ALAT - Assistant Laboratory Animal Technician Regulations and Compliance Questions and Answers — Questions and Answers
Question 1: Which of the following documents must be submitted to the Office of Laboratory Animal Welfare (OLAW) by an institution to receive Public Health Service (PHS) funding for research involving animals?
- A detailed budget for animal care
- An Animal Welfare Assurance (Correct answer)
- A list of all research personnel
- The facility's disaster plan
Correct answer: An Animal Welfare Assurance
Institutions receiving PHS funds for research involving live vertebrate animals must provide a written Animal Welfare Assurance to OLAW. This document describes the institution's program for the care and use of animals and commits the institution to complying with the PHS Policy, the Guide for the Care and Use of Laboratory Animals, and the Animal Welfare Act regulations.
Question 2: An ALAT notices that a new research protocol involving dogs seems to lack a plan for exercise. According to the Animal Welfare Act (AWA), which entity is responsible for ensuring this requirement is met?
- The attending veterinarian (AV)
- The individual research technician
- The Institutional Animal Care and Use Committee (IACUC) (Correct answer)
- The United States Department of Agriculture (USDA)
Correct answer: The Institutional Animal Care and Use Committee (IACUC)
The Animal Welfare Act, through the Improved Standards for Laboratory Animals Act (ISLAA) amendment, mandates that research facilities provide exercise for dogs. The Institutional Animal Care and Use Committee (IACUC) is responsible for the oversight of the animal care and use program, which includes reviewing and approving protocols to ensure they comply with all regulations, including the AWA's exercise requirement for dogs.
Question 3: The 'Guide for the Care and Use of Laboratory Animals' is a primary reference document for animal care programs. Which of the following best describes its role in U.S. regulations?
- It is a voluntary set of best practices with no regulatory authority.
- It is a federal law passed by Congress.
- It is used by the PHS Policy as a required standard for animal care programs. (Correct answer)
- It only applies to research involving nonhuman primates.
Correct answer: It is used by the PHS Policy as a required standard for animal care programs.
The Public Health Service (PHS) Policy requires that institutions base their animal care and use programs on the 'Guide for the Care and Use of Laboratory Animals'. While not a law itself, its standards are mandated for any institution receiving PHS funding, making it a key component of U.S. animal welfare oversight.
Question 4: Which of the following is NOT a required member of an Institutional Animal Care and Use Committee (IACUC) according to the PHS Policy?
- A practicing scientist experienced in animal research
- A Doctor of Veterinary Medicine with program responsibility
- A member of the institution's public relations department (Correct answer)
- A member not affiliated with the institution
Correct answer: A member of the institution's public relations department
The PHS Policy mandates that an IACUC must have at least five members, including a veterinarian with program responsibility, a practicing scientist, a non-scientist, and a member who is not affiliated with the institution. There is no requirement for a member from the public relations department.
Question 5: A research study intended to support a premarket submission to the FDA must be conducted in compliance with which specific set of regulations designed to ensure the quality and integrity of safety data?
- The Animal Welfare Act (AWA)
- The Public Health Service (PHS) Policy
- The Guide for the Care and Use of Laboratory Animals
- Good Laboratory Practices (GLP) (Correct answer)
Correct answer: Good Laboratory Practices (GLP)
Good Laboratory Practices (GLP) are regulations that apply to nonclinical laboratory studies supporting applications for research or marketing permits for products regulated by agencies like the FDA. GLPs are intended to ensure the quality and integrity of the safety data by defining requirements for study conduct, personnel, facilities, records, and reporting.
Question 6: The Animal Welfare Act (AWA) and its regulations, enforced by the USDA, apply to many species used in research but specifically exclude which of the following?
- Dogs and cats
- Nonhuman primates
- Birds, rats of the genus Rattus, and mice of the genus Mus bred for research (Correct answer)
- Guinea pigs and hamsters
Correct answer: Birds, rats of the genus Rattus, and mice of the genus Mus bred for research
The Animal Welfare Act has been amended to explicitly exclude birds, rats of the genus Rattus, and mice of the genus Mus that are bred for use in research from its definition of 'animal'. Therefore, the USDA does not regulate their use under the AWA, although they are covered under the PHS Policy if the research is federally funded.
ALAT - Assistant Laboratory Animal Technician Regulations and Compliance Questions and Answers
Which of the following documents must be submitted to the Office of Laboratory Animal Welfare (OLAW) by an institution to receive Public Health Service (PHS) funding for research involving animals?