Attempts to summarize the basic ethical principles of human
subject research. February 1976.
Objective: To provide an analytical framework that will
guide the resolution of ethical problems arising from research involving human subjects.
Practice: Designed solely to enhance the well-being of an
individual patient or client and that have a reasonable expectation of
success. Behavioral practice: To provide
diagnosis, preventive treatment or therapy to particular individuals.
Research: designates an activity designed to test an
hypothesis, permit conclusions to be drawn, and thereby to develop or
contribute to generalizable knowledge.
Research is usually described in a formal protocol that sets forth an
objective and a set of procedures designed to reach that objective.
When a clinician departs in a significant way from standard
oar accepted practice, the innovation does not , in and of itself, constitute
research. The fact that a procedure is
“experimental,” in the sense of new, untested or different, does not
automatically place it in the category fo research. Research and practice may be carried on
together when research is designed to evaluate the safety and efficacy of a
therapy.
Basic Ethical Principles:
1.
Respect for Persons.
a.
Individuals should be treated as autonomous
agents
b.
Persons with diminished autonomy are entitled to
protections.
2.
Beneficence.
a.
Do not harm: one should not injure one person
regardless of the benefits that might come to others.
b.
Maximize possible benefits and minimize possible
harms
i.
Physicians are required to benefit their
patients “according to their best judgment.”
3.
Justice.
a.
To each person an equal share
b.
To each according to individual need
c.
To each according to individual effort
d.
To each according to societal contribution
e.
To each according to merit
Applications:
1.
Informed Consent. Respect for person requires
that subjects be given the opportunity to choose what shall or shall not happen
to them. This opportunity is provided when adequate standards for informed
consent are satisfied.
a.
Information
i.
Disclosure; sufficient information
1.
Research procedure
2.
Purposes
3.
Risks
4.
Anticipated benefits
5.
Alternative procedures (where therapy is
involved)
6.
Statement offering the subject the opportunity
to ask questions and to withdraw at any time.
7.
The subject should understand clearly the range
of risk and the voluntary nature of participation.
ii.
When informing subjects of some pertinent
information of the research is likely to
impair the validity of:
1.
Incomplete disclosure is truly necessary to
accomplish the goals of the research,
2.
There are no undisclosed risks to subjects that
are more than minimal
3.
There is an adequate plan for debriefing
subjects, when appropriate, and for dissemination of research results to them.
b.
Comprehension
i.
Necessary to adapt the presentation of the
information to the subject’s capacities. (on occasion, it may be suitable to
give some oral or written tests of comprehension.)
ii.
Special provisions may need to be made when
comprehension is severely limited (e.g. immaturity or mental disability)
1.
Respect for persons also requires seeking the
permission of other parties in order to protect the subjects from harm. Such
persons are thus respected both by acknowledging their own wishes and by the
use of third parties to protect them from harm.
c.
Voluntariness:
i.
Free of coercion
1.
Coercion occurs when an overt threat of harm is
intentionally presented by one person to another in order to obtain compliance.
ii.
Free of undue influence
1.
Under influence occurs through as offer of an
excessive, unwarranted, inappropriate or improper reward or other overture in
order to obtain compliance.
2.
Also, Inducements that would ordinarily be
acceptable may become undue influences if the subject is especially vulnerable.
2.
Assessment of Risks and Benefits:
a.
For the investigator, it is a means to examine
whether the proposed research is properly designed.
b.
For a review committee, it is a method for
determining whether the risks that will be presented to subjects are justified.
c.
For prospective subjects, the assessment will
assist the determination whether or not to participate.
d.
Previous codes and Federal regulations have
required that risks to subjects be outweighed by the sum of both the
anticipated benefit to the subject, if any, and the anticipated benefit to
society in the form of knowledge to be gained from the research. In balancing these different elements, the
risks and benefits affecting the immediate research subject will normally carry
special weight. On the other hand,
interests other than those of the subject may on some occasions be sufficient
by themselves to justify the risks involved in the research, so long as the
subjects’ rights have been protected.
Beneficence thus requires that we protect against risk of harm to
subjects and also that we be concerned about the loss of substantial benefits
that might be gained from research.
e.
Procedure of assessment:
i.
Determination of the validity of the
presuppositions of the research
ii.
The nature, probability and magnitude of risk
should be distinguished with as much clarity as possible.
iii.
The method of ascertaining risks should be
explicit, especially where there is no alternative to the use of such vague
categories as small or slight risk.
iv.
It should also be determined whether an
investigator’s estimates of the probability of harm or benefits are reasonable,
as judged by known facts or other available studies.
f.
Justifiability:
i.
Brutal or inhumane treatment of human subjects
is never morally justified
ii.
Risks should be reduced to those necessary to
achieve the research objective. It
should be determined whether it is in fact necessary to use human subjects at
all. Risk can perhaps never be entirely
eliminated, but it can often be reduced by careful attention to alternative
procedures.
iii.
When research involves significant risk of
serious impairment, review committees should be extraordinarily insistent on
the justification of the risk (looking usually to the likelihood of benefit to
the subject – or, in some rare cases, to the manifest voluntariness of the
participating.
iv.
When vulnerable populations are involved in
research, the appropriateness of involving them should itself be demonstrated.
A number of variables go into such judgments, including the nature and degree
of risk, the condition of the particular population involved, and the nature
and level of the anticipated benefits.
v.
Relevant risks and benefits must be thoroughly
arrayed in documents and procedures used in the informed consent process.
3.
Selection of subjects:
a.
Individual justice: selection must exhibit
fairness: They should not offer potentially beneficial research only to some
patients who are in their favor or select only “undesirable” persons for risky
research.
b.
Social justice: requires that distinction be
drawn between classes of subjects that ought, and ought not, to participate in
any particular kind of research, based on the ability of members of that class
to bear burdens and on the appropriateness of placing further burdens on
already burdened persons.
c.
Thus, it can be considered a matter of social
justice that there is an order of preference in the selection of classes of
subjects (e.g., adults before children) and that some clases of potential
subjects (e.g., the institutionalized mentally infirm or prisoners) may be
involved as research subjects, if at all, only on certain conditions.
