ANIMAL USE IN RESEARCH

ANIMAL USE IN RESEARCH: Regulations, Policies, and Procedures Tracy M. Heenan, D.V.M. Director Office of Animal Care and Use Institutional Animal Care and Use Committee IACUC Web Address: http://research.unc.edu/iacuc/ IACUC Email Address: iacuc@med.unc.edu IACUC Phone Number: 966-5569 Institutional Official: Tony Waldrop, 962-1319 IACUC MEMBERSHIP • Doctor of Veterinary Medicine with laboratory animal experience • Participating scientist member • Non-scientist member • Non-affiliated member who does not use laboratory animals Application to Use Live Vertebrate Animals • Before conducting any animal procedures, first describes the proposed procedures in Animal Use Application • Must be reviewed and approved before animals work can begin • Variety of proposed use from simple to complex Introduction “…no issue, with the exception of abortion, has generated more heated controversy than the appropriate use of laboratory animals. Consequently, the care and use of laboratory animals is among the most strictly regulated industries in the country, ranking close behind air traffic safety and the manufacture of safe drugs, devices, biologics, and food products.” Battle Wages on • News release coincided with Senate vote on 2002 “Helms Amendment” to Animal Welfare Act • Helms amendment proposed the exclusion of rats, mice, birds from coverage by USDA • Scientists, lawmakers, and animal activists battled for several decades over the coverage of rats, mice, birds by USDA • Believe rats, mice adequately covered under existing federal, accrediting, institutional policies Animal Welfare Act • United States Department of Agriculture (USDA) enforces the AWA • Covers warm blooded animals such as dogs, cats, primates, hamsters, rabbits • Requires establishment of IACUCs • IACUCs are charged with ensuring humane treatment of research animals • USDA officers conduct unannounced inspections Rats, Mice, and Birds Animal Welfare Act • The 1970 amendment to the Animal Welfare Act defined “animal” as any live dog, cat…or other warm-blooded animal used or intended for use in research… • Definition of “animal” specifically excluded birds, and Rattus and Mus species bred for research. Rats, Mice, and Birds Helms 2002 Amendment to the Animal Welfare Act The term “animal” excludes (1) birds, rats of the genus Rattus and mice of the genus Mus, bred for use in research,… not used for research purposes. Farm Bill Amendment U.S. senate passed the Farm Bill in May 2002 with the Helms’ amendment to exclude rats, mice and birds from the Animal Welfare Act What Federal Regulations apply to the use of Animals in Research? • Animal Welfare Act – United States Department of Agriculture (USDA) – warm blooded animals except, rats, mice, birds • Public Health Service Policy on the Human Care and Use of Laboratory Animals – Office of Laboratory Animal Welfare (OLAW) – all institutions receiving NIH funding – all vertebrate animals Animal Welfare Assurance of Compliance • Describes the institutional commitment to humane care and use of animals • Describes the institutional lines of authority • Program for Animal Care and Use • Lists approved animal facilities • Lists IACUC members OLAW’s Approval of the Assurance Statement Commits the institution and its officials, investigators, and other agents to full compliance with the PHS Policy Association for the Accreditation and Assessment for Laboratory Animal Care (AAALAC) • Voluntary, international accreditation • Rigorous evaluation of institution’s animal care and use program and animal facilities • Provides non-regulatory evaluation • AAALAC requires uniform standards for ALL vertebrate species • Provides written evaluation with mandatory and suggested items for correction Guide for the Care and Use of Laboratory Animals • Standard on animal care and use • Provides scientifically, technically, and humanely appropriate guides for animal care and use • OLAW uses the Guide as its Standard Federally Mandated IACUC Functions: • • • • • Semi-annual review of the Animal Program Satisfactory program of veterinary care Personnel qualified to work with animals Adequate animal facilities and husbandry Program of occupational health and safety Federally Mandated IACUC Functions: • Inspect every 6 months all animal facilities to ensure adherence to federal regulations and accepted standards • DLAM animal housing facilities • Investigator maintained housing facilities • Investigator laboratories where animal procedures are performed Federally Mandated IACUC Functions • Semi-annually prepare report of IACUC evaluations and recommendations about animal facilities, animal program, personnel training • Identify deficiencies • Schedule for correction • Prompt reporting to OLAW of serious or continuing noncompliance with PHS Policy or the Guide Federally Mandated IACUC Functions • • • • Review of Animal Use Applications Consumes most of the IACUC member time Describe proposed activities using animals IACUC reviews and approves, requests modifications, or denies approval of proposed new activities Federally Mandated IACUC Functions • Review of Amendments to the Animal Use Application • IACUC receives about 50 a month • IACUC reviews and approves, requests modification, or withholds approval on proposed significant changes in ongoing activities Amendments to an approved animal use application • P.I. must submit in writing to IACUC any proposed changes to the approved procedures involving animals • Any changes to procedures described in the originally approved application must be reviewed and approved by IACUC prior to implementation • Performance of procedures without IACUC approval is reportable to the federal regulators Federally Mandated IACUC Functions • Investigate concerns involving the care and use of animals How to Report Animal Mistreatment or Animal Use Application Noncompliance To report concerns, contact one of the following: • Office of Animal Care and Use at 966-5569, iacuc@med.unc.edu or CB # 7193. Ask for the IACUC Compliance Coordinators or Director. • Campus-wide Research Compliance Coordinator, Adrian Shelton at 962-0338, Adrian_Shelton@unc.edu or CB # 2105. • UNC-CH Compliance Line (866)294-8688. REPORTING TO OLAW • • • • Non-compliance with approved applications Initiating unapproved animal work Deviations from approved SOPs Animal activities conducted by unauthorized or unqualified individuals • Ongoing, unresolved problems • Shortcomings in the animal care program that jeopardize the health of animals Federally Mandated IACUC Functions • Suspend activities involving animals • Take corrective action • Report to the funding agency and federal regulators • Most serious IACUC responsibility • Can adversely affect institution reputation and PI funding Investigator Responsibilities Responsible for all aspects of animal use application • Training of personnel in proper use of animals • Research personnel adhere to approved application • Establish a Laboratory Coordinator • Establish a 24-hour contact name and number Laboratory Coordinator Certification Program • PIs with active animal applications must appoint a Laboratory Coordinator (LC) • LC coordinates animal activities and personnel • LC must attend formal training and be certified by IACUC to ensure that they are qualified and experienced for conducting procedures on living animals Animal Care and Use Application • Application describes the experimental procedures and is a binding contract between the research laboratory and the University concerning every aspect of the in-life portion of an animal use study. Animal Use Application • Rationale and purpose of proposed animal use (lay summary) • Summarize scientific objectives and describe how important to improving human or animal health • Justification of animal species • Justification of animal number Animal Use Application Animal Welfare Act 9CFR 2.31 (d) • Consider alternatives to procedures that cause more than momentary or slight pain or distress • Provide methods and sources used to determine that alternatives are not available • Research activities do not unnecessarily duplicate previous experiments • Painful/distressful procedures performed with analgesics or anesthetics unless withholding is justified for scientific reason, in writing, by PI and will continue for only necessary period Animal Use Application • Appropriate post procedural care and monitoring • Criteria used to ensure removal of animals from a study • Death (other than by euthanasia) is not an acceptable experimental endpoint • Appropriate method of euthanasia Euthanasia • 2000 Report of the AVMA Panel on Euthanasia http://www.avma.org/resources/euthanasia.pdf “Researchers should assume that others besides their peers may read their grants. These other individuals may hold a different philosophy about the use of animals.” Andrew Monjan, Ph.D., National Institute of Aging Public Information • • • • • North Carolina Open Meetings Law Freedom of Information Act (FOIA) PETA FOIA request January – April 2002 7000 pages Halted work in IACUC office for a week Improved Animal Program • • • • lowered threshold for non- compliance with policy increased IACUC oversight of the animal care program revised policies and standard operating procedures animal users are more aware of investigator responsibilities and animal care and use policy • UNC demonstrated strong desire to comply fully with commitments in Animal Welfare Assurance Statement Virtually every medical achievement of the last century has depended directly or indirectly on research in animals US Public Health Service