From: Robina Suwol
Date: 14 Mar 2006
Time: 17:19:49
Remote Name: 68.95.254.130
From the Office of the Secretary
The National Commission for the Protection of Human Subjects of Biomedical
and Behavioral Research
April 18, 1979
http://ohrp.osophs.dhhs.gov/humansubjects/guidance/belmont.htm
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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.
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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.
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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
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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.
[RETURN TO TABLE OF CONTENTS]
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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 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.
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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.
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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.
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(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.
National Institutes of Health
Bethesda, Maryland 20892