Annual Review Application/ Continuation Form Continuing Review

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Annual Review Application/ Continuation Form
Continuing Review - 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.
Principal Investigator(s):
Protocol Number:
Protocol Title:
Expiration Date:
A. Funding Information:
Not funded
This study is funded or funding is being sought. Attach a copy of the grant application.
a. Funding agency:
b. Grant number:
B. Current Status of the Research:
Awaiting funding
Anticipate enrolling new subjects
Follow up on previously enrolled subjects/Analyzing data
Data analysis complete. Project complete.
C. Total Number of Subjects Accrued:
1. Indicate the total number of subjects enrolled to date:
2. Indicate the number of subjects currently approved for this study:
D. New Research Findings:
If yes to any of the questions below, please summarize the change(s) or events and describe your
response
Yes
No
1. Since the last review period, have there been any complications, reactions, or adverse
effects on human subjects?
If yes, describe:
Yes
No
2. 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:
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Revised: 4/2013
Research Integrity & Assurance
Annual Review Application/ Continuation Form
Yes
No
3. Has the informed consent form, or the procedures for obtaining consent been altered?
If yes, describe:
Yes
No
4. Has the subjects’ compensation schedule or method of subject recruitment changed?
If yes, describe:
E. New Risks/Unanticipated Problems/Adverse Events:
1. 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.
2. 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
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.
F. Modifications:
3. 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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Revised: 4/2013
Research Integrity & Assurance
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