IACUC: Protocol Review Process

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IACUC Protocol Review Process

1The Principal Investigator (PI) must submit the required protocol forms via IRBNet. Qualification Forms for all personnel listed on the protocol must be be completed prior to IACUC review for any new applications or modifications involving adding new personnel.

2. The Research Integrity office completes an initial review of the submission materials. Incomplete and/or unsigned submission packages will be unlocked in IRBNet for correction by the PI.

3. The IACUC Chair completes a pre-review that includes resolution of any open questions with the PI and assignment of Designated Member Reviewers.

4. Unless the IACUC Chair has called for Full Committee Review (FCR) during the pre-review process, the protocol forms are shared with all IACUC members for review. Any IACUC member may call for FCR. Responses are due within five business days. If no member calls for FCR by the response date, the protocol is reviewed by Designated Member Review (DMR) by the reviewers assigned by the Chair. All comments and questions raised during the initial review are incorporated into the materials provided for DMR.

5. The DMR process may result in approval or request for modifications in order to secure approval. All designated reviewers must be unanimous in their response. If they cannot agree, then the protocol is returned for FCR.

6. When FCR is implemented, protocols are reviewed only at a convened meeting of the IACUC with a quorum present.  The available outcomes of FCR are (1) approval, (2) modifications required to secure approval, or (3) disapproval.  If modifications are necessary to secure approval, the PI must re-submit and the review process begins again.