The Belmont Report:
Ethical Principles and Guidelines for
the Protection of Human Subjects of Research
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
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
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 "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
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
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.
TEXT PROVIDED BY National
Institutes of Health Bethesda, Maryland 20892
