Current federal regulations set no limits on the level of risk that a competent adult may voluntarily choose to undertake for the sake of science. The regulations require prior approval by a review board (IRB) to ensure the research meets scientific and ethical justification, to ensure that the risks and benefits (if any) are fully disclosed to the subject, and that the subject can exercise the right to give or withhold informed consent.

"The voluntary consent of the human subject is absolutely essential."
[Nuremberg Code, 1947]

"Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. [ Code of Federal Regulations 45 CFR 46.102 (f)]

On October 30, 2001, the National Human Research Protection Advisory Committee (NHRPAC) signed off on recommendations redefining the term "human subject" in an effort to accommodate research that invades people's privacy by declaring that "human subjects" are only those "who interact personally with research investigators."

A cornerstone of the Declaration of Helsinki (adopted by the World Medical Association in 1964, and reaffirmed on Oct. 2000) is the distinction between research that is intended to be "therapeutic" (potentially beneficial) to the subject and "nontherapeutic" research, which is not intended to be beneficial to the subject. The U.S. Code of Regulations affirms that distinction for research involving children (45 CFR 46 Sections 405, 406), and the U.S. Code affirms that distinction for the military (10 USC 980).

Widely disparate perspectives are presented in an article in the Maryland Daily Record re: The Court of Appeals of Maryland decision (Gimes v Kennedy Krieger Institute, Aug 16, 2001). That 6-to-1 landmark decision severely criticized the practice of exposing healthy children to risks of harm in health related research. Children, we must bear in mind, are powerless to exercise that inviolable human right, the right to refuse to assume risks for research.

Will this decision undermine the legitimacy of research that puts healthy children at risk in clinical trials? AHRP believes it will, and that the decision will be sustained by other courts in other states.