Reconsiderations

In accordance with 21 CFR §56.109(e) and 45 CFR §46.109(d), WCG IRB notifies investigators in writing of the Board’s decision to approve or disapprove proposed research activities, or of modifications required to secure approval. Disapproval notifications include a statement of the reasons for the Board’s decision and offers an opportunity to address the Board in writing or in person.

Requests for reconsiderations are given the same priority in scheduling as new review requests. There is no fee for the review. Requests for reconsideration and supporting materials may be directed to the WCG IRB contact identified in the letter conveying the Board’s action and rationale.

If you disagree with the Board’s re-consent instructions directed for a change in research, you may promptly contact WCG IRB and ask for reconsideration; however, we advise you not to delay complying with the Board’s instructions.