Most everyone now knows that the former Office for Protection from Research Risks (OPRR) Division of Animal Welfare has a new name and elevated status at the National Institutes of Health (NIH). It is now the Office of Laboratory Animal Welfare, or OLAW, and has Office (as opposed to Division) status within the NIH Office of Extramural Research.
Why did the OPRR Division of Animal Welfare remain at NIH, while the Division of Human Subjects was organizationally placed at the Department of Health and Human Services? This is a complex question, but the following facts about OLAW may shed some light on the matter:
OLAW’s primary function is the administration of the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals. The statutory authority for this policy was clearly delegated by Congress to the director of NIH. The opening sentence of the enabling legislation, the Health Research Extension Act of 1985, Public Law 99-158 (November 20, 1985), reads “...The Secretary, acting through the Director of NIH, shall establish guidelines for...proper care of animals…proper treatment of animals…used in research…”.
Public Law 99-158 also clearly associates the requirements of the PHS policy with grant and contract mechanisms administered by NIH. That is, compliance with the requirements of the PHS Policy is a condition of receiving a grant or contract from the NIH (or other PHS agency). Thus it is appropriate that OLAW be located within the NIH Office of Extramural Research, the primary administrative and policy office for NIH grants.
As part of the NIH research community, OLAW effectively performs in a mode of education, consultation, and collaboration. This emphasis is crucial as the PHS policy is based on a system of institutional self-regulation. Institutions are required to report noncompliance to OLAW and are expected to seek advice as necessary; they must be able to develop appropriate corrective actions without fear of regulatory reprisal.
Appropriate animal care and use are integral parts of good research. They can affect research findings, reproducibility of results, and reliability. Accordingly, OLAW’s focus is supportive of the research enterprise as opposed to being strictly regulatory. The PHS policy approach towards noncompliance stems directly from language in Public Law 99-158, which states that the NIH Director shall suspend or revoke a grant or contract only after an institution has been given reasonable opportunity to take corrective actions. In nearly all instances of noncompliance, the goal of OLAW is therefore to facilitate compliance and ensure that mechanisms are in place to prevent recurrence so important research may go forward, rather than to punish noncompliance.
For additional information about OLAW, the PHS policy, or Public Law 99-158, visit OLAW’s web site at: http://grants.nih.gov/grants/olaw/olaw.htm.
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Contents, Animal Welfare Information Center Bulletin
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The Animal Welfare Information Center
U.S. Department of Agriculture
Agricultural Research Service
National Agricultural Library
10301 Baltimore Ave.
Beltsville, MD 20705-2351
Phone: (301) 504-6212
FAX: (301) 504-7125
E-mail: awic@nal.usda.gov
