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IACUC Policy 002: Designated Member Review Eligibility

1. Purpose:This policy outlines the criteria for the designated member review (DMR) process eligibility. 

2. Scope:This policy applies to all IACUC protocols at Ohio University, including:

  • initial submissions 
  • currently approved protocols and other form types (i.e. renewals, amendments) 
  • Use of DMR subsequent to full committee review (FCR).

3. Policy:There are two valid methods of IACUC review allowed by the PHS Policy: (1) full-committee review by a convened quorum of the members of the IACUC, or (2) designated member review by one or more members, employed only after all voting members have been provided an opportunity to call for full-committee review (6.1). 

3.1 Designated member review may be utilized only after all members have been provided the opportunity to call for full-committee review. If any member requests full committee review then that method must be used. If not, the IACUC Chairperson may appoint one or more appropriately qualified IACUC members to serve as the designated reviewer(s). Designated review may result in approval, a requirement for modifications (to secure approval), or referral to the full committee for review. Designated review may not result in withholding of approval(6.1). 

3.2 As allowed by PHS Policy (6.2), the IACUC may also use DMR after FCR.  In this case, all members of the IACUC must agree in advance in writing that the quorum of members present at a convened meeting may authorize the DMR process subsequent to FCR by unanimous vote of the quorum. Please refer to Section K. of the IACUC Approved Guidelines for more information (6.3).

4. Process:Form Types or Scenarios meeting the criteria listed in Table 1 below are eligible to be routed to members for the opportunity for DMR. 

4.1 Requesting Review by DMR: In cases where a PI wishes to request review by DMR for a non-personnel update-protocol and or amendment, the PI must email the IACUC Chair to request review by DMR and provide adequate justification as to why review by DMR is being requested. 

4.2 The Chair (or Vice-Chair) reserves the right to require that the protocol be reviewed by the full committee. Moreover, any member of the committee reserves the right to call for full committee review after the submission is assigned to DMR (during the period of recall). The Chair will inform the members of the PI’s name, study title, study number and reason for deviating from the regular procedure. The Chair will email all voting members to notify them that a request for DMR will be coming.

Form Type/and or Scenario

Reviewers*

Antibody Protocols that qualify under IACUC Guidelines, Section E.  
Chair (or Vice-Chair) 
Chair (or Vice-Chair) 
Chair (or Vice-Chair), Safety Department representative or designee 
Personnel Amendments  
Chair (or Vice-Chair), Safety Department representative or designee 
Amendments- DMR eligibility for non-personnel amendments are assessed on a case-by-case basis by the IACUC Chair (see process described in Step 4.2 above). 
Assigned by the Chair (Vice-Chair) based on subject matter expertise. 
Subsequent to FCR 
To be assigned as appropriate by Chair (or Vice Chair’s) discretion, after unanimous vote at convened meeting. 
Deferrals  
Decision maker: Chair (or Vice-Chair) 
Annual Reports  
Chair (or Vice-Chair), LAR Director 
Other- DMR eligibility for protocols (amendments, renewals, etc.). are assessed on a case-by-case basis by the IACUC Chair (see process described in Step 4.1 above). 
Assigned by the Chair (Vice-Chair) based on subject matter expertise. 
*The Chair (or Vice Chair) reserves the right to include additional DMR reviewers as appropriate. 

5. Definitions:

  • DMR- The designated member review process is where one or more IACUC members are assigned to review a protocol. DMR reviewers do not vote to determine the outcome, thus the outcomes must be unanimous. DMR reviewers can elect to approve the protocol, require modifications to secure approval, or referral to the full committee for review. DMR reviewers cannot withhold approval.
  • FCR- The full committee review process entails a convened meeting of a quorum of IACUC members where protocols are reviewed. Members vote to determine outcomes: approval, require modifications to secure approval, or withhold approval.
  • Quorum- greater than 50% of voting IACUC members

6. References & Resources:

7. Change History: 

Version Number

Details of Change

Approval Date

1.0

This is a new IACUC policy.

06/03/2024

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