- Assistant Laboratory Animal Technician Regulations and Compliance Flashcards
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What is the role of OLAW (Office of Laboratory Animal Welfare) in regulating animal research?
Answer: OLAW administers the PHS Policy, negotiates institutional Assurances, reviews reports of non-compliance, and conducts for-cause site visits at PHS-funded institutions
OLAW administers the PHS Policy on behalf of NIH. It reviews and approves institutional Assurances, investigates reports of non-compliance, conducts site visits when needed, and can restrict or withdraw PHS funding for serious violations.
What is the difference between the Animal Welfare Act and the PHS Policy in terms of species coverage?
Answer: The AWA excludes purpose-bred rats, mice, and birds, while the PHS Policy covers ALL vertebrate animals at funded institutions
The AWA specifically excludes purpose-bred rats (Rattus), mice (Mus), and birds used in research. The PHS Policy covers all vertebrate animals regardless of species, including those excluded from AWA.
What are the consequences for an institution found in non-compliance with animal welfare regulations?
Answer: Consequences can include fines, suspension of research, loss of funding, AAALAC accreditation jeopardy, and reputational damage
Non-compliance can result in: USDA fines and citations, suspension of animal activities by IACUC, restriction or loss of PHS funding by OLAW, jeopardized AAALAC accreditation, and significant institutional reputational damage.
What must an institution do to maintain its AAALAC accreditation?
Answer: Submit annual reports, undergo triennial site visits, address any findings, maintain compliance with the Guide, and demonstrate continuous program improvement
Maintaining AAALAC accreditation requires: annual reports documenting significant program changes, triennial site visits by peer reviewers, addressing any findings or recommendations, maintaining Guide compliance, and demonstrating ongoing program improvement.
What regulatory documents should be available for review in a laboratory animal facility at all times?
Answer: Current IACUC-approved protocols, SOPs, the Guide, AWA regulations, PHS Policy, occupational health program documentation, and training records
Facilities should have readily available: IACUC-approved protocols (for all active studies), SOPs for all procedures, the Guide (8th edition), AWA regulations and standards, PHS Policy and Assurance, OHSP documentation, training records, and environmental monitoring logs.
How does continuing IACUC review differ from initial protocol review?
Answer: Continuing review occurs at least annually to verify ongoing protocol compliance, assess adverse events, confirm the research still justifies animal use, and ensure Three Rs alternatives have been considered
Continuing review (at least annually) evaluates: ongoing compliance with approved procedures, review of any adverse events or unexpected outcomes, confirmation that the research still justifies animal use, personnel changes, and updated alternatives searches.