Goals:

• Understand departures from the provisions of the Guide
• Manage departures to ensure compliance

Objectives:

• Define “departure” from the provision of the Guide
• Identify examples of departures
• Apply tools to manage departures
• Determine reporting requirements

Module Developers: Ron Banks, Beth Ford, Neera Gopee, Marley Thrasher, Jim Weed

Goal: IACUC members completing this module will develop an understanding of the value of facility inspections as part of a high quality program of animal care and use.

Objectives:

1. Provide examples of animal welfare and health concerns that may be discovered and describe how you would address these concerns
2. Describe regulatory requirements for facility inspection
3. Differentiate significant versus minor deficiencies
4. Indicate different component areas of facilities and concerns related to these areas
5. Identify occupational health and safety concerns

Module Developers: Chieko Azuma, George Babcock, Linda Brovarney, Natalie Mays, Cynthia Pekow

Audience: Experienced IACUC members and administrators

Goal: To have the audience develop a skill set to evaluate departures from the Guide in conjunction with animal welfare and sound scientific practices.

Objectives:

• Recognize the relevant resources
• Identify perceived departures from the standards
• Differentiate between perceived and true departures
• Evaluate potential impacts from the departure
• Identify reporting requirements and process

Module Developers: Elizabeth Dodemaide, Jo Ann Henry, Alison Pohl, Claudia Swanson, Sandra Wilkins

Goals: The goals of this training are to help IACUC members and administrative staff categorize “departures” from the Guide and fulfill the committee’s relevant oversight responsibilities.

Objectives:

• Define “departure” relative to the Guide
• Compare the terms “must” vs “should” vs “may”
• Differentiate between departures and noncompliance
• Use published guidance on departures correctly
• Determine when departures need to be reported in the semiannual report and/or tracked

Module Developers: Wayne Barbee, Susan Harper, Eileen Morgan, Noé Tirado-Muñiz, Jennifer Perkins

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