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
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
enforced 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.