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The Belmont Report

™◊ËÕÀπ—ß ◊Õ : √“¬ß“π‡∫≈¡Õßμå The Belmont Report

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National Library of Thailand Cataloging in Publication Data

√“¬ß“π‡∫≈¡Õßμå = The Belmont report. - °√ÿ߇∑æœ : Õߧ尓√ ß‡§√“–Àå∑À“√ºà“π»÷°

„πæ√–∫√¡√“™Ÿª∂—¡¿å, 2551.

50 Àπâ“.

1. ¡πÿ…¬å«‘®—¬®√√¬“∫√√≥.

2. °“√∑¥≈Õß„π¡πÿ…¬å (·æ∑¬»“ μ√å) - ®√√¬“∫√√≥.

I. «‘™—¬ ‚™§«‘«—≤π, ºŸâ·ª≈. II. ∑‘æ‘™“ ‚ª…¬“ππ∑å, ºŸâ·ª≈√à«¡. III. ™◊ËÕ‡√◊ËÕß.

174.28

ISBN 978-974-10-1693-8

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Õ—π∑’Ë®√‘ß √“¬ß“π‡∫≈¡Õßμå (Belmont Report) ∑’ËÕ¬Ÿà„π¡◊Õ¢Õß∑à“π¢≥–π’È¡‘‰¥â¡’ ∂“𖇪ìπÀ≈—°‡°≥±å®√‘¬∏√√¡°“√«‘®—¬„π¡πÿ…¬å„π√–¥—∫ “°≈À√◊Õ√–¥—∫π“π“™“μ‘Õ¬à“ß ªØ‘≠≠“‡Œ≈ ‘́ß°‘ (Declaration of Helsinki) ª√–¡«≈°ÆÀ¡“¬πŸ‡√¡‡∫‘√å°(Nuremberg Code) À√◊ÕÀ≈—°‡°≥±å®√‘¬∏√√¡ “°≈ ”À√—∫°“√»÷°…“«‘®—¬∑’ˇ°’ˬ«¢âÕß°—∫¡πÿ…¬å¢Õß ¿“Õߧ尓√ “°≈¥â“π«‘∑¬“»“ μ√å°“√·æ∑¬å (ClOMSû Guidelines) ∑’ˇªìπ∑’Ë√Ÿâ®—°°—πÕ¬à“ß°«â“ߢ«“ß ·∑â∑’Ë®√‘ß·≈â«√“¬ß“π‡∫≈¡Õßμ凪ìπ‡æ’¬ß à«π‡≈Á°Ê „π√“¬ß“π¢Õߧ≥–°√√¡°“√™ÿ¥Àπ÷Ëß∑’Ëμ—Èߢ÷Èπμ“¡æ√–√“™∫—≠≠—μ‘«‘®—¬·Ààß™“μ‘ æ.». 2517 ¢Õß À√—∞(PL93 - 348) ∑’Ë°”Àπ¥„ÀâμâÕß¡’°“√®—¥μ—Èß ç§≥–°√√¡°“√·Ààß™“쑇æ◊ËÕ°“√§ÿ⡧√ÕßÕ“ “ ¡—§√„π°“√«‘®—¬∑“ß™’«‡«™»“ μ√å·≈–æƒμ‘°√√¡»“ μ√åé (The National Commis-sion for the Protection of Human Subjects of Biomedical and BehavioralResearch) ‡æ◊ËÕ∑”Àπâ“∑’˧ÿ⡧√ÕßÕ“ “ ¡—§√¥—ß°≈à“«Õ¬à“߇À¡“– ¡

§≥–°√√¡°“√¥—ß°≈à“«„™â‡«≈“√à«¡ 4 ªï ∑”ß“πÕ¬à“ßμàÕ‡π◊ËÕß®π‰¥â¢âÕ √ÿª‡ªìπ√“¬ß“π‡≈à¡‚μ ´÷Ëß à«πÀπ÷Ëߧ◊Õ¢âÕ‡ πÕ‡√◊ËÕß çÀ≈—°®√‘¬∏√√¡·≈–·π«∑“ß°“√§ÿ⡧√ÕßÕ“ “ ¡—§√«‘®—¬é (Ethical Principles and Guidelines for the Protection ofHuman Subjects of Research) ÷́Ë߇ πÕ‡¡◊ËÕ«—π∑’Ë 18 ‡¡…“¬π æ.». 2522

§≥–°√√¡°“√¥—ß°≈à“«‰¥â¡’°“√ª√–™ÿ¡‡¢â¡¢âπ‡ªìπ‡«≈“ 4 «—π„π‡¥◊Õπ°ÿ¡¿“æ—π∏å æ.». 2519 ∑’Ë»Ÿπ¬å°“√ª√–™ÿ¡‡∫≈¡Õßμå ¢Õß ∂“∫—π ¡‘∏‚´‡π’¬π √“¬ß“π©∫—∫π’È®÷߉¥â™◊ËÕ«à“ ç√“¬ß“π‡∫≈¡Õßμåé

¢âÕ‡ πÕ¢Õß√“¬ß“π¥—ß°≈à“« π—∫‡ªìπ¢âÕ‡ πÕ∑’Ë¥’‡¬’ˬ¡‡æ√“–‡ªìπ§√—Èß·√°„π‚≈°∑’Ë¡’°“√𔇠πÕÀ≈—°°“√æ◊Èπ∞“π “¡ª√–°“√¥â“π®√‘¬∏√√¡¢Õß°“√«‘®—¬„π¡πÿ…¬å §◊ÕÀ≈—°§«“¡‡§“√æ„π∫ÿ§§≈ À≈—°º≈ª√–‚¬™πå ·≈–À≈—°§«“¡¬ÿμ‘∏√√¡ À≈—°®√‘¬∏√√¡æ◊Èπ∞“π∑—Èß “¡ª√–°“√π’È ‰¡à‡§¬ª√“°Ø¡“°àÕπ„πÀ≈—°‡°≥±å®√‘¬∏√√¡ “°≈°“√«‘®—¬„π¡πÿ…¬å∑’ˇ¢’¬π¢÷Èπ°àÕπÀπâ“π—Èπ ∑—Èߪ√–¡«≈°ÆÀ¡“¬πŸ‡√¡‡∫‘√å°·≈–ªØ‘≠≠“‡Œ≈´‘ß°‘√“¬ß“π‡∫≈¡Õßμå®÷߉¥â ∂“𖇪ìπÀ≈—°‡°≥±å®√‘¬∏√√¡°“√«‘®—¬∑’ˉ¥â√—∫°“√¬Õ¡√—∫Õ¬à“ß°«â“ߢ«“߉¡à‡©æ“–·μà„π À√—∞Õ‡¡√‘°“ ´÷Ë߇ªìπμâ𰔇𑥇∑à“π—Èπ ∑—Èßπ’ȥ⫬‡Àμÿº≈ ”§—≠πÕ°‡Àπ◊Õ®“°°“√‡ πÕÀ≈—°®√‘¬∏√√¡æ◊Èπ∞“π “¡ª√–°“√∑’Ë°≈à“«·≈â« §◊Õ

ª√–°“√·√° ¡’°“√·¬°·¬–™—¥‡®π√–À«à“ß °“√ªØ‘∫—μ‘ (Practice) °—∫°“√«‘®—¬ (Research)

ª√–°“√∑’Ë Õß À≈—°®√‘¬∏√√¡∑—Èß 3 ¢âÕ  Õ¥§≈âÕß·≈–‡ªìπÀ≈—°‡¥’¬«°—π°—∫À≈—°®√‘¬∏√√¡ “°≈„π‡«™ªØ‘∫—μ‘ (Medical Practice) ‡æ’¬ß·μà√–¥—∫§«“¡≈÷° °“√ª√–¬ÿ°μå„™â·≈–°“√‡πâπ·μ°μà“ß°—π

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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 Californiaat San Francisco.

Patricia King, J.D., Associate Professor of Law, Georgetown University Law Center.

Karen Lebacqz, Ph.D. Associate Professor of Christian Ethics, Pacific Schoolof 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 PhysiologicalPsychology, University of Pennsylvania.

***Robert H. Turtle, LL.B., Attorney, Vombaur, Coburn, Simmons&Turtle,Washington D.C.

***Deceased.

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2. °“√ª√–‡¡‘𧫓¡‡ ’ˬ߷≈–º≈ª√–‚¬™πå „π°“√ª√–‡¡‘𧫓¡‡ ’ˬ߷≈–º≈ª√–‚¬™πå®”‡ªìπμâÕß¡’¢âÕ¡Ÿ≈∑’ˇ°’ˬ«¢âÕß∑’Ë®—¥√–‡∫’¬∫‰«âÕ¬à“ߥ’·≈â« √«¡∑—Èß„π∫“ß°√≥’μâÕßæ‘®“√≥“∂÷ßÀπ∑“߇≈◊Õ°„π°“√‰¥â√—∫º≈ª√–‚¬™πå∑’Ë®–À“‰¥â®“°°“√«‘®—¬. ¥—ßπ—Èπ„π°“√ª√–‡¡‘π®÷߇ªìπ∑—Èß‚Õ°“ ·≈–§«“¡√—∫º‘¥™Õ∫„π°“√√«∫√«¡¢âÕ¡Ÿ≈¢à“« “√®“°°“√«‘®—¬Õ¬à“߇ªìπ√–∫∫·≈–Õ¬à“ߧ√∫∂â«π.  ”À√—∫ºŸâ«‘®—¬°“√ª√–‡¡‘π‡ªìπ·π«∑“ß„π°“√μ√«® Õ∫«à“‚§√ß°“√«‘®—¬∑’ˇ πÕ¡’°“√ÕÕ°·∫∫¡“Õ¬à“ß∂Ÿ°μâÕß.  ”À√—∫§≥–°√√¡°“√®√‘¬∏√√¡°“√ª√–‡¡‘π‡ªìπ«‘∏’®–μ—¥ ‘π«à“§«“¡‡ ’ˬß∑’Ë®–‡°‘¥·°àÕ“ “ ¡—§√¡’‡Àμÿº≈Õ—π ¡§«√.  ”À√—∫ºŸâ∑’Ë®–‡ªìπÕ“ “ ¡—§√°“√ª√–‡¡‘π®–™à«¬μ—¥ ‘π„®«à“§«√®–Õ“ “ ¡—§√‡¢â“√à«¡°“√«‘®—¬À√◊Õ‰¡à

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§”«à“ çº≈ª√–‚¬™πåé ∑’Ë„™â„π∫√‘∫∑¢Õß°“√«‘®—¬À¡“¬∂÷ß∫“ß ‘Ëß∫“ßÕ¬à“ß∑’Ë¡’§ÿ≥§à“∑“ß∫«°‡°’ˬ«°—∫ ÿ¢¿“æÀ√◊Õ «— ¥‘°“√. ·μ°μà“ß®“° 秫“¡‡ ’ˬßé §◊Õ çº≈ª√–‚¬™πåé ‡ªìπ§”∑’ˉ¡à‡°’ˬ«°—∫ 秫“¡πà“®–‡ªìπé §«“¡‡ ’ˬ߷μ°μà“ßÕ¬à“ß™—¥‡®π®“°§«“¡πà“®–‡ªìπª√–‚¬™πå ·≈–º≈ª√–‚¬™πå·μ°μà“ßÕ¬à“ß™—¥‡®π®“°Õ—πμ√“¬ ¡“°°«à“®“°§«“¡‡ ’ˬß∑’Ë®–‡°‘¥Õ—πμ√“¬. ¥—ßπ—Èπ ‘Ëß∑’ˇ√’¬°«à“°“√ª√–‡¡‘𧫓¡‡ ’ˬß/º≈ª√–‚¬™πå®÷߇°’ˬ«¢âÕß°—∫

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The Belmont ReportOffice of the Secretary

Ethical Principles and Guidelines for the Protection of HumanSubjects of Research

The National Commission for the Protection of Human Subjectsof Biomedical and Behavioral Research

April 18, 1979

AGENCY: Department of Health, Education, and Welfare.

ACTION: Notice of Report for Public Comment.

SUMMARY: On July12, 1974, the National Research Act (Pub. L. 93-348)was signed into law, there-by creating the National Commission for the Protectionof Human Subjects of Biomedical and Behavioral Research. One of the chargesto the Commission was to identify the basic ethical principles that should underliethe conduct of biomedical and behavioral research involving human subjectsand to develop guidelines which should be followed to assure that such researchis conducted in accordance with those principles. In carrying out the above, theCommission was directed to consider: (i) the boundaries between biomedicaland behavioral research and the accepted and routine practice of medicine, (ii)the role of assessment of risk-benefit criteria in the determination of theappropriateness of research involving human subjects, (iii) appropriate guidelinesfor the selection of human subjects for participation in such research and (iv) thenature and definition of informed consent in various research settings.

The Belmont Report attempts to summarize the basic ethical principles identifiedby the Commission in the course of its deliberations. It is the outgrowth of anintensive four-day period of discussions that were held in February 1976 at the

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Smithsonian Institutionûs Belmont Conference Center supplemented by the monthlydeliberations of the Commission that were held over a period of nearly fouryears. It is a statement of basic ethical principles and guidelines that shouldassist in resolving the ethical problems that surround the conduct of researchwith human subjects. By publishing the Report in the Federal Register, andproviding reprints upon request, the Secretary intends that it may be madereadily available to scientists, members of Institutional Review Boards, andFederal employees. The two-volume Appendix, containing the lengthy reportsof experts and specialists who assisted the Commission in fulfilling this part ofits 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 PrintingOffice, Washington, D.C. 20402.

Unlike most other reports of the Commission, the Belmont Report does notmake specific recommendations for administrative action by the Secretary ofHealth, Education, and Welfare. Rather, the Commission recommended thatthe Belmont Report be adopted in its entirety, as a statement of the Departmentûspolicy. The Department requests public comment on this recommendation.

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National Commission for the Protection of Human Subjectsof 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 Californiaat San Francisco.

Patricia King, J.D., Associate Professor of Law, Georgetown University Law Center.

Karen Lebacqz, Ph.D. Associate Professor of Christian Ethics, Pacific Schoolof 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 PhysiologicalPsychology, University of Pennsylvania.

***Robert H. Turtle, LL.B., Attorney, Vombaur, Coburn, Simmons&Turtle,Washington D.C.

***Deceased.

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Table of Contents

Ethical Principles and Guidelines for Research Involving Human SubjectsA. Boundaries Between Practice and ResearchB. Basic Ethical Principles

1. Respect for Persons2. Beneficence3. Justice

C. Applications1. Informed Consent2. Assessment of Risk and Benefits3. Selection of Subjects

Ethical Principles & Guidelines for Research Involving Human Subjects

Scientific research has produced substantial social benefits. It has also posedsome troubling ethical questions. Public attention was drawn to these questionsby reported abuses of human subjects in biomedical experiments, especiallyduring the Second World War. During the Nuremberg War Crime Trials, theNuremberg code was drafted as a set of standards for judging physicians andscientists who had conducted biomedical experiments on concentration campprisoners. This code became the prototype of many later codes(1) intended toassure that research involving human subjects would be carried out in an ethicalmanner.

The codes consist of rules, some general, others specific, that guide the investigatorsor the reviewers of research in their work. Such rules often are inadequate tocover complex situations; at times they come into conflict, and they are frequentlydifficult to interpret or apply. Broader ethical principles will provide a basis onwhich specific rules may be formulated, criticized and interpreted.

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Three principles, or general prescriptive judgments, that are relevant to researchinvolving human subjects are identified in this statement. Other principles mayalso be relevant. These three are comprehensive,however, and are stated at alevel of generalization that should assist scientists, subjects, reviewers and interestedcitizens to understand the ethical issues inherent in research involving humansubjects. These principles cannot always be applied so as to resolve beyonddispute particular ethical problems. The objective is to provide an analyticalframework that will guide the resolution of ethical problems arising from researchinvolving human subjects.

This statement consists of a distinction between research and practice, a discussionof the three basic ethical principles, and remarks about the application of theseprinciples.

[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, onthe one hand, and the practice of accepted therapy on the other, in order to knowwhat activities ought to undergo review for the protection of human subjects ofresearch. The distinction between research and practice is blurred partly becauseboth often occur together (as in research designed to evaluate a therapy) andpartly because notable departures from standard practice are often calledçexperimentalé when the terms çexperimentalé and çresearché are not carefullydefined.

For the most part, the term çpracticeé refers to interventions that are designedsolely to enhance the well-being of an individual patient or client and that havea reasonable expectation of success. The purpose of medical or behavioral

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practice is to provide diagnosis, preventive treatment or therapy to particularindividuals. (2) By contrast, the term çresearch - designates an activity designedto test an hypothesis, permit conclusions to be drawn, and thereby to develop orcontribute to generalizable knowledge (expressed, for example, in theories,principles, and statements of relationships). Research is usually described in aformal protocol that sets forth an objective and a set of procedures designed toreach 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 aprocedure is çexperimental,é in the sense of new, untested or different, does notautomatically place it in the category of research. Radically new procedures ofthis description should, however, be made the object of formal research at anearly stage in order to determine whether they are safe and effective. Thus, it isthe responsibility of medical practice committees, for example, to insist that amajor innovation be incorporated into a formal research project.(3)

Research and practice may be carried on together when research is designed toevaluate the safety and efficacy of a therapy. This need not cause any confusionregarding whether or not the activity requires review; the general rule is that ifthere is any element of research in an activity, that activity should undergoreview for the protection of human subjects.

Part B: Basic Ethical Principles

B. Basic Ethical Principles

The expression çbasic ethical principlesé refers to those general judgments thatserve as a basic justification for the many particular ethical prescriptions andevaluations of human actions. Three basic principles,among those generallyaccepted in our cultural tradition, are particularly relevant to the ethics of researchinvolving human subjects: the principles of respect of persons, beneficence andjustice.

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1. Respect for Persons.-- Respect for persons incorporates at least two ethicalconvictions: first, that individuals should be treated as autonomous agents, andsecond, that persons with diminished autonomy are entitled to protection. Theprinciple of respect for persons thus divides into two separate moralrequirements:the requirement to acknowledge autonomy and the requirement toprotect those with diminished autonomy.

An autonomous person is an individual capable of deliberation about personalgoals and of acting under the direction of such deliberation. To respect autonomyis to give weight to autonomous personsû considered opinions and choices whilerefraining from obstructing their actions unless they are clearly detrimental toothers. To show lack of respect for an autonomous agent is to repudiate thatpersonûs considered judgments,to deny an individual the freedom to act on thoseconsidered judgments, or to withhold information necessary to make a consideredjudgment, when there are no compelling reasons to do so.

However, not every human being is capable of self-determination. The capacityfor self- determination matures during an individualûs life, and some individualslose this capacity wholly or in part because of illness, mental disability, orcircumstances that severely restrict liberty. Respect for the immature and theincapacitated may require protecting them as they mature or while they areincapacitated.

Some persons are in need of extensive protection, even to the point of excludingthem from activities which may harm them; other persons require little protectionbeyond making sure they undertake activities freely and with awareness ofpossible adverse consequence. The extent of protection afforded should dependupon the risk of harm and the likelihood of benefit. The judgment that anyindividual lacks autonomy should be periodically reevaluated and will vary indifferent situations.

In most cases of research involving human subjects, respect for persons demandsthat subjects enter into the research voluntarily and with adequate information.In some situations, however, application of the principle is not obvious. The

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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 requiresthat prisoners not be deprived of the opportunity to volunteer for research. Onthe other hand, under prison conditions they may be subtly coerced or undulyinfluenced to engage in research activities for which they would not otherwisevolunteer.Respect for persons would then dictate that prisoners be protected.Whether to allow prisoners to çvolunteeréor to çprotecté them presents a dilemma.Respecting persons, in most hard cases, is often a matter of balancing competingclaims urged by the principle of respect itself.

2. Beneficence. -- Persons are treated in an ethical manner not only by respectingtheir decisions and protecting them from harm, but also by making efforts tosecure their well-being. Such treatment falls under the principle of beneficence.The term çbeneficenceé is often understood to cover acts of kindness or charitythat go beyond strict obligation. In this document, beneficence is understood ina stronger sense, as an obligation. Two general rules have been formulated ascomplementary expressions of beneficent actions in this sense: (1) do not harmand (2) maximize possible benefits and minimize possible harms.

The Hippocratic maxim çdo no harmé has long been a fundamental principle ofmedical ethics. Claude Bernard extended it to the realm of research, saying thatone should not injure one person regardless of the benefits that might come toothers. However, even avoiding harm requires learning what is harmful; and, inthe process of obtaining this information, persons may be exposed to risk ofharm. Further, the Hippocratic Oath requires physicians to benefit their patientsçaccording to their best judgment.é Learning what will in fact benefit mayrequire exposing persons to risk. The problem posed by these imperatives is todecide 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 societyat large, because they extend both to particular research projects and to theentire enterprise of research. In the case of particular projects,investigators and

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members of their institutions are obliged to give forethought to the maximizationof benefits and the reduction of risk that might occur from the researchinvestigation. In the case of scientific research in general, members of the largersociety are obliged to recognize the longer term benefits and risks that mayresult from the improvement of knowledge and from the development of novelmedical,psychotherapeutic, and social procedures.

The principle of beneficence often occupies a well-defined justifying role inmany areas of research involving human subjects. An example is found inresearch involving children. Effective ways of treating childhood diseases andfostering healthy development are benefits that serve to justify researchinvolving children--even when individual research subjects are not directbeneficiaries. Research also makes it possible to avoid the harm that may resultfrom the application of previously accepted routine practices that on closerinvestigation turn out to be dangerous. But the role of the principle of beneficenceis not always so unambiguous. A difficult ethical problem remains, for example,about research that presents more than minimal risk without immediate prospectof direct benefit to the children involved. Some have argued that such researchis inadmissible, while others have pointed out that this limit would rule outmuch research promising great benefit to children in the future. Here again, aswith all hard cases, the different claims covered by the principle of beneficencemay 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 çfairness in distributioné or çwhatis deserved.é An injustice occurs when some benefit to which a person isentitled is denied without good reason or when some burden is imposedunduly.Another way of conceiving the principle of justice is that equals ought tobe treated equally. However, this statement requires explication. Who is equaland 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 criteriajustifying differential treatment for certain purposes. It is necessary, then, toexplain in what respects people should be treated equally. There are several

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widely accepted formulations of just ways to distribute burdens and benefits.Each formulation mentions some relevant property on the basis of which burdensand benefits should be distributed. These formulations are (1) to each person anequal share, (2) to each person according to individual need, (3) to each personaccording 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 aspunishment, taxation and political representation. Until recently these questionshave not generally been associated with scientific research. However, they areforeshadowed even in the earliest reflections on the ethics of research involvinghuman subjects. For example, during the 19th and early 20th centuries theburdens 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 inNazi concentration camps was condemned as a particularly flagrant injustice. Inthis country, in the 1940ûs, the Tuskegee syphilis study used disadvantaged,rural black men to study the untreated course of a disease that is by no meansconfined to that population. These subjects were deprived of demonstrablyeffective treatment in order not to interrupt the project, long after such treatmentbecame generally available.

Against this historical background, it can be seen how conceptions of justice arerelevant to research involving human subjects. For example, the selection ofresearch subjects needs to be scrutinized in order to determine whether someclasses (e.g., welfare patients, particular racial and ethnic minorities, or personsconfined to institutions) are being systematically selected simply because oftheir easy availability, their compromised position, or their manipulability, ratherthan for reasons directly related to the problem being studied. Finally, wheneverresearch supported by public funds leads to the development of therapeuticdevices and procedures, justice demands both that these not provide advantagesonly to those who can afford them and that such research should not undulyinvolve persons from groups unlikely to be among the beneficiaries of subsequentapplications of the research.

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Part C: Applications

C. Applications

Applications of the general principles to the conduct of research leads toconsideration of the following requirements: informed consent, risk/benefitassessment, and the selection of subjects of research.

1. Informed Consent. -- Respect for persons requires that subjects, to thedegree that they are capable, be given the opportunity to choose what shall orshall not happen to them. This opportunity is provided when adequate standardsfor informed consent are satisfied.

While the importance of informed consent is unquestioned, controversy prevailsover the nature and possibility of an informed consent. Nonetheless, there iswidespread agreement that the consent process canbe analyzed as containingthree elements: information, comprehension and voluntariness.

Information. Most codes of research establish specific items for disclosureintended to assure that subjects are given sufficient information. These itemsgenerally include: the research procedure, their purposes, risks and anticipatedbenefits, alternative procedures (where therapy is involved), and a statementoffering the subject the opportunity to ask questions and to withdraw at any timefrom the research. Additional items have been proposed, including how subjectsare selected, the person responsible for the research, etc.

However, a simple listing of items does not answer the question of what thestandard should be for judging how much and what sort of information shouldbe provided. One standard frequently invoked in medical practice, namely theinformation commonly provided by practitioners in the field or in the locale, isinadequate since research takes place precisely when a common understandingdoes not exist. Another standard, currently popular in malpractice law, requiresthe practitioner to reveal the information that reasonable persons would wish toknow in order to make a decision regarding their care. This, too, seems insufficient

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since the research subject, being in essence a volunteer, may wish to knowconsiderably more about risks gratuitously undertaken than do patients whodeliver themselves into the hand of a clinician for needed care. It may be that astandard of çthe reasonable volunteeré should be proposed: the extent and natureof information should be such that persons, knowing that the procedure isneither necessary for their care nor perhaps fully understood, can decide whetherthey wish to participate in the furthering of knowledge. Even when some directbenefit to them is anticipated, the subjects should understand clearly the rangeof risk and the voluntary nature of participation.

A special problem of consent arises where informing subjects of some pertinentaspect of the research is likely to impair the validity of the research. In manycases, it is sufficient to indicate to subjects that they are being invited to participatein research of which some features will not be revealed until the research isconcluded. In all cases of research involving incomplete disclosure, such researchis justified only if it is clear that (1) incomplete disclosure is truly necessary toaccomplish the goals of the research, (2) there are no undisclosed risks tosubjects that are more than minimal, and (3) there is an adequate plan fordebriefing subjects, when appropriate, and for dissemination of research resultsto them. Information about risks should never be withheld for the purpose ofeliciting the cooperation of subjects, and truthful answers should always begiven to direct questions about the research. Care should be taken to distinguishcases in which disclosure would destroy or invalidate the research from cases inwhich disclosure would simply inconvenience the investigator.

Comprehension. The manner and context in which information is conveyed isas important as the information itself. For example, presenting information in adisorganized and rapid fashion, allowing too little time for consideration orcurtailing opportunities for questioning, all may adversely affect a subjectûsability to make an informed choice.

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Because the subjectûs ability to understand is a function of intelligence, rationality,maturity and language, it is necessary to adapt the presentation of the informationto the subjectûs capacities. Investigators are responsible for ascertaining that thesubject has comprehended the information. While there is always an obligationto ascertain that the information about risk to subjects is complete and adequatelycomprehended,when the risks are more serious, that obligation increases. Onoccasion, 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 ofsubjects that one might consider as incompetent(e.g., infants and young children,mentally disable patients, the terminally ill and the comatose) should be consideredon its own terms. Even for these persons, however, respect requires giving themthe opportunity to choose to the extent they are able, whether or not to participatein 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 inorder to protect the subjects from harm. Such persons are thus respected both byacknowledging their own wishes and by the use of third parties to protect themfrom harm.

The third parties chosen should be those who are most likely to understand theincompetent subjectûs situation and to act in that personûs best interest. Theperson authorized to act on behalf of the subject should be given an opportunityto observe the research as it proceeds in order to be able to withdraw the subjectfrom the research, if such action appears in the subjectûs best interest.

Voluntariness. An agreement to participate in research constitutes a validconsent only if voluntarily given.This element of informed consent requiresconditions free of coercion and undue influence. Coercion occurs when an overt

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threat of harm is intentionally presented by one person to another in order toobtain compliance. Undue influence, by contrast, occurs through an offer of anexcessive, unwarranted,inappropriate or improper reward or other overture inorder to obtain compliance. Also, inducements that would ordinarily be acceptablemay become undue influences if the subject is especially vulnerable.

Unjustifiable pressures usually occur when persons in positions of authority orcommanding influence -- especially where possible sanctions are involved --urge a course of action for a subject. A continuum of such influencing factorsexists, however, and it is impossible to state precisely where justifiable persuasionends and undue influence begins. But undue influence would include actionssuch as manipulating a personûs choice through the controlling influence of aclose relative and threatening to withdraw health services to which an individualwould otherwise be entitle.

2. Assessment of Risks and Benefits. -- The assessment of risks and benefitsrequires a careful arrayal of relevant data, including, in some cases, alternativeways of obtaining the benefits sought in the research.Thus, the assessmentpresents both an opportunity and a responsibility to gather systematic andcomprehensive information about proposed research. For the investigator, it is ameans to examine whether the proposed research is properly designed. For areview committee, it is a method for determining whether the risks that will bepresented to subjects are justified. For prospective subjects, the assessment willassist the determination whether or not to participate.

The Nature and Scope of Risks and Benefits. The requirement that research bejustified on the basis of a favorable risk/benefit assessment bears a close relationto the principle of beneficence, just as the moral requirement that informedconsent be obtained is derived primarily from the principle of respect forpersons.The term çriské refers to a possibility that harm may occur. However,

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when expressions such as çsmall riské or çhigh riské are used, they usuallyrefer (often ambiguously) both to the chance (probability) of experiencing aharm and the severity (magnitude) of the envisioned harm.

The term çbenefité is used in the research context to refer to something ofpositive value related to health or welfare. Unlike, çrisk,é çbenefité is not a termthat expresses probabilities. Risk is properly contrasted to probability of benefits,and benefits are properly contrasted with harms rather than risks ofharm.Accordingly, so-called risk/benefit assessments are concerned with theprobabilities and magnitudes of possible harm and anticipated benefits. Manykinds of possible harms and benefits need to be taken into account. There are,for example, risks of psychological harm, physical harm, legal harm, socialharm and economic harm and the corresponding benefits. While the most likelytypes of harms to research subjects are those of psychological or physical painor injury, other possible kinds should not be overlooked.

Risks and benefits of research may affect the individual subjects, the families ofthe individual subjects, and society at large (or special groups of subjects insociety). Previous codes and Federal regulations have required that risks tosubjects 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 begained from the research. In balancing these different elements, the risks andbenefits affecting the immediate research subject will normally carry specialweight. On the other hand, interests other than those of the subject may on someoccasions be sufficient by themselves to justify the risks involved in the research,so long as the subjectûs rights have been protected. Beneficence thus requiresthat we protect against risk of harm to subjects and also that we be concernedabout the loss of the substantial benefits that might be gained from research.

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The Systematic Assessment of Risks and Benefits. It is commonly said thatbenefits and risks must be çbalancedé and shown to be çin a favorable ratio.éThe metaphorical character of these terms draws attention to the difficulty ofmaking precise judgments. Only on rare occasions will quantitative techniquesbe 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 tobe thorough in the accumulation and assessment of information about all aspectsof the research, and to consider alternatives systematically. This procedure rendersthe assessment of research more rigorous and precise, while making communicationbetween review board members and investigators less subject to misinterpretation,misinformation and conflicting judgments. Thus, there should first be adetermination of the validity of the presuppositions of the research; then thenature, probability and magnitude of risk should be distinguished with as muchclarity as possible. The method of ascertaining risks should be explicit, especiallywhere there is no alternative to the use of such vague categories as small orslight risk. It should also be determined whether an investigatorûs estimates ofthe probability of harm or benefits are reasonable, as judged by known facts orother available studies.

Finally, assessment of the justifiability of research should reflect at least thefollowing considerations: (i) Brutal or inhumane treatment of human subjects isnever morally justified. (ii) Risks should be reduced to those necessary toachieve the research objective. It should be determined whether it is in factnecessary to use human subjects at all. Risk can perhaps never be entirelyeliminated, but it can often be reduced by careful attention to alternative procedures.(iii) When research involves significant risk of serious impairment, reviewcommittees should be extraordinarily insistent on the justification of the risk(looking usually to the likelihood of benefit to the subject-- or in some rarecases, to the manifest voluntariness of the participation). (iv) When vulnerable

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populations are involved in research, the appropriateness of involving themshould itself be demonstrated. A number of variables go into such judgments,including the nature and degree of risk, the condition of the particular populationinvolved, and the nature and level of the anticipated benefits. (v) Relevant risksand benefits must be thoroughly arrayed in documents and procedures used inthe informed consent process.

3. Selection of Subjects. -- just as the principle of respect for persons findsexpression in the requirements for consent, and the principle of beneficence inrisk/benefit assessment, the principle of justice gives rise to moral requirementsthat 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 socialand the individual. Individual justice in the selection of subjects would requirethat researchers exhibit fairness: thus, they should not offer potentially beneficialresearch only to some patients who are in their favor or select only çundesirableépersons for risky research. Social justice requires that distinction be drawnbetween classes of subjects that ought, and ought not, to participate in anyparticular kind of research, based on the ability of members of that class to bearburdens and on the appropriateness of placing further burdens on already burdenedpersons. Thus, it can be considered a matter of social justice that there is anorder of preference in the selection of classes of subjects (e.g., adults beforechildren) and that some classes of potential subjects(e.g., the institutionalizedmentally infirm or prisoners) may be involved as research subjects, if at all, onlyon certain conditions.

Injustice may appear in the selection of subjects, even if individual subjects areselected fairly by investigators and treated fairly in the course of research. Thusinjustice arises from social, racial, sexual and cultural biases institutionalized insociety. Thus, even if individual researchers are treating their research subjects

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fairly, and even if IRBs are taking care to assure that subjects are selectedfairly within a particular institution, unjust social patterns may neverthelessappear in the overall distribution of the burdens and benefits of research.Although individual institutions or investigators may not be able to resolve aproblem that is pervasive in their social setting, they can consider distributivejustice in selecting research subjects.

Some populations, especially institutionalized ones, are already burdened inmany ways by their infirmities and environments. When research is proposedthat involves risks and does not include a therapeutic component, other lessburdened classes of persons should be called upon first to accept these risks ofresearch, except where the research is directly related to the specific conditionsof the class involved. Also,even though public funds for research may oftenflow in the same directions as public funds for health care,it seems unfair thatpopulations dependent on public health care constitute a pool of preferred researchsubjects if more advantaged populations are likely to be the recipients of thebenefits.

One special instance of injustice results from the involvement of vulnerablesubjects. Certain groups, such as racial minorities, the economically disadvantaged,the very sick, and the institutionalized may continually be sought as researchsubjects, owing to their ready availability in settings where research is conducted.Given their dependent status and their frequently compromised capacity for freeconsent, they should be protected against the danger of being involved in researchsolely for administrative convenience, or because they are easy to manipulate asa result of their illness or socioeconomic condition.

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(1) Since 1945, various codes for the proper and responsible conduct of humanexperimentation in medical research have been adopted by different organizations.The best known of these codes are the Nuremberg Code of 1947, the HelsinkiDeclaration of 1964 (revised in 1975), and the 1971 Guidelines (codified intoFederal Regulations in 1974) issued by the U.S. Department of Health, Education,and Welfare Codes for the conduct of social and behavioral research have alsobeen adopted, the best known being that of the American PsychologicalAssociation, published in 1973.

(2) Although practice usually involves interventions designed solely to enhancethe well-being of a particular individual, interventions are sometimes applied toone individual for the enhancement of the well - being of another (e.g., blooddonation, skin grafts, organ transplants) or an intervention may have the dualpurpose of enhancing the well-being of a particular individual, and, at the sametime, providing some benefit to others (e.g., vaccination, which protects both theperson who is vaccinated and society generally).The fact that some forms ofpractice have elements other than immediate benefit to the individual receivingan intervention, however, should not confuse the general distinction betweenresearch and practice. Even when a procedure applied in practice may benefitsome other person, it remains an intervention designed to enhance the well-being of a particular individual or groups of individuals; thus, it is practice andneed not be reviewed as research.

(3) Because the problems related to social experimentation may differ substantiallyfrom those of biomedical and behavioral research, the Commission specificallydeclines to make any policy determination regarding such research at this time.Rather, the Commission believes that the problem ought to be addressed by oneof its successor bodies.