THE BELMONT REPORT
When the
National Research Act was signed into law on July 12, 1974, the National
Commission for the Protection of Human Subjects of Biomedical and Behavioural
Research was created. The Commission was charged with identifying the basic
ethical principles that should underlie the condct of biomedical and behavioural
research involving human subjects and to develop guidelines which should
be followed to assure that research is conducted in accordance with those
principles. During their discussions the Commission considered the boundaries
between medical practice and research, the role of assessment of risk-benefit
in the determination of the appropriateness of research involving human
subjects, guidelines for the selection of human subjects and the nature
and definition of informed consent. The Belmont
Report thus attempts to summarize the basic ethical principles identified
by the Commission in the course of its deliberations in February 1976.
The report itself does not make specific recommendations for administrative
action, but rather its objective is to provide an analytical framework
that will guide the resolution of ethical problems arising during research
involving human subjects.
BASIC
ETHICAL PRINCIPLES
1.
Respect
for Persons ~ all volunteers are treated as individuals and are entitled
to protection.
-
Informed
Consent: ģ...each subject to the degree they are capable, be
given the opportunity to choose what shall or shall not happen
to them.ī
Information: The
extent and nature of the information should be such that persons can decide
whether they wish to participate in the furthering of knowledge. That is
to say,
consenting individuals are aware that the procedure is neither necessary
for their care
nor perhaps fully understood, and they understand clearly the range of
the risks.
Comprehension: The
ability of a subject to understand is a function of intelligence, rationality,
maturity
and language and therefore it is necessary to adapt the presentation of
the
information to the subject's capacities. Investigators are responsible
for ascertaining
that the subject has comprehended the information.
Voluntariness: The agreement to participate
in research is considered a valid consent, if and only if
voluntarily given under conditions free of coercion and undue influence.
2.
Beneficence
-
Do
not harm
-
Maximize
possible benefits and minimize possible harms
-
Assessment
of Risks and Benefits
3.
Justice
~ ģfairness in distributionī
-
To
each person an equal share
-
To
each person according to individual need
-
To
each person according to individual effort
-
To
each person according to societal contribution
-
To
each person according to merit