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The Belmont Report
Ethical Principles and Guidelines for the Protection of Human
Subjects of Research
The
National Commission for the Protection of Human Subjects
of Biomedical and Behavioral Research
April 18, 1979
AGENCY: Department
of Health, Education, and Welfare.
ACTION:
Notice of Report for Public Comment.
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.
The Belmont Report attempts to summarize the basic ethical
principles identified by the Commission in the course of
its deliberations. It is the outgrowth of an intensive four-day
period of discussions that were held in February 1976 at
the Smithsonian Institution's Belmont Conference Center
supplemented by the monthly deliberations of the Commission
that were held over a period of nearly four years. It is
a statement of basic ethical principles and guidelines that
should assist in resolving the ethical problems that surround
the conduct of research with human subjects. By publishing
the Report in the Federal Register, and providing reprints
upon request, the Secretary intends that it may be made
readily available to scientists, members of Institutional
Review Boards, and Federal employees. The two-volume Appendix,
containing the lengthy reports of experts and specialists
who assisted the Commission in fulfillingthis part of its
charge, is available as DHEW Publication No. (OS) 78-0013
and No. (OS) 78-0014, for sale by the Superintendent of
Documents, U.S. Government Printing Office, Washington,
D.C. 20402.
Unlike most other reports of the Commission, the Belmont
Report does not make specific recommendations for administrative
action by the Secretary of Health, Education, and Welfare.
Rather, the Commission recommended that the Belmont Report
be adopted in its entirety, as a statement of the Department's
policy. The Department requests public comment on this recommendation.
National Commission for
the Protection of Human Subjects
of Biomedical and Behavioral Research
Members of the Commission
Kenneth John Ryan, M.D., Chairman,
Chief of Staff, Boston Hospital for Women.
Joseph V. Brady, Ph.D., Professor of Behavioral Biology, Johns
Hopkins University.
Robert E. Cooke, M.D., President, Medical College of Pennsylvania.
Dorothy I. Height, President, National Council of Negro Women,
Inc.
Albert R. Jonsen, Ph.D., Associate Professor of Bioethics,
University of California at San Francisco.
Patricia King, J.D., Associate Professor of Law, Georgetown
University Law Center.
Karen Lebacqz, Ph.D., Associate Professor of Christian Ethics,
Pacific School of Religion.
*** David W. Louisell, J.D., Professor of Law, University
of California at Berkeley.
Donald W. Seldin, M.D., Professor and Chairman, Department
of Internal Medicine, University of Texas at Dallas.
Eliot Stellar, Ph.D., Provost of the University and Professor
of Physiological Psychology, University of Pennsylvania.
*** Robert H. Turtle, LL.B., Attorney, VomBaur, Coburn, Simmons
& Turtle, Washington, D.C.
*** Deceased.
Table of Contents
Ethical Principles and Guidelines for Research
Involving Human Subjects
A. Boundaries Between Practice and Research
B. Basic Ethical Principles
1. Respect for Persons
2. Beneficence
3. Justice
C. Applications
1. Informed Consent
2. Assessment of Risk and Benefits
3. Selection of Subjects
Ethical
Principles & Guidelines for Research Involving Human Subjects
Scientific research has produced substantial social benefits.
It has also posed some troubling ethical questions. Public
attention was drawn to these questions by reported abuses
of human subjects in biomedical experiments, especially during
the Second World War. During the Nuremberg War Crime Trials,
the Nuremberg code was drafted as a set of standards for judging
physicians and scientists who had conducted biomedical experiments
on concentration camp prisoners. This code became the prototype
of many later codes(1) intended to assure
that research involving human subjects would be carried out
in an ethical manner.
The codes consist of rules, some general, others specific,
that guide the investigators or the reviewers of research
in their work. Such rules often are inadequate to cover complex
situations; at times they come into conflict, and they are
frequently difficult to interpret or apply. Broader ethical
principles will provide a basis on which specific rules may
be formulated, criticized and interpreted.
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.
Part A: Boundaries
Between Practice & Research
A. Boundaries Between Practice
and Research
It is important to distinguish between biomedical and behavioral
research, on the one hand, and the practice of accepted
therapy on the other, in order to know what activities ought
to undergoreview for the protection of human subjects of
research. The distinction between research and practice
is blurred partly because both often occur together (as
in research designed to evaluate a therapy) and partly because
notable departures from standard practice are often called
"experimental" when the terms "experimental"
and "research" are not carefully defined.
For the most part, the term "practice" refers
to interventions that are designed solely to enhance the
well-being of an individual patient or client and that have
a reasonable expectation of success. The purpose of medical
or behavioral practice is to provide diagnosis, preventive
treatment or therapy to particular individuals. (2)
By contrast, the term "research' designates an activity
designed to test an hypothesis, permit conclusions to be
drawn, and thereby to develop or contribute to generalizable
knowledge (expressed, for example, in theories, principles,
and statements of relationships). 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
or 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
of research. Radically new procedures of this description
should, however, be made the object of formal research at
an early stage in order to determine whether they are safe
and effective. Thus, it is the responsibility of medical
practice committees, for example, to insist that a major
innovation be incorporated into a formal research project.
(3)
Research and practice may be carried on together when research
is designed to evaluate the safety and efficacy of a therapy.
This need not cause any confusion regarding whether or not
the activity requires review; the general rule is that if
there is any element of research in an activity, that activity
should undergo review for the protection of human subjects.
Part B: Basic Ethical Principles
B. 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.
1. 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.
An autonomous person is an individual capable of deliberation
about personal goals and of acting under the direction of
such deliberation. To respect autonomy is to give weight
to autonomous persons' considered opinions and choices while
refraining from obstructing their actions unless they are
clearly detrimental to others. To show lack of respect for
an autonomous agent is to repudiate that person's considered
judgments, to deny an individual the freedom to act on those
considered judgments, or to withhold information necessary
to make a considered judgment, when there are no compelling
reasons to do so.
However, not every human being is capable of self-determination.
The capacity for self-determination matures during an individual's
life, and some individuals lose this capacity wholly or
in part because of illness, mental disability, or circumstances
that severely restrict liberty. Respect for the immature
and the incapacitated may require protecting them as they
mature or while they are incapacitated.
Some persons are in need of extensive protection, even to
the point of excluding them from activities which may harm
them; other persons require little protection beyond making
sure they undertake activities freely and with awareness
of possible adverse consequence. The extent of protection
afforded should depend upon the risk of harm and the likelihood
of benefit. The judgment that any individual lacks autonomy
should be periodically reevaluated and will vary in different
situations.
In most cases of research involving human subjects, respect
for persons demands that subjects enter into the research
voluntarily and with adequate information. In some situations,
however, application of the principle is not obvious. The
involvement of prisoners as subjects of research provides
an instructive example. On the one hand, it would seem that
the principle of respect for persons requires that prisoners
not be deprived of the opportunity to volunteer for research.
On the other hand, under prison conditions they may be subtly
coerced or unduly influenced to engage in research activities
for which they would not otherwise volunteer. Respect for
persons would then dictate that prisoners be protected.
Whether to allow prisoners to "volunteer" or to
"protect" them presents a dilemma. Respecting
persons, in most hard cases, is often a matter of balancing
competing claims urged by the principle of respect itself.
2. 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.
The Hippocratic maxim "do no harm" has long been
a fundamental principle of medical ethics. Claude Bernard
extended it to the realm of research, saying that one should
not injure one person regardless of the benefits that might
come to others. However, even avoiding harm requires learning
what is harmful; and, in the process of obtaining this information,
persons may be exposed to risk of harm. Further, the Hippocratic
Oath requires physicians to benefit their patients "according
to their best judgment." Learning what will in fact
benefit may require exposing persons to risk. The problem
posed by these imperatives is to decide when it is justifiable
to seek certain benefits despite the risks involved, and
when the benefits should be foregone because of the risks.
The obligations of beneficence affect both individual investigators
and society at large, because they extend both to particular
research projects and to the entire enterprise of research.
In the case of particular projects, investigators and members
of their institutions are obliged to give forethought to
the maximization of benefits and the reduction of risk that
might occur from the research investigation. In the case
of scientific research in general, members of the larger
society are obliged to recognize the longer term benefits
and risks that may result from the improvement of knowledge
and from the development of novel medical, psychotherapeutic,
and social procedures.
The principle of beneficence often occupies a well-defined
justifying role in many areas of research involving human
subjects. An example is found in research involving children.
Effective ways of treating childhood diseases and fostering
healthy development are benefits that serve to justify research
involving children -- even when individual research subjects
are not direct beneficiaries. Research also makes it possible
to avoid the harm that may result from the application of
previously accepted routine practices that on closer investigation
turn out to be dangerous. But the role of the principle
of beneficence is not always so unambiguous. A difficult
ethical problem remains, for example, about research that
presents more than minimal risk without immediate prospect
of direct benefit to the children involved. Some have argued
that such research is inadmissible, while others have pointed
out that this limit would rule out much research promising
great benefit to children in the future. Here again, as
with all hard cases, the different claims covered by the
principle of beneficence may come into conflict and force
difficult choices.
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.
Questions of justice have long been associated with social
practices such as punishment, taxation and political representation.
Until recently these questions have not generally been associated
with scientific research. However, they are foreshadowed
even in the earliest reflections on the ethics of research
involving human subjects. For example, during the 19th and
early 20th centuries the burdens of serving as research
subjects fell largely upon poor ward patients, while the
benefits of improved medical care flowed primarily to private
patients. Subsequently, the exploitation of unwilling prisoners
as research subjects in Nazi concentration camps was condemned
as a particularly flagrant injustice. In this country, in
the 1940's, the Tuskegee syphilis study used disadvantaged,
rural black men to study the untreated course of a disease
that is by no means confined to that population. These subjects
were deprived of demonstrably effective treatment in order
not to interrupt the project, long after such treatment
became generally available.
Against this historical background, it can be seen how conceptions
of justice are relevant to research involving human subjects.
For example, the selection of research subjects needs to
be scrutinized in order to determine whether some classes
(e.g., welfare patients, particular racial and ethnic minorities,
or persons confined to institutions) are being systematically
selected simply because of their easy availability, their
compromised position, or their manipulability, rather than
for reasons directly related to the problem being studied.
Finally, whenever research supported by public funds leads
to the development of therapeutic devices and procedures,
justice demands both that these not provide advantages only
to those who can afford them and that such research should
not unduly involve persons from groups unlikely to be among
the beneficiaries of subsequent applications of the research.
Part C: Applications
C. Applications
Applications of the general principles to the conduct of
research leads to consideration of the following requirements:
informed consent, risk/benefit assessment, and the selection
of subjects of research.
1. Informed Consent. -- Respect
for persons requires that subjects, to the degree that they
are capable, 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.
While the importance of informed consent is unquestioned,
controversy prevails over the nature and possibility of
an informed consent. Nonetheless, there is widespread agreement
that the consent process can be analyzed as containing three
elements: information, comprehension and voluntariness.
Information. Most codes of research establish specific
items for disclosure intended to assure that subjects are
given sufficient information. These items generally include:
the research procedure, their purposes, risks and anticipated
benefits, alternative procedures (where therapy is involved),
and a statement offering the subject the opportunity to
ask questions and to withdraw at any time from the research.
Additional items have been proposed, including how subjects
are selected, the person responsible for the research, etc.
However, a simple listing of items does not answer the question
of what the standard should be for judging how much and
what sort of information should be provided. One standard
frequently invoked in medical practice, namely the information
commonly provided by practitioners in the field or in the
locale, is inadequate since research takes place precisely
when a common understanding does not exist. Another standard,
currently popular in malpractice law, requires the practitioner
to reveal the information that reasonable persons would
wish to know in order to make a decision regarding their
care. This, too, seems insufficient since the research subject,
being in essence a volunteer, may wish to know considerably
more about risks gratuitously undertaken than do patients
who deliver themselves into the hand of a clinician for
needed care. It may be that a standard of "the reasonable
volunteer" should be proposed: the extent and nature
of information should be such that persons, knowing that
the procedure is neither necessary for their care nor perhaps
fully understood, can decide whether they wish to participate
in the furthering of knowledge. Even when some direct benefit
to them is anticipated, the subjects should understand clearly
the range of risk and the voluntary nature of participation.
A special problem of consent arises where informing subjects
of some pertinent aspect of the research is likely to impair
the validity of the research. In many cases, it is sufficient
to indicate to subjects that they are being invited to participate
in research of which some features will not be revealed
until the research is concluded. In all cases of research
involving incomplete disclosure, such research is justified
only if it is clear that (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, and (3) there is an adequate
plan for debriefing subjects, when appropriate, and for
dissemination of research results to them. Information about
risks should never be withheld for the purpose of eliciting
the cooperation of subjects, and truthful answers should
always be given to direct questions about the research.
Care should be taken to distinguish cases in which disclosure
would destroy or invalidate the research from cases in which
disclosure would simply inconvenience the investigator.
Comprehension. The manner and context in which information
is conveyed is as important as the information itself. For
example, presenting information in a disorganized and rapid
fashion, allowing too little time for consideration or curtailing
opportunities for questioning, all may adversely affect
a subject's ability to make an informed choice.
Because the subject's ability to understand is a function
of intelligence, rationality, maturity and language, 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.
While there is always an obligation to ascertain that the
information about risk to subjects is complete and adequately
comprehended, when the risks are more serious, that obligation
increases. On occasion, it may be suitable to give some
oral or written tests of comprehension.
Special provision may need to be made when comprehension
is severely limited -- for example, by conditions of immaturity
or mental disability. Each class of subjects that one might
consider as incompetent (e.g., infants and young children,
mentally disable patients, the terminally ill and the comatose)
should be considered on its own terms. Even for these persons,
however, respect requires giving them the opportunity to
choose to the extent they are able, whether or not to participate
in research. The objections of these subjects to involvement
should be honored, unless the research entails providing
them a therapy unavailable elsewhere. 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.
The third parties chosen should be those who are most likely
to understand the incompetent subject's situation and to
act in that person's best interest. The person authorized
to act on behalf of the subject should be given an opportunity
to observe the research as it proceeds in order to be able
to withdraw the subject from the research, if such action
appears in the subject's best interest.
Voluntariness. An agreement to participate in research
constitutes a valid consent only if voluntarily given. This
element of informed consent requires conditions free of
coercion and undue influence. Coercion occurs when an overt
threat of harm is intentionally presented by one person
to another in order to obtain compliance. Undue influence,
by contrast, occurs through an offer of an excessive, unwarranted,
inappropriate or improper reward or other overture in order
to obtain compliance. Also, inducements that would ordinarily
be acceptable may become undue influences if the subject
is especially vulnerable.
Unjustifiable pressures usually occur when persons in positions
of authority or commanding influence -- especially where
possible sanctions are involved -- urge a course of action
for a subject. A continuum of such influencing factors exists,
however, and it is impossible to state precisely where justifiable
persuasion ends and undue influence begins. But undue influence
would include actions such as manipulating a person's choice
through the controlling influence of a close relative and
threatening to withdraw health services to which an individual
would otherwise be entitle.
2. Assessment of Risks and Benefits.
-- The assessment of risks and benefits requires a careful
arrayal of relevant data, including, in some cases, alternative
ways of obtaining the benefits sought in the research. Thus,
the assessment presents both an opportunity and a responsibility
to gather systematic and comprehensive information about proposed
research. For the investigator, it is a means to examine whether
the proposed research is properly designed. For a review committee,
it is a method for determining whether the risks that will
be presented to subjects are justified. For prospective subjects,
the assessment will assist the determination whether or not
to participate.
The Nature and Scope of Risks and Benefits. The requirement
that research be justified on the basis of a favorable risk/benefit
assessment bears a close relation to the principle of beneficence,
just as the moral requirement that informed consent be obtained
is derived primarily from the principle of respect for persons.
The term "risk" refers to a possibility that harm
may occur. However, when expressions such as "small
risk" or "high risk" are used, they usually
refer (often ambiguously) both to the chance (probability)
of experiencing a harm and the severity (magnitude) of the
envisioned harm.
The term "benefit" is used in the research context
to refer to something of positive value related to health
or welfare. Unlike, "risk," "benefit"
is not a term that expresses probabilities. Risk is properly
contrasted to probability of benefits, and benefits are
properly contrasted with harms rather than risks of harm.
Accordingly, so-called risk/benefit assessments are concerned
with the probabilities and magnitudes of possible harm and
anticipated benefits. Many kinds of possible harms and benefits
need to be taken into account. There are, for example, risks
of psychological harm, physical harm, legal harm, social
harm and economic harm and the corresponding benefits. While
the most likely types of harms to research subjects are
those of psychological or physical pain or injury, other
possible kinds should not be overlooked.
Risks and benefits of research may affect the individual
subjects, the families of the individual subjects, and society
at large (or special groups of subjects in society). 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 the substantial benefits that might be gained
from research.
The Systematic Assessment of Risks and Benefits. It
is commonly said that benefits and risks must be "balanced"
and shown to be "in a favorable ratio." The metaphorical
character of these terms draws attention to the difficulty
of making precise judgments. Only on rare occasions will
quantitative techniques be available for the scrutiny of
research protocols. However, the idea of systematic, nonarbitrary
analysis of risks and benefits should be emulated insofar
as possible. This ideal requires those making decisions
about the justifiability of research to be thorough in the
accumulation and assessment of information about all aspects
of the research, and to consider alternatives systematically.
This procedure renders the assessment of research more rigorous
and precise, while making communication between review board
members and investigators less subject to misinterpretation,
misinformation and conflicting judgments. Thus, there should
first be a determination of the validity of the presuppositions
of the research; then the nature, probability and magnitude
of risk should be distinguished with as much clarity as
possible. 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. 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.
Finally, assessment of the justifiability of research should
reflect at least the following considerations: (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 participation). (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. -- Just as the principle
of respect for persons finds expression in the requirements
for consent, and the principle of beneficence in risk/benefit
assessment, the principle of justice gives rise to moral
requirements that there be fair procedures and outcomes
in the selection of research subjects.
Justice is relevant to the selection of subjects of research
at two levels: the social and the individual. Individual
justice in the selection of subjects would require that
researchers exhibit fairness: thus, they should not offer
potentially beneficial research only to some patients who
are in their favor or select only "undesirable"
persons for risky research. 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. 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 classes of potential subjects (e.g.,
the institutionalized mentally infirm or prisoners) may
be involved as research subjects, if at all, only on certain
conditions.
Injustice may appear in the selection of subjects, even
if individual subjects are selected fairly by investigators
and treated fairly in the course of research. Thus injustice
arises from social, racial, sexual and cultural biases institutionalized
in society. Thus, even if individual researchers are treating
their research subjects fairly, and even if IRBs are taking
care to assure that subjects are selected fairly within
a particular institution, unjust social patterns may nevertheless
appear in the overall distribution of the burdens and benefits
of research. Although individual institutions or investigators
may not be able to resolve a problem that is pervasive in
their social setting, they can consider distributive justice
in selecting research subjects.
Some populations, especially institutionalized ones, are
already burdened in many ways by their infirmities and environments.
When research is proposed that involves risks and does not
include a therapeutic component, other less burdened classes
of persons should be called upon first to accept these risks
of research, except where the research is directly related
to the specific conditions of the class involved. Also,
even though public funds for research may often flow in
the same directions as public funds for health care, it
seems unfair that populations dependent on public health
care constitute a pool of preferred research subjects if
more advantaged populations are likely to be the recipients
of the benefits.
One special instance of injustice results from the involvement
of vulnerable subjects. Certain groups, such as racial minorities,
the economically disadvantaged, the very sick, and the institutionalized
may continually be sought as research subjects, owing to
their ready availability in settings where research is conducted.
Given their dependent status and their frequently compromised
capacity for free consent, they should be protected against
the danger of being involved in research solely for administrative
convenience, or because they are easy to manipulate as a
result of their illness or socioeconomic condition.
(1) Since 1945, various codes for the proper
and responsible conduct of human experimentation in medical
research have been adopted by different organizations. The
best known of these codes are the Nuremberg Code of 1947,
the Helsinki Declaration of 1964 (revised in 1975), and the
1971 Guidelines (codified into Federal Regulations in 1974)
issued by the U.S. Department of Health, Education, and Welfare
Codes for the conduct of social and behavioral research have
also been adopted, the best known being that of the American
Psychological Association, published in 1973.
(2) Although practice usually involves interventions
designed solely to enhance the well-being of a particular
individual, interventions are sometimes applied to one individual
for the enhancement of the well-being of another (e.g., blood
donation, skin grafts, organ transplants) or an intervention
may have the dual purpose of enhancing the well-being of a
particular individual, and, at the same time, providing some
benefit to others (e.g., vaccination, which protects both
the person who is vaccinated and society generally). The fact
that some forms of practice have elements other than immediate
benefit to the individual receiving an intervention, however,
should not confuse the general distinction between research
and practice. Even when a procedure applied in practice may
benefit some other person, it remains an intervention designed
to enhance the well-being of a particular individual or groups
of individuals; thus, it is practice and need not be reviewed
as research.
(3) Because the problems related to social experimentation
may differ substantially from those of biomedical and behavioral
research, the Commission specifically declines to make any
policy determination regarding such research at this time.
Rather, the Commission believes that the problem ought to
be addressed by one of its successor bodies.
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