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Ethical Conduct of Clinical Research Involving Children
to give consent” (Nuremberg Code, 1949, p. 181–182). The directives did not mention children. Strictly construed, they would have precluded research involving children or mentally or legally incapacitated adults.10
Although ethicists, investigators, and policymakers have considerably refined and extended the principles of ethical research (e.g., to cover children), many of the basic tenets in current national and international statements on the conduct of research are similar to those set forth by the Nuremberg judges in 1947. In addition to voluntary, informed, and competent consent, these tenets provided that the research should be necessary and that its risks should be balanced by its social importance and potential benefits. Research should also be designed and conducted by scientifically qualified investigators to produce valid results and minimize risk to participants.
1948 to 1974
It was just that we were so ethically insensitive that it never occurred to us that you ought to level with people that they were in an experiment.
Louis Lasagna on research in 1950s, 1994
(quoted in ACHRE, 1995)
By mid-1960, NIH officials were concerned about the agency’s traditional practice of relying exclusively on the moral character of investigators to safeguard humans in research. Moreover, NIH had no way to monitor the conduct of the investigators it was funding.
Irene Stith-Coleman, 1994, p. 7
As medical research accelerated in the 1950s and 1960s, the Nuremberg principles were both increasingly recognized and increasingly questioned in certain of their specifics (Faden and Beauchamp, 1986; ACHRE, 1995). Some of the questions highlighted the lack of provision for research involving children and others not competent to consent to research in their own right.
Early in the 1950s, the new Clinical Center at NIH developed explicit policies for the protection of human participants in research (which applied to studies conducted at the facility). Among other elements, the policies
The statements by Dr. Leo Alexander and Dr. Andrew Ivy appear to have included provisions for consent by next of kin or guardians for people lacking mental competence. These provisions may have been excluded from the directives because they were not relevant in the case before the judges (ACHRE, 1995).