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Laws, Regulations and GuidelinesLast updated 04/09/02 All animals used in research (except mice and rats bred for that purpose, birds, and farm animals not used for biomedical research) are covered by the Animal Welfare Act and its sequels. If the institution receives funding from the Public Health Service (PHS), the animals are also covered by the Guide for the Care and Use of Laboratory Animals and the PHS Policy. The USDA periodically issues "Animal Care Policies" which are intended to explain their regulations more completely. In the UK, the relevant regulation is the Animals (Scientific Procedures) Act 1986. Genetically-modified organisms are covered in the UK by the Genetically Modified Organisms (Contained Use) Regulations 2000. Human health and safety in the UK is covered by COSHH. An excellent reference is available from AWIC that is geared toward IACUC members, but contains abstracts of relevant laws and regulations{4190}. If you're looking for something less in the mainstream, check out the "other regulations" page.
Study area/ satellite facility Alternatives to using animalsGuide: Not specifically mentioned AWR: Alternatives to procedures likely to cause pain or distress must be considered PHS Policy: PHS proposals contain the rationale for involving animals{4253} "Animal"
Guide: Any vertebrate animal used in research, teaching, or
testing.
AWR: Any live or dead dog, cat, nonhuman primate, guinea pig, hamster,
rabbit, or any other warm-blooded animal, which is being used, or is intended
for use for research, teaching, testing, experimentation, or exhibition
purposes, or as a pet. PHS Policy: Any live, vertebrate animal used or intended for use in research,
research training, experimentation, or biological testing or for related
purposes. Ag Guide: Any warm-blooded vertebrate animal used in agricultural research or teaching for which the scientific objectives are to improve understanding of the animal's use in production agriculture and that may require a simulated or actual production agricultural setting consistent with consideration of the animal's well-being.{4191} "IACUC"
Guide: The IACUC "should be established."{4253}
At least 3 members: attending DVM, at least one practicing
scientist, and at least one public member. AWR: The "Animal Care Committee shall be required."{4253}
At least 3 members: Chairman, Attending DVM and member not affiliated. PHS Policy: "Each institution shall appoint" an IACUC{4253}.
Not less than 5 members: DVM, one practicing
scientist, nonscientific member, non-affiliated member. Ag Guide: "Each institution should establish." "Should include" at least 5 members: scientist with agricultural animal research or teaching experience; animal/dairy/poultry scientist; veterinarian (licensed or eligible); person whose primary concerns are outside the field of science (faculty, staff, student or administrator); non-affiliated person.{4191} IACUC review of protocolsGuide: Review the care and use of lab animals{4253} AWR: Review and approve, require modifications in, or withhold approval of those components of proposed activities related to the care and use of animals... PHS Policy: Committee to review and approve those sections of applications for grant funds relating to care and use of animals{4253} IACUC facility inspectionGuide: Annual evaluation of care and use program AWR: Semi-annual inspections PHS Policy: Annual inspections "Institutional Official"Guide: the IO is not indicated except in the reporting procedure{4253} AWR: the Chief Executive Officer{4253} PHS Policy: Institutional official responsible for animal care and use must be identified{4253} "Major operative procedure/Major surgery"
Guide: penetrates and exposes a body cavity or produces substantial impairment of physical or physiologic function. AWR: any surgical intervention that penetrates and exposes a body cavity or
any procedure which produces permanent impairment of physical or
physiological functions. Multiple surgeryGuide: Discouraged, but can be performed with committee approval AWR: Not allowed unless either (1) justified by PI, (2) required for veterinary health care, or (3) permission granted by Administrator{4253} PHS Policy: not specifically mentioned, use the Guide{4253} "Restraint"
Guide (pg. 11): Prolonged restraint, including chairing of nonhuman
primates, should be avoided unless it is essential for achieving research
objectives and is approved by the IACUC. Minimum required to accomplish
the research objectives. AWR §3.81: Nonhuman primates must not be maintained in restraint devices
unless required for health reasons as determined by the attending veterinarian
or by a research proposal approved by the Committee at research facilities.
Maintenance under such restraint must be for the shortest period possible.
In instances where long-term (more than 12 hours) restraint is required, the
nonhuman primate must be provided the opportunity daily for unrestrained
activity for at least one continuous hour during the period of restraint, unless
continuous restraint is required by the research proposal approved by the
Committee at research facilities. "Study area/Satellite facility"
AWR: any building room, area, enclosure, or other containment outside of a
core facility or centrally designated or managed area in which animals are
housed for more than 12 hours. PHS Policy: any containment outside of a core facility or centrally
designated or managed area in which animals are housed for more than 24
hrs. |
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©1999, Janet Becker Rodgers, DVM, MS, DipACLAM, MRCVS All rights reserved. Comments? Send an email to janet.rodgers@vet.ox.ac.uk |
Common exam fodder includes
questions about the often subtle differences among the various regulations (the
Guide, the Animal Welfare Regulations [AWR], and the PHS Policy). A synopsis of
some of these follows: