Protocol Review Fundamentals B11

Mary Jo Shepherd, DVM, CPIA Tanise L. Jackson, DVM, DACLAM, CPIA

March 20, 2017

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Presenters

Mary Jo Shepherd, DVM, CPIA Executive Director of the Office of the IACUC Office of the Executive Vice President for Research Columbia University Tanise L. Jackson, DVM, DACLAM, CPIA Director, Animal Welfare and Research Integrity Division of Research Florida A&M University

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Disclosure: MJ Shepherd, Tanise Jackson

Mary Jo Shepherd, Tanise L. Jackson, have no relevant personal/professional/financial

relationship(s) with respect to this educational activity

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Learning Objectives

!  Analysis of protocol review requirements !  Discuss the pros and cons of using

subcommittees !  Explore the benefits and disadvantages of

designated member review versus full committee review

!  Review the use of checklists in the process !  Examine ways to improve consistency among

reviewers and reduce burden

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Requirements of Protocol Review

According to the Regulations: USDA and PHS Policy : !  Each IACUC member shall be provided with a list of

proposed activities to be reviewed. !  Written descriptions of all proposed activities shall be

available to all members !  Any member may obtain, upon request, full Committee

review (FCR) of those activities. !  If no member requests FCR then a member designated

by the chairman (DMR) and qualified to conduct the review, shall review those activities.

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Requirements of Protocol Review

Types of Review !  The Designated member (DMR) has the

authority to approve, require modifications in (to secure approval).

!  Full Committee Review (FCR) is in a convened meeting of a quorum of the IACUC, and with the approval vote of a majority of the quorum present at meeting. Outcomes: approve, require modifications in order to secure approval and disapproval.

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Requirements of Protocol Review

Conflict of Interest (COI) !  No member may participate in the IACUC review

or approval of an activity in which that member has a conflicting interest (e.g., is personally involved in the activity)

!  A member who has a conflicting interest contribute to the constitution of a quorum

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Requirements of Protocol Review

Notification to the PI IACUC shall notify principal investigators and the research facility in writing of its decision to approve or withhold approval of those activities related to the care and use of animals, or of modifications required to secure IACUC approval.

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Subcommittees

Use of Subcommittees !  Serve to coach designated reviewers !  Provide enhanced review of protocols !  Improve consistency among reviewers/educate

reviewers !  Could slow turnaround time !  Assure that Subcommittee processes are

compliant

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DMR vs FCR

Designated Member Review (DMR) vs. Full Committee Review (FCR) !  DMR improves review turnaround times !  DMR useful for large institutions !  DMR may intensify inconsistencies among reviewers !  FCR results in more thorough reviews !  FCR enhances review consistency !  FCR slows review turnaround times

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Consistency of Reviews

Improve Consistency Among Reviewers !  Use of Subcommittees !  New member mentoring !  Reviewer training !  Availability of guidelines and policies !  IACUC/veterinary staff support !  Use of checklists

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Use of Checklist

!  Why Use a animal protocol check list? 1. To ensure that the protocol includes the key elements based on the regulations. 2. Aids in the training of new IACUC members 3. Ensure more uniformity among IACUC members Design your checklist based on the format of the animal protocol. Allows the review the follow a natural sequence of questions that must be addressed in the protocol.

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Burden Reduction

!  Only require annual reviews for USDA species protocols

!  Offer protocol preparation assistance by IACUC staff

!  Eliminate requirements for non-regulatory mandated information in the protocol

!  Use of pre-approved procedures/SOPs

Questions?

Thank you!