Goals:

• At the end of this session, you will be able to understand use of FCR and DMR for protocols and …
• You will be able 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

Module Developers: Joe Crossno, Larissa Dobbeleare, Nicole Duffee, Cyd Gillett, Tracy Thompson

Audience: New IACUC members

Goals:

• Understand the acceptable methods of protocol review and approval
• 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

Module Developers: Marcy Brown, Monte Matthews, Christina Nascimento, Nicolette Petervary, Jerry Poling

Goal: Understand how to effectively review protocols to ensure pain and distress are minimized consistent with sound research design

Objectives:

• Define pain, distress, experimental endpoints, and humane endpoints
• Evaluate the potential for pain and distress
• Determine the acceptability of the management of possible pain and distress
• Ensure an appropriate link between experimental and humane endpoints

Module Developers: Alice Huang, Kiirsa Pokryfke, Ernie Prentice, Stacy Pritt, William Singleton

Audience: IACUC administrators

Goal: Understanding significant changes to animal use protocols

Objectives:

You will be able to:

• 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

Module Developers: Claire Johnson, Elaine Kim, Carolyn McKinnie, Gina Prochilo-Cawston, Michael Taylor

Goal: The IACUC training module is to provide an understanding of the facility inspection process to safeguard animal welfare.

Objectives:

1. Define responsibility of IACUC members
2. Perform an inspection
3. Identify and classify deficiencies
4. Create a report documenting the findings/results and a corrective action plan

Module Developers: Janna Barcelo, Deborah Holland, Sally Light, Gregory Reinhard, Obed Rutebuka

Goals:

• To understand noncompliance in relation to animal welfare concerns
• To determine reportability and the impact on animal welfare and science

Objectives:

The learner should be able to:

• Recognize potential noncompliance in animal care and use programs
• Describe the steps for communicating and verifying concerns
• Categorize compliant vs. noncompliant incidents
• Evaluate whether a noncompliance is reportable and to whom
• Explore implications of reporting noncompliances

Module Developers: Rob Anderson, Becky Armstrong, Amy Chuang, Randy Nelson, Sally Thompson-Iritani

Audience: Operations staff (i.e., veterinary, husbandry, and research) primarily; also the IACUC (protocol reviewers)

Goals:

• Understanding and recognizing pain and distress
• Knowledge of how to manage pain and distress

Objectives:

• Recognize species specific behaviors and distinguish them from pain and distress
• Distinguish what is scientifically justified pain and distress, consistent with sound research design
• Use tools (e.g., scoring system) to assess pain level
• Document an incident of pain and distress

Module Developers: Bruce Kennedy, Gene Hines, Kelly Fusco, Tanise Jackson, Trina Smith

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)

Module Developers: Tim Allen, Mike Andrews, Javier Cisneros, Claire Hankenson, Rachel Murray