SUMMARY: On July 12, 1974, the National Research Act (Pub.
L. 93-348) was signed into law, there-by creating the National
Commission for the Protection of Human Subjects of Biomedical
and Behavioral Research. One of the charges to the Commission
was to identify the basic ethical principles that should underlie
the conduct of biomedical and behavioral research involving human
subjects and to develop guidelines which should be followed to
assure that such research is conducted in accordance with those
principles. In carrying out the above, the Commission was directed
to consider: (i) the boundaries between biomedical and behavioral
research and the accepted and routine practice of medicine, (ii)
the role of assessment of risk-benefit criteria in the determination
of the appropriateness of research involving human subjects, (iii)
appropriate guidelines for the selection of human subjects for
participation in such
research and (iv) the nature and definition of informed consent
in various research settings.
Three Principles
Three principles, or general prescriptive judgments, that are
relevant to research involving human subjects are identified in
this statement. Other principles may also be relevant. These three
are comprehensive, however, and are stated at a level of generalization
that should assist scientists, subjects, reviewers and interested
citizens to understand the ethical issues inherent in research
involving human subjects. These principles cannot always be applied
so as to resolve beyond dispute particular ethical problems. The
objective is to provide an analytical framework that will guide
the resolution of ethical problems arising from research involving
human subjects.
This statement consists of a distinction between research and practice, a discussion of the three basic ethical principles, and remarks about the application of these principles.
Basic Ethical Principles
The expression "basic ethical principles" refers to those general judgments that serve as a basic justification for the many particular ethical prescriptions and evaluations of human actions. Three basic principles, among those generally accepted in our cultural tradition, are particularly relevant to the ethics of research involving human subjects: the principles of respect of persons, beneficence and justice.
Respect for Persons. -- Respect for persons incorporates at
least two ethical convictions: first, that individuals should
be treated as autonomous agents, and second, that persons with
diminished autonomy are entitled to protection. The principle
of respect for persons thus divides into two separate moral requirements:
the requirement to acknowledge
autonomy and the requirement to protect those with diminished
autonomy.
Beneficence. -- Persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being. Such treatment falls under the principle of beneficence. The term "beneficence" is often understood to cover acts of kindness or charity that go beyond strict obligation. In this document, beneficence is understood in a stronger sense, as an obligation. Two general rules have been formulated as complementary expressions of beneficent actions in this sense: (1) do not harm and (2) maximize possible benefits and minimize possible harms.
3. Justice. -- Who ought to receive the benefits of research
and bear its burdens? This is a question of justice, in the sense
of "fairness in distribution" or "what is deserved."
An injustice occurs when some benefit to which a person is entitled
is denied without good reason or when some burden is imposed unduly.
Another way of conceiving the principle of justice is that equals
ought to be treated equally. However, this statement requires
explication. Who is equal and who is unequal? What considerations
justify departure from equal distribution? Almost all commentators
allow that distinctions based on experience, age, deprivation,
competence, merit and position do sometimes constitute criteria
justifying differential treatment for certain purposes. It is
necessary, then, to explain in what respects people should be
treated equally. There are several widely accepted formulations
of just ways to distribute burdens and benefits. Each formulation
mentions some relevant property on the basis of which burdens
and benefits should be distributed. These formulations are (1)
to each person an equal share, (2) to each person according to
individual need, (3) to each person according to individual effort,
(4) to each person according to societal contribution, and (5)
to each person according to merit.