The
Belmont
Report
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

DHEW Publication No. (OS) 78-0012

For sale by the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402

National Commission for the Protection of Human Subjects
of Biomedical and Behavioral Research
September 30, 1978

Westwood Building, Room 125
5333 Westbard Avenue
Bethesda, Maryland 20016

Honorable Joseph A. Califano, Jr.
Secretary of Health, Education, and Welfare
Washington, D.C. 20201
Dear Mr. Secretary:
On behalf of the National Commission for the Protection of Human
Subjects of Biomedical and Behavioral Research, I am pleased to transmit our "Belmont Report: Ethical Principles and Guidelines for the
Protection of Human Subjects of Research." The identification of basic
ethical principles that should underlie the conduct of research involving
human subjects, and the development of guidelines to assure that such
principles are followed, were topics of studies set forth in the Commission's mandate under Public Law 93-348. This mandate also
directs the Commission to submit its report to the President, the
Congress, and the Secretary of Health, Education, and Welfare.
Unlike most of the previous reports of the Commission, the
Belmont Report does not make specific recommendations for administrative actions by the Secretary of Health, Education, and Welfare.
Instead, it is our recommendation that the Belmont Report be adopted
in its entirety as a statement of departmental policy on the conduct of
research involving human subjects. Publication and dissemination of
this policy will provide federal employees, members of Institutional
Review Boards and scientific investigators with common points of
reference for the analysis of ethical issues in human experimentation.
While the principles cannot always be applied so as to resolve beyond
dispute particular ethical problems, they provide an analytical framework that will guide the resolution of ethical problems arising from
research involving human subjects.
The Belmont Report 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 and the monthly Commission's
deliberations that have been conducted over the nearly four years of
our existence.
We appreciate the opportunity to have worked on this fundamental
task in the protection of human research subjects.
Respectfully,

Kenneth J. Ryan, M.D.
Chairman

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

NATIONAL COMMISSION FOR THE PROTECTION OF HUMAN SUBJECTS
OF BIOMEDICAL AND BEHAVIORAL RESEARCH

COMMISSION STAFF
PROFESSIONAL STAFF

SUPPORT STAFF

Michael S. Yesley, J.D.
Staff Director

Pamela L. Driscoll

Barbara Mishkin, M.A.
Assistant Staff Director
Duane Alexander, M.D.
Pediatrics

Marie D. Madigan
Coral M. Nydegger
Erma L. Pender

Tom L. Beauchamp, Ph.D.
Philosophy
Bradford H. Gray, Ph.D.
Sociology
Miriam Kelty, Ph.D.
Psychology
Betsy Singer
Public Information Officer
Dorle Vawter
Research Assistant

SPECIAL CONSULTANTS
Robert J. Levine, M.D.
Stephen Toulmin, Ph.D.

TABLE OF CONTENTS

A.

Boundaries Between Practice and Research. . . . . . . .

2

B.

Basic Ethical Principles. . . . . . . . . . . . . . .

4

1.

Respect for Persons . . . . . . . . . . . . . . . .

4

2.

Beneficence . . . . . . . . . . . . . . . . . . . .

6

3.

Justice . . . . . . . . . . . . . . . . . . . .

8

C.

Applications. . . . . . . . . . . . . . . . . . . . . 10
1.

Informed Consent. . . . . . . . . . . . . . . . . . . 10

2.

Assessment of Risks and Benefits. . . . . . . . . . . 14

3.

Selection of Subjects . . . . . . . . . . . . . . . . 18

B E L M O N T R E P O R T
ETHICAL PRINCIPLES AND GUIDELINES FOR RESEARCH
INVOLVING HUMAN SUBJECTS
Scientific research has produced substantial social benefits.
al so posed some troubling ethical questions.

It has

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 Crimes 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.

*

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.
1

Other principles may also be relevant.

These three are comprehensive, how-

ever, 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

2

individuals.* By contrast, the term "research" designates an activity designed to test a 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

*

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 wellbeing of a particular individual or groups of individuals; thus, it is
practice and need not be reviewed as research.

3

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.
1.

Respect for Persons
Respect for persons incorporates at least two basic ethical convictions:

first, that individuals should be treated as autonomous agents, and second,
that persons with diminished autonomy are entitled to protection.

*

The

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.

4

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 a 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.

Res-

pect 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 judg-

ment that any individual lacks autonomy should be periodically reevaluated
and will vary in different situations.

5

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.
would then dictate that prisoners be protected.

Respect for persons

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 pos-

sible harms.

6

The Hippocratic maxim "do no harm" has long been a fundamental princiClaude Bernard extended it to the realm of research,

ple of medical ethics.

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."
what will in fact benefit may require exposing persons to risk.

Learning
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.
found in research involving children.

An example is

Effective ways of treating childhood

diseases and fostering healthy development are benefits that serve to

7

justify research involving children -- even when individual research subjects
are not the 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.
role of the principle of beneficence is not always so unambiguous.

But the
A diffi-

cult ethical problem remains, for example, about research that presents more
than minimal risk withhout 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 per-

son 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.
Who is equal and who unequal?
equal distribution?

However, this statement requires explication.
What considerations justify departure from

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

8

equally. There are several widely accepted formulations of just ways to distribute burdens and benefits.

Each formulation mentions some relevant proper-

ty 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 condemmed as
a particularly flagrant injustice.

In this country, in the 1940s, the Tuske-

gee 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

9

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
Application of the general principles to the conduct of research leads
to consideration of the following requirements:

informed consent, risk/bene-

fit 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
to them.

or shall not happen

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.

10

Information.

Most codes of research establish specific items for dis-

closure 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 prac-

tice, 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 mal practice 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
hands of a clinician for needed care.

It may be that a standard of "the

reasonable volunteer" should be proposed:

the extent and nature of infor-

mation 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.
11

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 informa-

tion 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.

12

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 test 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.

Res-

pect for persons also requires seeking the permission of other parties
in order to protect the subjects from harm.

Such persons are thus res-

pected 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 able to withdraw the subject from the research,
appears in the subject's best interest.

13

if such action

Voluntariness.

An agreement to participate in research constitutes

a valid consent only if voluntarily given.

This element of informed con-

sent requires conditions free of coercion and undue influence.
occurs when

Coercion

an overt threat of harm is intentionally presented by one

person to another in order to obtain compliance.

Undue influence, by

contrast, occures 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

relevent 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.

14

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 sub-

jects, 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.
bility that harm may occur.

The term "risk" refers to a possi-

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.
and benefits need be taken into account.

Many kinds of possible harms

There are, for example, risks

of psychological harm, physical harm, legal harm, social harm and economic harm and the corresponding benefits.

15

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 the 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 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 quan-

titative 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

16

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 me-

thod 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 re-

duced 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 re-

search 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 appro-

priateness of involving them should itself be demonstrated.

17

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:
should not offer potentially beneficial

thus, they

research on to some patients who are

in their favor or select only "undesirable" persons for risky research.

So-

cial justice requires that a 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.

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Injustice may appear in the selection of subjects, even if individual
subjects are selected fairly by investigators and treated fairly in the
course of the research.

This 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

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may continually be sought as research subjects, owing to their ready
availability in settings where research is conducted.

Given their de-

pendent status and their frequently compromised capacity for free consent, they should be protected against the danger of being involved in
research solely for administrative convenience, or because they are
easy to manipulate as a result of their illness or socioeconomic condition.

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