515. Continuing Review - Submission Requirements for Full Committee Review

Updated August 23, 2021

Continuing review (renewal) requests are submitted as subsequent packages for existing projects in IRBNet.

The following submission requirements apply to continuing reviews for research approved by Full Committee Review.

NOTE: Under specific conditions, research approved by Full Committee Review may be eligible for expedited continuing review (for information, see the Expedited Review section in the IRB Policy Manual Review Types or DHHS Categories of research eligible for review by expedited procedures, 8(a), 8(b), 8(c) or 9).

NOTE: Project amendments may NOT be submitted at the time of continuing review.

New Materials for Full Committee Continuing Review

Principal Investigators (PIs) must add the following new documents to a Continuing Review package for the existing project:

• Continuing Review/Progress Report researcher form
• Routine safety reports when no safety concerns are identified and no changes are required (if not previously submitted)

NOTE: Safety reports that involve safety concerns or require substantive changes in study procedures or consent documents must be submitted to the IRB promptly via the Unanticipated Problems reporting form (see IRB Policy Manual for reporting problems to the IRB).

• For clinical investigations only, summary of local and external adverse events (AEs) or adverse device effects not previously submitted, such as when external AEs are not unanticipated problems or sponsor does not require submission of external AEs.

Signature Requirements for Full Committee Continuing Review

• PI signature for the Continuing Review package, obtained electronically through IRBNet

Materials Available for IRB Review

Researchers do not need to resubmit project documents because all the documents attached to the project in IRBNet are available for IRB review. The attachments vary for each project (for a comprehensive list, see IRB policy for submission requirements for new protocols for Full Committee review) and include the following as applicable:

• Part I, Protocol, and applicable supplemental applications such as for vulnerable populations; federal agency requirements; blood, drug, device research;
• clinical research protocol, investigator brochure, and form 1572 (required for FDA-regulated clinical trials only);
• recruitment materials;
• consent and HIPAA documents, or waiver requests;
• research instruments;
• previously approved amendment packages with related amended materials;
• problem reports previously submitted for assessment/review;
• documentation of external approvals; and
• IRB correspondence.