|IACUC Policy:||Designated Member Review|
|Policy #||IBT-109.03||IACUC Approval:||October 23, 2017|
In its review of proposals, the Institutional Animal Care and Use Committee’s (IACUC) 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.
The use of all live vertebrate animals subject to oversight by the Texas A&M Houston/Kingsville IACUC, whether for research, education, production (breeding), or health surveillance purposes must be submitted for evaluation by the IACUC. Most protocol submissions are eligible for some method of Designated Member Review.
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 through iRIS.
The IACUC Office is responsible for processing submitted documents and notifying the PI of IACUC decisions through iRIS.
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, at least one member of the committee will serve as DMR to review the proposed research document(s) on behalf of the committee. 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 committee member 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:
a. All voting IACUC members receive a notification from the iRIS system telling them of an open review period for a new submission. At least one committee member will be appointed, by the chair or designee, as the DMR(s).
b. The entire committee is given a five -business day period for new AUPs and two-business days for amendments 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. This can be done via email or through iRIS.
c. DMR(s) will submit their decision through the iRIS reviewer form: 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 a member for DMR upon a unanimous 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.
i. All IACUC members agree in advance in writing that the quorum of members present at a convened meeting may decide by unanimous vote to use DMR subsequent to FCR when modification is needed to secure approval. However, any member of the IACUC may, at any time, request to see the revised protocol and/or request FCR of the protocol.
b. DMR(s) assigned during the FCR will submit their decision to the IACUC Office: approve, require modification to secure approval, or send back to FCR.
c. The document can be approved once the DMR approves (or if multiple DMRs, they unanimously approve).
i. If a protocol is assigned to more than one designated reviewer, the reviewers must be unanimous in any decision. They must all review identical versions of the protocol and, if modifications are requested by any one of the reviewers, the other reviewers must be aware of and agree to the modifications
d. 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 Procedure: Protocol Review, #106
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. Guide exceptions, IACUC procedure exceptions, food and fluid restriction, prolonged restraint
e. Submissions involving USDA covered species (note: DMR is acceptable for amendments that do not negatively affect pain or distress )
IV. DMR Records
DMR review actions are recorded in iRIS and available for the entire committee to view.
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 Procedure: Protocol Review, #106
Version 00 – Initial approval: January 27, 2014
Version 01 – Approval: May 2, 1016
Version 02 – Approval: September 26, 2016
Version 03 – Approval: October 23, 2017