Full Committee Review FCR vs Designated Member Review

Full Committee Review (FCR) vs. Designated Member Review (DMR) For New IACUC Members Marcy Brown Monte Matthews Christina Nascimento Nicolette Petervary Jerry Poling

GOALS l Understand the acceptable methods of protocol review and approval. l Explore how to reduce self-imposed "regulatory" burden by the appropriate use of DMR.

OBJECTIVES l Describe and characterize the federal requirements for FCR and DMR. l Examine IACUC member responsibilities for the protocol review process. l Determine l Assess potential risks and burdens of each review method. institutional best practices for use of FCR vs. DMR.

METHODS OF PROTOCOL REVIEW There are only two valid methods of IACUC review for approval allowed by PHS Policy, the AWARS and the Guide: l Full Committee Review (FCR); or, l Designated Member Review (DMR) PHS IV. C. 2 & 9 CFR 2. 3. 1(d)(2)

FCR l Convened meeting of a quorum of IACUC members – Face to face is preferable, but can do telecommunication (see appendices) l Quorum is defined as simple majority (e. g. half plus one) – Both primary and alternate can’t contribute to quorum at same time l Approval of a protocol requires a simple majority vote of the members present – Approve, require modifications (to secure approval) or disapprove l Written notification of outcome given to the PI l Anyone with a conflict of interest may not count towards a quorum

DMR l DMR begins only after all IACUC members have had an opportunity to request FCR. – Time period for opportunity to request FCR should be defined – All IACUC members should be given (at least) a list of protocols with written descriptions of the protocol made available. – IACUC members do not vote during this time period. l At least one qualified IACUC member serves as the designated reviewer (DR) and conducts the DMR. l The DR must be designated by the IACUC Chair.

DMR l There is no requirement for a written response of a “no call” for FCR. l If no IACUC member requests FCR, then the IACUC Chair can chose one or more designated member reviewers. l The DR(s) may approve the protocol, require modification of the protocol (to secure approval), or refer to FCR. – DR(s) may not disapprove a protocol l If DMR involves more than one reviewer, consensus must be achieved. l DRs do not vote.

What do you think? A protocol is sent out to all IACUC members requesting if any member wants to call for full committee review. Your institution’s policy is to allow 3 business days for any member to request FCR. After 3 business days, 10 out of the 13 members have replied no request for FCR. Can the protocol be sent to a qualified, designated member reviewer? 1. Yes 2. No 3. Maybe

What types of protocols might be best practice for FCR? Category E protocols All USDA species Behavior Studies Non-human primates Exceptions to Standards Major Survival Surgery Minor Survival Surgery Multiple Operative Procedures Food and/or Fluid Regulation Breeding Prolonged Restraint Euthanasia/tissue harvest Dogs/cats Complete Freund’s Adjuvant

DMR or FCR? The Institution oversees 200 protocols (average 25 submissions per month including New, Renewals, Amendments). The Committee meets the 3 rd Wednesday of the month, and suggested DMRs are sent to the Committee daily. All protocols going to FCR must be submitted at least 2 weeks before the meeting. On the first day of the month, a PI submits a hamster protocol involving minor muscle biopsy procedures followed by blood draws.

DMR vs. FCR Each group will defend the review method assigned. Consider potential risks, burdens, and impacts on animal welfare. l Group: A, B: FCR l Group D, E, F: DMR l. A pair with D l B pair with E & F

You should now be able to…. l Describe and characterize the federal requirements for FCR and DMR. l Examine IACUC member responsibilities for the protocol review process. l Determine l Assess potential risks and burdens of each review method. institutional best practices for use of FCR vs. DMR.

Summative Assessments l See Handout

Summative Assessment: FCR vs. DMR What are the requirements for Full Committee Review (FCR) and approval? Check all that apply __Quorum of IACUC Members at a Convened Meeting __Approval vote of majority of IACUC members present __Attending Veterinarian must be present __Approval of majority of all IACUC members __Non-affiliated member must be present

Summative Assessment: FCR vs. DMR For the assigned designated member reviewer, what are the protocol review options? Check all that apply. __Approval __Return to PI for modification (to secure approval) __Approval with modified conditions __Referral to Full Committee Review __Disapproval

FCR vs. DMR Summative Assessments: University of PRIM&R has 12 primary members with 2 alternates. At a convened meeting, 6 primary members show up and one alternate member. Can U of P IACUC conduct Full Committee Review of protocols? Explain your answer for any of the following choices. 1. Yes 2. No 3. Maybe

FCR vs. DMR Summative Assessment: The IACUC develops a process whereby certain studies (e. g. , primate, dog, survival surgery) automatically must have Full Committee Review whereas other studies (e. g. antibody production, rodent behavior) are directed to a designated member reviewer who begins the review. Is this method acceptable? Explain your answer. 1. Yes 2. No 3. Maybe

Summative Assessment: FCR vs. DMR Prior to the initiation of the designated member review process, each IACUC member must indicate if they want the protocol to be reviewed via FCR or not. ____True ____False

Appendices

Guidance on Use of Telecommunications l All members are given notice of the meeting. l Documents normally provided to members during a physicallyconvened meeting are provided to all members in advance of the meeting. l All members have access to the documents and the technology needed. l The forum allows for real time verbal interaction equivalent to that occurring in a physically-convened meeting (i. e. , members can actively and equally participate and there is simultaneous communication). NOT–OD-06 -052

DMR subsequent to FCR When substantive information is lacking from a protocol that is reviewed by FCR, the committee may have questions requiring a response from the PI. In such situations, the IACUC may take the following actions: – If all members of the IACUC are present at the meeting, the committee may vote to require modifications to secure approval and have the revised AUP reviewed and approved by DMR, or returned for FCR at a convened meeting. – If all members are not present, the IACUC may use DMR subsequent to FCR if all members have agreed in advance in writing that a quorum… may decide by unanimous vote to use DMR subsequent to FCR.

Guidance on Use of Telecommunications l If a vote is called for, the vote occurs during the meeting and is taken in a manner that ensures an accurate count of the vote. A mail ballot or individual telephone polling cannot substitute for a convened meeting. l Opinions of absent members that are transmitted by mail, telephone, fax or e-mail may be considered by the convened IACUC members but may not be counted as votes or considered as part of the quorum. l Written minutes of the meeting are maintained in accord with the PHS Policy, IV. E. 1. b.

DMR subsequent to FCR If all members are not present -– All members agree in advance in writing that a quorum… may decide by unanimous vote to use DMR subsequent to FCR… – The institution should specify its intention … in its Assurance with OLAW – … If the IACUC lacks written standard procedures, the IACUC has the option to vote to return the protocol for FCR or employ DMR. In this case, the revised protocol must be available to all members, including those not at the meeting, for the opportunity to call for FCR