Methods of Protocol Review

These modules are useful for educators seeking to teach IACUC members and staff to recognize the federal requirements necessary for Full Committee Review (FCR) and Designated Member Review (DMR), and to understand the potential risks and burdens of these procedures.

Module A: Methods of Protocol Review: DMR, FCR, and Continuing Review

Target Audience: This module can be adapted to any audience.

Goal: Understand the use of designated member review and full committee review for protocols and to understand continuing review of protocols.

Objectives:

  • Differentiate between FCR and DMR.
  • Justify the use of FCR and DMR.
  • Evaluate how the use of FCR and DMR may affect regulatory burden, animal welfare and occupational safety.
  • Formulate guidance on when to use FCR and DMR.
  • Contrast the PHS Policy and AWA when using continuing review.
  • Evaluate how continuing review may affect regulatory burden, animal welfare and occupational safety.
  • Formulate guidance on conducting continuing review.

Active Learning Methods: Concept Mapping, Group Work, Response Systems

Developers:

Joseph E. Crossno, MS
Research Compliance Analyst
Central Michigan University

Larissa Dobbeleare, BS, LATg
Training Coordinator
University of Kansas Medical Center

Nicole Duffee, DVM, PhD
Director, Education & Scientific Affairs
AALAS

Cynthia S. Gillett, DVM, DACAM, CPIA
IACUC, AAALAC, and Laboratory Animal Program Consultant

Tracy A. Thompson, DVM
Veterinary Medical Officer, Wildlife Health Branch
National Parks Service

Module B: FCR vs DMR for New IACUC Members

Target Audience: New IACUC Members

Goals: Understand the acceptable methods of protocol review and approval and to explore how to reduce self-imposed “regulatory” burden by the appropriate use of DMR

Objectives:

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

Active Learning Methods: Group Work, Jigsaw, Problem-Based Learning

Developers:

Marcy Brown, BS, MA, CMAR, CPIA
Animal Welfare Regulatory Compliance Lead
Pfizer Worldwide Research & Development

Monte Matthews, BA, CPIA
Director, Animal Care Services
University of Oregon

Christina Nascimento, MS, CPIA
IACUC Manager, Office of Research Compliance & Administration
Brigham and Women’s Hospital

Nicolette Petervary, VMD
Regional Animal Care Specialist, Eastern Region
United States Department of Agriculture, Animal Plant Health Inspection Services, Animal Care

Jerry Poling, BS, LAT
IACUC Administrator
Eli Lilly and Company

This material is based upon work supported by the National Science Foundation under Grant Nunber 1546975. Any opinions, findings, and conclusions or recommendations expressed in this material are those of the author(s) and do not necessarily reflect the views of the National Science Foundation.