7860-U1D2 - Describe the type of quantative research, the key concepts, what is meant by scientific merit, ect. See details below.
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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.
Office for Human Research Protections
U.S. Department of Health & Human Services 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.
[RETURN TO TABLE OF CONTENTS]
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.
Part B: Basic Ethical Principles
B. Basic Ethical Principles
The expression "basic ethical principles" refers to those general judgments that serve as a basic
justification for the many particular ethical prescriptions and evaluations of human actions. Three basic
principles, among those generally accepted in our cultural tradition, are particularly relevant to the ethics
of research involving human subjects: the principles of respect of persons, beneficence and justice. 1. Respect for Persons. -- Respect for persons incorporates at least two ethical convictions: first, that
individuals should be treated as autonomous agents, and second, that persons with diminished autonomy
are entitled to protection. The principle of respect for persons thus divides into two separate moral
requirements: the requirement to acknowledge autonomy and the requirement to protect those with
diminished autonomy.
An autonomous person is an individual capable of deliberation about personal goals and of acting under
the direction of such deliberation. To respect autonomy is to give weight to autonomous persons'
considered opinions and choices while refraining from obstructing their actions unless they are clearly
detrimental to others. To show lack of respect for an autonomous agent is to repudiate that person's
considered judgments, to deny an individual the freedom to act on those considered judgments, or to
withhold information necessary to make a considered judgment, when there are no compelling reasons to
do so.
However, not every human being is capable of self-determination. The capacity for self-determination
matures during an individual's life, and some individuals lose this capacity wholly or in part because of
illness, mental disability, or circumstances that severely restrict liberty. Respect for the immature and the
incapacitated may require protecting them as they mature or while they are incapacitated.
Some persons are in need of extensive protection, even to the point of excluding them from activities
which may harm them; other persons require little protection beyond making sure they undertake activities
freely and with awareness of possible adverse consequence. The extent of protection afforded should
depend upon the risk of harm and the likelihood of benefit. The judgment that any individual lacks
autonomy should be periodically reevaluated and will vary in different situations.
In most cases of research involving human subjects, respect for persons demands that subjects enter into
the research voluntarily and with adequate information. In some situations, however, application of the
principle is not obvious. The involvement of prisoners as subjects of research provides an instructive
example. On the one hand, it would seem that the principle of respect for persons requires that prisoners
not be deprived of the opportunity to volunteer for research. On the other hand, under prison conditions
they may be subtly coerced or unduly influenced to engage in research activities for which they would not
otherwise volunteer. Respect for persons would then dictate that prisoners be protected. Whether to allow
prisoners to "volunteer" or to "protect" them presents a dilemma. Respecting persons, in most hard cases,
is often a matter of balancing competing claims urged by the principle of respect itself.
2. Beneficence. -- Persons are treated in an ethical manner not only by respecting their decisions and
protecting them from harm, but also by making efforts to secure their well-being. Such treatment falls
under the principle of beneficence. The term "beneficence" is often understood to cover acts of kindness
or charity that go beyond strict obligation. In this document, beneficence is understood in a stronger
sense, as an obligation. Two general rules have been formulated as complementary expressions of
beneficent actions in this sense: (1) do not harm and (2) maximize possible benefits and minimize
possible harms. The Hippocratic maxim "do no harm" has long been a fundamental principle of medical ethics. Claude
Bernard extended it to the realm of research, saying that one should not injure one person regardless of
the benefits that might come to others. However, even avoiding harm requires learning what is harmful;
and, in the process of obtaining this information, persons may be exposed to risk of harm. Further, the
Hippocratic Oath requires physicians to benefit their patients "according to their best judgment." Learning
what will in fact benefit may require exposing persons to risk. The problem posed by these imperatives is
to decide when it is justifiable to seek certain benefits despite the risks involved, and when the benefits
should be foregone because of the risks.
The obligations of beneficence affect both individual investigators and society at large, because they
extend both to particular research projects and to the entire enterprise of research. In the case of
particular projects, investigators and members of their institutions are obliged to give forethought to the
maximization of benefits and the reduction of risk that might occur from the research investigation. In the
case of scientific research in general, members of the larger society are obliged to recognize the longer
term benefits and risks that may result from the improvement of knowledge and from the development of
novel medical, psychotherapeutic, and social procedures.
The principle of beneficence often occupies a well-defined justifying role in many areas of research
involving human subjects. An example is found in research involving children. Effective ways of treating
childhood diseases and fostering healthy development are benefits that serve to justify research involving
children -- even when individual research subjects are not direct beneficiaries. Research also makes it
possible to avoid the harm that may result from the application of previously accepted routine practices
that on closer investigation turn out to be dangerous. But the role of the principle of beneficence is not
always so unambiguous. A difficult ethical problem remains, for example, about research that presents
more than minimal risk without immediate prospect of direct benefit to the children involved. Some have
argued that such research is inadmissible, while others have pointed out that this limit would rule out
much research promising great benefit to children in the future. Here again, as with all hard cases, the
different claims covered by the principle of beneficence may come into conflict and force difficult choices.
3. Justice. -- Who ought to receive the benefits of research and bear its burdens? This is a question of
justice, in the sense of "fairness in distribution" or "what is deserved." An injustice occurs when some
benefit to which a person is entitled is denied without good reason or when some burden is imposed
unduly. Another way of conceiving the principle of justice is that equals ought to be treated equally.
However, this statement requires explication. Who is equal and who is unequal? What considerations
justify departure from equal distribution? Almost all commentators allow that distinctions based on
experience, age, deprivation, competence, merit and position do sometimes constitute criteria justifying
differential treatment for certain purposes. It is necessary, then, to explain in what respects people should
be treated equally. There are several widely accepted formulations of just ways to distribute burdens and
benefits. Each formulation mentions some relevant property on the basis of which burdens and benefits should be distributed. These formulations are (1) to each person an equal share, (2) to each person
according to individual need, (3) to each person according to individual effort, (4) to each person
according to societal contribution, and (5) to each person according to merit.
Questions of justice have long been associated with social practices such as punishment, taxation and
political representation. Until recently these questions have not generally been associated with scientific
research. However, they are foreshadowed even in the earliest reflections on the ethics of research
involving human subjects. For example, during the 19th and early 20th centuries the burdens of serving as
research subjects fell largely upon poor ward patients, while the benefits of improved medical care flowed
primarily to private patients. Subsequently, the exploitation of unwilling prisoners as research subjects in
Nazi concentration camps was condemned as a particularly flagrant injustice. In this country, in the
1940's, the Tuskegee syphilis study used disadvantaged, rural black men to study the untreated course of
a disease that is by no means confined to that population. These subjects were deprived of demonstrably
effective treatment in order not to interrupt the project, long after such treatment became generally
available.
Against this historical background, it can be seen how conceptions of justice are relevant to research
involving human subjects. For example, the selection of research subjects needs to be scrutinized in order
to determine whether some classes (e.g., welfare patients, particular racial and ethnic minorities, or
persons confined to institutions) are being systematically selected simply because of their easy
availability, their compromised position, or their manipulability, rather than for reasons directly related to
the problem being studied. Finally, whenever research supported by public funds leads to the
development of therapeutic devices and procedures, justice demands both that these not provide
advantages only to those who can afford them and that such research should not unduly involve persons
from groups unlikely to be among the beneficiaries of subsequent applications of the research.
Part C: Applications
C. Applications
Applications of the general principles to the conduct of research leads to consideration of the following
requirements: informed consent, risk/benefit assessment, and the selection of subjects of research.
1. Informed Consent. -- Respect for persons requires that subjects, to the degree that they are capable,
be given the opportunity to choose what shall or shall not happen to them. This opportunity is provided
when adequate standards for informed consent are satisfied.
While the importance of informed consent is unquestioned, controversy prevails over the nature and
possibility of an informed consent. Nonetheless, there is widespread agreement that the consent process
can be analyzed as containing three elements: information, comprehension and voluntariness. Information. Most codes of research establish specific items for disclosure intended to assure that
subjects are given sufficient information. These items generally include: the research procedure, their
purposes, risks and anticipated benefits, alternative procedures (where therapy is involved), and a
statement offering the subject the opportunity to ask questions and to withdraw at any time from the
research. Additional items have been proposed, including how subjects are selected, the person
responsible for the research, etc.
However, a simple listing of items does not answer the question of what the standard should be for
judging how much and what sort of information should be provided. One standard frequently invoked in
medical practice, namely the information commonly provided by practitioners in the field or in the locale, is
inadequate since research takes place precisely when a common understanding does not exist. Another
standard, currently popular in malpractice law, requires the practitioner to reveal the information that
reasonable persons would wish to know in order to make a decision regarding their care. This, too, seems
insufficient since the research subject, being in essence a volunteer, may wish to know considerably more
about risks gratuitously undertaken than do patients who deliver themselves into the hand of a clinician for
needed care. It may be that a standard of "the reasonable volunteer" should be proposed: the extent and
nature of information should be such that persons, knowing that the procedure is neither necessary for
their care nor perhaps fully understood, can decide whether they wish to participate in the furthering of
knowledge. Even when some direct benefit to them is anticipated, the subjects should understand clearly
the range of risk and the voluntary nature of participation.
A special problem of consent arises where informing subjects of some pertinent aspect of the research is
likely to impair the validity of the research. In many cases, it is sufficient to indicate to subjects that they
are being invited to participate in research of which some features will not be revealed until the research is
concluded. In all cases of research involving incomplete disclosure, such research is justified only if it is
clear that (1) incomplete disclosure is truly necessary to accomplish the goals of the research, (2) there
are no undisclosed risks to subjects that are more than minimal, and (3) there is an adequate plan for
debriefing subjects, when appropriate, and for dissemination of research results to them. Information
about risks should never be withheld for the purpose of eliciting the cooperation of subjects, and truthful
answers should always be given to direct questions about the research. Care should be taken to
distinguish cases in which disclosure would destroy or invalidate the research from cases in which
disclosure would simply inconvenience the investigator.
Comprehension. The manner and context in which information is conveyed is as important as the
information itself. For example, presenting information in a disorganized and rapid fashion, allowing too
little time for consideration or curtailing opportunities for questioning, all may adversely affect a subject's
ability to make an informed choice.
Because the subject's ability to understand is a function of intelligence, rationality, maturity and language,
it is necessary to adapt the presentation of the information to the subject's capacities. Investigators are
responsible for ascertaining that the subject has comprehended the information. While there is always an obligation to ascertain that the information about risk to subjects is complete and adequately
comprehended, when the risks are more serious, that obligation increases. On occasion, it may be
suitable to give some oral or written tests of comprehension.
Special provision may need to be made when comprehension is severely limited -- for example, by
conditions of immaturity or mental disability. Each class of subjects that one might consider as
incompetent (e.g., infants and young children, mentally disable patients, the terminally ill and the
comatose) should be considered on its own terms. Even for these persons, however, respect requires
giving them the opportunity to choose to the extent they are able, whether or not to participate in research.
The objections of these subjects to involvement should be honored, unless the research entails providing
them a therapy unavailable elsewhere. Respect for persons also requires seeking the permission of other
parties in order to protect the subjects from harm. Such persons are thus respected both by
acknowledging their own wishes and by the use of third parties to protect them from harm.
The third parties chosen should be those who are most likely to understand the incompetent subject's
situation and to act in that person's best interest. The person authorized to act on behalf of the subject
should be given an opportunity to observe the research as it proceeds in order to be able to withdraw the
subject from the research, if such action appears in the subject's best interest.
Voluntariness. An agreement to participate in research constitutes a valid consent only if voluntarily
given. This element of informed consent requires conditions free of coercion and undue influence.
Coercion occurs when an overt threat of harm is intentionally presented by one person to another in order
to obtain compliance. Undue influence, by contrast, occurs through an offer of an excessive, unwarranted,
inappropriate or improper reward or other overture in order to obtain compliance. Also, inducements that
would ordinarily be acceptable may become undue influences if the subject is especially vulnerable.
Unjustifiable pressures usually occur when persons in positions of authority or commanding influence --
especially where possible sanctions are involved -- urge a course of action for a subject. A continuum of
such influencing factors exists, however, and it is impossible to state precisely where justifiable
persuasion ends and undue influence begins. But undue influence would include actions such as
manipulating a person's choice through the controlling influence of a close relative and threatening to
withdraw health services to which an individual would otherwise be entitled.
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.
Content created by Office for Human Research Protections
Content last reviewed on March 15, 2016
