Significant Changes

These modules are useful for educators seeking to teach IACUC members and staff to define significant changes to IACUC-approved protocols, and to build participants’ confidence in implementing available forms of protocol review, including Veterinary Verification and Consultation (VVC).

Module A: Significant Changes…What the IACUC Administrator Needs to Know

Target Audience: IACUC Members, IACUC Staff

Goal: Understanding significant changes to animal use protocols

Objectives:

  • Define significant changes to animal use protocols
  • Differentiate between significant and minor changes
  • Evaluate how the processes in OLAW Notice NOT-OD-14-126 may support a reduction in regulatory burden

Active Learning Methods: Case-Based Learning, Jigsaw, Role Play

Developers:

Claire Johnson
IACUC/IBC Regulatory Coordinator
Tufts University/Tufts Medical Center

Elaine Kim, BS, CPIA
Senior IACUC Coordinator, Research Integrity & Compliance Review Office
Colorado State University

Carolyn McKinnie, BA, DVM
Supervisory Veterinary Medical Officer
United States Department of Agriculture, Animal Plant Health Inspection Service, Animal Care

Gina R. Prochilo-Cawston, MS, CPIA, PMP, CHRC
Senior Regulatory Compliance Specialist
OvaScience

Michael Taylor
University of Kansas Medical Center

Module B: Significant Changes to IACUC-Approved Protocols

Target Audience: IACUC Members, IACUC Staff

Goals:

  • Provide IACUC members with a basic understanding as to what constitutes a significant change to an IACUC-approved protocol.
  • Allow IACUC members to gain an understanding of the review methods available to them for review and approval of significant changes.
  • Empower the IACUC to implement the Veterinary Verification and Consultation (VVC) process at their institution.

Objectives:

  • Define significant changes.
  • Describe the review methods for significant changes.
  • Formulate a template process to implement Veterinary Verification and Consultation (VVC).

Active Learning Methods: Case-Based Learning, Think-Pair-Share, Technology-Enhanced Learning

Developers:

Tim Allen
Technical Information Specialist
United States Department of Agriculture, Agricultural Research Service

Michael P. Andrews, BS, MBA, CPIA, RLATg
IACUC Training & Compliance Coordinator
IACUC Post-Approval Monitor
University of Iowa

Javier Cisneros, DVM, MS, PhD, CPIA
Owner/Consultant
Swan Consultants LLC

F. Claire Hankenson, DVM, MS, DACLAM
Director, Campus Animal Resources
Attending Veterinarian
Professor, Laboratory Animal Medicine
Michigan State University

Rachel A. Murray, MS, CPIA, RLATG
Research Compliance Specialist
Cincinnati Children’s Hospital Medical Center

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.