iacuc member training june 15, 2006. training objectives a quick overview of the rules basics of...
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IACUC Member Training
June 15, 2006
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Training Objectives
A Quick Overview of the Rules
Basics of Protocol Review
IACUC Member Standards
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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.)
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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
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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
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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.
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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
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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)
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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
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The “Guide”
Performance Standards: Institutional policies and
responsibilities Animal environment,
housing, and management
Veterinary medical care Physical plant (facilities)
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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.
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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
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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
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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
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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
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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
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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
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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
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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
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Special Review Issues
Multiple Survival Surgery
Prolonged Restraint
Food and Water Restriction
Use of paralytic agents
Category E procedures
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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)
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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.
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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
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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
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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
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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
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Committee Decisions
Approved
Tabled Administratively (M)
Tabled for Subcommittee Review (T)
Resubmission Required (R)
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Approved!
All IACUC concerns and administrative issues have been addressed adequately in the submission. No changes are required.
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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
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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
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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).
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IACUC Member Standards
Attendance
Confidentiality
Participation
Conflict of Interest Disclosure
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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.
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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.
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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
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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.
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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.
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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
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…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?
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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!