Health Research Extension Act

Question 1

When was the Health Research Extension Act developed?

Answer 1

1985

Question 2

What Public Law is the Health Research Extension Act? What is it also known as?

Answer 2

Public Lab 99-158
“Animals in Research”

Question 3

Who is responsible for establishing guidelines for the HREA?

Answer 3

Secretary, acting through the Director of NIH

Question 4

What guidelines must be established under the HREA?

Answer 4

1. Proper care of animals used in biomedical and behavioral research
2. Proper treatment of animals used in such research, including a. The appropriate use of tranquilizers, analgesics, anesthetics, paralytics, and euthanasia for animals in such research and b. Appropriate pre-surgical and post-surgical veterinary medical and nursing care for animals in such research
3. The organization and operation of animal care committees

Question 5

Per the HREA, who appoints members of the IACUC?

Answer 5

CEO of the entity

Question 6

Per the HREA, how many and what members must be on the IACUC?

Answer 6

At least three, with one individual who has no association with the entity and at least one DVM.

Question 7

Per the HREA, how often must the IACUC inspect all study areas and facilities?

Answer 7

At least semiannually.

Question 8

What are the three responsibilities of the IACUC under the HREA?

Answer 8

a. Review study areas and facilities at least semiannually to evaluate compliance with appropriate animal care and treatment
b. Keep appropriate records of review conducted from these inspections
c. For each review, file with the Director of NIH at least annually i) a certification that the review has been conduced ii) reports of any violations of guidelines established under the HREA or assurances required which were observed in such review and which have continued after notice by the committee to the research entity involved of the violations. Shall include any minority views.

Question 9

Each applicant for a grant, contract, or cooperative agreement involving research on animals which is administered by the NIH or any national research institute shall include what in their application?

Answer 9

1. Assurances satisfactory to the Director of NIH that A. Applicant meets the requirements for proper care of animals and proper treatment of animals (Section A, 1 and 2) and has an animal care committee which meets requirements; B. Scientists, animal technicians, and other personnel are trained
2. Statement of the reasons for use of animals in the research to be conducted with funds provided under such grant or contract

Question 10

What must scientists, animal technicians, and other personnel involved with animal care, treatment, and use be trained in?

Answer 10

Human practice of animal maintenance and experimentation
Concept, availability, and use of research or testing methods that limit the use of animals or limit animal distress

Question 11

Under what circumstances may the Director of NIH suspend or revoke a grant or contract?

Answer 11

If the Director of NIH determines that:
1. Conditions of animal care, treatment, or use in an entity do not meet applicable guidelines established under subsection A (animal care and IACUC)
2. Entity has been notified of such determination and has been given a reasonable opportunity to take corrective action
3. No action has been taken by entity to correct such conditions

Question 12

Does NIH require a research entity to disclose publicly trade secrets or commercial or financial information which is privileged or confidential?

Answer 12

No