Significant Changes

Overview

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).

This material is based upon work supported by the National Science Foundation under Grant Number 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.

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

Claire Johnson

IACUC/IBC Regulatory Coordinator
Tufts University/Tufts Medical Center

Elaine Kim, BS, CPIA

Elaine Kim, BS, CPIA

Senior IACUC Coordinator, Research Integrity & Compliance Review Office
Colorado State University

Carolyn McKinnie, BA, DVM

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

Gina R. Prochilo-Cawston, MS, CPIA, PMP, CHRC

Senior Regulatory Compliance Specialist
OvaScience

Michael Taylor

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

Tim Allen

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

Michael P. Andrews, BS, MBA, CPIA, RLATg

Michael P. Andrews, BS, MBA, CPIA, RLATg

IACUC Training & Compliance Coordinator
IACUC Post-Approval Monitor
University of Iowa

Javier Cisneros, DVM, MS, PhD, CPIA

Javier Cisneros, DVM, MS, PhD, CPIA

Owner/Consultant
Swan Consultants LLC

F. Claire Hankenson, DVM, MS, DACLAM

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

Rachel A. Murray, MS, CPIA, RLATG

Research Compliance Specialist
Cincinnati Children’s Hospital Medical Center