University of Saint Mary

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Institutional Review
Board
for the Protection of
Human Subjects in
Research

For Official Use Only

Date received:
End date:
File No.:

Application Form to Request a Review of a Research Protocol Involving Human Subjects

This form is to be used for requesting IRB review for exempt, expedited, and full-board studies.
** Please note that handwritten and/or incomplete forms will be returned to you. **

Part I - Investigator and Key Research Personnel

1) Principal Investigator
(To be a Principal Investigator, graduate students must have a completed student PI worksheet: see
Appendix A). (Undergraduate students cannot serve as Principal Investigators, but may be listed as a
Co-Investigators.)
Name:
Highest Degree Completed:
Investigator Status:

Dr.

Bridget Trom
Faculty X

Graduate Student

Bridget.trom@hotmail.com

College/Department:

Master of Arts in Education

Daytime Phone:

Ms.

Professor

Mr.

Ms.

Professor

B.S., Elementary Education

E-mail Address:
Campus Mailing Address:

Mr. X

Staff

507-254-2519

2) Co-Investigator 1 (if applicable)

Name:

Highest Degree Completed:

Investigator Status:

Faculty
Graduate Student
Other

E-mail Address:

College/Department:

Campus Mailing Address:

Home Mailing Address:

Daytime Phone:

Dr.

Undergraduate

Staff

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3) Co-Investigator 2 (if applicable)
Name:

Highest Degree Completed:

Faculty
Graduate Student
Other

Investigator Status:
E-mail Address:

College/Department:

Campus Mailing Address:

Home Mailing Address:

Daytime Phone:

Dr.

Mr.

Ms.

Undergraduate

Professor

Staff

4) Faculty Sponsor (if applicable)

Name:

Highest Degree Completed:

Faculty
Graduate Student
Other

Investigator Status:
E-mail Address:

College/Department:

Campus Mailing Address:

Home Mailing Address:

Daytime Phone:

Dr.

Mr.

Undergraduate

Ms.

Professor

Staff

Part II - Funding Information

1) Check all of the appropriate boxes for funding sources for this research. Include pending funding source(s).
Extramural

College

Department

Other:
P.I. of Grant or Contract:

Sponsor:

Contract/Grant No.
(if available):

Contract/Grant Title:

Please provide one complete copy of the proposal submitted to the sponsor with this application.
Please note that submission of your grant application to the IRB is a regulatory requirement and will be
maintained for the record with your application. The IRB will not utilize the grant during the review process,
other than to confirm that the grant proposal is consistent with the IRB proposal. You must submit all
necessary documentation for this IRB application in addition to the copy of the grant.

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Part III - Education and Training
All key research personnel must complete this section (i.e., be trained in human subjects research). This
includes: faculty, staff, graduate students working on a qualifying research project, anyone using human subjects
data for purposes of independent research, faculty sponsors of qualifying student projects, persons receiving
grant monies for human subject research, and those personnel with grant or research management
responsibilities.
If you are conducting any research involving human subjects, you must be cognizant of the Code of Federal
Regulations on the subject: see Title 45, Part 46 - Protection of Human Subjects
(http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html/). Anyone submitting documentation to
the IRB must simultaneously submit proof (a certificate of training) pertaining to human subjects
research.
Training is free at the site below. It should take you about 2 hours to complete this essential training. Dont
forget to print two copies of the certificate you earn at this site. You may also wish to save a copy digitally.
Training must be completed every three years.
http://phrp.nihtraining.com/users/login.php or
http://www2.kumc.edu/researchcompliance/human_subjects_tutorial_inst.htm (request a guest pass)
Certification of Training
Have all key research personnel completed the required IRB training?

No

Yes

If you answered: No, then DO NOT submit this application. Your application will not be considered until you
have completed the required training and can provide a copy of your course completion certificate.
If yes, please indicate the date of completion as identified on your course completion certificate: 09/02/2013.
Attach your most recent IRB course completion certificate to each application submitted.

Part IV Description of Project

Project Title
The Impact of Sustained Silent Reading on Students Reading Stamina

1) What is the proposed duration of data collection/analysis in this research study?

Note: Do not indicate a period of collection greater than 12 months.
Start date: 11-11-13 End date: TBD, but not greater than 12 months
Regulations specify that the project duration be not more than one year, unless periodic reviews are scheduled.
Should the PIs need an extension beyond the proposed duration (if beyond 12 months), they must apply for an
extension of research by filing the Continuing Review Progress Report Form.

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2) If this research will result in a thesis or dissertation, please check the appropriate box.
Thesis

Dissertation

Other (specify) _______________________

Study population:
3) Number of Subjects: 17
4) Age Range: 5 to 6 (include low/high age range)
5) Gender: X

Males

Females

6) Site of Subject Recruitment: Fernbrook Elementary School where I am employed as a kindergarten teacher.
7) Inclusion Criteria: All 17 of the students in my PM kindergarten section will be included in the research
8) Exclusion Criteria: None of my current students will be excluded
9) Will medical clearance or medical screening be necessary for participants to participate because of tissue or
blood sampling, administration of substances such as food or drugs, or physical exercise conditioning?
No X

Yes

If yes, explain how clearance will be obtained. If a screening instrument will be used, please attach a copy to the
application.
Clearance is given when: ________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
10) Potentially Vulnerable Populations:
Please check any of the following groups if they are included in the study.
X

Children (under 18 years of age)

Pregnant Women
Elderly (65 & older)
Psychologically Impaired

Cognitively Impaired
Prisoners
Native American Tribes and/or Tribal Organizations
X Students enrolled in a class in which the instructor
is the investigator

If you checked any of the above groups, your proposal will require full
review.
11) Other Research Elements that Require Institutional Oversight:

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Check the items listed below that apply to this research project.
Radiation Safety (i.e., radiation exposure)
Biosafety (i.e., recombinant DNA, infectious agents, biological toxins, etc.)
Appropriate Departmental Scientific Review Committee
Note: Special training and appropriate review is required for research involving radiation and biological hazards.

Project Narrative
Submission of a copy of a grant application does not replace completion of this form. Please respond to
each item. Incomplete forms will be returned to you for completion.
12) Site of Study:

Fernbrook Elementary School in Maple Grove, MN

13) Provide background information for the study including the objective / purpose of the proposed research, the
research question, the hypothesis, and other summary information that will assist the IRB in understanding and
reviewing your research.

My research question will investigate how implementation of daily Sustained Silent

Reading will affect the growth of students reading stamina as measured by classroom
observations. Stamina is the ability to stick with something for periods of time. For the
purpose of my study, reading stamina will be defined as the students ability to concentrate
and engage independently in silent reading while displaying on-task behavior. Ultimately, I
want to increase the reading stamina of my students and will attempt to do so through the use
of daily silent reading.
The objective of Sustained Silent Reading is to encourage students to read selfselected materials silently without interruption for an extended period of time (Bylut
Ermitage & Van Sluys, 2007). SSR includes student self-selection of materials, teacher
modeling (the teacher is reading along with the students), and no accountability for what has
been read (Langford & Allen, 1983; Yoon, 2002).
The purpose of SSR is to raise student reading achievement and foster positive
perspectives toward reading (Bylut Ermitage & Van Sluys, 2007). It has been found that
Sustained Silent Reading is an effective way to achieve these goals as students are provided
with the opportunity to read material above their reading level without worrying about
making mistakes (Bylut Ermitage & Van Sluys, 2007). The National Assessment for
Educational Progress reports that the more you read the better your vocabulary, your
knowledge of the world, your ability to read and so on (NICHD, 2000). SSR also provides
time for students to develop knowledge of spelling, vocabulary, and complex sentence forms
(Bylut Ermitage & Van Sluys, 2007).
As a classroom teacher, I know and understand the importance of exposing children to
fiction and non-fiction texts. In fact, researchers have found a significant association
between early cultivation of childrens reading habits and their future success (Organization
for Economic Cooperation and Development, 2007). Teachers can use methods such as read
alouds and shared reading to be positive leaders in this experience. However, it is crucial to
provide students with time to connect and investigate texts on their own. Utilizing SSR

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allows students the chance to be in charge of their own learning and provide them with the
opportunity to work independently.
References
Bylut Ermitage, J. & Van Sluys, K. (2007). Reading, learning, relaxing and having fun:
Third-grade perspectives on sustained silent reading. Illinois Reading Council
Journal, 35 (2), 11-21.
Organization for Economic Cooperation and Development (2007). Literacy skills for the
world oftomorrow.http://www.oecd.org/document/49/0,3343,en_2649_33723_2997
873_1_1_1_1,00.html (accessed July 5, 2003).
Yoon, J. (2002). Three decades of sustained silent reading: A meta-analytic review of the
effects of SSR on attitude towards reading. Reading Improvement, 39, 186-195.

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14) Describe the research design of the study.

I will work as an independent researcher while conducting my action research study

on Sustained Silent Reading in my kindergarten class. Although SSR will only be used as a
supplemental resource and will not replace any current literacy curriculum in my classroom,
it will be important to receive approval from my administrator before starting any research.
Informing my principal of my research is a great way to open up the lines of communication
about my action research study thus allowing him to provide me with feedback and
information concerning my research. I will also receive approval from my students parents
with the use of parental consent forms.
A variety of reading materials will be necessary to conduct my action research study.
I will utilize materials at school through the use of the classroom and school library along
with individual student readers. Students will also be allowed to bring their own reading
materials to school to use during SSR time.
I am currently unable to identify any possible obstacles in my action research plan. I
have conducted a large amount of research on the topic of Sustained Silent Reading, which
gives me a sound framework to start with. I also believe that I have created a plan that is
structured and organized to effectively avoid any potential obstacles.
15) Describe the tasks that participants will be asked to perform including a step-by-step description of the
procedures you plan to use with your subjects. Provide the approximate duration of subject participation for each
procedure. If data collection instruments are to be used, indicate the time necessary to complete them, the
frequency of administration, and the method/setting in which they will be administered, such as via telephone,
mail, live interaction, or face-to-face interview. (You must submit a copy of each study instrument, including all
questionnaires, surveys, protocols for interviews, manual or evaluative procedures, etc.)

Students will be active participants in Sustained Silent Reading on a daily basis. The
duration of time in which they will be engaged in this activity will vary. The length of time
will start at five minutes and will increase gradually as students reading stamina increases
throughout the study.
I will use a tally sheet to record and organize data collected from my students.
Creating a tally sheet to record classroom observations during SSR will allow me to easily
display, read, and identify patterns in the data collected. The tally sheet will list the most
frequently occurring student distractions during SSR. For example, looking around/not
reading the self-selected reading material, talking, playing, and initiating conversation with
the teacher will all be categories listed on the tally sheet.
Measures of central tendency will be used to interpret the data recorded on the tally
sheets. I will use the mode to identify the most frequently occurring disruptive behavior
displayed by students during each daily session of SSR. I will also find the mean for the
amount of student distractions each week to analyze the effectiveness of my action research
topic over a period of time. I will be able to use the mean and mode as formative data
throughout my research to adjust the environment and/or any other factors, if necessary.
16) Describe the recruitment and informative procedures. Attach a copy of any material used to recruit and
inform subjects (e.g., informed consent forms, advertisements, flyers, telephone scripts, verbal recruitment
scripts, cover letters, etc.) Explain who will approach potential participants, how researchers will interact with
participants, and explain how you will protect the participants privacy.

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There is no recruitment process. All students in my PM kindergarten section will be
included in the study. Because the activity of Sustained Silent Reading is research based, is
currently used at my school, and will be used to supplement current reading curriculum, I do
not see it necessary to have informed consent forms.
I will interact will students as the action researcher and will follow all current student
privacy laws.

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Part V Conflict of Interest
All possible conflicts of interest must be identified.
Are there any potential / perceived conflicts of interest between the researcher, the sponsor and/or USM?
No X

Yes

If yes, please explain: __________________________________________________________

________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
Additional information may be needed by the full Board of the IRB to resolve conflicts of interest.

Part VI - Privacy Procedures

Considerations for confidentiality should be given to the following: a) Nature of the response, b) Possible
punishment for the response, c) Possible punishment for participation, d) Perceived punishment for the
participation, e) Fear of embarrassment, f) Participants answer differently if they think that privacy may be
compromised, f) Personal liability depending on the topic of the study, g) Effect on employment, etc.
Personal identifiable information should not be collected nor maintained unless absolutely necessary. Research
staff should be properly trained in procedures to maintain confidentiality.
1) Will data be recorded by audio?

No X

Yes

2) Will data be recorded by video?

No X

Yes

3) Will photographs be taken?

No X

Yes

4) Please explain how the disposition of the tapes/photographs/negatives will be handled. Indicate if the
tapes/photographs/negatives will be erased or destroyed after transcription/development at the
conclusion of the study. If you wish to retain the tapes/photographs/negatives beyond
transcription/development, you must provide justification. Subjects must be informed of the disposition
of the tapes/photographs/negatives via the informed consent process.

5) Please clarify how subjects will be identified in audio or videotaped responses.

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6) Will you record any direct identifiers, names, social security numbers, addresses, telephone numbers,
etc? No X
Yes
7) If yes, explain why it is necessary to record findings using these identifiers. Describe the coding system
you will use to protect against disclosure of these identifiers. Describe how subject identifiers will be
maintained or destroyed after the study is completed.

8) Will you retain a link between the study code numbers and direct identifiers after the data collection is
complete? No X
Yes
If yes, explain why this is necessary and state how long you will
keep this link.

9) Will you provide a link or identifier to anyone outside the research team?
explain why and to whom.

No X

Yes

If yes,

10) Where, how long, and in what format (such as paper, digital or electronic media, video, audio, or
photographic) will data be kept?

Where: _________________________________________________________________________

How Long: ______________________________________________________________________

What Format: ____________________________________________________________________

In addition, describe what security provisions will be taken to protect these data (password protection,
encryption, etc): ______________________________________________________________________
___________________________________________________________________________________
11) Will you place a copy of the consent form or other research study information in the participants record
such as medical, personal or educational record? (This information should be clearly explained in the
consent document and/or process.) No X
Yes
If yes, explain why this is necessary:
Certificates of Confidentiality are issued by the National Institutes of Health (NIH) to protect
identifiable research information from forced disclosure. They allow the investigator and others who have access

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to research records to refuse to disclose identifying information on research participants in any civil, criminal,
administrative, legislative, or other proceeding, whether at the federal, state, or local level. Will you obtain a
Federal Certificate of Confidentiality for this research? No X
Yes . If yes, submit documentation of
application (and a copy of the Certificate of Confidentiality award if granted) with this application form.
If the data collected contain information about illegal behavior, visit the NIH Certificates of
Confidentiality Kiosk http://grants.nih.gov/grants/policy/coc for information about obtaining a Federal
Certificate of Confidentiality.

Part VII - Informed Consent

1) USM IRB requires that all activity involving human subjects be carried out only after obtaining proper
consent from the participants of the research/survey. Thus an information sheet or cover letter that
contains all required elements of informed consent must be attached to this application. (Please attach
an assent form for children/youth participation and permission forms for parents/legal guardians; or
consent forms for adult participation).
2) Request for Waiver of Informed Consent: Provide a written justification for a waiver of informed consent
according to Section 46.116 of 45 CFR 46
(http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.116).
Are you requesting a waiver of informed consent?

No

Yes X

If yes, please explain.

The research presents no more than minimal risk of harm to subjects. In fact,
it is a method of literacy practice that is currently being utilized in my school that the
study will take place in. This literacy strategy of SSR is research-based and will not
replace any current curriculum, procedures, or daily activities currently in place.
Also, the only record linking the subject and the research would be the consent
document.
3) Request for Waiver of Documentation of Consent (The rules for waiving informed consent apply.)
Examples of reasons to waive informed consent:

That the only record linking the subject and the research would be the consent document, and the
principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be
asked whether the subject wants documentation linking the subject with the research, and the subject's
wishes will govern; or
That the research presents no more than minimal risk of harm to subjects, and involves no
procedures, for which written consent is normally required outside of the research context.
Note: the IRB may require the investigator to provide subjects with a written statement regarding the
research.
Are you requesting a waiver of documentation of consent?

No

YesX

If yes, provide a written justification for a waiver of documentation of consent according to Section
46.117 of 45 CFR 46, see: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.116.

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Part VIII - Risks and Benefits
Per DHHS regulations (45 CFR 46.111), two of the required criteria for granting
IRB approval of research are:
A. Risks to subjects are minimized by using procedures which are consistent
with sound research design and which do not unnecessarily expose
subjects to risk, and whenever appropriate, by using procedures already
being performed on the subjects for diagnostic or treatment purposes.
B. Risks to subjects are reasonable in relation to anticipated benefits, if any,
to subjects, and the importance of the knowledge that may reasonably be
expected to result. In evaluating risks and benefits, the IRB Committee will
consider only those risks and benefits that may result from the research,
as distinguished from risks and benefits of therapies subjects would
receive even if not participating in the research.
1) Does the research involve any of these possible risks or harms to subjects
listed below?
No X
Yes
If Yes, careful review may be required to determine if scientific merit
justifies this risk.

Check all that apply:

Use of deception*
*If deception is used, please describe in detail here. Also, describe the
debriefing process and include the debriefing script. In addition, the
principal investigator should offer the participant the opportunity to
withdraw his/her data after finding out that deception was used in the
study. Please include this information in the debriefing script
submitted to the IRB. A sample debriefing form is included at the end
of this document.
Use of confidential records (e.g., educational or medical records)
Manipulation of psychological or social variables such as sensory
deprivation, social isolation, psychological stressors
Any probing for personal or sensitive information in surveys or
interviews
Presentation of materials which subjects might consider sensitive,
offensive, threatening, or degrading
Possible invasion of privacy of subject or family
Social or economic risk
Legal risk
Employment/occupational risk
Other risks (specify):

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2) Will any record of the subjects participation in this study be made available
to his or her supervisor, teacher, or employer?
No
Yes
If yes, please explain.

3) Describe the nature and degree of the risk or harm checked above. The
described risks/harms must be disclosed in the consent form.

4) Explain what steps will be taken to minimize risks or harms and to protect
subjects welfare. If the research includes protected populations (See Part
IV, Item 5), please identify each group and answer this question for each
group.

5) Describe the anticipated benefits of this research for individual participants in

each subject group. If none, state none.

6) Describe the anticipated benefits of this research for society, and explain how
the benefits outweigh the risks.

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Part IX - Compensation Benefits
Most often healthy volunteers who will derive no medical benefit from their
participation in the research study are compensated reasonably for the time they
devote to research projects. Monetary compensation is not intended to be the
only motivating force to induce subjects to participate. The goal of IRB oversight
of research subject compensation is to ensure that stipends paid to research
subjects provide fair compensation without undue pressure (coercion) to
participate.
1) Will any compensation or inducements, i.e., monetary compensation, course
credit, etc., be offered to the subjects for their participation?
No X

Yes

If yes, describe those inducements and include a statement in the

informed consent document explaining how compensation will be
handled in the event the participant withdraws from the study.

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Part X - Principal Investigator Assurances and
Signatures
1. I certify that the information provided in this application is complete and
correct.
2. I understand that as Principal Investigator, I have the responsibility for the
conduct of the study, the ethical performance of the project, and the
protection of the rights and welfare of human participants.
3. I agree to comply and to assure that all affiliated personnel comply with all
USM IRB policies and procedures, as well as with all applicable federal,
state and local laws regarding the protection of human participants in
research.
4. I assure that this study is performed by qualified personnel adhering to the
protocol approved by the USM IRB.
Graduate student Principle
Investigators (PIs) must attach the Student PI Worksheet, see
Appendix A.
5. I assure that if modifications to the approved protocol and consent
materials are necessary, the modifications will first be submitted for
review and approval by the USM IRB as an amendment to the
approved protocol.
6. I agree to obtain informed consent from the research participants as
applicable to this research, and as prescribed in the approved protocol.
7. I will promptly report unanticipated problems to the USM IRB by using the
appropriate notification form.
8. I will adhere to all requirements for continuing review, which require yearly
reviews at a minimum and a final report at the end of the research study.
9. I will advise the USM IRB of any change of address or contact information
of the Principal Investigator during the research study.
10.I assure that I have obtained all necessary approvals from entities other
than the USM IRB that are necessary to conduct this research.
By my signature on this research application, I certify that I am
knowledgeable about the regulations and policies governing research
with human subjects and have sufficient training and experience to
conduct this particular study in accordance with the research protocol.

Bridget Trom

10/31/13

Principal Investigator

Date (mm/dd/yyyy)

Co-Investigator

Date (mm/dd/yyyy)

Faculty Sponsor

Date (mm/dd/yyyy)

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