Legal and regulatory issues for neural grafts Page: 3
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Basic ethical and legal tenets govern experimentation on human beings. Many of
these legal principles in this area have been developed in response to the abuses of research
subjects that occurred in Nazi Germany during World War II.4 In addition, examples of
unethical research in America further stimulated public discussion and policy considerations.5
In the trials of Nazi physicians, the court set forth standards that should be complied
with before and during research.6 Those standards, subsequently adopted by the United
Nations General Assembly, are known as the Nuremberg Code.7 The tenets of the code
significantly influenced subsequent state laws8 and federal regulations9 in the United States
dealing with research.
I L. Andrews, Medical Genetics: A Legal Frontier 28 (Chicago: American Bar Foundation,
5 The most well known examples of research abuses in the United States were the Willowbrook
hepatitis study and the Tuskegee syphilis study. In the 1960s, institutionalized mentally
disabled children at Willowbrook Institution were injected with live hepatitis virus in an effort
to develop a vaccine. The researchers justified their procedures by noting that hepatitis ran
rampant through the institution and that all children would eventually contract the disease. See
S. Golby, "Experiments at the Willowbrook State School," 1 Lancet 749 (April 1971). From
1932 to 1972, a United States Public Health Service study of 400 black men suffering with
syphilis deliberately deprived them of treatment in order to study the effects of allowing the
disease to take its course, even though penicillin had been found to be an effective treatment.
At least twenty-eight and as many as one hundred and seven men died. Tuskegee Syphilis
Study Ad Hoc Panel to the Department of Health, Education and Welfare, Final Report (1973)
and J. Jones Bad Blood: The Tuskegee Syphilis Experiment (New York: The Free Press,
6 Trials of War Criminals Before the Nuremberg Military Tribunals 2 The Medical Case 181
(1949). The Nazi doctors tried to defend themselves by pointing out the abuses in research that
had occurred elsewhere, including ones in the United States. However, this defense did not
succeed and 15 of the 23 doctors were found guilty of war crimes and crimes against humanity.
A.M. Capron, "Human Experimentation," 1 BioLaw 10 217, 229 (1986).
7 G. Annas, L. Glantz, and B. Katz, Informed Consent to Human Experimentation: The
Subject's Dilemma 8 (Cambridge, MA: Ballinger Publishing Co., 1977).
8 The preamble to the California human experimentation law states that the law was necessary
since the Nuremberg Code was not codified and thus is unenforceable. Cal. Health & Safety
Code 24171(b) (West 1984).
9 R. Greenwald, M. Ryan and J. Mulvihill, Human Subjects Research: A Handbook for
Institutional Review Boards 21 (New York: Plenum Press, 1982). For a description of the
history of the development of the federal regulations on research, see R. Faden and T.
Beauchamp, A History and Theory of Informed Consent 200-22 (New York: Oxford University
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Andrews, Lori B. Legal and regulatory issues for neural grafts, report, October 1989; (digital.library.unt.edu/ark:/67531/metadc97321/m1/3/: accessed June 24, 2018), University of North Texas Libraries, Digital Library, digital.library.unt.edu; crediting UNT Libraries Government Documents Department.