Institutional Review Board for Human Subjects Annual Review

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Institutional Review Board for Human Subjects
Annual Review Application/Continuation Form
Principal Investigator(s):
Protocol Number:
Protocol Title:
The IRB must conduct continuing review of previously approved non-exempt research at least once per year. The
IRB must reassess the totality of the project and assure that, among other things, risks to subjects are being
minimized and are still reasonable in relation to anticipated benefits, if any, to the subjects and the knowledge that is
expected to result. In that regard, the IRB must ensure that all criteria for IRB approval of research continue to be
met.
The following questions are designed to elicit this information.
1. Please specify the total number of subjects enrolled to date, and state whether subjects are still being
recruited, if data collection and/or data analysis of identifiable information will still continue or state whether
recruitment has been completed.
If yes to any of the questions below, please summarize the change(s) or events and describe your
response
Yes
No
A. Since the last review period, have there been any complications, reactions, or adverse
effects on human subjects?
If yes, describe:
Yes
No
B. Since the last review period, have there been any changes or amendments to your research
activity, (e.g. changes in experimental manipulations, the consent process, survey or interview
questions, etc.) Please note: Proposed changes must be approved by the IRB prior to
implementation?
If yes, describe:
Yes
No
C. Has the informed consent form, or the procedures for obtaining consent been altered?
If yes, describe:
Yes
No
D. Has the subjects’ compensation schedule or method of subject recruitment changed?
If yes, describe:
2. Described any new knowledge available, from your laboratory or elsewhere, to suggest that any aspect of
your research protocol might create higher levels of risk than previously anticipated and indicate how it alters
the risks to subjects.
3. Regardless of changes in the research protocol, please comment on research subjects’ reactions to the
various aspects of the research. We are especially interested in your observations on the level of distress or
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Research Integrity & Assurance
discomfort experienced by subjects. Also, if there have been any unanticipated problems or adverse
reactions on the part of any of the subjects; please characterize them as well as the steps taken in response
to them.
4. Are you requesting any modifications to your study protocol at this time?
Yes
No
(A modification is any change to the previously approved protocol, e.g. subject selection, recruitment
procedures, survey or interview guide revisions, personnel, etc.)
If yes, attach a completed Modification Form and supporting documents for review.
RESEARCH: OHRP - Guidance on IRB Continuing Review of Research
http://www.hhs.gov/ohrp/policy/continuingreview2010.html
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Research Integrity & Assurance
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