Continuing Review of IRB Approved Research
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Previously approved research must undergo continuing IRB review at intervals appropriate to the degree of risk, but not less than once per year (45 CFR 46.109, 21 CFR 56.109). IRB approval must be granted before the end of the current approval period to avoid lapse, and review must be performed at a convened IRB meeting unless the research meets the regulatory criteria for expedited review. At the time of both initial and continuing review, the IRB must ensure that the criteria to approve research are satisfied, including determinations regarding risks, potential benefits, informed consent, and safeguards for participants.
Continuing Review of Human Subjects Research version 2.2 - Updated: 9/25/09
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** Note: Appendix O, Q, and T can be used at both Continuing Review and for Amendments/Changes in Research. The Amendment form is not needed at the time of continuing review if using these appendices.
Guidelines
To perform continuing review, the IRB must review a protocol summary and progress report for the research, including:
- Number of participants;
- Summary of adverse events and any unanticipated problems involving risks to subjects or others;
- Any participant withdrawals or complaints about the research;
- Amendments to the research, and any relevant recent literature or interim findings;
- Other relevant information (including multi-center reports), especially about risks and benefits associated with the research; and
- A copy of the current informed consent document (unless waived).
Principal Investigators are responsible for completing and submitting continuing review applications and associated materials on time to avoid lapses in IRB approval. If approval expires, the research must stop, unless the IRB finds that it is in the best interests of individual subjects to continue participating in the research. Enrollment of new subjects cannot occur after the expiration of IRB approval. ORRP staff send reminders to all PIs to assist in meeting these requirements. Protocol expiration dates can also be checked in the PI Profile, available through the PI Portal.
