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it was at any rate an impossibility. However, the report echoed Bernard’s stricture that researchers
are morally prohibited from performing experiments that could be harmful to the subject, even if
the results could benefit others.
The Declaration of Helsinki (1964) was an attempt to overcome some of the shortcomings of the
Nuremberg Code and extend human subjects protections. It was the first attempt by the international
medical community to regulate itself. Unlike the Nuremberg Code, the declaration makes
a distinction between therapeutic and nontherapeutic research and was likely a response to the
growing pharmaceutical industry and drug testing. In its original draft form the declaration prohibited
research on vulnerable populations (children, prisoners, the elderly, the mentally handicapped,
students and employees). The Helsinki representatives were divided on the use of children
and prisoners—institutionalized children and prisoners had been a continuing source of experimental
subjects in the U.S.— the document ultimately omitted all mention of children and prisoners.
The most controversial condition concerns the use of placebos—some interpretations allow
the use of placebos while others insist that a placebo should never be used if effective therapy for
the condition exists. The declaration has been revised five times, most recently in October 2000.
The National Institutes of Health created the Office of Protection from Research Risks (OPRR) in
1966. The guidelines set out by OPRR called for independent review bodies, later called Institutional
Review Boards (IRBs).
These review bodies have become an established element in higher education and are required for
an institution to be eligible to receive federal funding. IRBs effectively control the use of humans
in research of any nature.
France passed “la Loi Huriet” (the Huriet Law) in December 1988 explicitly for the protection
of healthy human research subjects. This legislation had its origins in the development of pharmaceuticals
for worldwide distribution and the medical community’s concerns for the safety of
human test subjects and the safety and efficacy of the drugs themselves. The law makes a clear
distinction between clinical and nonclinical research, between care of patient and research, and
emphasizes individual benevolence while acknowledging the essentially emergent nature of ethical
norms (Lechopier 2004).
After the Tuskegee syphilis study finally received public attention and notoriety, Congress reacted
by passing the National Research Act (Pub. L. 93-348) in 1974. This act created the National
Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which
subsequently composed the Belmont Report (April 18, 1979). Recognizing the prescriptive rules
“are inadequate to cover complex situations; at times they come into conflict, and they are frequently
difficult to interpret or apply,” it collapsed the Nuremberg Code and the Declaration of
Helsinki into a set of three basic principles that “are particularly relevant to the ethics of research
involving human subjects: the principles of respect of persons, beneficence and justice.” It is the
first document to make a distinction between biomedical and behavioral research and takes into
consideration “risks of psychological harm, physical harm, legal harm, social harm and economic
harm and the corresponding benefits.” The third section of the report lists applications of the three
basic principles and extends definitions to practice.
International biomedical research has come under increased scrutiny in the past few decades. In
1993 the Council for International Organizations of Medical Sciences (CIOMS) published guidelines
“designed to be of use to countries in defining national policies on the ethics of biomedical
research involving human subjects, applying ethical standards in local circumstances, and establishing
or improving ethical review mechanisms. A particular aim is to reflect the conditions
and the needs of low-resource countries, and the implications for multinational or transnational
research in which they may be partners.” The 2002 revision addressed concerns over genetic and
202 2005 Symposium Proceedings Book