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REGULATIONS & POLICIES REGARDING THE USE OF ANIMALS IN RESEARCH AND TEACHING. Responsible Conduct of Research. Federal Regulations. Public Health Service Policy on Humane Care and Use of Laboratory Animals.
REGULATIONS & POLICIESREGARDING THE USE OF ANIMALSIN RESEARCH AND TEACHING Responsible Conduct of Research
Public Health Service Policy on Humane Care and Use of Laboratory Animals • Enforced by the Office of Laboratory Animal Welfare (OLAW) of the National Institutes of Health (NIH) • Has jurisdiction over all aspects of vertebrate animal research conducted with PHS funds • Requires all institutions which accept PHS funds to have an accepted Assurance of Compliance on file with OLAW • Harvard applies PHS Policy to all vertebrate animal research regardless of funding source http://grants.nih.gov/grants/olaw/olaw.htm
Assurance of Compliance • Agreement between Institution and NIH’s Office of Laboratory Animal Welfare (OLAW) which assures that our program includes: • a properly constituted and functioning IACUC; • procedures for self-monitoring; • an adequate veterinary care program; • an occupational health and safety program; • a personnel training program; and • an environment, housing and management program for animals. • Forgoes on site inspections if fully AAALAC accredited • Assurance number = A3593-01
The Guide for the Care & Use of Laboratory Animals • Harvard states in its Assurance that it will follow the recommendations set forth in the Guide • The Guide is written in general terms • Specifies desired outcomes but allows institutions to develop their own means of achieving the outcome • Covers all aspect of animal care and use: • Animal monitoring – vet care, daily husbandry • Personnel qualifications, training and occupational health and safety • Physical environment of animal housing • Animal psychological well-being, procurement, transportation http://grants.nih.gov/grants/olaw/olaw.htm
The Animal Welfare Act (AWA) and Animal Welfare Regulations (AWR) • Enforced by the United States Department of Agriculture (USDA) • All research institutions using “covered” species (regardless of funding source) must be registered with the USDA (14-R-0128) • Conducts at least annual visits of all housing or use areas for “covered” species http://www.aphis.usda.gov/ac/publications.html
Association for the Assessment and Accreditationof Laboratory Animal Care, International (AAALAC) • AAALAC accreditation demonstrates an institution’s commitment to responsible animal care and use and good science; considered the “gold standard” • Accreditation is voluntary • Renewed every three years - involves submission of document and a site visit • Maintaining FULL ACCREDITATION facilitates research awards • More than 680 organizations, institutions and companies in 26 countries have earned AAALAC accreditation • Harvard file No. 000748
Additional Oversight • MA Fish and Wildlife • Cambridge Commissioner for Laboratory Animals / City of Cambridge Ordinance • City recognized loophole in federal regulations • Inspects annually • Upholds all federal regulations • Will levy fines for any infraction that remains uncorrected
Successful Animal Care & Use Program • Institutional Official (IO) • Institutional Animal Care & Use Committee (IACUC) • Research Administration Services • IACUC support office • Occupational health program • Research personnel training • Office of Animal Resources (OAR) • PI and research staff • Environmental Health & Safety (EH&S) • Committee on Microbiological Safety (COMS) • Embryonic Stem Cell Research Oversight (ESCRO) Committee
Institutional Official • The institutional official for animal care and use is Leslie A. Kirwan, Dean for Administration and Finance for the Faculty of Arts and Sciences • Makes all the decisions regarding the administrative, financial, and regulatory needs of the IACUC and the Office of Animal Resources • Oversees the work of the HU/FAS Standing Committee on the Use of Animals in Research and Teaching (IACUC) and the Director of the Office of Animal Resources in cooperation with the Chairman of the HU/FAS Standing Committee on the Use of Animals in Research and Teaching
Institutional Animal Care and Use Committee (IACUC) • Review and approve proposed activities involving animals in research, testing, or teaching, and significant changes to previously approved activities. • Evaluate the animal care and use program and the animal facility itself at least every six months. • Review any concerns about the care and use of animals at the institution. • Responsible for the training, health and well-being of personnel working with animals • Report to IO to make sure the institution is aware of issues affecting the animal research program.
Authority of the IACUC • The USDA Animal Welfare Act and PHS Policy grant the IACUC authority: • to approval proposed use animals in research, teaching or testing. Other committees or institutional officials are not allowed to approve activities involving animals in the absence of IACUC approval. • to suspend any activity previously approved BUT suspension power is not limited to IACUC • Other institutional officials for reason of non-IACUC related issues (lack of funds, changing research priorities, etc. • Members of the veterinary staff (via the Attending Veterinarian) for any procedure in progress in which the animal is clinically determined to be in unalleviated pain or distress.
IACUC Responsibilities • Ensures that animal care and use on campus is in accordance with: • The Guide for the Care & Use of Laboratory Animals • USDA Regulations (a.k.a., the Animal Welfare Act) and • Public Health Service (PHS) Policy • Accomplishes this type of oversight by: • developing policies, procedures and guidelines • assigning specific oversight tasks to professional units
Animal Experimentation Protocol (AEP) • Describes research use of animals in plain English • Emphasizes the 3 R’s: • Reduction of animal numbers, • Refinement of procedures, • Replacement of animal models with in vitro methods if possible • READ THE PROTOCOL!
Occupational Health & Safety Program • Personnel undergo a risk assessment at the time they are added to a protocol • Participation is mandatory for all personnel working with vertebrate animals • Enrollment group (HIGH or LOW) is based on RISK assessment • Occupational health nurse or physician review medical health questionnaires • Service providers are HIPAA regulated • Access to animals is conditioned on enrollment, clearance, and adequate training
Safety Reviews • All use of viral vectors and infectious agents, and creation of transgenic animal lines must be reviewed and approved by the Harvard Committee on Microbiological Safety (COMS) http://www.hms.harvard.edu/orsp/coms • All use of toxins must be reviewed by Environmental Health and Safety (EH&S) http://www.uos.harvard.edu/ehs • Use of isotopes must be reviewed and licensed by the Radiation Protection Office of EH&S http://www.uos.harvard.edu/ehs/rad.html
Oversight of Controlled Substances • DEA license required for purchase, possession, and use • Must be stored in a DOUBLE locking safe or wall mounted cabinet • Limited access; only authorized users • Must maintain log of use • Proper disposal is required • Institutional policy for use of controlled substances appears at: http://www.uos.harvard.edu/ehs/ih_controlled_substances.shtml • Website contains Harvard University Researchers’ Guide for Use of Controlled Substances, application, purchase request, usage log, substance inventory, and disposal requirements.
Principal Investigator Responsibilities • Ensure research staff and project is in compliance with laws and regulations • Ensure humane animal treatment • Supervise research staff • Assure safety compliance training via EH&S • Protect public and staff from research-related risks
Office of Animal Resources • Unit responsible for the environmental housing and management program • Centrally manages facilities and maintains oversight of satellite housing areas • Provides daily care for all vertebrate species housed on campus • Established polices and procedures to protect the integrity of the barrier: • Central ordering policy • Controlled access to animals • Standard operating procedures for moving animals and equipment/supplies among labs and facilities • Import and quarantine standards
Veterinary Care Program • Preventative Medicine • Survey, diagnose and prescribe treatment for animal illness including zoonosis control • Management of protocol-related disease, disability or other diseases or disorders caused by a preceding disease or injury in the same animal • Consultation on anesthesia, surgery & animal experimentation (review all protocols) • Assessment of animal well-being • Issues veterinary treatment orders regarding animal treatment and recommended euthanasia must be followed • Assures veterinary standards such as requiring that animals be treated with pharmaceutical grade agents
Personnel Requirements to Work on Animals • Must be listed on an IACUC approved protocol • Must be “cleared” by an occupational health professional to work with animals (achieved through enrollment in institution’s occupational health program to work with animals) • Must be trained in the procedures to be performed on the animals • Must complete assigned modules in the AALAS Learning Library • Must undergo animal facility orientation • Must attend the Course on the Humane Care and Use of Laboratory Animals
How to Report Animal Welfare Concerns • Harvard University has a “Whistle Blowing Policy.” • All calls are confidential and all allegations will be investigated. If preferred, anonymity will be observed. • Report animal welfare concerns to: • Dr. Arthur L. Lage, Director/Office of Animal Resources Institutional Attending Veterinarian 617-432-1289 or firstname.lastname@example.org • Ellyn Lane, Director of IACUC Administration 617-495-1510 or email@example.com • Leslie Kirwan, Dean of Administration and Finance for the Faculty of Arts and Sciences, Institutional Official 617-496-8729 firstname.lastname@example.org
Post-Approval Monitoring (PAM) • Routine semi-annual inspections • Provides guidance on mandatory communication for OAR Veterinary and Animal Care Staffs to the HU/FAS IACUC regarding issues of noncompliance or complaints • Animal abuse • Endangerment of animals or humans • Noncompliance with protocols • Repeated noncompliance with IACUC/OAR policies or practice • Chronic noncompliance with OAR facility procedures • Animal use area infractions • Use of cage based animal medical records • Rounds by veterinary staff • Random audits
Compliance / Noncompliance • Protocol is a contract • Serious or Continuing Noncompliance • Animal abuse, endangerment of animals • Failure to adhere to IACUC approved protocols • Repeated Non-Compliance with HU/FAS IACUC/OAR Approved Research Policies or Practices • Results • Retraining or suspension • Protocol closure • Loss of funding
Individual Responsibility • Working with vertebrate animals is a privilege • Requires: • Humane use of animals • Proper planning and training • Adherence to regulations • Adherence to parameters of protocol • Use of common sense: liken procedures to those used w/humans for perspective
References • The Guide for the Care and of Laboratory Animals, National Academy Press, 1996 • Institutional Animal Care and Use Committee Guidebook. 1992. NIH Pub. No. 92-3415, U.S. Department of Health and Human Services. Washington, D.C. • Public Health Service Policy on Humane Care and Use of Laboratory Animals. Office of Laboratory Animal Welfare, National Institutes of Health, August 2002. • Animal Welfare Act and Animal Welfare Guidelines, United States Department of Agriculture, Animal Plant and Health Inspection Service, 2005 • Care and Treatment of Laboratory Animals. June 14, 1971. (NIH 420), NIH Guide for Contracts, No. 7. • U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training. May 20, 1985. 50 FR 20864.
ELLYN LANE email@example.com 617 495-1510 DIRECTOR OF IACUC ADMINISTRATION RESEARCH ADMINISTRATION SERVICES