Per federal regulations, an IRB must conduct continuing review of previously approved research at intervals appropriate to the degree of risk, but not less than once per year [21 CFR 56.108(a)(1) and 56.109(f)].
Depending on the type of research, continuing review may be performed by expedited review or by convened IRB review. Continuing Review is not required for studies that have been granted an exemption from IRB review.
Both the Office for Human Research Protection (OHRP) agency’s 10 November 2010 Guidance on IRB Continuing Review of Research and the Food and Drug Administration’s (FDA) February 2012 Guidance for IRB’s Clinical Investigators and Sponsors IRB Continuing Review after Clinical Investigation Approval have reiterated that the key issues to focus on at continuing review are:
If you are submitting a continuing review (for studies previously determined to be expedited or required review by the convened IRB)* please submit the following documents to the IRB office (Box 817; Tupper 1), as a hard copy (paper copy)** with original ink signatures:
Submit a copy of the last (most recent) lCF that has been signed by a subject. All identifiers should be blacked out on this ICF prior to submission.
Submit a clean, unvalidated copy of the ICF currently in use for new validation. If any revisions are being made to the ICF with this continuing review, submit a tracked copy highlighting the changes and a clean/updated copy for validation.
If a DSMB exists for the study, submit a copy of sponsor’s, DSMB/DMC, and/or coordinating statistical center, progress report, or annual report, or DSMB/DMC report if available. This report should include the following:
A statement indicating what information (for example, study-wide adverse events, interim findings, and any recent literature that may be relevant to the research) was reviewed;
The date of the review; and
An assessment of the information reviewed.