Session 5- IACUC

Protocol life is

3 years

"Guide for the Care and Use of Laboratory Animals" aka "Guide"

first written in 1963 by scientists from the Government and private sector to preempt stricter federal regulation and was "voluntary" *Main guidance document use by: •OLAW (PHS Office of Laboratory Animal Welfare) •AAALAC (Association for Assessment and Accreditation of Laboratory Animal Care International) Has 5 chapters (performance standards): 2011, Eighth Edition

AWA Mandated Training Requires Instruction on

•the humane practice of animal maintenance and experimentation •research or testing methods that minimize the use of animals or limit pain and/or distress •methods to conduct literature searches to determine the availability of alternatives and to assure that duplication does not occur •methods for reporting deficiencies in animal care and treatment

the PHS policy directed NIH to establish guidelines for

•the proper care of animals to be used in biomedical & behavioral research •the appropriate use of anesthetics & analgesics •the appropriate surgical and post-operative care •required formation and utilization of animal care committees

Public Health Service 1985:

(PHS) Policy Congress Passed the Federal "Health Research Extension Act" that provides the Legislative / Statutory mandate for the PHS policy. The Policy states they will follow the AWA and the "Guide" and is applicable to all PHS conducted or supported activities involving animals (all vertebrate species)

IACUC general responsibilities:

*At least once every six months the IACUC must: •Review the research facility's program for humane care and use of animals. •Inspect all of the animal facilities, including animal study areas •Prepare reports of its evaluations conducted, and submit the reports to the Institutional Official of the research facility •Make recommendations to the IO regarding any aspect of the research facility's animal program, facilities, or personnel training

. Fed Regulations govern IACUC

-USDA (AWA 9 CFR), PHS (Policy on Humane care & Use of Laboratory -Animals & the "Guide", and the Health Research Extension Act of 1985) )

Guide Chapters

1. Key Concepts 2. Program (policies & responsibilities) 3. Environment, Housing and Management 4. Veterinary care 5. Physical Plant

PHS Policy Implementation-Animal Welfare Assurance

A written assurance statement must be submitted and approved before animal work supported by PHS can be conducted (VT's Assurance # is: A3208-01).

Animal Welfare Act-Inspections

Annually the USDA inspects... and fines can be issued **yearly inspections are unannounced •all facilities where regulated animals are housed or used must be opened for inspection; photos may be taken •all applicable records must be made available for review (Procurement & veterinary records, research records, IACUC records)

PHS Policy, Implementation by Institutions

Reporting Requirements -Every 12 Months *Annual report submitted to OLAW including: •any change in the institution's program of animal care or facilities or program of animal care, and any changes in the IACUC membership •provide the dates the IACUC conducted semiannual evaluations of the facilities and program of animal care and submitted the evaluations to the IO •all reports must include minority views expressed by IACUC members

AWA Mandated Duties & Responsibilities:

The Institution through the IO, CEO, etc. •Must submit an annual report which includes: •The number of animals used and pain category •Deviations from the AWA •Justification for Category E pain protocols

IACUC inspections are

every 6 months

The United States Department of Agriculture Animal Plant Health Inspection Service (USDA-APHIS)

responsible for drafting and enforcing the "Laboratory AWA Regulations

AWA Mandated IACUC Duties & Responsibilities:

•*Protocol Review: review and approve, require modifications in (to secure approval), or withhold approval of those components of proposed activities related to the care and use of animals - Individual reviewers cannot withhold approval without full committee review - Any member can request full committee review •Amendment Review: review and approve, require modifications in (to secure approval), or withhold approval of proposed significant changes regarding the care and use of animals in ongoing activities •*Annual Review of ongoing projects must be performed

Animal Welfare Act, Establishment & Operation of an Institutional Animal Care and Use Committee (IACUC)-

•*The members of each Committee must be appointed by the CEO (or designee IO) •*The Committee shall be composed of a Chairperson and at least 2 additional members for a total of (3) •At least 1 member must be a Doctors of Veterinary Medicine (DVM), with training or experience in laboratory animal science and medicine, who has direct or delegated program responsibility for activities involving animals at the research facility •At least 1 member must not be affiliated in any way with the facility other than as a member of the Committee, and shall not be a member of the immediate family of a person who is affiliated with the facility; this person will provide representation for general community interests in the proper care and treatment of animals.

PHS Policy Implementation-Animal Welfare Assurance, IACUC

•*the committee must have at least 5 members: 1.Chair 2.DVM with Lab animal medicine background 3.a scientist experienced in animal research 4.a nonscientist (e.g., lawyer or clergy) 5.a nonaffiliated member

Laboratory Animal Care = AAALAC

•Accrediting body so it is Voluntary ($$) •Gold Standard, ergo more NIH funding? •Re-inspected every three years •Best Practices with emphasis on Occupational Health AAALAC uses blend: of The Guide And AWA depending on what the research is, and which species used.

Animal Welfare Act Surgery & Postoperative Care(1985):

•designated / dedicated aseptic surgery area •use of aseptic techniques •use of appropriate anesthesia •intra-operative monitoring •post-op monitoring from anesthesia •post-op analgesics as required •adequate post-op care •adequate surgery recordkeeping

Species Covered by the AWA

•dogs •cats •rabbits •hamsters •guinea pigs •nonhuman primates •agricultural animals in biomedical use

Animal Welfare Act Standards Addressed

•housing •feeding •watering •shelter •ventilation •sanitization •separation of species •provision of "Adequate Veterinary Care"

PHS Policy, IACUC functions

•Review at least every 6 months the institution's program for humane animal care, using the "Guide" as a basis for the evaluation •Inspect at least every 6 months all of the institution's animal facilities, using the "Guide" as a basis for the evaluation •Prepare reports of the IACUC evaluations, noting minor or significant deficiencies, submitting them to the "Institutional Official" (IO) •Review concerns (complaints) involving the care and use of animals at the institution •Make recommendations to the Institutional Official regarding the animal program, facilities, or personnel training •Review and approve, require modifications in, or withhold approval of animal protocols and significant amendments •Suspend an activity involving animals, if that activity is not being conducted in accordance with the AWA, the "Guide", or the institution's Assurance [at a convened IACUC meeting with a quorum present, IACUC membership/two + one] With few exceptions, most PHS and USDA requirements are identical, practically word for word.

IACUC Functions

•Review, and investigate concerns involving the care and use of animals at the research facility resulting from public complaints received and from reports of noncompliance received from laboratory or research facility personnel or employees •The IACUC may suspend an activity if it determines that the activity is not in accordance with the description provided by the PI and approved by the Committee. •A protocol can only be suspended at a convened meeting of the IACUC with a quorum present.

IACUC- Protocol Must contain

•The species and approximate number of animals to be used •A rationale for using animals •A complete description of the use of the animals •A description of the euthanasia method •A description of procedures designed to assure that discomfort and pain to animals will be limited to that which is unavoidable, including provision for the use of analgesic, anesthetic, and sedation where indicated and appropriate to minimize discomfort and pain to animals

Implementation of PHS policy - Record keeping Requirements

•a copy of the approved Assurance must be maintained •copies of Minutes of IACUC meetings, including attendance, activities/actions, and committee deliberations must be maintained •copies of applications, proposals, and proposed significant changes in the care and use of animals, with indication of approval given or withheld, must be maintained •copies of semiannual IACUC reports and recommendations (including minority viewpoints) which had been forwarded to the IO must be maintained •all records must be kept for at least 3years after completion of the activity and must be available for inspection and/or copying by OLAW or PHS representatives

PHS Policy Implementation-Animal Welfare Assurance, Provisions

•be submitted to the NIH Office for Laboratory Animal Welfare (OLAW) and approved •fully describe the institution's program for the care and use of animals in research •list the IO, IACUC chair, Veterinarian and provide qualifications of the IACUC members. •describe the procedures that the IACUC will follow to fulfill the requirements of the Policy •*renewed every 5 years or earlier dependent on expiration from OLAW •describe the occupational health program for personnel who work with or have frequent contact with animals or their tissues •indicate that an IACUC has been appointed by the CEO (or designee(IO)), and that the members possess the requisite qualifications and experience, along with the name and title of the IACUC Chair, IO and Veterinarian •*the committee must have at least 5 members

Animal Welfare Act Required

•dealers who sold regulated animal species to be licensed •registration of Research institutions •maintenance of paperwork documenting the source(s) of animals and their final disposition •appropriate identification of dogs and cats and records on individual animals •annual inspection of facilities and records by USDA (only covered an animal while on experiment)