Methods of Reviewing Protocols

Purpose

To ensure compliance with federal regulations and promote an efficient and consistent review process for animal care and use protocols, this policy governs protocol submission, reviewer assignment, and the use of Designated Member Review (DMR) and Full Committee Review (FCR).

 

All animal care and use protocols must undergo appropriate IACUC review. Protocols may be reviewed via Full Committee Review (FCR) or Designated Member Review (DMR), depending on eligibility and committee determination.

 

Policy

1. Protocol Submission and Initial Processing

• • All protocols must be submitted electronically by the Principal Investigator (PI) or designee.
  • The IACUC office will determine whether the submission qualifies for DMR or requires FCR. (table 1)

2. Reviewer Assignment

• • Protocol submissions that are DMR or FCR will be assigned reviewers based on IACUC office SOPs
  • Reviewers remain for the life of the protocol when possible.
  • If original reviewers are unavailable, the Chair/Vice-Chair or current designated roles will assume responsibilities.

3. Designated Member Review (DMR)

• • All IACUC members are given the opportunity to request FCR.
  • If no FCR is requested, assigned reviewers conduct the review.
  • Reviewers may approve or require modifications but may not withhold approval.
  • Three-year renewals are generally processed via DMR.

4. DMR Following Full Committee Review (FCR)

• • Applies when protocols require modifications after FCR.
  • Revisions are submitted by the PI and reviewed by assigned reviewers.
  • All reviewers must agree for approval.

5. Criteria for DMR vs FCR

• • Protocols are assessed based on factors such as pain category, species, and invasiveness to determine appropriate review type. (Table 1)

6. Authority and Limitations

• • Designated reviewers may approve or require modifications but cannot withhold approval; only the full committee has that authority.

 

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

 

	Designated Member Review	Full Committed Review
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 USDA regulations
Protocol category	3-year renewals

 

Effective Dates:            June 4, 2026 through June 30, 2029

 

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