Full Committee Review (FCR) vs. Designated Member Review (DMR) - August 2016

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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

Module Materials
Slides (PPT) - UPDATED 10/4/2017 (Powerpoint - 140.73 KB)
Module Question

Submit comments or questions to olawdpe@mail.nih.gov.

Pain & Distress / Humane Endpoints - July 2016

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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

Module Materials
Mock IACUC Scenario (PDF - 208.2 KB)
Slides (PDF) - UPDATED 10/4/2017 (Powerpoint - 102.42 KB)
Module Question

Submit comments or questions to olawdpe@mail.nih.gov.

Significant Changes: What the IACUC Administrator Needs to Know - July 2016

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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

Module Materials
Slides (PPT) - UPDATED 10/12/2017 (Powerpoint - 19.65 MB)
Module Question

Submit comments or questions to olawdpe@mail.nih.gov.

Facility Inspection Module - July 2016

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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

Module Materials
Facilitator Manual (PDF) (PDF - 255.73 KB)
Slides (PPT) - UPDATED 10/3/2017 (Powerpoint - 4.3 MB)
Module Question

Submit comments or questions to olawdpe@mail.nih.gov.

Noncompliance and Reporting / FOIA - July 2016

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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

Module Materials
AAALAC Reporting (PDF) (PDF - 374.64 KB)
Decision Tree (PDF) (PDF - 91.97 KB)
OLAW Guidance (PDF) (PDF - 132.83 KB)
Slides (PPT) - UPDATED 10/4/2017 (Powerpoint - 15.12 MB)
Module Question

Submit comments or questions to olawdpe@mail.nih.gov.

Pain and Distress and Humane Endpoints - August 2016

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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

Module Materials
Goals (PDF) (PDF - 269.69 KB)
Module Question

Submit comments or questions to olawdpe@mail.nih.gov.

Significant Changes to IACUC-Approved Protocols - August 2016

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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

Module Materials
Slides (PPT) - UPDATED 10/12/2017 (Powerpoint - 845.47 KB)
Module Question

Submit comments or questions to olawdpe@mail.nih.gov.

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