Subcommittee Review a.k.a. DMR after FCR D – designated M – member R – review What we do by … F – full C – committee R – review What we do at meetings

Full Committee Review Procedure Prior to the Meeting:  Administrative and Veterinary Pre-review  IACUC Pre-review  LR revision period At the Convened Meeting:  Final Discussion and Approval -OR –  Tabled for Designated Member Review –OR  Tabled for Minor Changes

Pre-review Timeline Deadline – 3 weeks prior to meeting  Week 1 – Admin/vet pre-review and distribution to committee via web agenda  Week 2 – IACUC pre-review Protocols will be assigned to a primary and secondary reviewer, but all members are encouraged to review and comment all protocols Members’ pre-review comments must be returned to Administrator as soon as possible All pre-review comments are compiled and sent to LRs 10 days before meeting  Week 3 – LR revisions LR’s revised protocol materials are added to web agenda for review by primary and secondary reviewers prior to the IACUC meeting.

At the Meeting Primary/Secondary Reviewers will: BRIEF  Present a BRIEF synopsis of the project  Summarize the issues raised in pre-review and confirm that required changes were made  Recommend Approval, Resubmission or Table for further revisions

Prior to Approval… Before the final vote, it should be clear to all members:  That the need for live vertebrate animals in research, teaching or testing has been clearly articulated by the researcher.  That the committee’s decision is consistent with the humane care of animals

Committee Decisions  Approved  Tabled Administratively (M) Very minor non-scientific issues  Tabled for Subcommittee Review (T) Review by Primary/Secondary Reviewers  Resubmission Required (R) Complete rewrite – serious scientific or welfare issues

Tabled to Subcommittee – The Process  LR submits a response to the IACUC’s review  Revised application, appendices  Cover letter addressing each point of the IACUC’s memo  Response materials are ed to IACUC:  Entire committee has opportunity to view response (silence = agreement – no formal response required)  Primary and Secondary Reviewers, plus others as appropriate (must a formal response)

Tabled to Subcommittee – The Process (con’t)  Primary/Secondary Reviewers respond to Administrator via return OK to approve Additional information needed  Primary and Secondary Reviewer MUST a response before approval can be released because…..  response is filed as documentation in the official protocol record.