1. IACUC Member Training June 15, 2006

2. Training Objectives A Quick Overview of the Rules Basics of Protocol Review IACUC Member Standards

3. Current Animal Welfare Regulations, Policies & Guidelines Animal Welfare Act - 9 CFR Chapter 1 USDA Regulations and Animal Care Policies PHS Policy (1986) The Guide (NRC--5th Ed.)

4. U.S. Dept. of Agriculture Enforces and Administers the Animal Welfare Act Enforces the Act through the Animal Welfare Regulations 9 CFR Chap. 1, Parts 1-3 Provides clarification of the Regulations through the Animal Care Policies

5. USDA Regulations Cover all warm-blooded animals exclude rats, mice and birds Provide performance standards for: veterinary care animal husbandry animal transportation Animal Care policies cover more than just research Set requirements for committee (IACUC) composition and function Regs and Policies cover many other activities � pet breeders, circuses, marine mammal programs, swim with the dolphins, etc. Not to be outdone, the US Department of Health and Human Services was working on their own policy and regulations�..Regs and Policies cover many other activities � pet breeders, circuses, marine mammal programs, swim with the dolphins, etc. Not to be outdone, the US Department of Health and Human Services was working on their own policy and regulations�..

6. PHS Policy � NIH Office of Laboratory Animal Welfare (OLAW) Health Research Extension Act of 1985 is the legislative mandate for PHS Policy. Covers all vertebrate animals NIH-funded institutions must adhere to the PHS Policy Office of Laboratory Animal Welfare is responsible for assuring compliance with PHS policy. Each institution that accepts PHS funds must have an approved Assurance of Compliance with PHS Policy � essential a description of the institution�s program. There�s a copy in the member binder and on-line. Each institution that accepts PHS funds must have an approved Assurance of Compliance with PHS Policy � essential a description of the institution�s program. There�s a copy in the member binder and on-line.

7. PHS Policy Covers the use of all live vertebrate animals Applies to all institutions that accept money from the Public Health Service for research, testing and teaching. Requires negotiation of an animal welfare assurance with OLAW Hold up the booklets � Difference between the red and the green � the newest version (red, 2002) includes the just-in-time policy, allowing IACUC approval for animal work to be delayed until after the study section review of a protocol and assignment of a fundable score. Animal Welfare Assurance � ours was just renewed, in March 2003. Good until February 2008. It�s a negotiated agreement with NIH spelling out exactly how we assess and protect animals in research, testing and teaching. Hold up the booklets � Difference between the red and the green � the newest version (red, 2002) includes the just-in-time policy, allowing IACUC approval for animal work to be delayed until after the study section review of a protocol and assignment of a fundable score. Animal Welfare Assurance � ours was just renewed, in March 2003. Good until February 2008. It�s a negotiated agreement with NIH spelling out exactly how we assess and protect animals in research, testing and teaching.

8. Key Elements of PHS Policy: Requirements for the submission of funding applications (e.g., description of the use of animals, grant-protocol match) Record keeping requirements Reporting requirements to enable funding agencies and OLAW to exercise oversight Composition of the IACUC (somewhat different than USDA requirements) USDA regs require three members, PHS policy requires 5 (including a non-scientist and unaffiliated member) USDA regs and PHS policy are like overlapping spheres � some stuff is duplicated, but each has its own focus � USDA is all uses (including pets and displays like zoos and circuses), PHS covers all species but focuses on research.USDA regs require three members, PHS policy requires 5 (including a non-scientist and unaffiliated member) USDA regs and PHS policy are like overlapping spheres � some stuff is duplicated, but each has its own focus � USDA is all uses (including pets and displays like zoos and circuses), PHS covers all species but focuses on research.

9. Composition of the IACUC USDA requires: At least 3 members Veterinarian, Non-affiliated member PHS Policy requires: At least 5 members Veterinarian, Nonscientist, Non-affiliated, at least 1 practicing scientist

10. The �Guide� Performance Standards: Institutional policies and responsibilities Animal environment, housing, and management Veterinary medical care Physical plant (facilities) The Guide is considered to be the Gold Standard for performance standards relating to animal welfare. Lots more detail than the regulations � specifics about how to run a program Basis for AAALAC accreditationThe Guide is considered to be the Gold Standard for performance standards relating to animal welfare. Lots more detail than the regulations � specifics about how to run a program Basis for AAALAC accreditation

11. The Guide First edition issued in 1963 by the Animal Care Panel (renamed ILAR) The 5th and most recent edition was published in 1985. Used by AAALAC to evaluate animal care & use programs Covers all aspects of the animal care and use program, including facilities. First �Guide� was issued in 1963, 3 years before the AWA and 10 years before PHS policy Group of scientists/members of the National Research Council were already thinking about animal welfareFirst �Guide� was issued in 1963, 3 years before the AWA and 10 years before PHS policy Group of scientists/members of the National Research Council were already thinking about animal welfare

12. Other References 2000 Report from the AVMA Panel on Euthanasia Humane euthanasia techniques Endorsed by USDA and OLAW NASA Principles Respect for life Societal Benefit Non-maleficence Principles and organizations supporting the work of IACUCs AAALAC � private organization � Association for Assessment and Accreditation of Laboratory Animal CarePrinciples and organizations supporting the work of IACUCs AAALAC � private organization � Association for Assessment and Accreditation of Laboratory Animal Care

13. Ethical Principles of Animal Use The three Rs Principles of Humane Experimental Technique by Wllm. Russell and Rex Burch, 1959 Written a long time ago, resurfaced in the 90�s Use of animals in research involves responsibility � society places expectations on the scientific community that the use of living animals is of value to the furtherance of science and the good of society Groups such as NASA�s scientific advisory board began to think about applying ethics to research involving animals Use of animals in research involves responsibility � society places expectations on the scientific community that the use of living animals is of value to the furtherance of science and the good of society Groups such as NASA�s scientific advisory board began to think about applying ethics to research involving animals

14. The Three Rs Replacement Use something other than a live animal if possible Refinement Make the procedures as non-invasive and painless as possible Reduction Use as few animals as possible to achieve scientific significance without increasing pain and distress

15. Protocol Review Project Overview Experimental Design Justification of Animal Numbers Use of Live Animals Literature Searches for Alternatives Training & experience Procedural Description Pain, Distress and Discomfort Analgesia Euthanasia