IACUC Policy: Designated Member Review
Policy # IBT-109.00 IACUC Approval: January 27, 2014

Purpose:
In its review of proposals, the IACUC’s primary goal is to facilitate compliance with applicable laws, regulations and policies consistent with the performance of appropriate and productive scientific endeavors. The Designated Member Review process allows efficient management of the IACUC workload, resulting in more frequent committee reviews outside of the regularly scheduled IACUC meetings and timely turnaround of requests from investigators.

Scope:
The use of all live vertebrate animals subject to oversight by Texas A&M Health Science Center, whether for research, education, production (breeding), or health surveillance purposes must be submitted for evaluation by the IACUC. All protocol submissions are eligible for some method of Designated Member Review.

Responsibilities:
The IACUC is responsible for the review and approval of all animal care and use activities. 
Assigned Designated Member Reviewers are responsible for reviewing the assigned documents and submitting decisions to the IACUC office.
The IACUC office is responsible for processing submitted documents and notifying the PI of IACUC decisions.

Definitions:
Full Committee Review (FCR) – A process of IACUC review where all IACUC members are provided with the proposed research document(s) and requires a convened meeting of a quorum (>50%) of the IACUC members to take actions on the proposed research document(s).
Designated Member Review (DMR) – A process of IACUC review where all IACUC members are provided with the proposed research document(s) and, if no member requests that document receive a full committee review, the Chair designates two members to review the proposed research document(s). The designated members have authority to approve, require modifications, or request a full committee review.

I. Designated Member Review Process
The designated-member review system allows the IACUC to designate at least one individual to act on its behalf if no IACUC member requests a full committee review. The Designated Member Review (DMR) process may be utilized by either of the following methods:

1. DMR
     a. All voting IACUC members must be provided with a copy of the protocol document. At least one committee member will be appointed, by the chair or designee, as designated reviewer(s).
     b. The entire committee is given a three -business day period to review the protocol documents and respond either allowing the DMR(s) to review the protocol or to hold the protocol for the next FCR.  Failure to respond within the member consideration period is considered as approval to use DMR for review).
           i.            If any one member requests to send the document to FCR, then the protocol will be placed on the agenda for the next IACUC meeting.
          ii.            If all members respond to allow the DMR to review the protocol before the end of the member consideration period, then the consideration period is considered complete and the protocol is sent to DMR.
     c. Designated reviewers will submit their decision to the IACUC office: approve, require modifications to secure approval, or return for FCR. If multiple DMRs are utilized, their decisions must be unanimous; if not the protocol will be referred for FCR.

 2. DMR subsequent to full committee review (FCR).
      a. Documents reviewed by FCR that require modifications to receive approval may be sent to DMR upon a majority vote by the quorum present, as long as no member votes to review by FCR.   The DMR is assigned during the convened meeting during the vote.
      b. Once the requests of the FCR are addressed, the revised document will be distributed to all voting IACUC members.
      c. Committee members are given a three-business day member consideration period to review the revised protocol document (failure to respond within the member consideration period is considered as approval to use DMR for review).
           i.            If any one member requests to send the document to FCR, then the protocol will be placed on the agenda for the next IACUC meeting.
          ii.            If all members respond to allow the DMR to review the protocol before the end of the member consideration period, then the consideration period is considered complete and the protocol may be sent to DMR for review at that time.
      d. Designated reviewer(s) assigned during the FCR, will submit their decision to the IACUC office: approve, require modification, or send back to FCR.
      e. The document can be approved once the designated reviewer approves (or if multiple DMRs, they unanimously approve).
       f. The IACUC can also vote to allow the IACUC office to review the protocol if the changes are administrative in nature.

II. Designated Member Review Criteria
Even in DMR review of protocols involving animals, the IACUC will consider if the protocol is in accordance with PHS Policy, and recommendations in the “Guide” by using criteria established in the IACUC Policy: Protocol Review, #106.00

All amendments and protocols may be reviewed via DMR except:

a. Major survival surgery
b. Multiple survival surgery on the same animal
c. Unrelieved pain and distress (“category E” protocols)
d. Prolonged restraint
e. special considerations in the Guide and our policy-i.e. food and fluid restriction and prolonged restraint

IV. DMR Records
DMR review actions will be recorded in the next scheduled IACUC meeting minutes. For each submission reviewed via the DMR process, the comments will be available for the entire committee to view in the iRIS system.

References:
1. National Research Council. Institute for Laboratory Animal Research. 2011. Guide for the Care and Use of Laboratory Animals. Public Health Service, Bethesda, MD.
2. Public Health Service Policy on Humane Care and Use of Laboratory Animals http://grants.nih.gov/grants/olaw/references/phspol.htm.
3. ARENA/OLAW Institutional Animal Care and Use Committee Guidebook. Second edition, 2002.
4. IACUC Policy: Protocol Review, #106.00

History:
Version 00 -  Initial Approval:  Januray 27, 2014