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Utilizing DMR for New Protocol and Modification Submissions

Purpose

In order to comply with governmental regulations and to simplify the review process, the IACUC has established a policy on the ability to use the Designated Member Review (DMR) on new protocol submissions and modification submissions.

Action

1. New protocols and modifications will be reviewed by the IACUC coordinator to see if they meet the review criteria for a Designated Member Review (DMR). (Table 1)

2. If a protocol or modification meets these criteria, it will generally be assigned a primary (scientific), a veterinary, a safety reviewer, and a regulatory reviewer. These individuals will act as agents of the IACUC and can require and perform any function of the IACUC with the sole exception of withholding approval of a protocol. Only a full committee vote may do that.

3. All members of the committee will be assigned in InfoEd as a “Call for FCR or not” reviewer to allow for a call for a full committee review by the specified deadline.  In addition, primary reviewers will be assigned in InfoEd as “Primary review” with a deadline for review.

4. If no one calls for a FCR, then the primary reviewers will complete the review.  The review will be sent via InfoEd to the Principal Investigator for any required changes.  Subsequent changes will be reviewed by the primary reviewer without requiring a call for FCR by the Committee.

5. 3-year renewals will be processed as DMR regardless of pain category and species used.

Exceptions require the approval of the IACUC Chair.

Table 1: Criteria for Designated Member Review versus Full Committee Review

Designated Member Review (DMR) Full Committee Review (FCR)
Pain/Distress Level B and/or C D and/or E
Species Non-USDA regulated USDA regulated
Invasiveness
  • Euthanasia only (tissue harvest)
  • Breeding/holding protocols
  • Injections
  • Routine blood collections
  • Minor surgery
  • Non-survival surgery
  • Survival surgery
  • Death as an Endpoint
  • Prolonged restraint
  • Food/fluid restriction
  • Any exceptions to the regulations
Protocol Type
3 year renewal protocols (regardless of species or pain category)

Effective Dates:   August 20, 2020 through June 30, 2023

This policy has been approved by a majority vote of the IACUC members.

Joseph Lorenzo, M.D., Chair, Institutional Animal Care and Use Committee