regulations & policies regarding the use of animals in research and teaching
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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. - PowerPoint PPT PresentationTRANSCRIPT
REGULATIONS & POLICIESREGARDING 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
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 [email protected]
Ellyn Lane, Director of IACUC Administration
617-495-1510 or [email protected]
Leslie Kirwan, Dean of Administration and Finance for the Faculty of Arts and Sciences, Institutional Official
617-496-8729 or [email protected]
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
Any questions?
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
617 495-1510
DIRECTOR OF IACUC ADMINISTRATION
RESEARCH ADMINISTRATION SERVICES