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
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.
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
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.