IACUC Member Training June 15, 2006

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

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.)

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

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

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.

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

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)

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

The “Guide” Performance Standards: Institutional policies and responsibilities Animal environment, housing, and management Veterinary medical care Physical plant (facilities)

The Guide First edition issued in 1963 by the Animal Care Panel (renamed ILAR) The 5th and most recent edition was published in Used by AAALAC to evaluate animal care & use programs Covers all aspects of the animal care and use program, including facilities.

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

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

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

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

USDA pain category – What’s up with that? Letters refer to the columns on the USDA Animal Usage report we file once per year Column A = animal species is listed here (that’s why there’s no pain category A). Number of animals used in the preceeding year are listed in columns B – E

USDA Pain/Distress Categories B = animals used only for breeding purposes (breeder moms, stud males, culled pups, etc.) C = momentary pain or distress Needle Stick for blood draw or administration of euthanasia No anesthesia needed for a similar procedure in a human

USDA Pain/Distress Categories D = Some pain/distress, treated with anesthetic, analgesic or tranquilizing drugs Similar procedure in a human would require topical or systemic anesthesia Post-surgical pain treated with analgesia Anesthesia used for restraint

USDA Pain/Distress Categories E = Pain/distress for which the use of appropriate anesthetic, analgesic or tranquilizing drugs would adversely affect the research. Analgesic studies Death as an endpoint REQUIRES SCIENTIFIC JUSTIFICATION

Special Review Issues Multiple Survival Surgery Prolonged Restraint Food and Water Restriction Use of paralytic agents Category E procedures

Review of Scientific Merit Protocols involving animals should have a sound research design, the animals selected should yield valid results, and the project should have relevance and scientific value (i.e. merit). (based on PHS Policy and USDA Regulations)

It’s your responsibility … IACUC review of merit is not just for unfunded projects; both USDA and PHS delegate much of the responsibility for protocol review, including the assessment of merit, to the institution.

PHS Policy on Scientific Merit “Procedures with animals will avoid or minimize discomfort, distress, and pain to the animals, consistent with sound research design.” - PHS Policy (IVC1a) “The animals selected for a procedure should be of an appropriate species and quality and the minimum number required to obtain valid results.” - U.S. Government Principles III

The USDA on Scientific Merit “Rationale for…species” “Appropriate species…to obtain valid results” “Activities do not unnecessarily duplicate…” “Procedures… for the conduct of scientifically valuable research” - 9 CFR 2.31

Protocol Review Process Pre Review - before the meeting : Read the protocol carefully, as far in advance of the meeting as possible Consult with veterinarians and the administrator with general questions. Discuss protocol with primary or secondary reviewer Reach out to Lead Researchers with questions as appropriate

Protocol Review Process Before the final vote : Participate in the review and discussion Understand why the researcher should be allowed to use live vertebrate animals in research, teaching or testing. Ask yourself whether your decision is consistent with the humane care of animals

Committee Decisions Approved Tabled Administratively (M) Tabled for Subcommittee Review (T) Resubmission Required (R)

Approved! All IACUC concerns and administrative issues have been addressed adequately in the submission. No changes are required.

Tabled Administratively (M) Minor administrative details or modifications are required to address concerns that do not alter the content of the protocol itself. No subcommittee review – approval is processed on receipt of clarifications. Examples: Minor miscalculation of animal numbers Missing contact information Procedure boxes incorrectly marked

Tabled for Subcommittee Review Animal welfare issues have been adequately addressed, but additional information, details or clarifications are necessary before approval can be granted. Examples: Clarification of experimental design or justification of animal numbers Additional descriptive information regarding procedures. Alternatives search is missing or inadequately documented Significance of the research is not in lay language

Resubmission Required (R) A reasonable judgement cannot be made regarding the experimental design or scientific merit of the proposed work, based on the information supplied. Serious animal welfare concerns have not been adequately addressed. Modification request is are beyond the scope of work described in the original protocol (must be resubmitted as a stand-alone protocol).

IACUC Member Standards Attendance Confidentiality Participation Conflict of Interest Disclosure

Attendance Members are responsible for attending all convened meetings and staying until business has been completed. If you cannot attend a meeting, notify the IACUC Administrative Office as soon as possible so an alternate member can be contacted if necessary to maintain quorum. Official committee business, including protocol review, cannot be conducted without a quorum of voting members.

Confidentiality  IACUC protocols may contain personal, confidential and proprietary information.  Members of the IACUC are responsible for maintaining all committee proceedings and documents in strict confidence.  Information discussed at IACUC meetings may not be disclosed without the prior written permission of the Vice Chancellor for Research.

Participation  Keep up-to-date with regulations, policies, etc.  Attend the meetings, including the semi- annual Program Evaluation  Participate in Semi-Annual Facility Inspections  Volunteer to serve on subcommittees

Conflicts of Interest  Members of the IACUC must disclose all potential conflicts to the IACUC Chair or Administrator  Examples of a conflict of interest:  IACUC member is the Lead Researcher, faculty sponsor or collaborator on the project  IACUC member has a significant financial or management interest in the sponsor of a project under review.  IACUC member believes existing circumstances may effect his/her objectivity.

AAALAC Accreditation – Why bother? AAALAC International is a private, nonprofit organization that promotes the humane treatment of animals in science through its voluntary accreditation and assessment programs. AAALAC works with institutions and researchers and serves as a bridge between progress and animal well- being. Through AAALAC's voluntary accreditation process, research programs demonstrate that they meet the minimum standards required by law, and are going the extra step to achieve excellence in animal care and use.

Who ARE those guys? AAALAC site visit teams typically consist of a member of the Council on Accreditation and an ad-hoc member: AAALAC Council Member – Brian Ermeling, DVM Dartmouth University Ad hoc Member – Barton Weick, DVM NIH/NIDA Intramural Research

…and what do they want from me? AAALAC site visitors may ask you: What policies does the IACUC have, and how are they implemented? How you were trained as a committee member? Where do you go to find help in reviewing protocols?

Questions? “Especially for IACUC Committee Members” New web page under construction Member Binder You got one when you joined the committee When in doubt, ASK!