Submitting your continuing review form
Continuing Review Form
Exempt Continuing Review Form
NEW: We have eliminated the Status Form and have combined the Clinical and Health Services form into one Continuing Review Form that will be used for most studies. If your project was approved as an exempt study, choose this form. The principal investigator must sign the end of the submitted form.
What are the Regulatory Requirements for Continuing Review?
Department of Health and Human Services (DHHS) (45 CFR 46) and U.S. Food and Drug Administration (FDA) (21 CFR 56) regulations require the Institutional Review Board (IRB) to perform continuing review of research at intervals appropriate to the degree of risk but not less than once per year. All investigators are responsible for submitting a progress report in sufficient time to permit the IRB to complete a meaningful continuing review of the research.
The primary purpose of continuing review is to ensure that:
1) Selection of subjects is equitable,
2) The risk/benefit relationship of the research remains acceptable,
3) The consent document contains information which is accurate, complete and up to date, and
4) Adequate safeguards for human subjects are in place
5) At this institution, some of the requested information is reviewed by research administration for institutional oversight.
Continuing review by the IRB is just as important as initial review. Initial review and approval of research requires the IRB to make a judgment largely on the basis of background data and the investigator"s risk/benefit analysis. However, continuing review and re-approval of ongoing research verifies the correctness of the decisions of both the investigator and the IRB using the study results to date and other relevant new information to make this judgment. Continuing review is designed to ensure that the rights and welfare of subjects continue to be fully protected in ongoing research.
After IRB review of your progress report, you will be given an approval letter to continue. An original (all versions) of the IRB approved consent/assent forms should be kept on file. If you make copies of the original consent form, ensure that any outdated forms are destroyed and the currently approved version is being used.
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