Biomedical Engineering Reference
In-Depth Information
the Office of Human Research Protections [1] as: “[A] systematic investigation,
including research development, testing and evaluation, designed to develop or con-
tribute to generalizable knowledge.” After World War II, atrocities committed by
the Nazi researchers against prisoners in concentration camps drew international
attention. A proper set of standards for judging the physicians and scientists who
had conducted experiments on the prisoners was drawn up by the presiding inter-
national military tribunal. The tribunal formulated a 10-point statement in 1948,
called the Nuremberg Code, delimiting permissible medical experimentation on
human subjects. According to this statement, humane experimentation is justified
only if its results benefit society and it is carried out in accord with basic principles
that “satisfy moral, ethical, and legal concepts.” The basic ethics of the Nuremberg
Code continue to serve as a cornerstone for modern regulations regarding the use
of human participants in experimentation.
In the 1950s another disaster occurred in Europe with the usage of thalidomide
as a sedative. Thalidomide caused significant toxicity to the nervous system and
this incidence led to the adoption of the “Kefauver Amendment” in 1962 to the
Food, Drug, and Cosmetic Act of the United States, requiring drug manufacturers
to prove the safety and effectiveness of their products and physicians to obtain in-
formed consent from potential subjects before administering investigational medi-
cations. The World Medical Association in 1964 responded with the Declaration of
Helsinki, built on the Nuremberg code to develop good clinical practices. It must
be stressed that the standards as drafted are only a guide to physicians all over the
world. Physicians are not relieved from criminal, civil, and ethical responsibilities
under the law of their own countries. There have been a number of amendments
to the original declaration, which can be obtained directly from the World Medical
Association [2].
11.3.2 BelmontReport
In the United States, the National Research Act was passed in 1974, which helped
with the creation of the National Commission for the Protection of Human Subjects
of Biomedical and Behavioral Research (NCPHSBBR). To codify the requirement
that human participants in research must be protected, the NCPHSBBR published
guidelines for review of research involving human subject research in 1979 known
as
The Belmont Report: Ethical Principles for the Protection of Human Subjects
of Research
[3].
The Belmont Report
considers three “principles” or concepts to
be integral to the investigator-subject relationship: respect for persons, beneficence,
and justice. Some points from
The Belmont Report
are given here:
1.
Respect for Persons
has at least two ethical considerations: the individual
human research participant needs to be treated as an autonomous being,
a person who makes decisions or deliberates for himself or herself about
personal goals and then acts upon them; those persons who are not able
to make and carry out decisions for themselves, such as children or sick
people or those who have a mental disorder, must be protected from coer-
cion by others and from activities that harm them. How much to protect
them is related to the risk of harm and the likelihood of benefi t to them. In
