Why Data-Sharing Policies Matter

Author(s): Alan E. Guttmacher, Elizabeth G. Nabel and Francis S. Collins

Source: Proceedings of the National Academy of Sciences of the United States of America,
Vol. 106, No. 40 (Oct. 6, 2009), p. 16894
Published by: National Academy of Sciences
Stable URL: http://www.jstor.org/stable/40485105 .
Accessed: 20/04/2014 04:40
Your use of the JSTOR archive indicates your acceptance of the Terms & Conditions of Use, available at .
http://www.jstor.org/page/info/about/policies/terms.jsp

.
JSTOR is a not-for-profit service that helps scholars, researchers, and students discover, use, and build upon a wide range of
content in a trusted digital archive. We use information technology and tools to increase productivity and facilitate new forms
of scholarship. For more information about JSTOR, please contact support@jstor.org.

National Academy of Sciences is collaborating with JSTOR to digitize, preserve and extend access to
Proceedings of the National Academy of Sciences of the United States of America.

http://www.jstor.org

This content downloaded from 111.68.97.227 on Sun, 20 Apr 2014 04:40:50 AM

All use subject to JSTOR Terms and Conditions

<

t
O
H

policiesmatter
Whydata-sharing
Alan E. Guttmcher31, Elizabeth G. Nabelt and FrancisS. Collins0

^National Human Genome Research Institute,National Institutesof Health, Bethesda, MD 20892; bNational Heart, Lung,
and Blood Institute,National Institutesof Health, Bethesda, MD 20892; and ^National Institutesof Health, Bethesda, MD 20892

frombiomedicairesearch
are more broadlyavailable to
the researchcommunitytoday
than in the past. Technical
developments,such as web-baseddatabases, have playeda role in thistransition,but so has a fundamentalshiftin
the view of who "owns" researchdata.
The model of the investigator
owning
data has been increasingly
replaced by
one in whichsocietyowns data. Scientificand culturalforceshave converged
in the past decade to fosterthisnew
model. Numerousexamplesof broad
data sharing,rangingfromthe Human
Genome Project,to the Framingham
Heart Study,to the myriadgenomewide associationstudiesdepositedin the
dbGaP database of the National Institutesof Health (NIH) (see www.ncbi.
offer
nlm.nih.gov/sites/entrez?Db=gap),
to how broad accompellingtestimony
cess acceleratesand empowersscientific
to benefitsociety.
investigation
However,forboth ethicalreasons and
the purelypracticalconcernof making
broad data access workable,it is vital to
recognizeand protectboth participants'
and investigators'
interests(1). Participant protectionsincludea numberof
measures,includingappropriateconsent
processes,InstitutionalReview Board
review,technicaland statisticaldatabase
safeguards,and requiringresearchers
who access data to agree not to attempt
to identify
participantswhose data are
included.
1. Toronto International Data Release Workshop Authors (2009) Prepublication data sharing. Nature

who
The interestsof the investigator
cess, includinga 12-monthperiod of
exclusivity.
places data in an accessible database
A recentbreachby a recipientinvestialso requireprotection.The major availled
able protectionis the guaranteeof a
gatorof the Data Use Certification
in submissionof
to the on-linepublicationby PNAS of a
period of exclusivity
abstractsand publicationsfora number manuscriptthatshould nevereven have
been submitted(2). While both PNAS
of months(usually6 to 12). This excluand the NIH will deal withthisspecific
sive period is assuredby allowingdata
access onlyto end userswho agree to
breach,it is the widerresearchcommualso freabide by it. The investigator
nitythatmustpolice itselfand prevent
inappropriatepublicationin the future.
quentlyprofitsboth fromthe value
This will requirethatrecipientusersof
added to the data in its depositionin a
communitydata resourcesbe fully
communitydatabase (for instance,the
aware of data use limitationsto which
data
added
in
and
dbGaP)
genotypic
fromthe collaboratorsthatthe wider
theyagree and be scrupulousin honordata availabilityattracts.However,the
ing them.It will requirethatreviewers
is the keybenefitto questionwhetherdata access termshave
period of exclusivity
been followedin submittedmanuscripts.
the investigator;
breachingthisguaranIt will requirethatpublishersensure
tee threatensthe veryexistenceof
thatauthorsobservethe same level of
broad access to data in biomedicai
ethicalbehaviorfordata access as for
research.
conflictof interestor researchmisconWiththese principlesin mindand afduct. It will requirethatthe NIH design
ter considerablepublic input,the NIH
effectivestrategiesforalertingthe rea
for
of
Sharing
implemented "Policy
searchcommunityto thisissue and imData Obtained in NIH Supportedor
ConductedGenome-Wide Association
plementsteps thatmake breachesdiffiStudies (GWAS)" (see http://grants.nih.cult to commitand easy to discover.
gov/grants/guide/notice-files/NOT-OD- Wide access to data benefitsthe researchcommunityand society.We must
07-088.html).This policyprovidesguidance forresearcherswho are interested all play an activerole in protectingthe
in accessingdata fromthe National
rightsof both researchparticipantsand
if thisimportant
CenterforBiotechnologyInformation
principalinvestigators
practiceis to flourish.
(NCBI) database dbGaP, requiringreand theirinstitucipientinvestigators
tional officialsto signan agreement(the
Data Use Certification)bywhichthey
1To whom correspondence should be addressed: Email:
will complywiththe termsof data acguttmach9mail.nih.gov.
461:168-170.
2. Schekman R (2009) PNAS takes action regarding

16894-16894 | PNAS | October6. 2009 | vol.106 | no. 40

breach of NIH embargo policy on a PNAS paper. Proc

Nati Acad Sci USA, 10. 1073/pnas.O9103 17 106.

www.pnas.org/cgi/doi/10.1073/pnas.0910378106

This content downloaded from 111.68.97.227 on Sun, 20 Apr 2014 04:40:50 AM

All use subject to JSTOR Terms and Conditions