The Belmont Report
Office of the Secretary
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 fulfilling this 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
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.
[RETURN TO TABLE OF CONTENTS]
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 undergo review 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.
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.
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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