Audience: Seasoned IACUC members

Goals:
IACUC members recognize their role includes:

• Ensuring minimization of pain and distress
• Evaluating humane endpoints

Objectives:

• Define pain and distress
• Define experimental and humane endpoints
• Evaluate procedure for pain, distress and humane endpoints (IACUC role)
• Recognize methods to manage pain and distress
• Assess protocol which includes unrelieved pain and distress

Module Developers: Mary Lou James, Eugene Matullo, Brent Morse, Jim O’Malley, Nora Wineland, JoAnne Zurlo

Goals:

• Understand what constitutes a reportable noncompliance event and identify the institution’s process for reporting noncompliance
• Understand why reporting and open records reflect a public mandate and how can provide either an accurate view or encourage public misconceptions
• Understand how to write a noncompliance report and to whom it should be reported

Objectives:

• Discriminate between reportable and non-reportable noncompliance events
• Explain how your institution reports noncompliance to internal stakeholders and to federal agencies
• Identify the purpose and use of FOIA
• Identify the potential consequences of FOIA release of noncompliance reports
• Explain the ways in which noncompliance can be reported to a federal agency and who is responsible
• Understand the creation and use of an optimal noncompliance report

Module Developers: Allyson Bennett, Robert Gibbens, William Greer, Swapna Mohan, Christian Newcomer, Jerald Silverman

Goals:

• Improve the research environment for the PI by defining the significant change process
• Foster understanding of regulatory requirements
• Increase efficiency of significant change approval process

Objectives: By the end of this session, participants will be able to:

• Explain the difference between significant and other changes
• Outline processes for making protocol changes
• Provide constructive suggestions to the IACUC in consideration of significant changes
• Assess how the protocol can be written to enable flexibility and avoid the need for future modifications

Module Developers: Kristina Adams, Lynn Anderson, Doreen Bartlett, John Dennis, JR Haywood

Goals: To understand the IACUC’s role in noncompliance reporting

Objectives:

• Assess or develop process for evaluating animal welfare allegation
• Define the IACUC’s role in reporting noncompliant events
• Define the four types of noncompliant reportable events
• Describe the contents of a report keeping in mind the content may be subject to FOIA

Module Developers: Eric Allen, Deborah Frolicher, Sherri Goss, Julie Kramer, Marie Ortega, William Stokes

View Module  (Prezi)

Audience: New IACUC members

Goals:

• Understand FCR and DMR in the context of the regulations and “PRIMO! University” policy
• IACUC members will know their role when a protocol is proposed for FCR or DMR
• Appreciate the value of applying FCR and DMR

Objectives:

• Define FCR and DMR methods and their associated regulations
• Analyze how FCR and DMR are applied at our institution and how this differs from minimum regulatory requirements and guidelines
• Outline the roles and responsibilities of IACUC members and other reviewers in conducting FCR and DMR at our institution
• Evaluate the reasons for selecting FCR or DMR for individual protocols

Module Developers: Marlene Cole, Paula Gladue, Lauren Danridge, Larry Carbone, Eric Hutchinson, Venita Thornton

Module Materials:  PowerPoint slides (ppt) 

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