Biomedical Engineering Reference
In-Depth Information
4. No experiment should be conducted, where there is an a priori reason to
believe that death or disabling injury will occur, except, perhaps, in those
experiments where the experimental physicians also serve as subjects.
5. The degree of risk to be taken should never exceed that determined by the
humanitarian importance of the problem to be solved by the experiment.
6. Proper preparations should be made and adequate facilities provided to pro-
tect the experimental subject against even remote possibilities of injury,
disability, or death.
7. The experiment should be conducted only by scientifically qualified
persons. The highest degree of skill and care should be required through
all stages of the experiment of those who conduct or engage in the
experiment.
8. During the course of the experiment, the human subject should be at liberty
to bring the experiment to an end, if he/she has reached the physical or
mental state where continuation of the experiment seemed to him/her to be
impossible.
9. During the course of the experiment, the scientist in charge must be pre-
pared to terminate the experiment at any stage, if he/she has probable cause
to believe, in the exercise of the good faith, superior skill and careful judg-
ment required of him/her that a continuation of the experiment is likely to
result in injury, disability, or death to the experimental subject.
The United States elected not to formalize the Code into a binding document
to prescribe and proscribe particular activities within the responsible conduct
of research, 10 although Secretary of Defense Charles E. Wilson made the Code
established policy within the Pentagon. 11 The principles of the Code guided the
Declaration of Helsinki in 1964, in which the World Medical Association estab-
lished recommendations to guide biomedical research that involved human par-
ticipants. Revised in 1975, 1983, 1989, and 1996, the Declaration is viewed as the
basis for Good Clinical Practices used today. 12 The 1948 Universal Declaration of
Human Rights (U.N. General Assembly) in principle has global authority but is not
enforceable in court.
The current U.S. system of protection for human research subjects is embodied
in the Federal Policy for the Protection of Human Subjects, often referred to as
the “Common Rule,” 13 published in 1991 (HHS.gov 1991). The rule flowed from
the principles enunciated in the Helsinki Declaration (World Medical Association
1964). This regulatory framework binds the Department of Defense (DoD)
(Moreno 2006). Rules require that a research ethics committee review proposals
and the basis for, and acquisition of, informed consent of volunteers in experi-
ments. It enshrines notions of beneficence, justice, respect for persons, privacy for
research participants, the right to withdraw, the return of results, and informed
consent.
Although not enforceable in U.S. Courts, certain international protocols or agree-
ments inform policy for evaluating legal rules that should apply to national secu-
rity and defense uses of neurotechnology. The Geneva Conventions of 1949 14 (ICRC
1949) and the additional Protocols of 1977 (Protocols I and II) stand out as particularly
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