|
The Belmont Report
|
|
Ethical Issues and Guidelines
|
|
Belmont ReportDepartment of Health, Education, and Welfare
Office of the Secretary
PROTECTION OF HUMAN SUBJECTS
BELMONT REPORT: ETHICAL PRINCIPLES AND GUIDELINES FOR THE PROTECTION
OF HUMAN SUBJECTS OF RESEARCH
Report of the National Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research
Table of Contents
- Summary
- Members of the Commission
- The Belmont Report: An Introduction
- Boundaries Between Practice and Research
- Basic Ethical Principles
- Respect for Persons
- Beneficence
- Justice
- Applications
- Informed Consent
- Assessment of Risk and Benefits
- Selection of Subjects
Summary
On July 12, 1974, the National Research Act (Public Law 93348) was
signed into law, thereby 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) 780013 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.
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.
THE BELMONT REPORT
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 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.
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. 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.
Research and practice may be carried on together, when research is designed to
evaluate the safety and efficacy of a therapy. This need not cause any
confusion regarding whether or not the activity requires review; the general
rule is, that if there is any element of research in an activity, that activity
should undergo review for the protection of human subjects.
B. Basic Ethical Principles
The expression "basic ethical principles" refers to those general
judgments that serve as a basic justification for the many particular ethical
prescriptions and evaluations of human actions. Three basic principles, among
those generally accepted in our cultural tradition, are particularly relevant
to the ethics of research involving human subjects: the principles of respect
for persons, beneficence and justice.
- 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 consequences. 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.
- 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.
- 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 vagrant injustice. In this country, in the 1940's, the Tuskegee
syphilis study used disadvantaged, rural black men to study the untreated
course of a disease that is by no means confined to that population. These
subjects were deprived of demonstrably effective treatment in order not to
interrupt the project, long after such treatment became generally available.
Against this historical background, it can be seen how conceptions of justice
are relevant to research involving human subjects. For example, the selection
of research subjects needs to be scrutinized in order to determine whether some
classes (e.g., welfare patients, particular racial and ethnic
minorities, or persons confined to institutions) are being systematically
selected, simply because of their easy availability, their compromised
position, or their manipulability, rather than for reasons directly related to
the problem being studied. Finally, whenever research supported by public
funds leads to the development of therapeutic devices and procedures, justice
demands both that these not provide advantages only to those who can afford
them, and that such research should not unduly involve persons from groups
unlikely to be among the beneficiaries of subsequent applications of the
research.
C. Applications
Applications of the general principles to the conduct of research leads
to consideration of the following requirements: informed consent, risk /
benefit assessment, and the selection of subjects of research.
- 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 disabled 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.
- 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 harms, 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.
- 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 institutional review
boards 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.
|
|
|
|
|