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 1985.

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 amember of the Council on Accreditation and

anad-hoc member: AAALAC Council Member –

Brian Ermeling, DVM Dartmouth University

Ad hoc Member – Barton Weick, DVMNIH/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!