IACUC Policy 002: Designated Member Review Eligibility

1. Purpose: This policy outlines the criteria for the Designated Member Review (DMR) process eligibility. This policy is intended to provide transparency for Principal Investigators (PIs), enabling them to effectively plan for submission deadlines and anticipate review turnaround times.

2. Scope: This policy applies to all Institutional Animal Care and Use Committee (IACUC) protocols at Ohio University and governs the use of DMR in the following scenarios:

  • Amendments of currently approved protocols or New/De Novo (Observation Only Protocols) of currently approved protocols that meet eligibility criteria for DMR.
  • Use of DMR subsequent to Full Committee Review (FCR), as permitted by PHS Policy. Please refer to IACUC Policy 010: Designated Member Review (DMR) Subsequent to Full Committee Review (FCR) for more information. 

3. Policy: In accordance with the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals, the IACUC may conduct protocol reviews using DMR under specific conditions. DMR is a valid method of review when: 

  • All IACUC members are provided with the protocol materials, and 
  • Each member is given the opportunity to request FCR. 

NOTE: At Ohio University, IACUC members are allotted three (3) business days to call for FCR. 

4. Process: Outlined below is a typical list of submission types that the IACUC generally considers eligible for DMR.

Form Type/and or Scenario*
Reviewers*
Amendment: Change in transportation of animals LAR Director 
Amendment: Change in animal numbers, sex, age/weight range, animal ID method Attending Veterinarian & LAR Director 
Amendment: Change in animal source LAR Director 
Amendment: Change in strains used IACUC Chair & LAR Director 
Amendment: Change in literature search Subject Librarian IACUC Member  
Amendment: Change in procedures or addition of procedures that DO NOT involve surgery, anesthesia, or prolonged restraint.Assignment is determined by the IACUC Chair, taking into account the relevant subject matter expertise needed for the review.
Amendment: Change of housing location LAR Director  
New/DeNovo/Amendments to Observation Only Protocols Assignment is determined by the IACUC Chair, taking into account the relevant subject matter expertise needed for the review. 
DMR Subsequent to FCR Assignment is determined by the IACUC Chair, taking into account the relevant subject matter expertise needed for the review. 

*Reviewer Assignments: The Designated Member Review (DMR) assignees listed in this table represent the most likely reviewers for applicable submissions. However, assignments are subject to change at the discretion of the IACUC Chair or Vice Chair (in the absence of the IACUC Chair). Changes may occur due to a variety of circumstances, including but not limited to role transitions, scheduling conflicts, vacation, or workload distribution. This list should be used as a general guide for reviewer assignments, not a definitive designation. 

*Special Circumstances: In exceptional circumstances, DMR may be considered on a case-by-case basis by the IACUC Chair or Vice Chair (in absences of the IACUC Chair). These situations typically involve emergencies or instances where delays in review could significantly compromise the integrity or continuity of the research. Investigators who believe their situation may warrant such consideration should contact the IACUC Chair directly to determine eligibility for DMR assignment.  

DMR Eligibility Does Not Guarantee DMR Review: While a submission may meet the criteria outlined above and be deemed eligible for Designated Member Review (DMR) by the IACUC Chair, DMR is not guaranteed. Any IACUC member may request Full Committee Review (FCR) for any reason during the polling window described in Step 4.4 below. Investigators should be aware that such requests override DMR eligibility and may result in Full Committee Review at a convened meeting.  

4.1 Initial Review by IACUC Administrator- The IACUC Administrator intercepts the submission and reviews it to determine if it meets the eligibility criteria for DMR, as outlined in the DMR policy. 

4.2 Verification of DMR Eligibility- If the submission qualifies for DMR, the Administrator proceeds with the DMR process. If not, it is routed for FCR or another appropriate review mechanism such as Veterinary Verification & Consultation (VVC) or Admin Review. 

4.3 FCR Polling Notification- All IACUC members are notified via Cayuse-generated email that a submission is being considered for DMR. The notification includes: 

a. Protocol Number & Title 

b. Assigned reviewer(s) 

c. Deadline to request FCR 

d. A link to go view the submission in Cayuse 

4.4 Three-Business-Day Polling Window- IACUC members are given three (3) business days to review the submission and request Full Committee Review if they believe DMR is not appropriate. 

4.5 Reviewer Assignment 

  • For Amendment Submissions- The IACUC Administrator assigns the DMR reviewer(s) based on the pre-determined assignments  in the table above and confers with the IACUC Chair when warranted.The Chai retains authority to designate or reassign reviewers in all cases. 
  • For DMR Subsequent to FCR-The IACUC Chair assigns one or more qualified IACUC members to serve as designated reviewers, based on subject matter expertise. NOTE: The FCR polling workflow is not conducted in this case because the decision to use DMR subsequent to FCR is communicated by unanimous vote at a convened meeting. 

4.6 Proceeding with DMR 

  • If no member requests FCR within the 3-day window, the designated reviewer(s) may approve, require modifications, or refer the amendment to FCR. DMR assignees are allotted 3-business days to complete their review. 
  • If any member requests FCR, the amendment is removed from DMR and scheduled for review at the next convened IACUC meeting. 

4.7 Documentation and Communication- The outcome of the DMR is documented in Cayuse, and the PI is notified of the decision and any required changes. Amendments and other submissions approved by DMR are reported to the IACUC on the monthly agenda.  

5. Definitions:

  • Designated Member Review (DMR)- A review process where one or more IACUC members are assigned to evaluate and approve a protocol outside of a full committee meeting.
  • Full Committee Review- A protocol review conducted during a convened meeting of the IACUC, where a quorum of members discusses and votes on the protocol.
  • DMR Subsequent to Full Committee Review- The submission requires further modifications before it can be approved. If the committee elects to use DMR to review the modified submission, please budget an additional three business days in your review timeline. 

6. References & Resources:

7. Change History:

Version Number:
Details of Change:
Approval Date:

1.0

This is a new IACUC policy. 

06/03/2024

2.0

Complete revision. This policy was revised to include more detailed eligibility guidelines and an updated workflow.

10/13/2025