations, the Center shall:
1. Use diligent efforts to ensure that the investigation is thorough and Sufficiently
documented and includes examination of all research records and evidence relevant to
reaching a decision on the merits of the Allegation;
2. Interview each respondent, complainant, and any other available person who has been
reasonably identified as having information regarding any relevant aspects of the
investigation, including witnesses identified by the respondent. and record or transcribe each
interview, provide the recording or transcript to the interviewee for correction, and include the
recording or transcript in the record of investigation;
3. Pursue diligently all significant issues and leads discovered that are determined relevant
to the investigation. including any evidence of additional Instances of possible research
misconduct, and continue the investigation to completion; and
4. Otherwise comply with the requirements for conducting an investigation 7
The Center shall prepare the draft and final institutional investigation reports in writing and provide the
draft report for comment as provided elsewhere in these poliCies and procedures and as required by
law8 . The final investigation report shall:
1. Describe the nature of the Allegation of research misconduct;
2. Describe and document the PHS support, including, for example any grant numbers,
grant applications, contracts, and publications listing PHS support;
3. Describe the specific Allegation of research misconduct considered in the investigation;
4. Include the Center's policies and procedures under which the investigation was
conducted, If not already provided to ORI;
5. Identify and summarize the research records and evidence reviewed, and Identify any
evidence taken into custody, but not reviewed. The report should also describe any
relevant records and evidence not taken into custody and explain why.
6. Provide a finding as to whether research misconduct did or did not occur for each
separate Allegation of research misconduct identified during the investigation, and If
misconduct was found:
a. id~ntify itas-faISificstion,fabric:stioh, or plagiarism and whether it was intentional,
knowing, or in reckless disregard;
b. summarize the facts and the analysis supporting the conclusion and consider the
merits of any reasonable explanation by the respondent and any evidence that rebuts
the respondent's explanations;
c. identify the specific PHS support;
NSF requirements for an inquiry can be found in 45 CFR Section 689.4 ~ Exhibit B).
HHS requirements for conducting an investigation can be found in 42 CFR Section 93.310 ~ Exhibit A).
NSF requirements for conducting an investigation can be found in 45 CFR Section 6S9.6 ~ Exhibit B).
8 HHS requirements for Investigation reports can be found In 42 CFR Section 93.312 ~ Exhibit A). NSF
requirements for Investigation reports can be found in 45 CFR Section 689.6 ~ Exhibit B).
6

HHS-PSC000426

RESEARCH MISCONDUCT POLICY AND PROCEDURES


d. identify any publications that need correction or retraction;
e. identify the person(s) responsible for the misconduct, and
f. list any current support or known applications or proposals for support that the
respondent has pending with non-PHS Federal agencies.
7. Include and consider any comments made by the respondent and complainant on the
draft investigation report.
The Center shall maintain and provide to ORI upon request all relevant research records and records of the
Center's research misconduct proceeding, Including results of all interviews and the transcripts or recordings
of such interviews.
III, ENSURING A FAIR RESEARCH MISCONDUCT PROCEEDING
The Center shall take all reasonable steps to ensure an impartial research misconduct proceeding to the
maximum extent practicable. The Center shall select those conducting the Inquiry or Investigation on the
basis of scientific expertise that Is pertinent to the matter and, prior to selection, the Center shall screen them
for any unresolved personal, profeSSional, or financial conflicts of Interest with the respondent, complainant,
potential witnesses, or others involved in the matter. Any such conflict which a reasonable person would
consider to demonstrate potential bias shall disqualify the Individual from selection.
A. Notice to Respondent and Complainanti~
During the research misconduct proceeding, the Center shall provide the following notifications to all
identified respondents 10:
B. Initiation of Inguiry.
Prior to or at the beginning of the inquiry, the Center shall provide the respondent written notification of
the inquiry and contemporaneously sequester all research records and other evidence needed to
conduct the research misconduct proceeding. If the inquiry subsequently identifies additional
respondents. they shall be promptly notified in writing.
C. Comment on Inguirv Report.
The Center shall provide the respondent, and may provide complainant at the Center's discretion, an
opportunity to comment on the inquiry report in a timely fashion so that any comments can be
aHached to the report. If there is more than one respondent, then the Center may prepare separate
reports to preserve confidentiality.
D. Results of the Inquiry.
The Center shall notify the respondent. and may notify the complainant at the Center's discretion, of
the results of the inquiry and attach to the notification copies of the inquiry report and the Center's
policies and procedures for the handling of research misconduct Allegations.
E. Initiation of Investigation.
Within a reasonable time after the Center's determination that an investigation is warranted, but not
later than thirty (30) calendar days after that determination, the Center shall notify the respondent, and
may notlfy1he complalnant-at the eenter'sdiscretion, in-writing-of the Allegation to-be investigated.
The Center shall give respondent written notice of any new Allegation within a reasonable time after
determining to pursue any Allegation not addressed in the inquiry or in the initial notice of the
investigation.

" NSF notification requirements can be found In 45 CFR Section 689 (See Exhibit B).
10 ORI notification requirements can be found in 42 CFR Section 93.309(a) (See Exhibit A). NSF notification
requirements can be found in 45 CFR Section 689 (See Exhibit B).

HHS-PSC000427

RESEARCH MISCONDUCT POLICY AND PROCEDURES

F. Scheduling of Interview.
The Center will notify the respondent sufficiently in advance of the scheduling of hisJher interview in
the investigation so that the respondent may prepare for the interview and anange for the attendance
of legal counsel at his/her own expense, if the respondent wishes.
G. Comment on Draft Investigation Report.
The Center shall give the respondent, and may provide the complainant at the Center's discretion, a
copy of the draft investigation report, and concurrently, a copy of, or supervised access to, the
evidence on which the report is based and notify the respondent and complainant that any comments
must be submitted within thirty (30) days of the date on which he/she received the draft report. If there
is more than one respondent, then the Center may prepare separate reports to preserve
confidentiality. The Center shall ensure that these comments are Included and considered in the final
investigation report.
IV. NOTIFYING ORI OF THE DECISION TO OPEN AN INVESTIGATION AND OF INSTITUTIONAL
FINDINGS AND ACTIONS FOLLOWING THE INVESTIGATION

On or before the date on which the Investigation begins (the investigation must begin within thirty (30)
calendar days of the Center's finding that an investigation is warranted), the Center shall provide ORI with the
written finding by the Center's Director and a copy of the Inquiry report containing the Infonnation required by
law11. Upon a request from ORI, the Center shall promptly send to ORI:
1. a copy of the Center's policies and procedures under which the inquiry was conducted;
2. the research records and evidence reviewed, transcripts or recordings of any interviews. and copies
of all relevant documents; and
3. the charges for the investigation to consider.
The Center shall promptly provide to ORI after the investigation:
1. a copy of the investigation report and all attachments;
2. a statement of whether the Center found research misconduct and, if so, who committed It;
3. a statement of whether the Center accepts the findings in the investigation report; and
4. a description of any pending or completed administrative actions against the respondent.
V. MAINTENANCE AND CUSTODY OF RESEARCH RECORDS AND EVIDENCE~

The Center shall take the following specific steps to obtain, secure, and maintain the research records and
evidence pertinent to the research misconduct proceeding:
A. Either before or when the Center notifies the respondent of the Allegation, the Center shall
prompUy take all reasonable and practical steps to obtain custody of all research records and
evidence needed to conduct the research misconduct proceeding, inventory those materials, and
sequester them in a secure manner. As an exception, in those cases where the research records or
evidence encompass scientific instruments shared by a number of users, custody may be limited to
copies of the data or evidence on such instruments, so long as those copies are substantially
equivalent to the evidentiary value of the instruments.
B. Where appropriate, tMCenter shall givetne respondent copies of, or reasonable, supervised
access to the research records.
C. The Center shall undertake all reasonable and practical efforts to take custody of additional
research records and evidence discovered during the course of the research misconduct proceeding.
including at the inquiry and investigation stages, or if new Allegations arise, subject to the exception
for scientific instruments in A. above.

11

12

~ 42 CFR Section 93.309(a) (See Exhibit A) and/or 45 CFR Section 689.4 (!! exhibit B).
NSF requirements for records and evidence can be found in 45 CFR Section 689 (See Exhibit B).

HHS-PSC000428

RESEARCH MISCONDUCT POLICY AND PROCEDURES


D. The Center shall maintain all records of the research -misconduct proceeding 13, for seven (7)
years after completion of the proceeding, or any ORI or HHS proceeding 14, whichever is later, unless
the Center has transferred custody of the records and evidence to HHS, or ORI has advised the
Center that it no longer need to retain the records.
VI. INTERIM PROTECTIVE ACTIONS
At any time during a research misconduct proceeding. the Center shall take appropriate Interim actions to
protect public health, federal funds and equipment, and the integrity of the PHS supported research process.
The necessary actions will vary according to the circumstances of each case, but examples of actions that
may be necessary include delaying the publication of research results, providing for closer supervision of one
or more researchers, requiring approvals for actions relating to the research that did not previously require
approval, auditing pertinent records, or taking steps to contact other institutions that may be affected by an
Allegation of research misconduct.
VII. NOTIFYING ORI OF SPECIAL CIRCUMSTANCES THAT MAY REQUIRE PROTECTIVE ACTIONSH
At any time during a research misconduct proceeding, the Center shall notify ORI immediately If the Center
has reason to believe that any of the following conditions exist:
A. Health or safety of the public is at risk, including an immediate need to protect human or animal
subjects.
B. HHS resources or interests are threatened.
C. Research activities should be suspended.
D. There is a reasonable indication of violations of civil or criminal law.
E. Federal action is required to protect the interests of those involved in the research misconduct
proceeding.
F. The Center believes the research misconduct proceeding may be made public prematurely, so
that HHS may take appropriate steps to safeguard evidence and protect the rights ofthose involved.
G. The Center believes the research community or public should be informed.
VIII. INSTITUTIONAL ACTIONS IN RESPONSE TO FINAL FINDINGS OF RESEARCH MISCONDUCT
The Center will cooperate with and assist ORI and HHS as needed, to carry out any administrative actions
those agencies may impose as a result of a final finding of research misconduct.
Violations of this Research Misconduct Policy and Procedures may result in discipline up to and including
termination of employment.
Situations that do not constitute research misconduct may be reviewed under the Center's other policies,
including but not limited to the Center's Research Integrity Policy and Procedures.
IX. RESTORING REPUTATIONS

A. Responaents.The Center shelll undertake all reasonal5le iffons to proteCt and restore the
reputation of any person alleged to have engaged in research misconduct. but against whom no
finding of research misconduct was made, if that person or his/her legal counselor other authorized
representative requests that the Center do so.
B. Complainants. Witnesses, and Committee Members. The Center shall undertake all reasonable
efforts to protect and restore the position and reputation of any complainant, witness, or committee
13 The

HHS definition for records is defined in 42 CFR Section 93.317(a) ~ Exhibit A).
The HHS description of proceedings can be found in Subparts 0 and E of 42 CFR Part 93 (see Exhibit A).
15 NSF notification requirements can be found in 45 CFR Section 689 (See Exhibit B).
14

HHS-PSC000429

RESEARCH MISCONDUCT POLICY AND PROCEDURES


member and to counter potential or actual retaliation against those complainants, witnesses and
committee members.

X. COOPERATION WITH OHlli


The Center shall cooperate fully and on a continuing basis with ORI during its oversight reviews of this
Institution and its research misconduct proceedings arid during the proc.ss under which thetespOndent may
contest ORI findings of reaearchmisconduct and proposed HHSadminlstrative actions; this Includes
providing, as necessary to develop a complete record of relevant evidence. all witnesses, research records,
and other evidence under the Center's control or custody, or In the possesSion of, or accesSible to, all persons
that are subject to the Center's authOrity.
Reporting to QRI The Center will report to ORI any proposed settlements, admissions of research
misconduct, or the Center's findings of misconduct as required by law.
Exhibit A: 42 CFR Part 93 (See: http://ori.dhhs.gov/documents/42

cfr parts 50 and 93 2005.Pdf

Exhibit B: 45 CFR Section 689 (See: http://www.nstgov/oiglresmisreg.pdO

16

The Center will cooperate with NSF as required under 45 CFR Section 689

c.su Exhibit B).

.,

HHS-PSC000430

Exhibit C: Center Correspondence with Respondent


A. November 10, 2008 Letter from Dr. Hartwell to Respondent re
Notification of Allegations and Initiation of Inquiry

HHS-PSC000431

II

FRED
HUTCHINSON
CANCER
RESEARCH

CENTEFI

Lee Hartwell, Ph.D.


President and Director
Phone: 206-667-5670

Pax: 2066675268

November 10, 2008

CONFIDENTIAL VIA FEDERAL EXPRESS

E    E  D  E  F
Re: Formal Notice of Inquiry Into Allegations
of Research Misconduct
E    E  D  E  F

This letter serves as a formal notice that Fred Hutchinson Cancer Research Center

("Center") will be conducting an inquiry into allegations of research misconduct


("Inquiry") that have been raised related to the research conducted by you that was

E    E  D  E  F
As you will see from a review of the Inquiry process, it is critical that you submit a written
response to the Center within 30 days of your receipt of this letter and fully participate in
the process described below. I would like to briefly review the definition of research
misconduct, the allegations, and the Inquiry process under Center policy.
Definition of Research/Scientific Misconduct
As required by federal regulations, the Center has established its own research misconduct
policies and procedures for investigating and reporting alleged research misconduct
("Policy',). Included in the Policy are tenus that are used throughout an Inquiry.

E    E  D  E  F
HHS-PSC000432

E    E  D  E  F

November 10. 2008


Page 2

CONFIDENTIAL

The pwpose of the Inquiry is to determine whether sufficient evidence of research


misconduct exists to WlUTant further investigation. At the time the work was done and the
2005 Manuscript was published. "scientific misconducf" was defmed by the fonner Center
"Policy For Dealing With And Reporting Possible Scientific Misconduct in Research." and
the fonner PHS Final Rule, 42 CFR Part 93 8S "fabrication, falsification. plagiarism, or
other practices that seriously deviate from those that are commonly accepted within the
scientific community for proposing. conducting, or reporting research." Although the
former Center Policy did not specifically define "fabrication" or "falsification,h federal
policy defined these tenDs as follows:
"fabrication" means "making up data or results and recording or reporting
them;" and

"faisifieation" means "manipulating research materials, equipment, or


processes or changing or omitting data or results such that the research is
not accurately represented in the research record."
~ Office of Science and Technology Policy (65 FR 76260, December 6, 2000). The
phrase "or other practices that seriously deviate from those that are commonly accepted
within the scientific community" is not defined by law or l'egWation and remains a matter
of interpretation.

Specifically excluded from the definition were "honest error or honest differences in
interpretation or judgments of data.,. These definitions come from the policy and
regulations that were in effect at the time that the 2005 Manuscript was published, so this is
what the Center will use. The procedures of the Inquiry will be conducted in accordance
with the cUlTent PHS Regulations, 42 CFR Part 93 and the Center's current "Research
Misconduct Policy and Procedures, a copy of which is enclosed." If you would like to
have copies of the regulations. please let Gerianne Sands, the Center's Associate General
Counsel and Research Integrity Officer, know.
Speeifie AUegatiODS

E    E  D  E  F
2I

will refer to scientific misconduct as research misconduct.

HHS-PSC000433

E    E  D  E  F

November 10, 2008


Page 3

CONFIDENTIAL

E    E  D  E  F

I encourage you to send a written response to these allegations as quickly as possible. but
no later than 30 days from your receipt of this letter. Ms. Sands will be managing the
Inquiry, so you can submit your response to Ms. Sands. and she will forward your response
to me and to the Inquiry Committee. Should the Inquiry Committee require additional
information from you or wish to speak with you directly. you will be notified by Ms.
Sands. Ms. Sands can be reached at:

Oerianne J. Sands
Fred Hutchinson Cancer Research Center
1100 Fairview Avenue North
Mail StopJ6-20S
Seattle, Washington 98109-1024
(206) 667-1224
gjsands@ihcrc.ol'g
Inquirv Process

The Inquiry process is an information-gathering and initial fact-finding process to


determine whether the allegations of research misconduct warrant formal inVestigation.
The purpose of the Inquiry is to cull out any insufficiently substantiated, eIToneous, or bad
faith allegations before a respondent is subjected to an investigation. The Inquiry does not
retum a finding whether research misconduct has occurred. but rather determines only
whether a fonnal investigation is warranted.
Consistent with federal requirements, steps have been taken to secure original research
records for the duration of this review. Ifthere are further relevant original records or data
relating to this matter that you have in your possession, please let Ms. Sands know
immediately. In no case should any existing record be destroyed or altered.

HHS-PSC000434

E    E  D  E  F

November 10.2008
Page 4

CONFIDENTIAL

It is the Center's goal to conduct a fair, thorough. and objective review according to the
E    E  D  E  F
Inquiry procedures outlined in the Center's Policy.
This committee will
review evidence and may interview you and others. by person or by telephone, who may
have relevant information. Any interviews may be tape recorded and transcribed. You
may have an attorney come with you to your interview to advise you if you wish.

During the course of the Inquiry, if you need access to the original research records and
other evidence submitted or sequestered in this case, which evidence Ms. Sands has
secured and inventoried. then please contact her. When you need to examine original
evidence. Ms. Sands, or someone from her office. will be present to assure that it is kept in
order and so that the chain of custody cannot be challenged.
If, during the course of the Inquiry, additional information becomes available that
substantially changes the subject matter of the Inquiry. or would suggest additional
respondents or amending the allegations, then Ms. Sands will notify you of the new subject
matter or provide notice to additional respondents.
.At the conclusion of the Inquiry. the Inquiry Committee will draft a report to me. as the
Center's President and Director, as to whether or not, based on its review, further
investigation is warranted. The format of the Inquiry Report is described in Section n.B. of
the Policy. For each allegation, the Inquiry Committee should decide that an investigation
is warranted if it fmds:
A reasonable basis for concluding that the allegation falls within the
definition of research misconduct; and
The allegation may have substance, based on the Inquiry Committee's
preliminary review.
The Inquiry Committee should cite in its report the pertinent evidence and the committee's
basis for recommending whether or not an investigation is wananted.
Ms. Sands will provide you with a copy of the draft report, and you will be given the
opportunity to review and make comments on it As the result of your comments, the
Inquiry Committee may change its report, and at the very least, your comments will be
appended to the final report provided to me. As President and Director of the Center. I will
make the final i:letermination as to whether or not the matter will' proceed to investigation.
Please understand that you are to take no steps to retaliate against anyone who came
forward with the allegations or against anyone who may participate in the Inquiry process.

HHS-PSC000435

E    E  D  E  F

November 10, 2008


PageS

CONFIDENTIAL

The Center considers this matter to be a confidential matter, and will make every effort to
ensure that confidentiality is maintained. In addition, all communications about this matter
should go through Ms. Sands or me to protect the integrity of the procedures. Please be
assured that we are committed to a fair, thorough, and objective process.
We appreciate your cooperation with this matter. Please do not hesitate to call Ms. Sands

if you have any questions.

Lee Hartwell, Ph.D.


President and Director

Enclosure
cc: Gerianne J. Sands, Associate General Counsel and Research Integrity Officer

HHS-PSC000436

Exhibit C: Center Correspondence with Respondent


B. December 5, 2008 Letter from the RIO to Respondent re Inquiry
Committee's December 2, 2008 Report of AUegations

HHS-PSC000437

I h:F i

"

December 5, 2008

HUTCHINSON

i L ;'I',f\I;: i i
I IJ I

,J I

',I 11

CENTER

i~

( I

Office of the General Counsel

CONFIDENTIAL VIA FEDERAL EXPRESS


E    E  D  E  F

Re:

Report of Allegations of Research Misconduct


E   $
(Center File

E    E  D  E  F

As a follow-up to Dr. Hartwell's November 10, 2008 letter notifYing you of the Inquiry, I
enclose a December 2, 2008 report of"Allegations of Research Misconduct" ("Report").
This Report was prepared to assist you in responding to the allegations pending in the
Center's Inquiry. If you did not receive IX. Hartwell's letter, please contact me
immediately using the contact information listed below.

To give you time to process this additional information and prepare a written response to
the Center, we encourage you to respond to both this letter and Dr. Hartwell's letter within
30 days of your receipt of this letter.
[ will be managing the Inquiry, so )UU can submit your response to me, and I will forward
your response to the Inquiry Committee and to Dr. Hartwell. I can be reached at:
Gerianne J. Sands
Fred Hutchinson Cancer Research Center
1100 Fairview Avenue North
Mail StopJ6-205
Seattle, Washington 98109-1024
(206) 667-1224

gjsands@fhc[C.org

We appreciate your cooperation with this matter. Please do not hesitate to call me if you
have any questions.
Sincerely,

Associate General Counsel and Research Integrity Officer


Enclosure

E    E  D  E  F

HHS-PSC000438

Exhibit C: Center Correspondence with Respondent


C. December 12 and 17,2008 Letters from the RIO to Respondent, re:
Inquiry Committee's December 2, 2008 Report of Allegations

HHS-PSC000439

IRHJ HUTCHINSON

( /\:-;( "1101 I;':ESF/W< "II CENTER


,\ lIn 01

December 12,2008

S( 11.1-;( l

Office of the General Counsel

CONFIDENTIAL VIA FEDERAL EXPRESS

E    E  D  E  F

Re:

Report of Al
of Research Misconduct
E   $
(Center File

E    E  D  E  F

Last Friday, December Slit, I attempted to send to you a letter regarding the Report of
Allegations of Research Misconduct. Federal Express not been able to confirm its
delivery, so I enclose a copy of that letterand enclosure.
We appreciate your cooperation with this matter. Please do not hesitate to call me if you

have any questions.

Sincerely,

Geri
J. Sands
Associate General Counsel and Research Integrity Officer
Enclosure
cc wlo encl.:

E    E  D  E  F

HHS-PSC000440

F'~':U

HUTCHINSON

i. ;\Nnl~ I~I SII\I~CH


A 1111

December 17> 2008

or .,(

CENTER

II:NCI

Office of the General Counsel

CONFIDENTIAL VIA FEDERAL EXPRESS

E    E  D  E  F
Re:

Report of Allegations of Research Misconduct


(Center File E   $

E    E  D  E  F

Thank you for sending us your new address. To malee sure you have everything, I am
resending:
a copy of Dr. Hartwell's November 10th , 2008 letter to you,
a copy of the Center's current Research Misconduct Policy and Procedures,
a copy of my December 5th and 12th, 2008 letters to you; and
a copy of the Allegations of Researoh Misconduct
As mentioned in Dr. Hartwell's letter, it is critical that you submit a written response to the
Center within 30 days of your receipt of this December 17, 2008 letter, and fully participate
in the Inquiry process described in his letter.
We appreciate your cooperation with this matter. Please do not hesitate to call me if you
have any questions.
Sincerely,

~~

V~~~~:~
Sands
Associate General Counsel and Research Integrity Officer
Enclosure
cc w/o encl.:

E    E  D  E  F

HHS-PSC000441

Exhibit C: Center Correspondence with Respondent


D. November 4, 2009 Letter from RIO to Respondent re: Notification of
Commencement of Misconduct Investigation

HHS-PSC000442

FI\.I::J) HUTCHINSON
'. !'-J I.. [ [

i~;~d

. , 1 I!!

,k( ;; CENTER

{);

',t :

>< { i

Ofiice of the General Counsel

November 4, 2009

CONFIDENTIAL, VIA EMAIL


E    E  D  E  F
RE:
E    E  D  E  F

E    E  D  E  F

Dr. Hartwell reviewed the September 17,2009 Inquiry Report prepared by E    E  D  E  F

, a copy of which report is enclosed. Based on his


review and on further discussions with the Inquiry Committee, on September 30, 2009,
Dr. Hartwell decided that an investigation should be conducted regarding the allegations
of research misconduct.

This letter serves as a formal notice to you that Fred Hutchinson Cancer Research Center
will be conducting an investigation into allegations of research misconduct
("Investigation") that have been raised related to the research conducted by you that was

E    E  D  E  F

I will be in touch with you about the Investigation process. In the meantime. if you have
any questions concerning this matter, please call me at (206) 667-1224 or email me at
gj sands(a),fhcrc.org.
Sincerely,

/~/~

1'/ Genanne 1. Sands

Associate General Counsel

cc:

E    E  D  E  F
Leland H. Hartwell, Ph.D., President and Director

E    E  D  E  F

E    E  D  E  F
HHS-PSC000443

Exhibit C: Center Correspondence with Respondent


E. November 12,2009 Letter from the RIO to Respondent re:
Commencement of Research Misconduct Investigation

HHS-PSC000444

ikL[i HUTCHINSON
",,' : I:

[<I':'f\l\;

,!

CENTER

November 12, 2009


Office of the General Counsel

E    E  D  E  F EMAIL

E    E  D  E  F

RE:
E    E  D  E  F

My October 30, 2009 letter to you serves as a formal notice to you that Fred Hutchinson Cancer
Research Center ("Center") will be conducting an investigation into an allegation of research
misconduct ("Investigation") that has been raised related to the research conducted by you that

E    E  D  E  F
This letter reviews the definition of research misconduct, the allegation, the Investigation process
under Center policy, your rights, and the potential actions that may be taken by the Center and by
the principal federal oversight agency for NIH, the Office of Research and Integrity ("ORI").

DEFINITION OF RESEARCH MISCONDUCT


As required by federal regUlation, the Center has established research misconduct policies and
procedures for investigating and reporting alleged research misconduct ("Policy"), a copy of
which is enclosed. Included in the Policy are terms that are used throughout an Investigation.
The purpose of the Investigation is to determine whether or not research misconduct occurred.
At the time the work was done and the 2005 Manuscript was published, "scientific misconduct,"
which we will refer to as "'research misconduct," was defined by the former Center "Policy For
Dealing With And Reporting Possible Scientific Misconduct in Research," and the former PHS
Final Rule, 42 CFR Part 93 as "fabrication, falsification, plagiarism. or other practices that
seriously deviate from those that are commonly accepted within the scientific community for
proposing, conducting, or reporting research." Although the former Center policy did not
specifically define ''fabrication'' or "falsification," federal policy defmed these terms as follows:

"fabrication" means "making up data or results and recording or reporting them;"


and

E    E  D  E  F
HHS-PSC000445

CONFIDENTIAL, VIA EMAIL

E    E  D  E  F

November 12, 2009


''falsification'' means "manipulating research materials, equipment, or processes
or changing or omitting data or results such that the research is not accurately
represented in the research record."
See Office of Science and Technology Policy (65 FR 76260, December 6, 2000). The phrase "or
other practices that seriously deviate from those that are commonly accepted within the scientific
community" is not defined by law or regulation and remains a matter of interpretation.
Specifically excluded from the definition are "honest error or honest differences in interpretation
or judgments of data.,. These defmitions come from the policy and regulations that were in

E    E  D  E  F

in the Investigation are consistent with the current PHS Regulations, 42 CFR Part 93 and the
current Center Policy.
ALLEGATION

E    E  D  E  F

INVESTIGATION PROCESS

The Center will follow the investigation procedures outlined in the Center's Policy. This
includes the appointment of an Investigation Committee. At this time, E    E  D  E  F
have been appointed to that committee. You have a right to object to these
appointments based on conflict of interest, so please let me know whether or not you have any
objections to these appointments by noon on Monday, November 22, 2009.
The Investigation Committee will conduct a "de novo review" of this matter, meaning that they
will start fresh and review the documentation and conduct interviews of persons who they think
have relevant information. Those interviews will be transcribed. At the discretion of the
Investigation Committee, all or a portion of the transcripts of those interviewed may be provided
to you upon request if necessary to prepare for your interview.

HHS-PSC000446

CONFIDENTIAL, VIA EMAIL

E    E  D  E  F

November 12, 2009


In advance of your interview with the Investigation Committee, you will be provided a list of
individuals who have already been interviewed and the documents to be reviewed during the
interview. Once you have reviewed the materials, you will be provided an opportunity to request
that the Investigation Committee interview additional individuals and review additional data.
While this matter is under Investigation, please do not use the manuscript in question, for
reference or for publication, pending completion of this Investigation process.
Consistent with federal requirements, steps have been taken to secure original research records
for the duration of this review. If there are further relevant original records or data relating to
this matter that you have in your possession, please let me know immediately. In no case should
any existing record be destroyed or altered.
During the course of the Investigation, if you need access to the original research record and
other evidence submitted or sequestered in this case, which evidence I have secured and
inventoried, then please contact me. When you need to examine original evidence, either I, or
someone from my office, will be present to assure that it is kept in order and so that the chain of
custody cannot be challenged.
If, during the course of the Investigation, additional information becomes available that
substantially changes the subject matter of the Investigation, or would suggest additional
respondents or amending the allegation, then I will notify you of the new subject matter or
provide notice to additional respondents.
It is the Center's goal to conduct a fair, thorough, and objective review according to the
Investigation procedures outlined in the Center's Policy.
At the conclusion of the Investigation, the Investigation Committee will draft a report to Dr. Lee
Hartwell, the Center's President and Director, as to whether or not, based on its review, research
misconduct has occurred. The format of the Investigation Report is described in Section II.C. of
the Policy. For each allegation, the Investigation Committee will make a finding whether or not,
by a preponderance of evidence (i.e. more likely than not) research misconduct has occurred.
The Investigation Committee should cite in its report the pertinent evidence and the committee's
basis for finding whether or not research misconduct has occurred.
I will provide you with a copy of the draft report, and you will be given the opportunity to review
and make comments on it. As the result of your comments, the Investigation Committee may
change its report, and at the very least, your comments will be included in the final report. Dr.
Hartwell, as President and Director of the Center, will make the final determination as to whether
or not research misconduct has occurred.
Please understand that you are to take no steps to retaliate against anyone who came forward
with the allegation or against anyone who may participate in the Investigation.

HHS-PSC000447

CONFIDENTIAL, VIA EMAIL

E    E  D  E  F

November 12, 2009


The Center considers this matter to be a confidential matter, and will make every effort to ensure
that confidentiality is maintained. In addition, all communications about this matter should go
through me to protect the integrity of the procedures. Please be assured that we are committed to
a fair, thorough, and objective process.

Your Rights
It is critical that you, and any attorney you select to advise you, understand the rights provided to
you in the Investigation process. Those rights include but are not limited to:

the right for the proceedings to be conducted as confidentially as possible (See Section I
of the Policy);

the right to challenge the membership of the Investigation Committee based on conflict
of interest;

the right to be interviewed by the Investigation Committee, and the right to correct the
recording or transcription of that interview (See Section II.C.2 of the Policy);

the right to sufficient notice in advance of your interview with the Investigation
Committee so you can prepare (See Section III.F of the Policy);

the right to arrange for legal counsel at your own expense (See Section HI.P of the
Policy);

the right to copies of or reasonable, supervised access to research records (See Section
V.B of the Policy);

the right to review a copy of the draft Investigation Report and comment on it within a
reasonable time established by the Investigation Committee, and to have those comments
considered by the Investigation Committee and included in the final Investigation Report
(See Section III G of the Policy); and

the right to receive a copy of the final Investigation Report.

You should be aware that the OR! will perform an oversight review of the report regarding PHS
issues. Also, you have the right to request a hearing before the Department of Health and
Human Services Departmental Appeals Board if there is an OR! fmding of misconduct under the
PHS definition. The ORI has general information on research misconduct at its website:
www.ori.dhhs.gov.
Since other funding sources were involved with the research for the 2005 Manuscript, those
agencies may require additional infonnation and/or procedures.

HHS-PSC000448

CONFIDENTIAL. VIA EMAIL

E    E  D  E  F

November 12,2009

Contact Information
I will be managing the Investigation, and I will forward correspondence from you to the
Investigation Committee, as is appropriate. Should the Investigation Committee require
additional information from you or wish to speak with you directly, you will be notified by me. I
can be reached at:
Gerianne J. Sands
Fred Hutchinson Cancer Research Center
11 00 Fairview Avenue North
Mail StopJ6-205
Seattle, Washington 98109-1024
(206) 667-1224
gjsands@tbcrc.org
As for your contact informatio~ you have requested that we correspond with you by email.as
you do not currently have a physical address or telephone number. Please update us immediately
with any changes to your contact information.
The Center appreciates your cooperation with this matter. I encourage you to participate in
responding to the allegation as we request, as quickly as possible. As mentioned earlier in this
letter, please let me know whether or not you have any objections to the Investigation Committee
appointments by noon on Monday, November 22, 2009.
Please do not hesitate to call or email me if you have any questions.
Sincerely, ~

GeriannJ.
Associate General Counsel and Research Integrity Officer
Enclosure (Research Misconduct Policy)
cc:

Lee Hartwell, Ph.D., President and Director

E    E  D  E  F

HHS-PSC000449

Exhibit C: Center Correspondence with Respondent


F. December 7, 2009 Email response from Respondent re: Commencement
of Research Misconduct Investigation (No objections to Investigation
Committee Members and Respondent's right to be intenriewed).

HHS-PSC000450

Page 10f2

Chapman, Claire
From:

E    E  D  E  F

Sent:
To:

Monday, December 07.20096:43 PM


Chapman, Claire

Subject: Re: FW: 11/12109 Letter re Investigation

No.

On Tue. Dec 8, 2009 at 9:05 AM, Chapman, Claire <cchapman@ihcrc,org> wrote:

E    E  D  E  F
Thanks.
Claire

Claire Chapman

Office of the General Counsel

Fred Hutchinson Cancer Research Center


1100 Fairview Avenue North, J6-205
Seattle, WA 98109-1024
(206) 667-1227; (206) 605-0336 - cell
(206) 667-6590 - fax
This electronic message transmission contains information which may be confldentlal or privileged. The informatlon is intended to be for the use of
the individual or entity named above. If you are not the Intended recipient, be aware that any disclosure, copying. distribution or use of the contents
of this informatlon is prohibited. If you have received this electronic transmission in error, please notify us by telephone at (206) 667-6458 or by
electronic reply, and delete this message.

From: Chapman, caire

Sent: Thursdayr November 12, 2009 4: 10 PM

E    E  D  E  F

Cc: E    E  D  E  F Hartwell, lee;


SUbject: 11/12/09 Letter re Investigation
Sensitivity: Confidential

E    E  D  E  F

Sands, Gerianne J

E    E  D  E  F

Gerianne asked that I send to you the attached letter from her regarding the Investigation.
Thanks.
Claire

412212010
HHS-PSC000451

Page 2 of2

Claire Chapman

Office of the General Counsel


Fred Hutchinson Cancer Research Center
1100 Fairview Avenue North. J6-205
Seattle. WA 98109-1024
(206) 667-1227; (206) 605-0336 - cell
(206) 667-6590 - fax
ThIs electronic message transmIssIon contaIns InfonnaUon whIch may be confidenUal or privileged. The Infonnat/on Is Intended to be for the ule of
the Individual or entity named above. If you are not the Intended recipient. be aware that any dIsclosure. copying. distribution or use of the contents
of this InfonnaUon Is prohlbHed. If you have receIved thIs electronic transmissIon In error. please notify us by telephone at (206) 667-6468 or by
electronic reply. and delete this message.

4122/2010
HHS-PSC000452

Exhibit C: Center Correspondence with Respondent


G. January 28, 2010 Email to Respondent and from Respondent re:
Investigation Committee's Written Questions to E    E  D  E  F

HHS-PSC000453

Page 1 of4

Chapman, Claire
From:
Sent:

E    E  D  E  F

To:

Thursday, January 28,20105:24 AM


Chapman, Claire

Subject: Re: Information For the Investigation Committee

Hi Clarie,

E    E  D  E  F

On
Thu, Jan 28,2010 at 7:45 AM, Chapman, Claire <cchap.man@fhcrc.org> wrote:
E    E  D  E  F
: Thank you for your response.

E    E  D  E  F
; Thanks.
Claire
i

Claire Chapman

: Office of the General Counsel


; Fred Hutchinson Cancer Research Center
; 1100 Fairview Avenue North, J6-205
Seattle, WA 98109-1024
(206) 667-1227; (206) 605-0336 - cell
(206) 667-6590 - fax
This electronic mesaage transmission contains infonnatlon which may be confidential or privileged. The Information Is Intended to be for the use of
the individual or entity named above. If you are not the Intended recipient, be aware that any disclosure, copying, distribution or use of the contents
of this information Is prohibited. If you have received this electronic transmission In error, please notify us by telephone at (206) 667-6458 or by
electroniC reply, and delete this message.

HHS-PSC000454

Exhibit C: Center Correspondence with Respondent


H. March 4, 2010 Letter from the RIO to Respondent re: Draft
Investigation Report

HHS-PSC000455

i-l~LL}

HUTCHINSON

.' i!< ? ic,l\f~'H

March 4,2010

CENTER

Ofiice of the General Counsel

CONFIDENTIAL VIA EMAIL AT RESPONDENT'S REQUEST

E    E  D  E  F
Re:

Draft Investigation Report


E   $
(Center File

E    E  D  E  F

In accordance with the Center's "Research Misconduct Policy and Procedures" ("Policy"),
I attach a copy of the draft Investigation Report ("Report") regarding the recent allegations
of research misconduct. At your request, I am sending this to you by email. Please
promptly confirm your receipt by way of reply email.
The Investigation Committee; consisting solely of
with my assistance as the Center's Research Integrity Officer, reviewed relevant
documentation and data to determine whether, by a preponderance of evidence (i.e. more
likely than not), research misconduct did or did not occur for each allegation of research
misconduct identified during the Investigation. This draft Report states the Investigation
Committee's findings.
E    E  D  E  F

You may provide your written comments to me by email. Your comments will be included
with the final Report. Please return your comments to me no later than Monday morning,
April 5th. If I do not hear from you by then, I will assume that you do not have any
comments, and I will forward the Report to Dr. Hartwell for his determination. In addition,
the Office of Research Integrity and appropriate funding agencies will be notified.
The Center considers this matter to be a confidential matter, and will make every effort to
ensure that confidentiality is maintained. Please be assured that the Center is committed to
a fair, thorough, and objective process.
We appreciate your cooperation with this matter. Please do not hesitate to contact me, at
(206) 667-1224 or gjsands@ibcrc.org, if you have any questions.
Sincerely,

~/~
/o;r:~e

J. Sands
Associate General Counsel and Research Integrity Officer

Enclosures
cc w/o encl.: E    E  D  E  F

HHS-PSC000456

CONFIDENTIAL

FRED HUTCIDNSON CANCER RESEARCH CENTER


DRAFT INVESTIGATION REPORT
Allegations of Research Misconduct
Case E   $

CONFIDENTIAL

DRAFT INVESTIGATION REPORT

Page 1 of 14

HHS-PSC000457

TABLE OF CONTENTS
CONFIDENTIAL ......................................................................................................................................................... 3
1.
BACKGROUND ................................................................................................................................................. 3
A.
Factual History ............................................................................................................................................... 3
B.
Data Sequestration.......................................................................................................................................... 4
C.
Pre-lnquiry Preliminary Assessment .............................................................................................................. 4
D.
inquiry ............................................................................................................................................................ 4
E.
Investigation .................................................................................................................................................... 4
n. PHS SUPP{)RT ................................................................................................................................................... 5
HI.
INVESTIGATION PROCESS ....................................................................................................................... 5
IV.
ALLEGATION .............................................................................................................................................. 6
V.
INVESTlGATION COMMITTEE FINDINGS/ANALYSIS OF ALLEGATIONS .......................................... 6
VI.
RESPONDENT'S COMMENTS ON DRAFT INVESTIGATION REPORT ............................................ II
See Exhibit J. ...... ............................ ....................... ...................................... ..................... ........................... ....... ........ II
VII.
COMPLAINANT'S COMMENTS ON DRAFTINVESTIGATION REPORT ......................................... II
See Exhibit K. ...... .......... ................. .......... ......... ...... ................. ....................... .............. .............. ................... ...... ...... II
VIII.
CONCLUSION ............................................................................................................................................ II
lX.
CENTER'S PRESIDENT AND DIRECTOR'S DECISION REGARDING INVESTIGATION ............... 13
X.
E    E  D  E  F .................. 14
Xl.
Exhibit B: Center Research Misconduct Policy ("Policy") (8 pages) ......................................................... 14
XU.
Exhibit C: Center Correspondence with Respondent .................................................................................. 14
A.
November 10, 2008 Letter from Dr. Hartwell to Respondent re Notification of Allegations and Initiation of
Inquiry ..................................................................................................................................................................... 14
B.
December 5, 2008 Letter from the RIO to Respondent re Inquiry Committee's December 2,2008 Report of
Allegations .............................................................................................................................................................. 14
C.
December 17, 2008 Letter from the RIO to Respondent, remailing prior correspondence .......................... 14
D.
November 4,2009 Letter from Dr. Hartwell to Respondent re Notification oflnvestigation ...................... 14
E.
November 12,2009 Letter from the RIO to Respondent re lnvestigation .................................................... 14
xm. Exhibit D: December 2,2008 "Report of Allegations" (18 pages) ............................................................. 14
XIV.
Exhibit E: January 16,2009 Comments from Respondent re Allegations (5 pages) ................................... 14
XV.
Exhibit F: Comments from Respondent re Draft Inquiry Report (2 pages) ................................................. 14
XVI.
Exhibit G: Comments from Complainant re Draft Inquiry Report (9 pages) .............................................. 14
XVII. Exhibit H: September 30,2009 Final Inquiry Report
(9 pages) ................................................................... 14
E    E  D  E  F
XVIII.
Exhibit I: January 20, 2010 Responses from
o Investigation Committee's Questions (3
pages)
14
XIX.
Exhibit J: Comments from Respondent re Draft Investigation Report (1 pages) ......................................... 14
XX.
Exhibit K: Comments from Complainant re Draft Investigation Report (1 pages) ..................................... 14
XXI.
Endnotes: ...................................................................................................................................................... 14

CONFIDENTIAL

DRAFT INVESTIGATION REPORT

Page 2 of 14

HHS-PSC000458

MEMORANDUM
DRAFT
CONFIDENTIAL

DATE:
TO:

March 4, 2010
Dr. Lee Hartwell, President and Director
Dr. Mark Groudine, Executive Vice President and Deputy Director

FROM:
Re:

E    E  D  E  F
Draft Investigation Report
Allegations of Research Misconduct Investigation, Case E   $
Respondent E    E  D  E  F

I. BACKGROUND
A. Factual History

E    E  D  E  F
In early August of 2007, Fred Hutchinson Cancer Research Center ("Center") management

CONFIDENTIAL

DRAFT INVESTIGATION REPORT

Page 3 ofl4

HHS-PSC000459

E    E  D  E  F

E    E  D  E  F
C. Pre-Inquiry Preliminary Assessment

On March 18,2008, Dr. Hartwell appointed us to serve as a Preliminary Assessment Committee


to review Respondent's work while at the Center. On July 29,2008, we concluded in the
Preliminary Assessment Committee Report that an Inquiry should proceed on the 2005
Manuscript
D. Inquiry

On November 10, 2008. Dr. Hartwell appointed us to serve as the Inquiry Committee and
charged us with conducting a preliminary review of the allegations of research misconduct
("Inquiry") under the Center's "Research Misconduct Policy and Procedures" ("Policy"), a copy
of which is attached as Exhibit Bvi. and to make findings and recommendations to Dr. Hartwell,
President and Director of the Center, for appropriate action. On September 17. 2009. we
submitted our final Inquiry Report to Dr. Hartwell. On September 30, 2009, Dr. Hartwell agreed
with our findings that the matter should proceed to Investigation E    E  D  E  F

E. Investigation
On November 4. 2009 Dr. Hartwell sent to Respondent a letter notifying
of the
Investigation, attached as Exhibit C. On November 7. 2009, the Investigation commenced upon
the Center receiving Respondent's email that had received Dr. Hartwell's letter notifying
of the Investigation. On November 12.2009. Dr. Hartwell sent to Respondent a letter notifying
of the allegation of research misconduct, attached as Exhibit C.
E    E  D  E  F

E    E  D  E  F

E    E  D  E  F

E    E  D  E  F

On November 9, 2009, Dr. Hartwell appointed us to serve as the Investigation Committee and
charged us with conducting a review of the allegation of research misconduct (''Investigation'')
under the Center's Policy. and to make findings and recommendations to Dr. Hartwell, President
and Director of the Center. for appropriate action.
This is the Investigation Report that makes those findings and recommendations.
CONFIDENTIAL

DRAFT INVESTIGATION REPORT

Page 4 ofl4

HHS-PSC000460

As Investigation Committee members, we agreed to conduct the Investigation in an objective


manner free of bias, conflicts. of interest (personal, professional or fmancial) or conflicts of
commitment Respondent did not object to our appointment to the Investigation Committee.
On December 16,2009 we met as the Investigation Committee to discuss the matter.
ber 18, 2009, in lieu of an interview, we submitted questions for written answers to

E    E  D  E  F

On January 20, 2010,

E    E  D  E  F

On January 28, 2010, we sent


declined to comment.

esponded in writing to our questions.

E    E  D  E  F

E    E  D  E  F

esponses to

and on January 28, 2010,

E    E  D  E  F

E    E  D  E  F

On February 8, 2010, we met as the Investigation Committee to discuss


and our findings.

responses

On March 4, 2010, a draft of this Investigation Report was shared with Respondent and
Complainant. Their comments on the draft are attached as Exhibit Jand Exhibit K.
respectively. On [ ].2010, a final Investigation Report was sent to Dr. Hartwell. On [ ] 2010,
Dr. Hartwell (agreed or disagreed) with the Investigation Committee that research misconduct
(did or did not) .occur.

II. PHS SUPPORT

E    E  D  E  F
E    E  D  E  F

III. INVESTIGATION PROCESS

The purpose of the Investigation is to provide a finding as to whether, by a preponderance of


evidence (i.e. more likely than not), research misconduct did or did not occur for each separate
Allegation of research misconduct identified during the Investigation. At the time the work was

E    E  D  E  F
CONFIDENTIAL

DRAFT INVESTIGATION REPORT

Page 5 of 14

HHS-PSC000461

proposing, conducting, or reporting research." Although the fonner Center policy did not
specificalIy define "fabrication" or "falsification," federal policy defined these tenns as follows:
"fabrication" means "making up data or results and recording or reporting them;"
and
"falsification" means "manipulating research materials, equipment, or processes
or changing or omitting data or results such that the research is not accurately
represented in the research record."
See Office of Science and Technology Policy (65 FR 76260, December 6,2000). The phrase "or
other practices that seriously deviate from those that are commonly accepted within the scientific
community" is not defined by law or regulation and remains a matter of interpretation.
Specifically excluded from the definition are "honest error or honest differences in interpretation
or judgments of data." These definitions come from the policy and regulations that were in

E    E  D  E  F

Investigation were consistent with the current PHS Regulations, 42 CFR Part 93 and the current
Center Policy.
IV. ALLEGATION

E    E  D  E  F

V. INVESTIGATION COMMITTEE FINDINGS/ANALYSIS OF ALLEGATIONS

The Investigation Committee addressed whether the following two-part test for scientific
misconduct was met:
(1) whether, by a preponderance of evidence (i.e. more likely than not, 50+%),

E    E  D  E  F

E    E  D  E  F

or intentionally or knowingly engaged in other practices that seriously


deviated from those that are commonly accepted within the scientific community, and

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DRAFT INVESTIGATION REPORT

Page 6 of14

HHS-PSC000462

(2) that these actions did not involve error or honest differences in interpretations or judgments
of data
To perfonn this Investigation, we reviewed numerous docwnents and images, and relied
primarily on:

E    E  D  E  F

Basis for fmdings

E    E  D  E  F
CONFIDENTIAL

DRAFT INVESTIGATION REPORT

Page 7 of 14

HHS-PSC000463

E    E  D  E  F

CONFIDENTIAL

DRAFT INVESTIGATION REPORT

Page 8 of 14

HHS-PSC000464

E    E  D  E  F

CONFIDENTIAL

DRAFT INVESTIGATION REPORT

Page 9 of 14

HHS-PSC000465

E    E  D  E  F

CONFIDENTIAL

DRAFT INVESTIGATION REPORT

Page 100f14

HHS-PSC000466

E    E  D  E  F

VI;. RESPONDENT'S COMMENTS ON DRAFf INVESTIGATION REPORT

See EXhibit J.

VII.

COMPLAINANT'S COMMENTS ON DRAFT INYESTIGATIONREPORT


See Exhibit K.

VIII. CONCLUSION

E    E  D  E  F
CONFIDENTIAL

DRAFT INVESTIGATION REPORT

Page 11 ofl4

HHS-PSC000467

E    E  D  E  F

Submitted by:

E    E  D  E  F

CONFIDENTIAL

DRAFT INVESTIGATION REPORT

Page 12 of 14

HHS-PSC000468

IX. CENTER'S PRESIDENT


INVESTIGATION

AND

DIRECTOR'S

DECISION

REGARDING

E    E  D  E  F

Dr. Leland Hartwell, President and Director

CONFIDENTIAL

[],2010

DRAFT INVESTIGATION REPORT

Page 13 of 14

HHS-PSC000469

X. Exhibit A:

E    E  D  E  F

XI. Exhibit B: Center Research Misconduct Policy ("Policy") (8 pages)


Xll.

Exhibit C: Center Correspondence with Respondent

A. November 10,2008 Letter from Dr. Hartwell to Respondent re NotifICation of AUegations and
Initiation of Inquiry
B. December S, 2008 Letter from the RIO to Respondent re Inquiry Committee's December 2, 2008
Report of Allegations
C. December 17. 2008 Letter from the RIO to Respondent, rem ailing prior correspondence
D. November 4,2009 Letter from Dr. Hartwell to Respondent re Notification of Investigation
E. November 12, 2009 Letter from the RIO to Respondent re Investigation

XIII. Exhibit D: December 2. 2008 "Report of Allegations" (18 pages)


XIV. Exhibit E: January 16.2009 Comments from Respondent re Allegations (5 pages)
XV.

Exhibit F: Comments from Respondent re Draft Inquiry Report (2 pages>

XVI. Exhibit G: Comments from Complainant re Draft Inqui", Report (9 pages)


XVII. Exhibit H: September 30. 2009 Final Inquiry Report (9 pages)
XVIII. Exhibit I: January 20. 2010 Responses from
Committee's Questions (3 pages)

E    E  D  E  F

to Investigation

XIX. Exhibit J: Comments from Respondent re Draft Investigation Report (1 pages)

xx.

Exhibit K: Comments from Complainant re Draft Investigation Report (1 pages)

XXI. Endnotes:

E    E  D  E  F

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DRAFT INVESTIGATION REPORT

Page 14 of 14

HHS-PSC000470

ALLEGATIONS OF RESEARCH MISCONDUCT

E    E  D  E  F

page 1

HHS-PSC000471

E    E  D  E  F

page 2

HHS-PSC000472

E    E  D  E  F

page 3

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page 4

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pageS

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page 6

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page 7

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page 8

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page 9

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page 10

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page II

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page 12

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page 13

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page 14

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page 15

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page 16

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page 17

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3 Summary

E    E  D  E  F

Date:

['2./'1.1 D t

page 18

HHS-PSC000488

January 16, 2009


Response to Allegations of Research Misconduct

E    E  D  E  F

- 1-

HHS-PSC000489

E    E  D  E  F

-2-

HHS-PSC000490

E    E  D  E  F

-3-

HHS-PSC000491

E    E  D  E  F

-4-

HHS-PSC000492

E    E  D  E  F

- 5-

HHS-PSC000493

May 18,2009
Comments on "042909 Draft Inquiry Report to Respondent and Complainant"

E    E  D  E  F

HHS-PSC000494

E    E  D  E  F

HHS-PSC000495

E    E  D  E  F
COMMENTS ON:
DRAFT INQUIRY REPORT: ALLEGATIONS OF RESEARCH MISCONDUCT
RESPONSE TO ALLEGATIONS OF RESEARCH MISCONDUCT BY E    E  D  E  F
NOTE: 'AnACHED' FIGURES ARE LOCATED AT THE END OF THIS DOCUMENT.

E    E  D  E  F

HHS-PSC000496

E    E  D  E  F

HHS-PSC000497

E    E  D  E  F

HHS-PSC000498

E    E  D  E  F

HHS-PSC000499

E    E  D  E  F

HHS-PSC000500

E    E  D  E  F

HHS-PSC000501

E    E  D  E  F

HHS-PSC000502

E    E  D  E  F

HHS-PSC000503

E    E  D  E  F

HHS-PSC000504

CONFIDENTIAL

FRED HUTCHINSON CANCER RESEARCH CENTER


INQUIRY REPORT
Allegations of Research Misconduct
Case E   $
September 30, 2009

CONFIDENTIAL.

INQUIRY REPORT

Page I of9

HHS-PSC000505

Table of Contents

CONFIDENTIAL .......................................................................................................................................................... 3
I.
BACKGROUND ................................................................................................................................................. 3
A.
Factual History ................................................................................................................................................ 3
B.
Data Sequestration .......................................................................................................................................... 4
C.
Pre-Inquiry Preliminary Assessment. .............................................................................................................. 4
D.
Inquiry ............................................................................................................................................................. 4
II.
PHS SUPPORT ................................................................................................................................................... 5
INQUIRY PROCESS ..................................................................................................................................... 5
III.
IV.
ALLEGATIONS ............................................................................................................................................. 5
V.
INQUIRY COMMITTEE FINDINGS/ANALYSIS OF ALLEGATIONS ......................................................... 6
VI.
RESPONDENT'S COMMENTS ON DRAFT INQUIRY REPORT.. ........................................................... 7
See Exhibit F................................................................................................................................................................. 7
COMPLAINANT'S COMMENTS ON DRAFT INQUIRY REPORT.. ........................................................ 7
VlI.
See Exhibit G ................................................................................................................................................................ 7
VHI.
CONCLUSION ............................................................................................................................................... 7
IX.
CENTER'S PRESIDENT AND DIRECTOR'S DECISION REGARDING INVESTIGATlON .................. 8
This Section IX is intentionally left blank ................................................................... Error! Bookmark not defined.
E    E  D  E  F ......................... 9
X.
Exhibit A:
XI.
Exhibit B: Center Research Misconduct Policy ("Policy") ( 8 pages) ........................................................... 9
XII.
Exhibit C: Center Correspondence with Respondent ..................................................................................... 9
A.
November 10, 2008 Letter fi'om Dr. Haltwell to Respondent I'e Notification of Allegations and Initiation of
Inquiry ....................................................................................................................................................................... 9
B.
December 5, 2008 Letter fi'om RIO Sands to Respondent re Inquiry Committee's December 2,2008 Report
of Allegations ............................................................................................................................................................ 9
C.
December ]7,2008 Letter from RIO Sands to Respondent, remailing prior correspondence ........................ 9
XIII.
Exhibit D: December 2, 2008 "Report of Allegations" (I8 pages) ................................................................ 9
XIV.
Exhibit E: January 16,2009 Comments ITom Respondent re Allegations (5 pages) .................................... 9
XV.
Exhibit F Comments from Respondent re Draft Inquiry Report .................................................................... 9
XVI.
Exhibit G: Comments ITom Complainant I'e Draft Inquiry Report ................................................................ 9
XVII. Endnotes: ......................................................................................................................................................... 9

CONFIDENTIAL

INQUIRY REPORT

Page 2 of9

HHS-PSC000506

MEMORANDUM

.CONFIDENTIAL
DATE:

September 17,2009

TO:

Dr. Lee Hartwell, President and Director


Dr. Mark Groudine, Executive Vice President and Deputy Director

FROM:
Re:

E    E  D  E  F
Inquiry Report
Allegations of Research Misconduct Inquiry, Case E   $
Respondent - E    E  D  E  F

I. BACKGROUND
A. Factual History

In early August of 2007, Fred Hutchinson Cancer Research Center ("Center") management

E    E  D  E  F

CONFIDENTIAL

INQUIRY REPORT

Page 3 of9

HHS-PSC000507

E    E  D  E  F
B. Data Sequestration

E    E  D  E  F
C. Pre-Inquiry Preliminary Assessment
On March 18, 2008, Dr. Hartwell appointed us to serve as a Preliminary Assessment Committee
to review Respondent's work while at the Center. On July 29,2008, we concluded in the
Preliminary Assessment Committee Report that an Inquiry should proceed on the 2005
Manuscript.
D. Inquiry
On November 10, 2008, Dr. Hartwell appointed us to serve as the Inquiry Committee and
charged us with conducting a preliminary review of the allegations of research misconduct
("Inquiry") under the Center's "Research Misconduct Policy and Procedures" ("Policy"), a copy
of which is attached as Exhibit Bvi , and to make findings and recommendations to Dr. Hartwell,
President and Director of the Center, for appropriate action. This is the Inquiry Report that
makes those findings and recommendations.
As Inquiry Committee members, we agreed to conduct the Inquiry in an objective manner free of
bias, conflicts of interest (personal, professional or financial) or conflicts of commitment.
The Policy provides that the Inquiry be completed within sixty (60) days from the date
Respondent receives notice of the allegations unless additional time is warranted. We requested
from Dr. Hru1well two requests for extensions of time due to: i)
i) the challenges of
locating the relevant evidence for the Inquiry; and iii) delays relating to the efforts by the RIO to
contact Respondent and his counsel to propose a resolution of the matter through a Respondent's
admission in coordination with the Office of Research Integrity, U.S. Public Health Services of
the U.S. Department of Health and Hwnan Services ("PHS").
E    E  D  E  F

CONFIDENTIAL

INQUIRY REPORT

Page 4 of9

HHS-PSC000508

II. PHS SUPPORT

E    E  D  E  F
III.INQUIRY PROCESS
The purpose of the Inquiry is to determine whether sufficient evidence of research misconduct
exists to warrant further investigation. A
E    E  D  E  F
"scientific misconduct," which we will refer to as "research misconduct," was
defined by the former Center "Policy For Dealing With And Reporting Possible Scientific
Misconduct in Research," and the fOlmer PHS Final Rule, 42 CFR Part 93 as "fabrication,
falsification, plagiarism, or other practices that seriously deviate from those that are commonly
accepted within the scientific community for proposing, conducting, or reporting research."
Although the former Center policy did not specifically define "fabrication" or "falsification,"
federal policy defined these terms as follows:

"fabrication" means "making up data or results and recording or reporting them;"


and
"falsification" means "manipulating research materials, equipment, or processes
or changing or omitting data or results such that the research is not accurately
represented in the research record."
See Office of Science and Technology Policy (65 FR 76260, December 6,2000). The phrase "01'
other practices that seriously deviate from those that are commonly accepted within the scientific
community" is not defined by law or regulation and remains a matter of interpretation.
Specifically excluded from the definition are "honest error or honest differences in interpretation
or judgments of data." These definitions come from the policy and regulations that were in

E    E  D  E  F

Inquiry were consistent with the current PHS Regulations, 42 CFR Part 93 and the current Center
Policy.
IV. ALLEGATIONS

E    E  D  E  F
CONFIDENTIAL

INQUIRY REPORT

Page 5 of9

HHS-PSC000509

E    E  D  E  F

v.

INQUIRY COMMITTEE FINDINGS/ANALYSIS OF ALLEGATIONS

E    E  D  E  F

CONFIDENTIAL

INQUIRY REPORT

Page 6 of9

HHS-PSC000510

E    E  D  E  F

VI. RESPONDENT'S COMMENTS ON DRAFT INQUIRY REPORT


Sec Exhibit F.
VIle

COMPLAINANT'S COMMENTS ON DRAFT INQUIRY REPORT


See E~hibjt G.

VIII. CONCLUSION

E    E  D  E  F

CONFIDENTIAL

INQUIRY REPORT

Page 7 of9

HHS-PSC000511

IX. CENTER'S PRESIDENT


INVESTIGATION

AND

DIRECTOR'S

DECISION

REGARDJNG

E    E  D  E  F
September 30, 2009

CONFIDENTIAL

INQUIRY REPORT

Page 80f9

HHS-PSC000512

X. Exhibit A:

E    E  D  E  F

XL ExhibitB: Center Research Misconduct Policy ("PoliCY") ( 8 pag~s)

XII.

Exhibit C: Center Correspondence with Respondent

A. November to. 2008 Letter from Dr. Hartwell to Respondent re Notification of Allegations aud
Initiation oflnquiry
B. December 5. 2008 Letter from RIO Sands to Respondent i'e Inquiry Committee's December 2,
1008 Report of Allegations
C. Deeember 17. 2008 Letter from RIO Sands to Respondent,remallhlg prior correspondence

XIIl. Exhibit D: December 2. 2008 "Report of Allegations" <18 pages)


XIV. Exhibit E: January 16.2009 Comments from Respond.ent reAliegations (5 pages)
XV.

Exhibit F Comments Ironi Respondent re DrafHnguiry Report

XVI. Exhibit G: Comments from Complainant i'e DraftInguiry Report

XVII. Endnotes:

E    E  D  E  F

CONFIDENTIAL

INQUIRY REPORT

Page 90f9

HHS-PSC000513

FRED

CANCE

MEMORANDUM
Decmber 18, 2009
CONFIDENTIAL
TO:

E    E  D  E  F

FROM: Gerianne J. Sands


Associate General Counsel and Research Integrity Officer
Re:

Research Misconduct Investigation, Case: E    E  D  E  F


Questions from the Investigation Committe

As we discussed by telephone earlier this week, the Investigation Committee in this case met
and considered what additional information they may need to complete their review. They

E    E  D  E  F

they would ask you to submit written responses to the questions outlined below.
Since we are required to complete the Investigation within 120 days and the Committee needs
to share the questions and responses with the Respondent for comment before the
Investigation concludes, we are requesting that you please answer each of the following
questions from the Investigation Committee to the best of your recollection, and return your
answers to me by January 11 th, 2010. Please call me if you need more time to respond.

E    E  D  E  F

1100 Fairview Ave. N. Mail Stop J6-205 PO Box 19024

Seattle, WA 98109-1024 206.667.5000 www.fhcrc.org

HHS-PSC000514

Questions fi'om the Investigation Committee


December 18, 2009
Page 2

CONFIDENTIAL

E    E  D  E  F

HHS-PSC000515

Questions from the Investigation Committee


December 18, 2009
Page 3

CONFIDENTIAL

E    E  D  E  F

HHS-PSC000516

Chapman, Claire
From:

E    E  D  E  F

Sent:

To:
Subject:

Thursday, April 01, 2010 7:20AM


Chapman, Claire
Re: Draft Investigation Report (03/04110)

Attachments:

Response-to-030410.doc

Response-to-03041

E    E  D  E  F
On Fri, Mar 5,2010 at 8:19 AM, Chapman, Claire <cchapman@fhcrc.org> wrote:
::

E    E  D  E  F

::>

::>

>

::>
::>
::>

>
::>

>
::>

::>
::>

>
>

I attach, for your review, the draft Investigation Report and Exhibits
A-H, along with a letter from Gerianne Sands. As the letter states,
please respond with your comments to the Report by the morning of
Monday, April 5th.
Also, please promptly reply to this email to confirm your receipt.
Let us know if you have any questions.
Thanks.
Claire

Claire Chapman
Office of the General Counsel
::> Fred Hutchinson Cancer Research Center 1100 Fairview Avenue North,
> J6-205 Seattle, WA 98109-1024
::> (206) 667-1227; (206) 605-0336 - cell
> (206) 667-6590 - fax
::>

>

::>

This electronic message transmission contains information which may be


confidential or privileged; The information is intended to be for the
::> use of the individual or entity named above.
If you are not the
::> intended recipient, be aware that any disclosure, copying,
> distribution or use of the contents of this information is prohibited.
::> If you have received this electronic transmission in error, please
::> notify us by telephone at
(206)
> 667-6458 or by electronic reply, and delete this message.
::>

>

>

::>

HHS-PSC000517

Response to "030410 Draft Investigation Report"

E    E  D  E  F

Other comments on "030410 Draft Investigation Report"

E    E  D  E  F

HHS-PSC000518

To: Gerianne
Sands
E    E  D  E  F
From:
Date: 4/4/10
Re: Draft Investigation Report, Allegations of Research Misconduct, case E   $
I have reviewed the Draft Investigation Report, which I received on 3/4/10. I
agree with its conclusions.
In the attached PDF of the Report document I received, I have made a number of
minor corrections for you to review. Most of these are corrections of the
designations of names for figures under discussion or the locations of specific

E    E  D  E  F

HHS-PSC000519

CONFIDENTIAL

FRED HUTCHINSON CANCER RESEARCH CENTER

DRAFT INVESTIGATION REPORT


Allegations of Researeh Misconduct
Case E   $

CONFIDENTIAL

DRAFT INVESTIGATION REPORT

Page 1 of 14

HHS-PSC000520

TABLE OF CONTENTS
CONFIDENTIAL ......................................................................................................................................................... 3
I.
BACKGROUND ................................................................................................................................................. 3
A.
Factual History ............................................................................................................................................... 3
B.
Data Sequestration .......................................................................................................................................... 4
Pre-Inquiry Preliminary Assessment .............................................................................................................. 4
C.
Inquiry ............................................................................................................................................................ 4
D.
E.
Investigation ................................................................................................................................................... 4
II.
PHS SUPPORT .................................................................................................................................................... 5
IH.
INVESTIGATION PROCESS ....................................................................................................................... 5
IV .
ALLEGATION .............................................................................................................................................. 6
V.
INVESTIGATION COMMmEE FINDINGS/ANALYSIS OF ALLEGATIONS .......................................... 6
VI.
RESPONDENrSCOMMENTSON DRAFT INVESTIGATION REPORT ............................................ 11
See Exhibit J............................................................................................................................................................... II
VII.
COMP.LAINANT'S COMMENTS ON DRAFT INVESTIGATION REPORT ......................................... II
See Exhibit J(. ...... ........ ..... ........................ .............................. ............... ........ .... ......... ....... ....... .................... ...... ........ II
VIII.
CONCLUSION ............................................................................................................................................ 11
lX.
CENTER'S PRESIDENT AND DlRECTOR'S DECISION REGARDING INVESTIGATION ............... 13
E    E  D  E  F ........................ 14
X.
Exhibit A:
Xl.
Exhibit B: Center Research Misconduct Policy ("Policy") (8 pages) ......................................................... 14
XU.
Exhibit C: Center Correspondence with Respondent ........ ........ ............ .............. ........ .............. ..... ............. 14
A.
November 10, 2008 Letter from Dr. Hartwell to Respondent re Notification of Allegations and Initiation of
Inquiry .................................................................................................................................................................... 14
B.
December 5,2008 Letter from the RIO to Respondent re Inquiry Committee's December 2,2008 Report of
Allegations .............................................................................................................................................................. 14
C.
December 17, 2008 Letter from the RIO to Respondent, remailing prior correspondence .......................... 14
D.
November 4,2009 Letter from Dr. Hartwell to Respondent re Notification of Investigation ...................... 14
E.
November 12, 2009 Letter from the RIO to Respondent re Investigation .................................................... 14
XIII.
Bxhibit D: December 2, 2008 "Report of Allegations" (18 pages) ............................................................. 14
XIV.
Exhibit E: January 16, 2009 Comments from Respondent re Allegations (5 pages) ................................... 14
XV.
Exbibit F: Comments from Respondent re Draft Inquiry Report (2 pages)................................................. 14
XVI.
Exhibit G: Comments from Complainant re Draft Inquiry Report (9 pages) .............................................. 14
XVII. Exhibit H: September 30,2009 Final Inquiry Report (9 pages) ................................................................... 14
XVIIl.
Exhibit 1: January 20,2010 Responses from E    E  D  E  F o Investigation Committee's Questions (3
pages)
14
XIX.
Exhibit J: Comments from Respondent re Draft Investigation Report (?pages)......................................... 14
XX.
Bxhibit K: Comments from Complainant re Draft Investigation Report (? pages) ." ...... ....... ..................... 14
XXI.
Endnotes: ...................................................................................................................................................... 14

CONFIDENTIAL

DRAFT INVESTIGATION REPORT

Page 2 of 14

HHS-PSC000521

MEMORANDUM
DRAFT
CONFIDENTIAL

DATE:
TO:
FROM:

Re:

March 4,2010
Dr. Lee Hartwell, President and Director
Dr. Mark Groudine, Executive Vice President and Deputy Director

E    E  D  E  F
Draft Investigation Report
Allegations of Research Misconduct Investigation, Case E   $
Respondent - E    E  D  E  F

I. BACKGROUND
A. Factual History
In early August of2007, Fred Hutchinson Cancer Research Center ("Center") management

E    E  D  E  F

CONFIDENTIAL

DRAFT INVESTIGATION REPORT

Page 3 of14

HHS-PSC000522

E    E  D  E  F
B. nata Sequestration

E    E  D  E  F
C. Pro-Inquiry Preliminary Assessment

On March 18, 2008, Dr. Hartwell appointed us to serve as a Preliminary Assessment Committee
to l"eView Respondent's work while at the Center. On July 29, 2008, we concluded in the
Preliminary Assessment Committee Report that an Inquiry should proceed on the 2005
Manuscript.

D. Inquiry
On November 10, 2008, Dr. Hartwell appointed us to serve as the Inquiry Committee and
charged us with conducting a preliminary review of the allegations of research. misconduct
("Inquiry") under the Center's "Research Misconduct Policy and Procedures" ("Polley'" a copy
of which is attached as Exhibit BVI, and to make findings and recommendations to Dr. Hartwell,
President and Director of the Center, for appropriate action. On September 17. 2009. we
submitted our final Inquiry Report to Dr. Hartwell. On September 30,2009. Dr. Hartwell agreed
with our findings that the matter should proceed to Investigation on one of the
E    E  D  E  F

E. InvestigatioD

E    E  D  E  F

CONFIDENTIAL

DRAFT INVESTIGATION REPORT

Page 4 of14

HHS-PSC000523

E    E  D  E  F

II. PHS SUPPORT

E    E  D  E  F
III.INVESTIGATION PROCESS
The purpose of the Investigation is to provide a finding as to whether, by a preponderance of
evidence (i.e. more likely than not), research misconduct did or did not occur for each separate
Allegation of research misconduct identified during the Investigation. At the time the work was

E    E  D  E  F

Reporting Possible Scientific Misconduct in Research," and the former PHS Final Rule, 42 CFR
Part 93 as intentional or knowing "fabrication, falsification. plagiarism, or other practices that
seriously deviate from those that are commonly accepted within the scientific community for

CONFIDENTIAL

DRAFf INVESTIGATION REPORT

Page 5 of 14

HHS-PSC000524

proposing, conducting. or reporting research." Although the former Center policy did not
specifically define "fabrication" or "falsification,tt federal policy defined these terms as follows:
"fabrication" means "making up data or results and recording or reporting them;"
and
"falsification" means "manipulating research materials, equipment, or processes
or changing or omitting data or results such that the research is not accurately
represented in the research record."
Office of Science and Technology Policy (65 FR 76260, December 6, 2000). The phrase "or
other practices that seriously deviate from those that are commonly accepted within the scientific
community" is not defined by law or regulation and remains a matter of interpretation.

Specifically excluded from the definition are "honest error or honest differences in inteipretation
or judgments of data." These definitions come from the policy and regulations that were in

E    E  D  E  F

Investigation were consistent with the current PHS Regulations, 42 CFR Part 93 and the current
.

Center Policy.

lVALLEGATION

E    E  D  E  F
V. INVESTIGATION COMMIITEE FINDINGS/ANALYSIS OF ALLEGATIONS

E    E  D  E  F
CONFIDENTIAL

DRAFT INVESTIGATION REPORT

Page60fl4

HHS-PSC000525

E    E  D  E  F

Basis for findinn

E    E  D  E  F
CONFIDENTIAL

DRAFT INVESTIGATION REPORT

Page 7 of 14

HHS-PSC000526

E    E  D  E  F

CONFIDENTIAL

DRAFT INVESTIGATION REPORT

Page 8 of 14

HHS-PSC000527

E    E  D  E  F

CONFIDENTIAL

DRAFT INVESTIGATION REPORT

Page 9 of 14

HHS-PSC000528

E    E  D  E  F

CONFIDENTIAL

DRAFT INVESTIGATION REPORT'

Page 10of14

HHS-PSC000529

E    E  D  E  F

VI. RESPONDENT'S COMMENTS ON BRAFf INVESTIGATION REPORT


See Eshibit J.
VII.

COMPLAINANT'S COMMENTS ON DRAFT INVESTIGATION REPORT

~ExhibitK.

VIII. CONCLUSION

E    E  D  E  F
CONFIDENTIAL

DRAFT INVESTIGATION REPORT

Page 11 of14

HHS-PSC000530

E    E  D  E  F

CONFIDENTIAL

DRAFT INVESTIGATION REPORT

Page 12 of 14

HHS-PSC000531

X. Exhibit A:

E    E  D  E  F

XI. Exhibit B: Center Research Misconduct Policy ("Policy") (8 pages)


XIL

Exhibit C: Center Correspondence with Respondent

A. November 10, 2008 Letter from Dr. Hartwdl to Respondent re Notifaeation of Allegations and
Initiation of Inquiry
B. Deeember 5, 2008 Letter from the RIO to Respondent re Inquiry Committee's December 2, lOO8
Report of Allegations
C. December 17,2008 Letter from tile RIO to Respondent, remalling prior correspondence
D. November 4.1009 Letter from Dr. Hartwell to Respondent re Notlfitation of Investigation
E. November 11, 2009 Letter from the RIO to Respondent re Investigation

XIII. Exhibit D: Dec:ember 2. 2008 "Report of AUegations" (18 pages)


XIV.

Exhibit E: January 16.2009 Comments from Respondent re AUegations (5 pages)

XV.

Exhibit F: Comments from Respondent re Draft Inquiry Report (2 pages)

XVI. Exhibit G: Comments from Complainant re Draft Inquiry Report (9 pages)


XVIL Exhibit H: September 30. 2009 Final Inquiry Report (9 pages)
XVDI.Exhibit I: January 20. 2010 Responses from
Committee's Questions (3 pages)

E    E  D  E  F

to Investigation

XIX.

Exhibit J: Comments from Respondent re Draft Investigation Report (?D!I!es)

XX.

Exhibit K: Comments from Complainant re Draft Investigation Report (?pges)

XXI.

Endnotes:

E    E  D  E  F

CONFIDENTIAL

DRAFT INVESTIGATION REPORT

Page 14 of 14

HHS-PSC000532

my edits to Revised Draft Investigation Report

Page 1 of3

Chapman, Claire
From:

E    E  D  E  F

Sent:

Thursday, May 06, 20106:56 PM

To:
Subject:

Chapman, Claire
my edits to Revised Draft Investigation Report

Attachments: 042610 Draft Inv.LB.editdoc

Dear Claire,

E    E  D  E  F

HHS-PSC000533

CONFIDENTIAL

FRED HUTCHINSON CANCER RESEARCH CENTER


DRAFT INVESTIGATION REPORT

ABegaaons of Researcla Miscondud


Case E   $

CONFIDENTIAL

DRAFT INVESTIGATION REPORT

Page 1 ofl6

HHS-PSC000534

TABLE OF CONTE"'TS

~N~~~~UND:::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::~:::: t
A.

'

')-D_telead;...;.;.;;.;.;.:';..3_ _ _ _ _ _-:

Deleted: 3

FactwII History ................. ,.................. ,..........,............................ ,......................., .......................................... ;.,~'

~: ':::,es::~;:~~i::::::::::::::::::::::::::::::::::::::::::::::::::=:::::::::::::::::::::::::::::::::::::::::::::::::::::::::: i-

. Deleted:)

re~ P';~~~~~l--:;:~:::-;:-::;;:;::~:;::~:J
V.
VL

Deleted: 4
Deleted: 4

Deleted: 4

lNVESTIGATlON COMMrITEE FCNDINGS/ANAL YSIS OF ALLEGATIONS .......................................... fl.'


RESPONDENT'S APRIL t, 2010 COMMENTS ON DRAFT INVESTiGATION REPORT ........... ,....... ll.:'

--<

;.-Del_eted
__:_s_ _ _ _ _ _

~~ Exhi~!:iPLAiNANT;SAPRiLi:20ioCOMMEN:rsONDRAFTlNVESTiGATIONREPORT:::::::::::::::: if" ',' ~)-=----::-------=i~

~~I~hi~~~CLUS[ON:::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::: fr-'~,"" ': >-Deleted---:-12-------<

CENTE
ON ............... li,.. , ' DeWell: 12
E    E  D  E  F ..................... ti~\ .. , >-DeItII--....
ExbibitA:
- - :1-2-------<
XI.
Exhibit B: Center ~search Misconduct Policy ("policyn) (8 pages) ..................................................... ,... ti '.', .
r-~"
. 1 - - with Respond eal.. ................................................................................ -'-"'
I ~'".. ' ", "' \ ~~~
Deleted: _
12 _ _ _ _ _ _
I It C'.......
"er Co rrespon"",....,
XI ,t.
A. . November 10.2008 Letter from Dr. Hartwell to Respondent re Notification of Allegations and Initiation of,:' " ,1~DeIeted~_::-:_12_ _ _ _ _ _

X.

X.

Exh'b'

-<

--i!

~~:;~~~f~~~~-=~~;g~~~=~~~.ti~ \\l)-:=--le-Id-:-:-;-::------->~,Il
D.
E.

November 4,2009 Letter from Dr. Hartwell to Respondent re Notification of Investigation ......................
November 12, 2009 Letter from the RIO to Respondent re Investigation .................................................... ti.

.',,' I Deleted: IS
. " ' ';)--;.;.;;.~-------;

~ ~her~:!~~~.~.~.~~.~~~~.~.~,~~!.~.~.~.~.~.v~~~~~.~.~~. ~~.~~. ~':',,:, f~:. . . ;IeIeI.;.;eta.;,; .; d;. ::;;.:_ _ _ _ _ _-<


Exhibit D: December 2, 200& "Report of Allegations" (18 pages) ............................................................. ti:'. ""{DeIemII: 15
Exhibit E: JIIIlWIr}' 16, 2009 Comments from. Respondent re Allegations (5 pages) ................................... ti . ',' \r>-----------;

XIn.
XIV,
XV.
X'V1.
XVII.
XVlll.

Exhibit F: Comments from Respondent re Draft Inquiry Report (2 pages} ................................................. ti= ,', ,'. \ )?-Delebld:
___'_S_ _ _ _ _ _-<
Exh~~t G: ~enlS from CorDflainant re Draft Inquiry Report (9 pages) .............................................. ti~\",', 1>-D_Ield--.I1!1..;.d;.."I;..S _ _ _ _~~""
September 30,2009 Fmal Inqwry Report (9 pages} ................................................................... ti.' ',', ' l Deleted: IS
Exhibit [: January 20, 2010 Responses from Complainant to investigation Committee's Questions (3
..'.. ' ',' '?-D-IeI-eII..;.lI!I...;d--------.<

ExhlbltH:

:;;.;-------<

Ffl :::~~: ~~114,2~~~O~=~~1~=~:::~r~~~ne:!:~0~t!~.~~~~.::::::::::::::::::fr>,:::::~?-:::..-..;IItII!II.;,;;.;.;..:


XXI.

Exhibit L: 2003 Manuscript (unpublished) (19 pages) ................................................................................ ti~\'.

'. ':.DeIeI:::-~IItIec-~d~:-IS------~

~l ~~~~~~~~.~:..~:.:::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::: tt':',:::,,<

Deleted: IS
':'\ ,.\?-DeIeI-eta--d:-I-S-~---==<:
,"\ '"

Deleted: IS

, ,';.;-.;.;.;,;;.;.;;.;,;..-------:
DeIeIJed: IS

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DeIeIJed: IS

',','

,\;-.;.;.;,;;.;.;;..;;..-------<
" DeIeIied: IS
i DeIetecl: IS

CONFIDENTIAL

DRAFT INVESTIGATION REPORT

Page 2 of 16

HHS-PSC000535

MEMORANDUM
DRAFT

CONFIDENTIAL

DATE:

April 1, 2010

TO:

Dr. Lee Hartwell, President and Director


Dr. Mark Groudine, Executive Vice President and Deputy Director

FROM:

Re:

E    E  D  E  F
DRAIT Investigation Report

Allegations ofR.esearch Misconduct Investigation, Case


Respondent -

E   $

E    E  D  E  F

BACKGROUND

A. Factual History
In early August of 2007, Fred Hutchinson Cancer Research Center ("Center") management

E    E  D  E  F

CONFIDENTIAL

DRAFT INVESTIGATION REPORT

Page 3 of 16

HHS-PSC000536

E    E  D  E  F
B. Data Sequestration

E    E  D  E  F
C. Pre-Inquiry Preliminary Asselsment
On March 18,2008, Dr. Hartwell appointed us to serve as a Preliminary Assessment Committee
to review Respondent's work while at the Center. On July 29, 2008, we concluded in the
Preliminary Assessment Committee Report that an Inquiry should proceed on the 200S
Manuscript.

D. Inquiry
On November 10, 2008. Dr. Hartwell appointed us to serve as the Inquiry Committee and
charged us with conducting a preliminary review of the allegations of research misconduct
("Inquiry") under the Center's "Research Misconduct Policy and Procedures" ("Policy"), a copy
of which is attached as Exhibit Bvi, and to make fmdings and recommendations to Dr. Hartwell,
President and Director of the Center. for appropriate action. On September 17. 2009, we
submitted our final Inquiry Report to Dr. Hartwell. On September 30, 2009, Dr. Hartwell agreed
with our fmdings that the matter should proceed to Investigation on one of the E    E  D  E  F
E. Investigation

E    E  D  E  F

CONFIDENTIAL

DRAFT INVESTIGATION REPORT

Page 4 of 16

HHS-PSC000537

E    E  D  E  F

IL PHS SUPPORT

E    E  D  E  F
m.INVESTIGATION PROCESS

CONFIDENTIAL

DRAFr INVESTIGATION REPORT

PageS of16

HHS-PSC000538

The purpose of the Investigation is to provide a finding as to whether. by a preponderance of


evidence (i.e. more likely thannot. 50+%). research misconduct did or did not occur for each
separate Allegation of research misconduct identified during the Investigation. At the time the

E    E  D  E  F

And Reporting Possible Scientific Misconduct in Research." and the fonner PHS Final Rule, 42
CFR Part 93 as intentional or knowing "fabrication, falsification, plagiarism. or other practices
that seriously deviate from those that are commonly accepted within the scientific commWlity for
proposing. conducting. or reporting research." Although the former Center policy did not
specifically defme ''fabrication" or "falsification," federal policy defined these terms as follows:
"fabrication" means "making up data or results and recording or reporting them;"
and
"falsification" means "manipulating research materials, equipment, or processes
or changing or omitting data or results such that the research is not accurately
represented in the research record."
Office of Science and Technology Policy (65 FR 76260, December 6. 2000). The phrase "or
other practices that seriously deviate from those that are commonly accepted within the scientific
community" is not defined by law or regulation and remains a matter of interpretation.

Specifically excluded from the definition are "honest error or honest differences in interpretation
or judgments of data." These definitions come from the policy and regulations that were in

E    E  D  E  F

Investigation were consistent with the current PHS Regulations. 42 CPR Part 93 and the current
Center Policy.

E    E  D  E  F
IV. ALLEGATION

V.

~STIGATION COMMITTEE

CONFIDENTIAL

FINDINGS/ANALYSIS OF ALLEGATIONS

DRAFT INVESTIGATION REPORT

Page 6 of 16

HHS-PSC000539

E    E  D  E  F

Basis for findings


CONFIDENTIAL

DRAFr INVESTIGATION REPORT

Page7of16

HHS-PSC000540

E    E  D  E  F

CONFIDENTIAL

DRAFT INVESTIGATION REPORT

PageS of 16

HHS-PSC000541

E    E  D  E  F

CONFIDENTIAL

DRAFT INVESTIGATION REPORT

Page90fl6

HHS-PSC000542

E    E  D  E  F

C01\"FIDENTIAL

DRAFT' INVESTIGA nON REPORT

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CONFIDENTIAL

DRAFT INVESTIGATION REPORT

Page 11 of16

HHS-PSC000544

E    E  D  E  F
VI. REspoNDENT'S
REPORT

APRIL

I. 2010 COMMENTS ON

DRAFT

myEmGATION

~ExhtbitJ,

VII.

COMPLAINANT'S

REPORT

APRD...

I. 2010 COMMENTS ON PRAFf INYEmGATION

~ExhibitK.

vm.

CONCLUSION

E    E  D  E  F

CONFIDENTIAL

DRAFf INVESTIGATION REPORT

Page 12 of16

HHS-PSC000545

E    E  D  E  F

CONFIDENTIAL

DRAFr INVESTIGATION REPORT

Page 13 of16

HHS-PSC000546

IX. CENTER'S PRESIDENT


INVESTIGATION

AND

DIRECTOR'S

DECISION

REGARDING

E    E  D  E  F
Dr. Leland Hartwell, President and Director

CONFIDENTIAL

May[],2010

DRAFT INVESTIGATION REPORT

Page 140f 16

HHS-PSC000547

E    E  D  E  F

X. Exbibit A:

XL Exhibit B: Center Researcb Misconduct Policy ("Policy") (8 pages)

XlL

Exbibit C: Center Correspondence witb Respondent

A. November 10,2008 Letter from Dr. Hartwell to Respondent re Notification of Allegations and
laitiatioa of IIlquiry
B. Deulllber S. 2008 Letter from the RIO to Respondent re lJIquiry Committee's Dece:mber 1, 2008
Report of Allegations
C. Dettmber 17.2088 Letter from tile RIO to RespOIldeat, remailiag prior correspoadenee
D. November 4,lOO9 Letter from Dr. Hartwell to Rapoadent re Notification of InvestigatiOD
E. November Il, lOO9 Letter from tile RIO to Respoadent re lavestigation
F. Deumber 7,lOO9 Eman rapoase from IlespoRdeat re objeetioBS to InvutigaiioA Committe.:
Members and right to be interviewed

xlIr. Exhibit D: December 2. 2008 "Report of Allegations" (18 pages)


XIV. Exhibit E: January 16,2009 Comments from Respondent re Allegations (5 pages)
XV.

Exhibit F: Comments from Respondent re Draft Ingniry Report (2 pages)

XVI.

Exbibit G: Comments from Complainant re Draft Inguiry RePOrt (9 pages)

XVIl. Exhibit H: September 30,2009 Finallnguiry Report (9 pages)


XVIII. Exhibit [: January 20. 2010 Responses from Complainant to Investigation
Committee's Ouestions (3 pages)
XIx. Exhibit J: April 1, 2010 Comments from Respondent re Draft Investigation Report
pages)

(2

xx.

Report

Exhibit K:

April 4, 2010 Comments from Complainant re Draft Investigation

XXI. Exbibit L: 2003 Manuscript (unpublished) Cl9 pages)


XXII. Exbibit M: Inventory (1 pages)

XX[f(. Endnotes:

E    E  D  E  F
CONFIDENTIAL

DRAFf INVESTIGATION REPORT

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HHS-PSC000548

E    E  D  E  F

CONFIDENTIAL

DRAFT INVESTIGATION REPORT

Page 160f16

HHS-PSC000549

E    E  D  E  F

HHS-PSC000550

E    E  D  E  F

HHS-PSC000551

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HHS-PSC000552

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HHS-PSC000553

E    E  D  E  F

5
HHS-PSC000554

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HHS-PSC000555

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HHS-PSC000556

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10

HHS-PSC000559

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11

HHS-PSC000560

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12

HHS-PSC000561

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13

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HHS-PSC000563

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HHS-PSC000564

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16

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HHS-PSC000566

E    E  D  E  F

18

HHS-PSC000567

E    E  D  E  F

19

HHS-PSC000568

E    E  D  E  F
5/12/2010

E    E  D  E  F
CONFIDENTIAL

HHS-PSC000569

-~~-

--

INVENTORY
CONFIDENTIAL
Exhibit II Evidence Number Record Description (What, num;;;rpages or slides, 'iiid'dates Date Received From
=

1.

E   $

Receipt!
Copies Re1!!Ted to

Copies to

Chain of Custody (Date, who


!:Viewed, with wh~~, ~ ~..:.L

E    E  D  E  F

2.

i---3.

Confidential

Page 2

5/12/2010

E    E  D  E  F

HHS-PSC000570

INVENTORY
CONFIDENTIAL
Exhibit # Evidence Number Record Description (What, n~fpages or slides, and dates Date Received From
or Date
etc.L.
E   $

.
Receipt!
Copies Returned to

~--.-...-

Copies to

Chain7r'Custody (Date, who


reviewed, with whom, what etc.)

E    E  D  E  F

4.

5.

6.

E    E  D  E  F

HHS-PSC000571

INVENTORV
CONFIDENTIAL
Exhibit # E;ceNumber Record Description (What, nwnber of pages or slides, and dates Date Received From
etc.)
or Date

'"-

E   $

Receipt/
Copies Returned to

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Chain of Custody (Date, who


reviewed, with whom, what etc.)

E    E  D  E  F

7.

8.

Confidential

Page 4

5/12/2010

E    E  D  E  F

HHS-PSC000572

E   $

lNVENTORV
CONFIDENTIAL
Exhibit # Evidence Number Record Description (What, number of pages or slides, and dates Date Received From
etc.)

9.

Receipt!
Copies Returned to

Copies to

Chain of Custody (Date, who


reviewed, with whom, what etc.)

E    E  D  E  F

10.

E    E  D  E  F

HHS-PSC000573

INVENTORY
CONFIDENTIAL
Exhibit # Evidence Number Record Description (What, number of pages or slides, and dates Date Received From
etc.)
or Date
E   $

Receipt!
Copies Returned to

Copies to

Chain of Custody (Date, who


reviewed, with whom, what etc.)

E    E  D  E  F

Confidential

Page 6

5/12/2010

E    E  D  E  F

HHS-PSC000574

E   $

lNVENTORY
CONFIDENTIAL
Exhibit # Evidence Number Record Description (What, number of pages or slides, and dates Date Received From
etc.)
or Date

Receipt!
Copies Returned to

Copies to

Chain of Custody (Date, who


reviewed, with whom, what etc.)

E    E  D  E  F

II.

Confidential

Page 7

5/12/2010

E    E  D  E  F

HHS-PSC000575

INVENTORY
CONFIDENTIAL
&hibit# Evidence Number Record Description (What, number of pages or slides, and dates Date Received From
etc.)
or Date
E   $

Receipt!
Copies Returned to

Copies to

Chain of CustDdy (Date, who


reviewed, with whom, what etc.)

E    E  D  E  F

12.

13.

Confidential

Page 8

5/12/2010

E    E  D  E  F

HHS-PSC000576

E   $

lNVENTORY
CONFIDENTIAL
Exhibit # Evidence Number Record Description (What, number of pages or slides, and dates Date Received From
or Date

14.

Receipt!
Copies Returned to

Copies to

Chain of Custody (Date, who


reviewed, with whom, what etc.)

E    E  D  E  F

15.

16.

Confidential

Page 9

5/1212010

E    E  D  E  F

HHS-PSC000577

E   $

NVENTORV
CONFIDENTIAL
Exhibit # Evidence Number Record Description (What, number of pages or slides, and dates Date Received From
etc.)
or Date

Receipt!
Copies Retwned to

Copies to

Chain of Custody (Date, who


reviewed, with whom, what etc.)

E    E  D  E  F

17.

IS.

Confidential

Page to

5/12/2010

E    E  D  E  F

HHS-PSC000578

E   $ NVENTORY

CONFIDENTIAL
Exhibit # Evidence Number Record Description (What, number of pages or slides, and dates Date Received From
etc.)
or Date
19.

Receipt!
Copies Returned to

Copies to

Chain of Custody (Date, who


reviewed, with whom, what etc.)

E    E  D  E  F

20.

Confidential

Page 11

5/12/2010

E    E  D  E  F

HHS-PSC000579

E   $

INVENTORV
CONFIDENTIAL
Exhibit # Evidence Number Record Description (What, number of pages or slides, and dates Date Received From

Receipt!
Copies Returned to

Copies to

Chain of Custody (Date, who


reviewed, with whom, what etc.)

E    E  D  E  F
etc.)

2l.

22.

--

E    E  D  E  F

HHS-PSC000580

E   $

lNVENTORV
CONFIDENTIAL
Exhibil# Evidence Nwnber Record Description (What, number of pages or slides, and dates Date Received From

-I

Receipt!

Copies to

Chain of Custody (Date, who

E    E  D  E  F

23.

24.

25.

Confidential

Page 13

5/12/2010

E    E  D  E  F

HHS-PSC000581

E   $

INVENTORY
CONFIDENTIAL
Exhibit # Evidence Number Record Description (What, number of pages or slides, and dates Date Received From
etc.)

--

Receipt!
Cooies Returned 10

Copies 10

Chain of Custody (Date, who


reviewed, with whom, what etc.)

E    E  D  E  F

26.

27.

28.

E    E  D  E  F

HHS-PSC000582

E   $

lNVENTORY
CONFIDENTIAL
Exhibit # Evidence Nwnber Record Description (What, nwnber of pages or slides, and dates Date Received From
etc.)
or Date

Receipt!
Copies Retwned to

Copies to

Chain of Custody (Date, who


reviewed, with whom, what etc.)

E    E  D  E  F

-~~

29.

30.

Confidential

Page 15

5/12/2010

E    E  D  E  F

HHS-PSC000583

E   $

NVENTORY
NFIDENTIAL
Exhibit # Evidence Number Record Descripti;;;i' (What, number of pages or slides, and dates Date Received From
etc.)
or Date

31.

Receipt!
Copies Returned to

Copies to

Chain of Custody (Date, who


reviewed, with whom, what etc.)

E    E  D  E  F

Confidential

Page 16

5/12/2010

E    E  D  E  F
HHS-PSC000584

E   $

INVENTORV
CONFIDENTIAL
Exhibit # Evidence Number Record Description (What, number of pages or slides, and dates Date Received From
etc.)
or Date

Receipt!
Copies Returned to

Copies to

Chain of Custody (Date, who


reviewed, with whom, what etc.)

E    E  D  E  F

32.

33.

Confidential

Page 17

5/12/2010

E    E  D  E  F

HHS-PSC000585

E   $

Exhibit # Evidence Number !Record Description (What, number of pages or slides, and dates
etc.)

NVENTORY
FIDENTIAL
Date Received From

ReceiptJ
CODies Returned to

Copies to

Chain of Custody (Date, who


reviewed, with whom, what etc.)

E    E  D  E  F

34.

35.
_ .. ___

Confidential

Page 18

5/12/2010

E    E  D  E  F
HHS-PSC000586

E   $

NVENTOR\,
CONFIDENTIAL
Exhibit # Evidence Number Record Description (What, number of pages or slides, and dates Date Received From
etc.)

Receipt!
Copies Returned to

Copies to

Chain of Custody (Date, who


reviewed, with whom, what etc.)

E    E  D  E  F

36.

Confidential

Page 19

5/12/2010

E    E  D  E  F

HHS-PSC000587

E   $

INVENTORY
CONFIDENTIAL
Exhibit # Evidence Number Record Description (What, number of pages or slides, and dates Date Received From
etc.)
or Date

Receipt!
Copies Returned to

Copies to

Chain of Custody (Date, who


reviewed, with whom, what etc.)

E    E  D  E  F

37.

38.

Confidential

Page 20

5/12/2010

E    E  D  E  F
HHS-PSC000588

E   $

INVENTORV
CONFIDENTIAL
Exhibit # Evidence Number Record Description (What, number of pages or slides, and dates Date Received From
etc.)
or Date

Receipt!
Copies Retwned to

Copies to

Chain of Custody (Date, who


reviewed, with whom, what etc.)

E    E  D  E  F

39.

Confidential

Page 21

5/12/2010

E    E  D  E  F

HHS-PSC000589

E   $

INVENTORY
CoNFIDENTIAL
Exhibit # Evidence Number Record Description (What, number of pages or slides, and dates Date Received From
40.

Receipt!
CODies Returned 10

Copies 10

Chain ofCuslOdy (Date, who


reviewed, with whom, what etc.)

E    E  D  E  F
etc.)

41.

42.

---'-

E    E  D  E  F

HHS-PSC000590

E   $
INVENTORV
CONFIDENTIAL
Exhibit # Evidence Number Record Description (What, number of pages or slides, and dates Date Received From
etc.)
or Date

Receipt!
Copies Returned to

Copies to

Chain of Custody (Date, who


reviewed. with whom, what etc.)

E    E  D  E  F

43.

44.

Confidential

Page 23

5/12/2010

E    E  D  E  F

HHS-PSC000591

E   $

NVENTORY
CONFIDENTIAL
Exhibit # Evidence Number Record Description (What, number of pages or slides, and dates Date Received From I
etc.)
or Date
I

Receipt!
CODies Returned to

Copies to

Chain of Custody (Date, who


reviewed, with whom, what etc.)

E    E  D  E  F

45.

46.

Confidential

Page 24

5/12/2010

E    E  D  E  F
HHS-PSC000592

E   $

lNVENTORY
CONFIDENTIAL
Exhibit # Evidence Number Record Description (What, number of pages or slides, and dates Date Received From

Receipt!
Copies Returned to

Copies to

Chain of Custody (Date, who


reviewed, with whom, what etc.)

E    E  D  E  F

47.

48.

E    E  D  E  F

HHS-PSC000593

E   $

lNVENTORY
CONFIDENTIAL
Exhibit # Evidence Nurnber Record Description (What, number of pages or slides, and dates Date Received From
etc.)
or Date

Receipt!
Copies Returned to

Copies to

Chain of Custody (Date, who


reviewed, with whom, what etc.)

E    E  D  E  F

49.

Confidential

Page 26

5/12/2010

E    E  D  E  F
HHS-PSC000594

E   $

INVENTORY
CONFIDENTIAL
Exhibit # Evidence Number Record Description (What, number of pages or slides, and dates Date Received From
etc.)
or Date

Receipt!
Copies Returned to

Copies to

Chain of Custody (Date, who


reviewed, with whom, what etc.)

E    E  D  E  F

50.

51.

Confidential

Page 27

5/1212010

E    E  D  E  F

HHS-PSC000595

E   $

INVENTORY
CONFIDENTIAL
Exhibit # Evidence Number Record Description (What, number of pages or slides, and dates Date Received From
etc.)
or Date

Receipt!
Copies Returned to

Copies to

Chain of Custody (Date, who


reviewed, with whom, what etc.)

E    E  D  E  F

52.

Confidential

Page 28

5112/2010

E    E  D  E  F

HHS-PSC000596

E   $

llNVENTORV
CONFIDENTIAL
Exhibit # Evidence Number Record Description (What, number of pages or slides, and dates Date Received From
etc.)
or Date

53.

Receipt!
Copies Returned to

Copies to

Chain of Custody (Date, who


reviewed, with whom, what etc.)

E    E  D  E  F

54.

Confidential

Page 29

5/12/2010

E    E  D  E  F

HHS-PSC000597

E   $

IINVENTORY
CONFIDENTIAL
Exhibit # Evidence Number Record Description (What, number of pages or slides, and dates Date Received From
etc.)
or Date

55.

Receipt!
Conies Returned to

Copies to

Chain of Custody (Date, who


reviewed, with whom, what etc.)

E    E  D  E  F

56.

.-.-~

Confidential

Page 30

5/12/2010

E    E  D  E  F

HHS-PSC000598

E   $

INVENTORY
CONFIDENTIAL
Exhibit # Evidence Number Record Description (What, number of pages or slides, and dates Date Received From
etc.)
or Date

Receipt!
Copies Retunled to

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Chain of Custody (Date, who


reviewed, with whom, what etc.)

E    E  D  E  F

57.

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E    E  D  E  F

HHS-PSC000599

E   $

NVENTORY
CONFIDENTIAL
Exhibit # Evidence Number Record Description (What, number of pages or slides, and dates Date Received From
etc.)
or Date

Receipt!
Covies Returned to

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Chain of Custody (Date, who


reviewed, with whom, what etc.)

E    E  D  E  F

59.

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Page 32

5/12/2010

E    E  D  E  F

HHS-PSC000600

E   $

iNVENTORY
CONFIDENTIAL
Exhibit # Evidence Number Record Description (What, number of pages or slides, and dates Date Received From
etc.)
or Date

Receipt!
Copies Returned 10

Copies 10

Chain of Custody (Date, who


reviewed, with whom, what etc.)

E    E  D  E  F

60.

61.

Confidential

Page 33

5/12/2010

E    E  D  E  F

HHS-PSC000601

E   $

INVENTORY
CONFIDENTIAL
Exhibit # Evidence Nwnber Record Description (What, number of pages or slides, and dates Date Received From
etc.)
or Date

Receipt!
Copies Returned to

Copies to

Chain of Custody (Date, who


with whom, what etc.)

E    E  D  E  F
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62.

Confidential

Page 34

5/12/2010

E    E  D  E  F
HHS-PSC000602

E   $
lNVENTORV
CONFIDENTIAL
Exhibit # Evidence Nwnber Record Description (What, nwnber of pages or slides, and dates Date Received From
etc.)
or Date

Receipt!
Copies Retwned to

Copies to

Chain of Custody (Date, who


reviewed, with whom, what etc.)

E    E  D  E  F

63.

64.

E    E  D  E  F
5/12/2010

HHS-PSC000603

E   $

NVENTORY
CONFIDENTIAL
Exhibit # Evidence Number Record Description (What, number of pages or slides, and dates Date Received From

Receipt!
Copies Returned to

Copies to

Chain of Custody (Date, who


reviewed, with whom, what etc.)

E    E  D  E  F

65.

66.

Confidential

Page 36

5/12/2010

E    E  D  E  F

HHS-PSC000604

-~

E   $

INVENTORY
CONFIDENTIAL
Exhibit # Evidence Number Record Description (What, number of pages or slides, and dates Date Received From I
etc.)
or Date

Receipt!
CODies Returned to

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Cruun of Custody (Dwre, who


reviewed, with whom, what etc.)

E    E  D  E  F

67.

Confidential

Page 37

. 5/12/2010

E    E  D  E  F

HHS-PSC000605

E   $

INVENTORV
CONFIDENTIAL
Exhibit # Evidence Nwnber Record Description (What, nwnber of pages or slides. and dates Date Received From
etc.)
or Date
68.

Receipt!
Copies Returned to

Copies to

Chain of Custody (Date. who


reviewed. with whom. what etc.)

E    E  D  E  F
I

69.

E    E  D  E  F

HHS-PSC000606

E   $

NVENTORY
CONFIDENTIAL
Exhibit # Evidence Number Record Description (What, number of pages or slides, and dates Date Received From
etc.)
or Date

ReceiptJ
CODies Returned to

Copies to

Chain of Custody (Date, who


reviewed, with whom, what etc.)

E    E  D  E  F

70.

71.

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Page 39

5/12/2010

E    E  D  E  F

HHS-PSC000607

E   $

INVENTORV
CONFIDENTIAL
Exhibit # Evidence Number Record Description (What, number of pages or slides, and dates Date Received From
etc.)
or Date

ReceiptJ
Copies Returned to

Copies to

C-hain of Custody (Date, who


reviewed, with whom, what etc.)

E    E  D  E  F

72.

Confidential

Page 40

5/12/2010

E    E  D  E  F
HHS-PSC000608

E   $

"

INVENTORY
NFIDENTIAL

Exhibit # Evidence Nwnber R.erord Description (What, number of pages or slides, and dates
etc.)

Date Received From

Receipt!
Copies Returned to

Copies to

Chain of Custody (Date, who


reviewed, with whom, what etc.)

E    E  D  E  F

73.

-'

Confidential

Page 41

E    E  D  E  F

HHS-PSC000609

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INVENTORY
CONFIDENTIAL
Exhibit # Evidence Number Record Description (What, number of pages or slides, and dates Date Received From
etc.)
74.

Receipt!
Copies Returned to

Copies to

Chain of Custody (Date, who


reviewed, with whom, what etc.)

E    E  D  E  F

Confidential

Page 42

5/12/2010

E    E  D  E  F

HHS-PSC000610

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NFIDENTIAL
Exhibit # Evidence Number Record Description (What, number of pages or slides, and dates Date Received From
or Date
etc.)

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75.

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Copies Returned to

Copies to

Chain of Custody (Date, who


reviewed, with whom, what etc.)

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E    E  D  E  F

E    E  D  E  F

HHS-PSC000611

FRED HUTCHINSON

C/\t"iCER RESEARCH CENTER


A LIFE OF SCIENCE

E   $

October 30,2009

Office of the General Counsel

CONFIDENTIAL
John E. Dahlberg, Ph.D.
U.S. Department of Health and Human Services
Office of Research Integrity
1101 Wootton Parkway, Suite 750
Rockville, Maryland 20852
RE:

Notification of Commencement of Misconduct Investigation

E    E  D  E  F

Dear Dr. Dahlberg:


This letter is to sent in accordance with 42 CFR 93.309 to advise you that Fred Hutchinson Cancer
Research Center ("Center") has initiated an investigation of alleged research misconduct in relation to the
above-referenced research funded, in part, by the
E    E  D  E  F

E    E  D  E  F

I enclose a copy of the Center's Inquiry Report, dated September 30, 2009, that details the Inquiry
Committee's recommendation and a written fmding by Dr. Lee Hartwell that the matter should proceed to
investigation. Consequently, the Center plans to move forward with its investigation.
Please contact me at (206) 667-1224 should you have any questions.
Sincerely,

Associate General Counsel


Enclosures
cc wi enc1s.:

Leland H. Hartwell, Ph.D., President and Director, the Center

E    E  D  E  F
1-

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HHS-PSC000612
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HHS-PSC000613

CONFIDENTIAL

FRED HUTCHINSON CANCER RESEARCH CENTER


INQUIRY REPORT
Allegations of Research Misconduct
Case E   $
September 30, 2009

CONFIDENTIAL

INQUIRY REPORT

Page 1 of9
HHS-PSC000614

Table of Contents

~-.

CONFIDENTIAL .......................................................................................................................................................... 3
I.
BACKGROUND ............................................................................................................................................ 3
A.
Factual History ................................................................................................................................................ 3
B.
Data Sequestration ......................................................................................................................................... 4
C.
Pre-Inquiry Preliminary Assessment ...............................................................................................................4
D.
Inquiry ............................................................................................................................................................. 4
D. PHS SUPPORT ................................................................................................................................................... 5
m.
IN"QUIRY PROCESS ..................................................................................................................................... 5
IV.
ALLEGATIONS ........................................................................................................................................ 5
V. IN"QUIRY COMMIITEE FINDIN"GS/ANALYSIS OF ALLEGATIONS ........................................................ 6
VI.
RESPONDENT'S COMMENTS ON DRAFT INQUIRY REPORT ............................................................. 7
See Exhibit F................................................................................................................................................................. 7
VD.
COMPLAINANT'S COMMENTS ON DRAFT INQUIRY REPORT .......................................................... 7
See Exln"bit G................................................................................................................................................................ 7
vm. CONCLUSION ............................................................................................................................................... 7
IX.
CENTER'S PRESIDENT AND DIRECTOR'S DECISION REGARDING INVESTIGATION .................. 8
This Section IX is intentionally left blank. ................................................... ;.............. Error! Bookmark not defmed.
X. ExIn"bitA:
E    E  D  E  F .................................. 9
XI.
Exhibit B: Center Research Misconduct Policy (''Policy'') ( 8 pages) ........................................................... 9
XII.
Exhibit C: Center Correspondence with Respondent ..................................................................................... 9
A.
November 10,2008 Letter from Dr. Hartwell to Respondent re Notification of Allegations and Initiation of
Inquiry ....................................................................................................................................................................... 9
B.
December 5, 2008 Letter from RIO Sands to Respondent re Inquiry Committee's December 2, 2008 Report
of Allegations ............................................................................................................................................................ 9
C.
December 17, 2008 Letter from RIO Sands to Respondent, remailing prior correspondence ........................ 9
XIII.
Exhibit D: December 2,2008 "Report of Allegations" (18 pages) ................................................................ 9
XIV. Exhibit E: January 16,2009 Comments from Respondent re Allegations (5 pages) .................................... 9
XV.
ExIn"bit F Comments from Respondent re Draft Inquiry Report .................................................................... 9
XVI. ExIn"bit G: Comments from Complainant re Draft Inquiry Report ....................:........................................... 9
XVII. Endnotes: ......................................................................................................................................................... 9

CONFIDENTIAL

INQUIRY REPORT

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MEMORANDUM

CONFIDENTIAL

DATE:

September 17, 2009

TO:

Dr. Lee Hartwell, President and Director


Dr. Mark Groudine, Executive Vice President and Deputy Director

FROM:
Re:

E    E  D  E  F
Inquiry Report
Allegations of Research Misconduct Inquiry, Case E   $
Respondent - E    E  D  E  F

I. BACKGROUND
A. Factual History

In early August of 2007, Fred Hutchinson Cancer Research Center ("Center") management

I'

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CONFIDENTIAL

INQUIRY REPORT

Page 3 of9
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E    E  D  E  F
B. Data Sequestration

E    E  D  E  F
C. Pre-Inquiry Preliminary Assessment
On March 18, 2008, Dr. Hartwell appointed us to serve as a Preliminary Assessment Committee
to review Respondent's work while at the Center. On July 29,2008, we concluded in the
Preliminary Assessment Committee Report that an Inquiry should proceed on the 2005
Manuscript.
D. Inquiry
On November 10, 2008, Dr. Hartwell appointed us to serve as the Inquiry Committee and
charged us with conducting a preliminary review of the allegations of research misconduct
("Inquiry") under the Center's "RC?search Misconduct Policy and Procedures" ("Poliey"), a copy
of which is attached as Exhibit BV., and to make findings and recommendations to Dr. Hartwell,
President and Director of the Center, for appropriate action. This is the Inquiry Report that
makes those findings and recommendations.
As Inquiry Committee members, we agreed to conduct the Inquiry in an objective manner free of
bias, conflicts of interest (personal, professional or financial) or conflicts of commitment.
The Policy provides that the Inquiry be completed within sixty (60) days from the date
Respondent receives notice of the allegations unless additional time is warranted. We requested
from Dr. Hartwell two requests for extensions of time due to: i) E    E  D  E  F
ii) the challenges of
locating the relevant evidence for the Inquiry; and iii) delays relating to the efforts by the RIO to
contact Respondent and his counsel to propose a resolution of the matter through a Respondent's
admission in coordination with the Office of Research Integrity, U.S. Public Health Services of
the U.S. Department of Health and Human Services ("PHS").

CONFIDENTIAL

INQUIRY REPORT

Page 4 of9
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n.PHSSUPPORT

E    E  D  E  F
ID.INQUIRY PROCESS
The purpose of the Inquiry is to determine whether sufficient evidence of research misconduct

E    E  D  E  F

defined by the former Center "Policy For Dealing With And Reporting Possible Scientific
Misconduct in Research," and the former PHS Final Rule, 42 CFR Part 93 as "fabrication,
falsification, plagiarism, or other practices that seriously deviate from those that are commonly
accepted within the scientific community for proposing, conducting, or reporting research)'
Although the former Center policy did not specifically define "fabrication" or "falsification,"
federal policy defined these terms as follows:

''fabrication'' means ''making up data or results and recording or reporting them;"


and
"falsification" means "manipulating research materials, equipment, or processes
or changing or omitting data or results such that the research is not accurately
represented in the research record."
See Office of Science and Technology Policy (65 FR 76260, December 6, 2000). The phrase "or
other practices that seriously deviate from those that are commonly accepted within the scientific
community" is not defined by law or regulation and remains a matter of interpretation.
Specifically excluded from the definition are "honest error or honest differences in interpretation
or judgments of data." These definitions come from the policy and regulations that were in

E    E  D  E  F

Inquiry were consistent with the current PHS Regulations, 42 CFR Part 93 and the current Center
Policy.

IV. ALLEGATIONS

E    E  D  E  F
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INQUIRY REPORT

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V. INQUIRY COMMITTEE FINDINGS/ANALYSIS OF ALLEGATIONS

E    E  D  E  F

CONFIDENTIAL

INQUIRY REPORT

Page 6 of9
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E    E  D  E  F

VI. RESPONDENT'S COMMENTS ON DRAFT INQUIRY REPORT


See Exhibit F.
VIT.

COMPLAINANT'S COMMENTS ON DRAFT INQUIRY REPORT


See Exhibit G.

VID. CONCLUSION

E    E  D  E  F
""

CONFIDENTIAL

INQUIRY REPORT

Page 70f9
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IX. CENTER'S PRESIDENT


INVESTIGATION

AND

DIRECTOR'S

DECISION

REGARDING

E    E  D  E  F
September 30, 2009

CONFIDENTIAL

INQUIRY REPORT

Page 8 of9
HHS-PSC000621

~~'~~"~-

x.

Exhibit A:

E    E  D  E  F

XI. Exhibit B: Center Research Misconduct Policy ("Policy") ( 8 pages)


XU.

Exhibit C: Center Correspondence with Respondent

A. November 10, 2008 Letter from Dr. Hartwell to Respondent re Notification of AUegations and
Initiation of Inquiry
.
B. December 5, 2008 Letter from RIO Sands to Respondent re Inquiry Committee's December 2,
2008 Report of Allegations
C. December 17,2008 Letter from RIO Sands to Respondent, remailing prior correspondence

XIII. Exhibit D: December 2,2008 "Report of Allegations" (18 pages)


XIV. Exhibit E: January 16,2009 Comments from Respondent re Allegations (5 pages)

xv.

Exhibit F Comments from Respondent re Draft Inquiry Report

XVI. Exhibit G: Comments from Complainant re Draft Inquiry Report


XVTI. Endnotes:

E    E  D  E  F

CONFIDEl\'7!AL

INQUIRY REPORT

Page 90f9
HHS-PSC000622

>

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HHS-PSC000624

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HHS-PSC000625

E    E  D  E  F

HHS-PSC000626

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HHS-PSC000627

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HHS-PSC000628

E    E  D  E  F

HHS-PSC000629

HHS-PSC000630

FRED HUTCHINSON CANCER RESEARCH CENTER


RESEARCH MISCONDUCT POUCY AND PROCEDURES
RESTATED 3114107
p()L,ICY$.tAt~E:Nt

In all of its research activities, Fred Hutchinson Cancer Research Center (the MCenter") expects the highest
standards of professional conduct. The enterprise of scientific research relies upon the trust and confidence
of both the scientific community and the public at large. Unethical behavior undermines confidence in the
reliability of science and the integrity of the Center. For these reasons, the Center considers misconduct in
science a betrayal of fundamental scientific principles and shall deal with all instances of possible research
misconduct firmly in accordance with the Center's Research Misconduct Policy and Procedures ("Policy").
Situations that do not constitute research misconduct may be' reviewed under the Center's other policies,
including but not limited to the Center's Research Integrity Policy and Procedures. In some cases, the
alleged conduct under review may be subject to both this Policy and the Center's Research Integrity Policy.

This Policy is developed to prevent, detect and deal with possible research misconduct in the Center's
research programs. It is designed to balance the need to deal firmly and effectively with allegations of
possible research misconduct with the need for openness and creativity in the scientific enterprise. In
responding to allegations of research misconduct, the Center also must comply with all applicable laws and
regulatory requirements of federal agencies supporting the research in question, as well as Center policies
and procedures. In cases involving research funded by the U.S. Department of Health and Human Services
("HHS"), the Office of Research Integrity ("ORn oversees the Center's compliance with HHS research
misconduct regulations ~ Exhibit "Ae). In cases involving research funded by the National Science
Foundation (MNSF-) ~ Exhibit "Be) and other federal agencies, the Office of the Inspector General ("OIG-)
generally carries out enforcement of research misconduct regulations. This POlicy will refer throughout Simply
to ORI except in those instances in which the procedures mandated by NSF regulations differ from those
imposed by HHS.
I'

The Center's President and Director ("Director") has the final authority and responsibility for defining the
ethical standards for the Center.
This Policy replaces in its entirety the Center's prior policy dated September 24, 2003.
P:R~NTlQ~.

The Center expects intellectual honesty in all of Its endeavors. All employees should maintain open
communication, submit work for peer review, disclose and cooperate in the management of conflicts of
interest, commit to self-regulation, and comply with Center processes for the disclosure and management of
conflicts of interest. (See: http://www.fhcrc.orglintranetlgeneral counsel/conflict interest 2002.pdf)
The Center shall educate and inform all employees regarding its ethical standards, Its guidelines for
conducting and reporting research, its philosophy and policy of dealing with and reporting possible research
misconduct and the importance of complying with the relevant policies and procedures.
As a regular element of its policy of maintaining the highest possible standard of Scientific productivity, the
Center will continue to maintain a regular and rigorous system of review of the quality of the scientific
programs of its investigators.

HHS-PSC000631

RESEARCH MISCONDUCT POLICY AND PROCEDURES


The Center's Director shall appoint a Research Integrity Officer to (Q assist with the education of all staff and
employees regarding the Center policies and procedures relating to research misconduct; (iQ provide
clarification and information to individuals with concerns regarding potential incidents of misconduct; (iii) assist .
individuals in understanding the Center's pOlicies and procedures in this area; (iv) assist with the
administration of this POlicy including inquiries and investigations conducted pursuant to this Policy; and (v)
provide mediation services where indicated.
The Center shall periodically evaluate its policy and procedures for educating its staff about the proper
conduct of research and assess whether additional efforts are necessary.
t{l~iii1;t'~~~t:l~;,;ql:H~;f~}j:32~;X'~f::tf!~jJ;;~Ii~)m8~!{~~~1Q.8~Q~Q~tJa;:tEGtiiS:ilt:i};i}2:i'r~i::i:~:;:;;/L(;::.:,

Research misconduct means fabrication, falsification, or plagiarism in proposing, performing, or reviewing


research, or in reporting research results.
Fabrication means making up data or results and recording or reporting them.
Falsification means manipulating research materials, equipment, or processes, or changing or omitting data or
results such that the research is not accurately represented in the research record.
Plagiarism means the appropriation of another person's ideas, processes, results, or words without giving
appropriate credit.
Research misconduct does not include honest error or honest differences in interpretations or judgments of

data.

A finding of research misconduct requires that (i) there is a Significant departure from accepted practices of
the relevant research community; (Ii) the misconduct is committed intentionally, knowingly, or recklessly; and
(iii) the allegation of research misconduct is proven by a preponderance of the evidence. There may be a
different standard of proof for misconduct under other Center pOlicies.

The procedures described in this POlicy represent the general approach to be employed by the Center in
instances of possible research misconduct, since no policy and procedures can anticipate every possible
issue that might arise in the course of an inquiry or investigation. The Center's Director is responsible for
implementing these procedures and modifying them as necessary to ensure adherence to the Policy.
I.

CONFIDENTIAUTY

To the extent allowed by law, the Center shall maintain the identity of the individual(s) against whom the
allegation of research misconduct is made (-respondents-) and the individual(s>. bringing forward the allegation
(complainants-) securely and confidentially and shall not disclose any identifying information, except to:
A. those who need to know in order to carry out a thorough, competent, objective and fair research
misconduct proceeding; and
B. ORI as It conducts its review of the research misconduct proceeding and any subsequent
proceedings.
To the extent allowed by law, any information obtained during the research misconduct proceeding that might
identify the subjects of research shall be maintained securely and confidentially and shall not be disclosed;
except to those who need to know in order to carry out the research misconduct proceeding.
The Center prohibits retaliation of any kind against a person who, acting in good faith, reports or provides
infonnation about suspected misconduct.

2
HHS-PSC000632

RESEARCH MISCONDUCT POUCY AND PROCEDURES


II. RESEARCH MISCONDUCT PROCEEPINGS-CBlTERIA. REPORTS. AND nME LlMITATIONSl

A. Preliminary Assessment
Disclosures of possible research misconduct received by the Center through any means of
communication (MAIlegationB) shall be promptly referred to the director of the division in which the
alleged research misconduct occurred (MDivision Director"). The Division Director shall assess the
Allegation to determine if:
.
1. it meets the definition of research misconduct2 ;
2. it involves Public Health Service (PHSB) supported research, applications for PHS
research support, or research records 3 ;
3. it is sufficiently credible and specific so that potential evidence of research misconduct
may be identified; and
4. It is timely. 4
If the Division Director determines that these criteria have not been met, then the matter will not
proceed to inquiry and may be reviewed under the Center's other policies, including but not limited to
the Center's Research Integrity Policy and Procedures. If the Center's Division Director determines
that these criteria have been met, then the matter will proceed to inquiry.

B. Inquiry6

An inquiry is an initial review of the evidence to determine if the criteria for conducting an investigation
have been met. The criteria for determining whether or not an investigation may be required include a

finding that:

1. There is a reasonable basis for concluding that the Allegation falls within this Policy's
definition of research misconduct; and
2. The preliminary review of the facts indicates thJt the Allegation has substance.

The Center shall complete the inquiry, including preparation of the inquiry report and giving the

respondent a reasonable opportunity to comment on It, within sixty (60) calendar days of Its initiation,
unless the circumstances warrant a longer period. If the inquiry takes longer than sixty (60) days to
complete, the Center shall include documentation of the reasons for the delay in the inquiry record.

The inquiry report shall contain the following information:


1. The name and position of the respondent;
2. A description of the Allegation of research misconduct;
3. The PHS support involved, including, for example, grant numbers, grant applications,
contracts, and publications listing PHS support; .
4. The basis for recommending that the alleged actions warrant an investigation; and
5. Any comments on the report by the respondent or the complainant.
The Center's Director will make a written determination of whether an investigation is warranted. If the
Center's Director determines that an investigation is not warranted, then the matter may be reviewed
1 NSF proceeding requirements can be found in 45 CFR Section 689.4 and Section 689.6 (B Exhibit B). In
absence of any specific requirements, the Center may follow the HHS requirements.
2 The definition of research misconduct can be found above and in 42 CFR Section 93.103 <ti Exhibit A)
and/or in 45 CFR Section 689.1 (B Exhibit B).
3 HHS describes research in 42 CFR Section 93.1 02 (b) ~ Exhibit A). NSF describes research in 45 CFR
Section 689.1 ~ Exhibit B).
4 In cases involving PHS supported research, the time limitations can be found in 42 CFR Section 93.103 (!!,
Exhibit A).
5NSF time limitations and extensions for an inquiry can be found in 45 CFR Section 689.4 (u Exhibit B).

3
HHS-PSC000633

RESEARCH MISCONDUCT POUCY AND PROCEDURES


under the Center's other policies, including but not limited to the Center's Research Integrity Policy
and Procedures, if warranted in the sole discretion of the Center's Director.
C. Investigation6
If the Center's Director detennlnes that an investigation is warranted, then the Center shall begin the
investigation within thirty (30) calendar days of that determination and, on or before the date on which
the investigation begins, send the Inquiry report and the written determination to ORI. The Center
shall use its best efforts to complete the investigation within one hundred and twenty (120) calendar
days of the date on which it began, including conducting the investigation, preparing the report of
findings, providing the draft report for comment, and sending the final report to ORI. If it becomes
apparent that the Center cannot complete the investigation within that period, the Center shall
promptly request an extension in writing from ORI.
In conducting all investigations, the Center shall:
1. uSe diligent efforts to ensure that the investigation is thorough and sufficiently
documented and includes examination of all research records and evidence relevant to
reaching a decision on the merits of the Allegation;
2. Interview each respondent, complainant, and any other available person who has been
reasonably identified as having Infonnation regarding any relevant aspects of the
investigation, including witnesses identified by the respondent, and record or transcribe each
interview, provide the recording or transcript to the intervieWee for correction, and include the
recording or transcript in the record of investigation;
3. Pursue diligently all significant issues and leads discovered that are determined relevant
to the investigation, including any evidence of additional instances of possible research
misconduct, and continue the investigation to completion; and
4. Otherwise comply wittl the requirements for conducting an investigation7
The Center shall prepare the draft and final institutional investigation reports in writing and provide the
draft report for comment as provided elsewhere in these policies and procedures and as required by
lawS. The final investigation report shall:
1. Describe the nature of the Allegation of research misconduct;
2. Describe and document the PHS support, including, for example any grant numbers,
grant applications, contracts, and publications listing PHS support;
3. Describe the specific Allegation of research misconduct considered in the investigation;
4. Include the Center's policies and procedures under which the investigation was
conducted, If not already provided to ORI;
5. Identify and summarize the research records and evidence reviewed, and Identify any
evidence taken into custody, but not reviewed. The report should also describe any
relevant records and evidence not taken into custody and explain why.
6. Provide a finding as to whether research misconduct did or did not occur for each
separate Allegation of research misconduct identified during the investigation, and if
misconduct was found:
a. identify it as falsification, fabrication, or plagiarism and whether it was intentional,
knowing, or in reckless disregard;
b. summarize the facts and the analysis supporting the conclusion and consider the
merits of any reasonable explanation by the respondent and any evidence that rebuts
the respondent's explanations;
c. identify the specific PHS support;
NSF requirements for an inquiry can be found in 45 CFR Section 689.4 (i! Exhibit B).
HHS requirements for conducting an investigation can be found in 42 CFR Section 93.310 (B Exhibit A).
NSF requirements for conducting an investigation can be found in 45 CFR Section 689.6 ~ Exhibit B).
SHHS requirements for investigation reports can be found in 42 CFR Section 93.312 (!! Exhibit A). NSF
requirements for investigation reports can be found in 45 CFR Section 689.6 ~ Exhibit B).

HHS-PSC000634

RESEARCH MISCONDUCT POLICY AND PROCEDURES


d. identify any publications that need correction or retraction;
e. identify the person(s) responsible for the misconduct, and
f. list any current support or known applications or proposals for support that the
respondent has pending with non-PHS Federal agencies.
7. Include and consider any comments made by the respondent and complainant on the
draft investigation report.
The Center shall maintain and provide to ORI upon request all relevant research records and records of the
Center's research misconduct proceeding, including results of all interviews and the transcripts or recordings
of such interviews.
III. ENSURING A FAIR RESEARCH MISCONDUCT PROCEEDING
The Center shall take all reasonable steps to ensure an impartial research misconduct proceeding to the
maximum extent practicable. The Center shall select those conducting the inquiry or investigation on the
basis of scientific expertise that is pertinent to the matter and, prior to selection, the Center shall screen them
for any unresolved personal, profesSional, or financial conflicts of interest with the respondent, complainant,
potential witnesses, or others involved in the matter. Any such conflict which a reasonable person would
consider to demonstrate potential bias shall disqualify the individual from selection.

A. Notice to Respondent and Complainanti ..


During the research misconduct proceeding, the Center shall provide the following notifications to all
identified respondents 10:
B. Injt!ation of Inquirv.
Prior to or at the beginning of the inquiry, the Center shall provide the respondent written notification of
the inquiry and contemporaneously sequester all research records and other evidence needed to
conduct the research misconduct proceeding. If the inquiry subsequently identifies addjt!onal
respondents, they shall be promptly notified in writing.
C. Comment on Inquirv Report.
The Center shall provide the respondent, and may provide complainant at the Center's discretion, an
opportunity to comment on the inquiry report in a timely fashion so that any comments can be
attached to the report. If there is more than one respondent, then the Center may prepare separate
reports to preseNe confidentiality.
D. Results of the Inquirv.
The Center shall notify the respondent, and may notify the complainant at the Center's discretion, of
the results of the inquiry and attach to the notification copies of the inquiry report and the Center's
policies and procedures for the handling of research misconduct Allegations.
E. Initiation of Investiqation.
Within a reasonable time after the Center's determination that an investigation is warranted, but not
later than thirty (30) calendar days after that determination, the Center shall notify the respondent, and
may notify the complainant at the Center's discretion, in writing of the Allegation to be investigated.
The Center shall give respondent written notice of any new Allegation within a reasonable time after
determining to pursue any Allegation not addressed in the inquiry or in the injt!al notice of the
investigation.

NSF notification requirements can be found in 45 CFR Section 6S9 (n Exhibit B).
ORI notification requirements can be found in 42 CFR Section 93.309(a) ~ Exhibit A). NSF notification
requirements can be found in 45 CFR Section 6S9 (!! exhibit B).

10

5
HHS-PSC000635

RESEARCH MISCONDUCT POUCY AND PROCEDURES


F. Scheduling of Interview.
The Center will notify the respondent sufficiently in advance of the scheduling of hislher interviENIln
the Investigation so that the respondent may prepare for the interviENI and arrange for the attendance
of legal counsel at hislher own expense, If the respondent wishes.
G. Comment on Draft Investigation Report.
The Center shall give the respondent, and may provide the complainant at the Center's discretion, a
copy of the draft Investigation report, and concurrently, a copy of, or supervised access to, the
evidence on which the report Is based and notify the respondent and complainant that any comments
must be submitted within thirty (30) days of the date on which he/she receivecl the draft report. If there
is more than one respondent, then the Center may prepare separate reports to preserve
confidentiality. The Center shall ensure that these comments are included and considered in the final
investigation report.
IV. NOTIfYING ORI OF THE DECIIION TO OPEN AN INVESTIGATION AND OF INSTITUTIONAL
FINDINGS AND ACTIONS FOLLOWING THE INVESTIGATION
On or before the date on which the investigation begins (the investigation must begin within thirty (30)
calendar days of the Center's finding that an investigation is warranted), the Center shall provide ORI with the
written finding by the Center's Director and a copy of the inquiry report containing the information required by
law11 Upon a request from ORI, the Center shall promptly send to ORI:
1. a copy of the Center's policies and procedures under which the inquiry was conducted;
2. the research records and evidence reviewed, tranScripts or recordings of any interviews, and copies
of all relevant documents; and
3. the charges for the investigation to consider.
The Center shall promptly provide to ORI after the investigation:
1. a copy of the investigation report and all attachments;
2. a statement of whether the Center found research misconduct and, If so, who committed It;
3. a statement of whether the Center accepts the findings in the investigation report; and
4. a description of any pending or completed administrative actions against the respondent.
V. MAINTENANCE AND CUSTODY OF RESEARCH RECORDS AND EVIDENCE'u
The Center shall take the following specific steps to obtain, secure, and maintain the research records and
evidence pertinent to the research misconduct proceeding:
A. Either before or when the Center notifies the respondent of the Allegation, the Center shall
promptly take all reasonable and practical steps to obtain custody of all research records and
evidence needed to conduct the research misconduct proceeding, inventory those materials, and
sequester them in a secure manner. As an exception, in those cases where the research records or
evidence encompass scientific instruments shared by a number of users, custody may be limited to
copies of the data or evidence on such instruments, so long as those copies are substantially
equivalent to the evidentiary value of the instruments.
B. Where appropriate, the Center shall give the respondent copies of, or reasonable, supervised
access to the research records.
C. The Center shall undertake all reasonable and practical efforts to take custody of additional
research records and evidence discovered during the course of the research misconduct proceeding,
including at the inquiry and investigation stages, or If new Allegations arise, subject to the exception
for scientific instruments in A. above.

11
12

See 42 CFR Section 93.309(a) ~ Exhibit A) and/or45 CFR Section 689.4 ~ exhibit B).
NSF requirements for records and evidence can be found in 45 CFR Section 689 ~ Exhibit B).
6
HHS-PSC000636

RESEARCH MISCONDUCT POLICY AND PROCEDURES


D. The Center shall maintain all records of the research misconduct proceeding 13, for seven (7)
years after completion of the proceeding, or any ORI or HHS proceeding 14, whichever is later, unless
the Center has transferred custody of the records and evidence to HHS, or ORI has advised the
Center that Hno longer need to retain the records.
VI. INTERIM PROTECTIVE ACTIONS
M. any time during a research misconduct proceeding, the Center shall take appropriate interim actions to

protect public health, federal funds and eqUipment, and the integrity of the PHS supported research process.
The necessary actions will vary according to the circumstances of each case, but examples of actions that
may be necessary include delaying the publication of research results, providing for closer supervision of one
or more researchers, requiring approvals for actions relating to the research that did not previously require
approval, auditing pertinent records, or taking steps to contact other institutions that may be affected by an
Allegation of research misconduct.
VII. NOTIFYING ORI OF SPECIAL CIRCUMSTANCES THAT MAY REQUIRE PROTECTIVE ACTlONS1i
M. any time during a research misconduct proceeding, the Center shall notify ORI immediately if the Center

has reason to believe that any of the following conditions exist:

A. Health or safety of the public is at risk, including an immediate need to protect human or animal
subjects.
B. HHS resources or interests are threatened.
C. Research activities should be suspended.
D. There is a reasonable indication of violations of civil or criminal law.
E. Federal action is required to protect the interests of those involved in the research misconduct
proceeding.
F. The Center believes the research misconduct proceeding may be made public prematurely, so
that HHS may take appropriate steps to safeguard evidence and protect the rights of those involved.
G. The Center believes the research community or public should be informed.
VIII. INSTITUTIONAL ACTIONS IN RESPONSE TO FINAL FIN pINGS OF RESEARCH MISCONDUCT
The Center will cooperate with and assist ORI and HHS as needed, to carry out any administrative actions
those agencies may impose as a result of a final finding of research misconduct.
Violations of this Research Misconduct Policy and Procedures may result in discipline up to and including
termination of employment.
Situations that do not constitute research misconduct may be reviewed under the Center's other policies,
including but not limited to the Center's Research Integrity Policy and Procedures.
IX. RESTORING REPUTATIONS
A. Respondents. The Center shall undertake all reasonable efforts to protect and restore the
reputation of any person alleged to have engaged in research misconduct, but against whom no
finding of research misconduct was made, if that person or his/her legal counselor other authorized
representative requests that the Center do so.
B. Complainants. Witnesses. and Committee Members. The Center shall undei'take all reasonable
efforts to protect and restore the position and reputation of any complainant, witness, or committee
The HHS definition for records is defined in 42 CFR Section 93.317(a) (U Exhibit A).
The HHS description of proceedings can be found in Subparts 0 and E of 42 CFR Part 93 (See Exhibit A).
15 NSF notification requirements can be found in 45 CFR Section 689 (u. Exhibit B).
13
14

7
HHS-PSC000637

RESEARCH MISCONDUCT POUCY AND PROCEDURES

member and to counter potential or actual retaliation against those complainants, witnesses and
committee members.
X. COOPERA110N WITH ORIl

The Center shall cooperate fully and on a continuing basis with ORI during its oversight reviews of this
institution and Its research misconduct proceedings and during the process under which the respondent may
contest ORI findings of research misconduct and proposed HHS administrative actions. This includes
providing, as necessary to develop a complete record of relevant evidence, all witnesses, research records,
and other evidence under the Centers control or custody, or in the possession of, or accessible to, all persons
that are subject to the Center's authority.
Reporting to ORI The Center will report to ORI any proposed settlements, admissions of research
misconduct, or the Center's findings of misconduct as required by law.
Exhibit A: 42 CFR Part 93 (See: http://orLdhhs.gov/documents/42 cfr parts 50 and 93 2005.pdf
Exhibit B: 45 CFR Section 689 (See: htto:/lwww.nsf.gov/oig/resmisreg.pdf)

16

The Center will cooperate with NSF as required under 45 CFR Section 689 (.!! Exhibit B).
8
HHS-PSC000638

HHS-PSC000639

II

FRED

HUTCHINSON
CANCER
RESEARCH

CENTER

Lee Hartwell, PIa.D.


Plesident and Director
Phone: 206-6675670

Fax: 206-6675268

November 10, 2008

CONFIDENTIAL VIA FEDERAL EXPRESS

E    E  D  E  F

Re: Formal Notice of Inquiry Into Allegations


of Research Misconduct
E    E  D  E  F

This letter serves as a formal notice that Fred Hutchinson Cancer Research Center
("Center") will be Conducting an inquiry into allegations of research misconduct
("Inquiry'') that have been raised related to the research conducted by you that was

E    E  D  E  F
As you will see from a review of the Inquiry process, it is critical that you submit a written
response to the Center within 30 days of your receipt of this letter and fully participate in
the process described below. I would like to briefly review the defiirltion of research

misconduct, the allegations, and the Inquiry process under Center policy.
pefinition of ResearehlScientiftc Misconduct

As required by federal ~gulations, the Center has established its own research misconduct
policies and procedures for investigating and reporting alleged research misconduct
("Policy"). Included in the Policy are terms that are used throughout an Inquiry.

E    E  D  E  F
HHS-PSC000640

E    E  D  E  F

CONFIDENTIAL

November 10, 2008


Page 2

The purpose of the Inquiry is to determine whether sufficient evidence of research


E    E  D  E  F
misconduct exists to wammt further investigation.
was defined by the fonner Center
"Policy For Dealing With And Reporting Possible Scientific Misconduct in Research," and
the fonner PHS Final Rule, 42 CFR Part 93 as "fabrication, falsification, plagiarism, or
other' practices that seriously deviate from those that are commonly accepted within the
scientific community for proposing, Conducting, or reporting research." Although the
fonner Center Policy did not specifically define "fabrication" or "falsification," federal
policy defined these terms as follows:
"fabrication" means ''making up data or results and recording or reporting

them;" and

"falsification" means ''manipulating research materials, equipment, or


processes or changing or omitting data or results such that the research is

not accurately represented in the research record.."

Office of Science and Technology Policy (65 FR 76260, December 6, 2000). The
phrase "01' other practices that seriously deviate from those that are commonly accepted
within the scientific community" is not defined by law or regulation and remains a matter
of interpretation.
~

Specifically excluded from the defj.nition were "honest en'Or or honest differences in
interpretation or judgments of data." These definitions come from the policy and

E    E  D  E  F

with the current PHS Regulations, 42 CFR Part 93 and the Center's current "Research
Misconduct Policy and Procedures, a copy of which is enclosed." If you would like to
have copies of the regulations, please let Gerianne Sands, the Center's Associate General
Counsel and Research Integrity Officer, mow.
Specific Allegations

E    E  D  E  F

HHS-PSC000641

E    E  D  E  F

November 10, 2008


Page 3

CONFIDENTIAL

E    E  D  E  F

I encourage you to send a written response to these allegations as quickly as possible. but
no later than 30 days from your receipt of this letter. Ms. Sands will be managing the
Inquiry, so you can submit your response to Ms. Sands, and she will forward your response
to me and to the Inquiry Committee. Should the Inquiry Committee require additional
infonn.ation from you or wish to speak with you directly, you will be notified by Ms.
Sands. Ms. Sands can be reached at:
Gerianne J. Sands

Fred Hutchinson Cancer Research Center


1100 Fairview Avenue North
Mail StopJ6-20S
Seattle, VV~n 98109-1024
. (206) 667-1224
gjsands@fucrc.ol'g

Inama Process
The Inquiry process is an information-gathering and initial fact-finding process to
determine whether the allegations of research misconduct warrant fonnal investigation.
The purpose of the Inquiry is to cull out any insufficiently substantiated, erroneous, or bad
faith allegations before a respondent is subjected to an investigation. The Inquiry does not
return a finding whether research misconduct has occurred, but rather determines only
whether a formal investigation is warranted.
Consistent with federal requirements, steps have been taken to secure original research
records for the duration ofthis review. If there are further relevant original records or data
relating to this matter that you have in your possession, please let Ms. Sands know
immediately. In no case should any existing record be destroyed or altered.

HHS-PSC000642

E    E  D  E  F

November 10. 2008


Page 4

CONFIDENTIAL

It is the Center's goal to conduct a fair, thorough, and objective review according to the
E    E  D  E  F
Inquiry procedures outlined in the Center's Policy. The Center has appointed
to an Inquiry Committee. This committee will
review evidence and may interview you and others, by person or by telephone, who may
have relevant information. Any interviews may be tape recorded and transcribed. You
may have an attorney come with you to your interview to advise you if you wish.
During the course of the Inquiry, if you need access to the original research records and
other evidence submitted or sequestered in this case, which evidence Ms. Sands has

secured and inventoried, then please contact her. When you need to examine original
evidence, Ms. Sands, or someone from her office, will be present to assure that it is kept in
order and so that the chain of custody cannot be challenged.
If, dwing the course of the Inquiry, additional information becomes available that
substantially changes the subject matter of the Inquiry, or would suggest additional
respondents or amending the allegations, then Ms. Sands will notify you of the new subject
matter or provide notice to additional respondents.

At the conclusion of the Inquiry, the Inquiry Committee will draft a report to me, as the
Center's President and Director, as to whether or not, based on its J;Cview, further
investigation is warranted. The format of the Inquiry Report is described in Section n.B. of
the Policy. For each allegation, the Inquiry Committee should decide that an investigation
is warranted if it finds:
A reasonable basis for concluding that the allegation falls within the
definition of research misconduct; and
The allegation may have substance, based on the Inquiry Committee's
prelimjnary review.

The Inquiry Committee should cite in its report the pertinent evidence and the committee's
basis for recommending whether or not an investigation is warranted.
Ms. Sands will provide you with a copy of the draft report, and you will be given the
opportunity to review and make comments on it As the result of your comments, the
Inquiry Committee may change its report, and at the very least, your comments will be
appended to the final report provided to me. As President and Director of the Center, I will
make the final determination as to whether or not the matter wilr proceed to investigation.
Please understand that you are to take no steps to retaliate against anyone who came
forward with the allegations or against anyone who may participate in the Inquiry process.

HHS-PSC000643

E    E  D  E  F

November 10, 2008


Page 5

CONFIDENTIAL

The Center considers this matter to be a confidential matter, and will make every effort to
ensure that confidentiality is maintained. In addition, all communications about this matter
should go through Ms. Sands or me to protect the integrity of the procedures. Please be
assmed that we are committed to a fair, thorough, and objective process.
We appreciate your cooperation with this matter. Please do not hesitate to call Ms. Sands
if you have any questions.

Lee Hartwell, Ph.D.


President and Director

Enclosure
cc: Gerianne J. Sands, Associate General Counsel and Research Integrity Officer

HHS-PSC000644

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'.:

HUTCHINSON

,',j

'r i:'<! ; CENTER

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December 5, 2008

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Office of the General Counsel

E    E  D  E  F EDERAL EXPRESS

Re:

Report of Allegations of Research Misconduct


(Center File E   $

E    E  D  E  F

As a follow-up to Dr. Hartwell's November 10, 2008 letter notifying you of the Inquiry, I
enclose a December 2, 2008 report of "Allegations of Research Misconduct" ("Report").
This Report was prepared to assist you in responding to the allegations pending in the
Center's Inquiry. If you did not receive Dr. Hartwell's letter, please contact me
immediately using the contact information listed below.
To give you time to process this additional information and prepare a written response to
the Center, we encourage you to respond to both this letter and Dr. Hartwell's letter within
30 days of your receipt of this letter.
I will be managing the Inquiry, so you can submit your response to me, and I will forward
your response to the Inquiry Committee and to Dr. Hartwell. I can be reached at:
Gerianne J. Sands
Fred Hutchinson Cancer Research Center
1100 Fairview Avenue North
Mail StopJ6-205
Seattle, Washington 981 09~ 1024
(206) 667-1224
gjsands@thcrc.org
We appreciate your cooperation with this matter. Please do not hesitate to call me if you
have any questions.
Sincerely,

Associate General Counsel and Research Integrity Officer


Enclosure

cc:

E    E  D  E  F
HHS-PSC000645

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FRED HUTCHINSON

( "i\NCt:!.(

RESF.t\I~CH

December 12, 2008

Office of the General Counsel

CONFIDENTIAL VIA FEDERAL EXPRESS


E    E  D  E  F

Re:

Report of Allegations of Research Misconduct


(Center File E   $ )

E    E  D  E  F

Last Friday, December 5th, I attempted to send to you a letter regarding the Report of

t,

We appreciate your cooperation with this matter. Please do not hesitate to call me if you
have any questions.

~,

CENTER

A lift OF SCI[NCE

Allegations of Research Misconduct. Federal Express not been able to confirm its
delivery, so I enclose a copy of that letter and enclosure.

Sincerely,

t,

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Geri

e J. Sands

Associate General counsel and Research Integrity Officer

Enclosure
cc wlo encl.:

E    E  D  E  F

.--------------------------------------~~---------HHS-PSC000646

~.-

FRED HUTCHINSON

(j\0JCER
,II

December 17, 2008

1~I:.SfARCI-I

urr or

CENTER

S(J[,,!U

Office of the Geoer.lI Counsel

CONFIDENTIAL VIA FEDERAL EXPRESS

E    E  D  E  F

Report of Allegations of Research Misconduct


(Center File E   $ )

Re:

E    E  D  E  F

Thank you for sending E    E  D  E  F To make sure you have everything, I am


resending:
a copy of Dr. Hartwell's November IOIIl, 2008 letter to you,

a copy of the Center's current Research Misconduct Policy and Procedures,


a copy of my December 5th and 12th, 2008 letters to you; and
a copy of the Allegations of Research Misconduct

As mentioned in Dr. Hartwell's letter, it is critical that you submit a written response to the

Center within 30 days of your receipt of this December 17, 2008 letter, and fully participate
in the Inquiry process described in his letter.
We appreciate your cooperation with this matter. Please do not hesitate to call me if you
have any questions.
Sincerely,

Gerianne J. Sands

Associate Genera1 Counsel and Research Integrity Officer


Enclosure
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HHS-PSC000656

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page 9
HHS-PSC000657

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page 10
HHS-PSC000658

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page 11
HHS-PSC000659

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page 12
HHS-PSC000660

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page 13
HHS-PSC000661

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HHS-PSC000667

January 16, 2009


Response to Allegations of Research Misconduct

E    E  D  E  F

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HHS-PSC000669

E    E  D  E  F

-3HHS-PSC000670

E    E  D  E  F

-4HHS-PSC000671

E    E  D  E  F

- 5HHS-PSC000672

HHS-PSC000673

May 18,2009
Comments on "042909 Draft Inquiry Report to Respondent and Complainant"

E    E  D  E  F

HHS-PSC000674

E    E  D  E  F

HHS-PSC000675

HHS-PSC000676

E    E  D  E  F
COMMENTS ON:
DRAFT INQUIRY REPORT: ALLEGATIONS OF RESEARCH MISCONDUCT
RESPONSE TO ALLEGATIONS OF RESEARCH MISCONDUCT BY E    E  D  E  F
NOTE: 'ATTACHED' FIGURES ARE LOCATED AT THE END OF THIS DOCUMENT.

E    E  D  E  F

HHS-PSC000677

E    E  D  E  F

HHS-PSC000678

E    E  D  E  F

HHS-PSC000679

E    E  D  E  F

HHS-PSC000680

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HHS-PSC000686

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HHS-PSC000688

E    E  D  E  F

HHS-PSC000689

E    E  D  E  F

HHS-PSC000690

E    E  D  E  F

HHS-PSC000691

E    E  D  E  F

HHS-PSC000692

E    E  D  E  F

HHS-PSC000693

E    E  D  E  F

HHS-PSC000694

E    E  D  E  F

HHS-PSC000695

E    E  D  E  F

HHS-PSC000696

Bittinger, Kristin L

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