[Weekly Compilation of Presidential Documents Volume 30, Number 7 (Monday, February 21, 1994)]
[Pages 323-324]
[Online from the Government Publishing Office, www.gpo.gov]

<R04>
Memorandum on Research Involving Human Subjects

February 17, 1994

Memorandum for the Vice President and the Heads of Executive Departments 
and Agencies

Subject:  Review of Federal Policy for the Protection of Human Subjects

    Federally funded biomedical and behavioral research has resulted in 
major advances in health care and improved the quality of life for all 
Americans. The pursuit of new knowledge in these fields of research 
often requires experiments that involve human subjects. Although human 
subjects research is an essential element of biomedical and behavioral 
research, bioethical considerations must influence the design and 
conduct of such research.
    Since 1947, when guidelines for research with human subjects were 
promulgated, there has been increasingly widespread recognition of the 
need for voluntary and informed consent and a scientifically valid 
design of experiments involving human subjects.
    Over time, this recognition has evolved into a rigorous and 
formalized system of regulations and guidelines, which were codified in 
governmental policies on human subject research, and were included in 
the former Department of Health, Education and Welfare's regulations in 
1974, 45 C.F.R. 46. In 1991, 16 agencies formally adopted the core of 
these regulations in a common Federal Policy for the Protection of Human 
Subjects. This Policy requires that all research protocols involving 
human subjects be reviewed by an Institutional Review Board. This review 
ensures that (1) risks are minimized and reasonable in relation to 
anticipated benefits; (2) there is informed consent; and (3) the rights 
and welfare of the subjects are maintained (56 Fed. Reg. 28003 (June 18, 
1991)).
    Although these regulations provide the framework for protecting 
human subjects in research, we must exercise constant care and ensure 
that these regulations are strictly en- 

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forced by departments and agencies. Therefore, I direct each department 
and agency of Government to review present practices to assure 
compliance with the Federal Policy for the Protection of Human Subjects 
and to cease immediately sponsoring or conducting any experiments 
involving humans that do not fully comply with the Federal Policy.
                                            William J. Clinton