Institutional Review Board (IRB)
Instructions for Submitting an IRB Proposal Summary
1) Please, remove this front page before submitting your proposal to the IRB.
2) Submit 1 electronic copy and 3 signed hard copies to the IRB chairperson.
3) AY 08-09 Chairperson Information: Peter Horn, Religion and Philosophy Department, Capital University,
Columbus, OH 43209, firstname.lastname@example.org
4) Who must submit a proposal to the IRB:
a) Prior to beginning any data collection using human participants, Capital University faculty, staff, or
students must obtain the approval of the IRB.
b) Prior to beginning any data collection using human participants, any researcher from outside the
University who would like to collect data from human participants at Capital University must obtain the
approval of the IRB.
5) Expedited Review:
a) Process: Two members of the IRB conduct expedited review of a proposal.
i) The researcher should expect a waiting period of 14 days between submitting the proposal for
expedited review and receiving the committee’s response about the proposal.
ii) The committee members conducting the expedited review may determine that a full review by the
IRB is necessary for the proposal.
b) Criteria: In order for the proposal to receive an expedited review, it must not exceed minimal risk to the
participants as determined by the reviewers. Examples of minimal risk research are:
i) The non-invasive collection of human matter (e.g., hair, sweat, saliva, etc.);
ii) Data collected non-invasively (e.g., weight, EKG, etc.);
iii) Voice recordings;
iv) Exercise by healthy subjects;
v) Non-deception psychological research;
vi) Surveys and in-class pedagogical research.
6) Submission Requirements:
a) The IRB meets once every month during the academic year (September to June); normally, it is the
second Thursday of the month.
b) All material must be submitted before 5:00 p.m. on the Friday two weeks before the meeting.
c) Incomplete submission of forms A – D will result in the proposal not being reviewed that month.
d) You are required to use the Capital University IRB forms, regardless of whether you have completed the
IRB forms of another institution.
e) Submit 3 paper copies and one electronic copy (a single WORD document is preferred) to the
i) The Research Proposal Summary (Forms A – C) to the IRB chairperson.
ii) EACH instrument (scale, questionnaire, etc.) to be used in the study.
iii) Information that will be given to the subjects about the study.
iv) The Consent Form that will be used (NOTE: The consent form template provided in Form D is a
guide, revise it as needed to serve the purpose and scope of your study. Anonymous survey
research typically does not require a consent form, include instead a cover letter or script).
v) NOTE: Failure to complete all Capital University IRB forms will result in the proposal being returned
without being reviewed.
NOTE: To assist the review process, researchers may wish to be available to answer questions when the
committee reviews the proposal. Contact the chairperson to make such arrangements.
Capital University IRB Human Subjects Review, Last Update 03.14.08, Page 1
Institutional Review Board (IRB)
Research Proposal Summary
FORM A –COVER PAGE
Principal Investigator (name typed and signed):
NOTE: The Principal Investigator must be a Capital University faculty member.
Student Investigator(s) (name(s) typed and signed):
Other Investigator(s) (name(s) typed and signed):
Add other investigators as needed.
Abstract (100-word limit):
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Institutional Review Board
FORM B – CHECKLIST
1. Does the proposal qualify for an expedited review?
_____ yes, this study is no more than minimal risk
2. Level of risk to the participants. Consult the federal regulations for definitions of risk. In Form C justify why the
proposal is the level of risk indicated here.
_____ no more than minimal risk
_____ more than minimal risk (full review necessary)
3. Type of harm to the participants:
_____ other _________________________
If there is risk or harm to the participants involved in the study, provide proof that medical care, psychological
care, or injury compensation will be provided. Explain the plan in FORM C and provide proof.
_____ Yes, proof of care or compensation is included.
4. Does the study involve deception?
If yes, then a full review is necessary and a statement of debriefing to the participants in FORM C is needed.
5. Identify the institution/ place/ class in which participants will be recruited: _______________.
6. How many participants do you anticipate recruiting? _______________
Type of participants:
_____ minors (age = _____) (NOTE: See the form: Working with Special Populations)
_____ college students (NOTE: If using college students, describe in FORM C (question 5) when you will recruit
participants and if these students will be in a course taught by one of the investigators.)
_____ seniors (> 65)
_____ cognitively impaired
_____ physically impaired
_____ incarcerated individuals (NOTE: See the form: Working with Special Populations.)
_____ other (describe) ___________________________
7. This study will use previously collected data from records or files.
If yes, answer the following questions:
a. What is the source of these data?
b. When were data collected and by whom?
c. Who has the right to exclude other researchers from using these data?
8. Will another Institutional Review Board review this study?
If yes, what is the status of that review and identify the Institution?
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_____ not submitted yet
_____ other ______________________________________________________________
Identify the institution and send a copy of the approval when obtained or enclose with proposal summary.
9. Will this study be considered for outside funding?
_____ Yes (a copy of the proposal must be submitted to the Faculty Grants Office)
If yes, is this a Capital University project? Please explain:
If this is a University project, has the Faculty Grants Office been notified?
10. Does the study capture video or audio images?
If yes, include a statement of how long audio or video images of subjects will be retained in Form C (question 4).
Indicate what will be done with the images after the study is complete.
11. Will any data from files, records, or archives be used?
If yes, answer these questions and describe in detail in Form C (question 8).
a. Has the subject been informed of this?
b. Who has legitimate access to these records? (NOTE: See the form: Working with Special
c. Will any data collected as part of this study become a part of the subject’s permanent record?
12. Will subjects be transported from one area to another?
If yes, there must be current and adequate liability insurance in the event of an accident. Include proof of such
liability insurance when proposal is submitted.
13. Will the data be collected by (check all that apply):
_____ The Principal Investigator
_____ The Student Investigator(s)
_____ Other Investigators or Individuals (NOTE: You must provide the names and qualifications of these
individuals; you must include the affiliation of each individual and their role in the research.)
14. Will the research be conducted in another country?
If YES, describe country in Form C (question 10).
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Institutional Review Board
FORM C – RESEARCH PLANS
Directions: Complete the following summary of your research plan. Be specific and
identify what the subjects will experience when they participate in your research
protocol, and the protections that have been provided for them. Careful attention to the
following will facilitate the review process. Be sure to address each part of the items
listed below and be sure that you have included all information requested in form B.
a) Describe the background and purpose of the study; include a review of research
literature as it relates to the human subjects concerns relevant to your proposal.
b) What benefits to society and the subjects will result from the study?
c) Identify all individuals who will collect data and summarize their qualification to do this
a) Describe each condition, measure, or observation that will be used in the study.
b) Provide a description of each questionnaire, test, or other instrument that will be used;
include reliability and validity data if available.
c) Attach a copy of the author’s or copyright holder’s permission for all instruments or
indicate when copy of this permission will be submitted.
a) Might any individual (including the investigators) be able to directly or indirectly identify
a specific individual’s data?
_____ yes (Complete all parts of item 4.)
_____ no (Skip to item 5. Ensure in your procedure, item 9, that there is no possible
way for any individual’s data to be directly or indirectly identified.)
a) What steps will be taken to insure the confidentiality of the data?
b) Describe how long and where data, images, and identification list of participants and
numbers will be kept. Check with the appropriate discipline’s ethical guidelines for the
appropriate amount of time to keep data and the participant identification list and cite
those guidelines in this response.
c) What will be done with the data, images, and identification list when the storage time is
over? Be specific.
5) Risk and Harm:
a) Describe the potential risks and harm to your subjects.
b) If you believe the subjects will experience “no risks” or “harm” of any kind, indicate
c) Describe the procedures to be used to protect or minimize risk or harm to the subjects.
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d) If the methods do create potential risks or harm, indicate why other methods
considered were rejected in favor of the methods chosen.
e) Describe the medical, psychological, or injury compensations to be provided in case
injury or harm does occur.
f) State why the benefits justify the risks to the subjects.
a) How will the proposed subjects be recruited?
b) What steps will be taken to ensure that the sample is representative of the population
from which it is drawn?
7) Voluntary Participation:
a) Are the proposed subjects competent and capable of giving informed consent? If not,
explain from whom and how consent will be obtained?
b) Are the persons in the research population in a free-choice situation? Are they
constrained by age or other factors that may limit their capacity to choose?
c) What, if any, inducement will be offered to participate and will the inducement
significantly reduce the potential subjects’ ability to freely choose to participate?
d) If subjects are members of the investigator’s course or are otherwise likely to be
beholden to the institution or the instructor, describe how the subjects will be protected
from coercion, real or imagined, and when the investigator will recruit subjects in a
8) Informed Consent (A template is available in Form D. This template is intended to be a
guide and should be adapted to the specific purpose and goal of the research project.):
a) How will the subjects be informed of the purpose of the study and their role in the
b) Who will inform your participants of the purpose of the study and their role in the
c) Provide the script, letter, or written consent form to be used to safeguard subjects’
rights. If you are not using a consent form, indicate why you believe a consent form is
d) If data from files, records, and/or archives will be used, then describe in detail how the
subjects will be informed of this use and if any of the data collected will become a part
of the subjects’ permanent record. Describe how records will be accessed.
e) How will you insure that the subjects have given their consent to prior to participating?
a) Provide a step-by-step account of your procedure; begin with your recruitment and
continue through your last contact with the participants. Your response must be
complete enough for the IRB members to know what you are doing throughout your
contact with the participants.
b) If your study includes deception, explain the procedure for debriefing subjects.
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a) If your study is going to be carried out in another country, describe social, religious,
cultural, and political factors that may influence this study.
b) Based upon these factors, if there are variations, which need to be incorporated into
your study, explain your rationale.
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Institutional Review Board (IRB)
FORM D – CONSENT FORM TEMPLATE
(This sample consent form is to be used as a guide. Address the intent of each question as it relates to your study.)
The name of this research study is _______________.
This research study was reviewed by the Capital University Institutional Review Board
(IRB). The goal is to assure that the study protects the rights and safety of the human
subjects of this research.
This research study's number is _______________.
The Capital University IRB gave its permission for the main researcher to begin his or
her use of human subjects in this study. The IRB has the right to put on hold or to stop
support of any research that does not follow the IRB’s rules. Also, the IRB can stop or
suspend studies that cause too much harm to subjects. You should contact the IRB
chair if you have questions, comments, or concerns about this research study. Also,
please contact the chair if you are concerned about your being in the study. The chair is
_______________, and can be reached at _______________.
1. This study is research and it may offer no benefits (help) to me.
2. I freely choose to be in this study. I may refuse to enter into the study and I may
leave the study at any time without being punished or losing any benefits to which I
would otherwise be entitled. The researcher may remove me from the study at any time.
3. My payment for being in this study is _______________.
4. The purpose of this research is _______________.
5. The length of time I will be in the research study is _______________. The study will
take place at _______________.
6. As a research subject I will be asked to _______________.
7. Possible good results. Possible benefits (good results) of this research are the
A. Benefits to me: _______________.
B. Benefits to others: _______________.
8. Possible bad results. Possible risks, pain, or other problems for me of my being in
the research study are _______________.
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9. Relevant information. I will be given any information that either the researcher or
the IRB reasonably believes is important to my choice about whether or not to be in this
10. Temporary withholding of information. Before I decide whether to be in the
study, I have the right to read both the research description (protocol) and any written
survey that I will be asked to complete. In some cases, IRBs give special permission to
withhold some information until after the study. If this does happen, and if I ask to see
any information, I will be told in writing of the temporary withholding.
11. Extent of anonymity. I have been told whether or not information specific to me is
to be placed on any form that I am asked to complete. I have also been told about
whether or not the researchers will be able to identify me from any written or spoken
responses that I will be asked to give.
12. Protection of privacy of records. I have been told of how my privacy and the
privacy of records identifying me will be kept. I also know how the researcher will
prevent the disclosure of any information, such as pictures or recordings, that would
enable people to identify me. I have also been told the kind of information and the
location where the information will be kept.
13. Protection of privacy about identity. I know that my identity, including my name,
and any pictures or recordings, will not be included in any report, paper, speech, or any
public discussion of this study. I also know that none of these will be printed unless I
have signed and been given a copy of a separate release for the information.
14. If I believe that I have been harmed while being in this research study, medical care
or psychological care will be available at _______________.
15. If I believe that I have been injured or hurt while being in this research study, I
should call _______________. That person's telephone number is _______________.
16. I may keep a signed copy of this consent form for my records.
17. The information about this research study was discussed with me by
_______________. I was allowed to ask questions about this research study. All of my
questions about the study have been answered to my satisfaction.
18. I agree to be in the study.
Signature of Subject Date
Signature of Witness (Optional) Date
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