TheBelmontReportEthical Principlesand Guidelines forthe Protection ofHuman Subjectsof ResearchThe National Commissionfor the Protection of Human Subjectsof Biomedical and BehavioralResearchDHEW Publication No. (OS) 78-0012For sale by the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402

National Commission for the Protection of Human Subjectsof Biomedical and Behavioral ResearchSeptember 30, 1978Westwood Building, Room 1255333 Westbard AvenueBethesda, Maryland 20016Honorable Joseph A. Califano, Jr.Secretary of Health, Education, and WelfareWashington, D.C. 20201Dear Mr. Secretary:On behalf of the National Commission for the Protection of HumanSubjects of Biomedical and Behavioral Research, I am pleased to transmit our "Belmont Report: Ethical Principles and Guidelines for theProtection of Human Subjects of Research." The identification of basicethical principles that should underlie the conduct of research involvinghuman subjects, and the development of guidelines to assure that suchprinciples are followed, were topics of studies set forth in the Commission's mandate under Public Law 93-348. This mandate alsodirects the Commission to submit its report to the President, theCongress, and the Secretary of Health, Education, and Welfare.Unlike most of the previous reports of the Commission, theBelmont 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 adoptedin its entirety as a statement of departmental policy on the conduct ofresearch involving human subjects. Publication and dissemination ofthis policy will provide federal employees, members of InstitutionalReview Boards and scientific investigators with common points ofreference for the analysis of ethical issues in human experimentation.While the principles cannot always be applied so as to resolve beyonddispute particular ethical problems, they provide an analytical framework that will guide the resolution of ethical problems arising fromresearch involving human subjects.The Belmont Report is the outgrowth of an intensive four-day periodof discussions that were held in February 1976 at the Smithsonian Institution's Belmont Conference Center and the monthly Commission'sdeliberations that have been conducted over the nearly four years ofour existence.We appreciate the opportunity to have worked on this fundamentaltask in the protection of human research subjects.Respectfully,Kenneth J. Ryan, M.D.Chairman

NATIONAL COMMISSION FOR THE PROTECTION OF HUMAN SUBJECTSOF BIOMEDICAL AND BEHAVIORAL RESEARCHMEMBERS OF THE COMMISSIONKenneth John Ryan, M.D., ChairmanChief of StaffBoston Hospital for WomenJoseph V. Brady, Ph.D.Professor of Behavioral BiologyJohns Hopkins UniversityRobert E. Cooke, M.D.PresidentMedical College of PennsylvaniaDorothy I. HeightPresidentNational Council of Negro Women, Inc.Albert R. Jonsen, Ph.D.Associate Professor of BioethicsUniversity of California at San FranciscoPatricia King, J.D.Associate Professor of LawGeorgetown University Law CenterKaren Lebacqz, Ph.D.Associate Professor of Christian EthicsPacific School of Religion* David W. Louisell, J.D.Professor of LawUniversity of California at BerkeleyDonald W. Seldin, M.D.Professor and ChairmanDepartment of Internal MedicineUniversity of Texas at DallasEliot Stellar, Ph.D.Provost of the University andProfessor of Physiological PsychologyUniversity of Pennsylvania* Robert H. Turtle, LL.B.AttorneyVomBaur, Coburn, Simmons & TurtleWashington, D.C.* Deceased

NATIONAL COMMISSION FOR THE PROTECTION OF HUMAN SUBJECTSOF BIOMEDICAL AND BEHAVIORAL RESEARCHCOMMISSION STAFFPROFESSIONAL STAFFSUPPORT STAFFMichael S. Yesley, J.D.Staff DirectorPamela L. DriscollBarbara Mishkin, M.A.Assistant Staff DirectorDuane Alexander, M.D.PediatricsMarie D. MadiganCoral M. NydeggerErma L. PenderTom L. Beauchamp, Ph.D.PhilosophyBradford H. Gray, Ph.D.SociologyMiriam Kelty, Ph.D.PsychologyBetsy SingerPublic Information OfficerDorle VawterResearch AssistantSPECIAL CONSULTANTSRobert J. Levine, M.D.Stephen Toulmin, Ph.D.

TABLE OF CONTENTSA.Boundaries Between Practice and Research. . . . . . . .2B.Basic Ethical Principles. . . . . . . . . . . . . . .41.Respect for Persons . . . . . . . . . . . . . . . .42.Beneficence . . . . . . . . . . . . . . . . . . . .63.Justice . . . . . . . . . . . . . . . . . . . .8C.Applications. . . . . . . . . . . . . . . . . . . . . 101.Informed Consent. . . . . . . . . . . . . . . . . . . 102.Assessment of Risks and Benefits. . . . . . . . . . . 143.Selection of Subjects . . . . . . . . . . . . . . . . 18

B E L M O N T R E P O R TETHICAL PRINCIPLES AND GUIDELINES FOR RESEARCHINVOLVING HUMAN SUBJECTSScientific research has produced substantial social so posed some troubling ethical questions.It hasPublic attention was drawnto these questions by reported abuses of human subjects in biomedical experiments, especially during the Second World War.During the NurembergWar Crimes Trials, the Nuremberg Code was drafted as a set of standards forjudging physicians and scientists who had conducted biomedical experimentson concentration camp prisoners.This code became the prototype of manylater codes* intended to assure that research involving human subjectswould be carried out in an ethical manner.The codes consist of rules, some general, others specific, that guidethe investigators or the reviewers of research in their work.Such rulesoften are inadequate to cover complex situations; at times they come intoconflict, and they are frequently difficult to interpret or apply.Broaderethical principles will provide a basis on which specific rules may be formulated, criticized and interpreted.Three principles, or general prescriptive judgments, that are relevantto research involving human subjects are identified in this statement.*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 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 ofsocial and behavioral research have also been adopted, the best knownbeing 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 issuesinherent in research involving human subjects.These principles cannot alwaysbe applied so as to resolve beyond dispute particular ethical problems. Theobjective is to provide an analytical framework that will guide the resolutionof 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 RESEARCHIt is important to distinguish between biomedical and behavioral research,on the one hand, and the practice of accepted therapy on the other, in orderto know what activities ought to undergo review for the protection of humansubjects of research.The distinction between research and practice is blurredpartly because both often occur together (as in research designed to evaluatea therapy) and partly because notable departures from standard practice areoften called "experimental" when the terms "experimental" and "research" arenot 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 thathave a reasonable expectation of success.The purpose of medical or behavioralpractice is to provide diagnosis, preventive treatment or therapy to particular2

individuals.* By contrast, the term "research" designates an activity designed to test a hypothesis, permit conclusions to be drawn, and thereby todevelop or contribute to generalizable knowledge (expressed, for example,in theories, principles, and statements of relationships). Research isusually described in a formal protocol that sets forth an objective anda set of procedures designed to reach that objective.When a clinician departs in a significant way from standard or acceptedpractice, the innovation does not, in and of itself, constitute research.The fact that a procedure is "experimental," in the sense of new, untestedor different, does not automatically place it in the category of research.Radically new procedures of this description should, however, be made theobject of formal research at an early stage in order to determine whetherthey are safe and effective.Thus, it is the responsibility of medicalpractice 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 ofanother (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 andsociety generally). The fact that some forms of practice have elementsother than immediate benefit to the individual receiving an intervention,however, should not confuse the general distinction between research andpractice. Even when a procedure applied in practice may benefit someother person, it remains an intervention designed to enhance the wellbeing of a particular individual or groups of individuals; thus, it ispractice 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 notcause 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 PRINCIPLESThe expression "basic ethical principles" refers to those general judgments that serve as a basic justification for the many particular ethicalprescriptions and evaluations of human actions. Three basic principles,among those generally accepted in our cultural tradition, are particularlyrelevant to the ethics of research involving human subjects:the principlesof respect for persons, beneficence and justice.1.Respect for PersonsRespect 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.*TheBecause the problems related to social experimentation may differ substantially from those of biomedical and behavioral research, the Commissionspecifically declines to make any policy determination regarding such research at this time. Rather, the Commission believes that the problemought 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 toprotect those with diminished autonomy.An autonomous person is an individual capable of deliberation aboutpersonal goals and of acting under the direction of such deliberation. Torespect autonomy is to give weight to autonomous persons' considered opinionsand choices while refraining from obstructing their actions unless they areclearly detrimental to others.To show a lack of respect for an autonomousagent 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 compellingreasons to do so.However, not every human being is capable of self-determination. Thecapacity for self-determination matures during an individual's life, andsome 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 asthey mature or while they are incapacitated.Some persons are in need of extensive protection, even to the pointof excluding them from activities which may harm them; other persons requirelittle protection beyond making sure they undertake activities freely and withawareness of possible adverse consequences.The extent of protection affordedshould depend upon the risk of harm and the likelihood of benefit.The judg-ment that any individual lacks autonomy should be periodically reevaluatedand will vary in different situations.5

In most cases of research involving human subjects, respect for personsdemands that subjects enter into the research voluntarily and with adequateinformation.In some situations, however, application of the principle isnot obvious.The involvement of prisoners as subjects of research providesan instructive example.On the one hand, it would seem that the principleof respect for persons requires that prisoners not be deprived of the opportunity to volunteer for research.On the other hand, under prison conditionsthey 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 personsWhether to allow prisonersto "volunteer" or to "protect" them presents a dilemma.Respecting persons,in most hard cases, is often a matter of balancing competing claims urgedby the principle of respect itself.2.BeneficencePersons are treated in an ethical manner not only by respecting theirdecisions and protecting them from harm, but also by making efforts to securetheir well-being.Such treatment falls under the principle of beneficence.The term "beneficence" is often understood to cover acts of kindness orcharity that go beyond strict obligation.In this document, beneficence isunderstood in a stronger sense, as an obligation.Two general rules havebeen formulated as complementary expressions of beneficent actions in thissense:(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 thatmight come to others.However, even avoiding harm requires learning what isharmful; and, in the process of obtaining this information, persons may beexposed to risk of harm.Further, the Hippocratic Oath requires physiciansto benefit their patients "according to their best judgment."what will in fact benefit may require exposing persons to risk.LearningThe problemposed by these imperatives is to decide when it is justifiable to seek certain benefits despite the risks involved, and when the benefits should beforegone because of the risks.The obligations of beneficence affect both individual investigatorsand society at large, because they extend both to particular research projects and to the entire enterprise of research.In the case of particularprojects, investigators and members of their institutions are obliged togive forethought to the maximization of benefits and the reduction of riskthat might occur from the research investigation.In the case of scientificresearch in general, members of the larger society are obliged to recognizethe longer term benefits and risks that may result from the improvement ofknowledge and from the development of novel medical, psychotherapeutic, andsocial procedures.The principle of beneficence oftenoccupies a well-defined justifyingrole in many areas of research involving human subjects.found in research involving children.An example isEffective ways of treating childhooddiseases and fostering healthy development are benefits that serve to7

justify research involving children -- even when individual research subjectsare not the direct beneficiaries.Research also makes it possible to avoidthe harm that may result from the application of previously accepted routinepractices that on closer investigation turn out to be dangerous.role of the principle of beneficence is not always so unambiguous.But theA diffi-cult ethical problem remains, for example, about research that presents morethan minimal risk withhout immediate prospect of direct benefit to the children involved.Some have argued that such research is inadmissible, whileothers have pointed out that this limit would rule out much research promisinggreat benefit to children in the future.Here again, as with all hard cases,the different claims covered by the principle of beneficence may come intoconflict and force difficult choices.3.JusticeWho 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 imposedunduly.Another way of conceiving the principle of justice is that equalsought to be treated equally.Who is equal and who unequal?equal distribution?However, this statement requires explication.What considerations justify departure fromAlmost all commentators allow that distinctions basedon experience, age, deprivation, competence, merit and position do sometimesconstitute criteria justifying differential treatment for certain purposes.It is necessary, then, to explain in what respects people should be treated8

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.Theseformulations 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) toeach person according to merit.Questions of justice have long been associated with social practicessuch as punishment, taxation and political representation.Until recentlythese questions have not generally been associated with scientific research.However, they are foreshadowed even in the earliest reflections on the ethicsof research involving human subjects.For example, during the 19th andearly 20th centuries the burdens of serving as research subjects fell largelyupon poor ward patients, while the benefits of improved medical care flowedprimarily to private patients.Subsequently, the exploitation of unwillingprisoners as research subjects in Nazi concentration camps was condemmed asa particularly flagrant injustice.In this country, in the 1940s, the Tuske-gee syphilis study used disadvantaged, rural black men to study the untreatedcourse of a disease that is by no means confined to that population.Thesesubjects were deprived of demonstrably effective treatment in order not tointerrupt the project, long after such treatment became generally available.Against this historical background, it can be seen how conceptions ofjustice 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 and9

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 directlyrelated to the problem being studied.Finally, whenever research supportedby public funds leads to the development of therapeutic devices and procedures,justice demands both that these not provide advantages only to those who canafford them and that such research should not unduly involve persons fromgroups unlikely to be among the beneficiaries of subsequent applications ofthe research.C. APPLICATIONSApplication of the general principles to the conduct of research leadsto consideration of the following requirements:informed consent, risk/bene-fit assessment, and the selection of subjects of research.1.Informed ConsentRespect for persons requires that subjects, to the degree that they arecapable, be given the opportunity to choose what shallto them.or shall not happenThis opportunity is provided when adequate standards for informedconsent are satisfied.While the importance of informed consent is unquestioned, controversyprevails 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 isinvolved),and a statement offering the subject the opportunity to askquestions and to withdraw at any time from the research.Additional itemshave 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 ofwhat 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 fieldor in the locale, is inadequate since research takes place precisely when acommon understanding does not exist.Another standard, currently popularin mal practice law, requires the practitioner to reveal the informationthat 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 risksgratuitously undertaken than do patients who deliver themselves into thehands of a clinician for needed care.It may be that a standard of "thereasonable volunteer" should be proposed:the extent and nature of infor-mation should be such that persons, knowing that the procedure is neithernecessary for their care nor perhaps fully understood, can decide whetherthey wish to participate in the furthering of knowledge.Even when somedirect benefit to them is anticipated, the subjects should understand clearlythe range of risk and the voluntary nature of participation.11

A special problem of consent arises where informing subjects of somepertinent aspect of the research is likely to impair the validity of theresearch.In many cases, it is sufficient to indicate to subjects that theyare being invited to participate in research of which some features willnot be revealed until the research is concluded.In all cases of researchinvolving incomplete disclosure, such research is justified only if it isclear that (1) incomplete disclosure is truly necessary to accomplish thegoals of the research, (2) there are no undisclosed risks to subjects thatare 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 elicitingthe cooperation of subjects, and truthful answers should always be given todirect questions about the research.Care should be taken to distinguishcases in which disclosure would destroy or invalidate the research from casesin which disclosure would simply inconvenience the investigator.Comprehension.The manner and context in which information is conveyedis 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 adverselyaffect 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 areresponsible for ascertaining that the subject has comprehended the information.12

While there is always an obligation to ascertain that the information aboutrisk to subjects is complete and adequately comprehended, when the risks aremore serious, that obligation increases.On occasion, it may be suitableto give some oral or written test of comprehension.Special provision may need to be made when comprehension is severelylimited - 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 illand the comatose) should be considered on its own terms.Even for thesepersons, however, respect requires giving them the opportunity to chooseto the extent they are able, whether or not to participate in research.The objections of these subjects to involvement should be honored, unlessthe research entails providing them a therapy unavailable elsewhere.Res-pect for persons also requires seeking the permission of other partiesin order to protect the subjects from harm.Such persons are thus res-pected both by acknowledging their own wishes and by the use of thirdparties 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'sbest interest.The person authorized to act on behalf of the subjectshould be given an opportunity to observe the research as it proceeds inorder to able to withdraw the subject from the research,appears in the subject's best interest.13if such action

Voluntariness.An agreement to participate in research constitutesa valid consent only if voluntarily given.This element of informed con-sent requires conditions free of coercion and undue influence.occurs whenCoercionan overt threat of harm is intentionally presented by oneperson to another in order to obtain compliance.Undue influence, bycontrast, 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 undueinfluences if the subject is especially vulnerable.Unjustifiable pressures usually occur when persons in positions ofauthority or commanding influence -- especially where possible sanctionsare involved -- urge a course of action for a subject.A continuum ofsuch influencing factors exists, however, and it is impossible to stateprecisely where justifiable persuasion ends and undue influence begins.But undue influence would include actions such as manipulating a person'schoice through the controlling influence of a close relative and threatening to withdraw health services to which an individual would otherwisebe entitled.2.Assessment of Risks and BenefitsThe assessment of risks and benefits requires a careful arrayal ofrelevent data, including, in some cases,alternative ways of obtainingthe benefits sought in the research.Thus, the assessment presents bothan opportunity and a responsibility to gather systematic and comprehensive information about proposed research.14For 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 risksthat will be presented to subjects are justified.For prospective sub-jects, the assessment will assist the determination whether or not toparticipate.The Nature and Scope of Risks and Benefits . The requirement that research be justified on the basis of a favorable risk/benefit assessmentbears a close relation to the principle of beneficence, just as the moralrequirement that informed consent be obtained is derived primarily fromthe principle of respect for persons.bility that harm may occur.The term "risk" refers to a possi-However, when expressions such as "smallrisk" or "high risk" are used, they usually refer (often ambiguously) bothto 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 properlycontrasted 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 magnitudesof possible harms and anticipated benefits.and benefits need be taken into account.Many kinds of possible harmsThere are, for example, risksof psychological harm, physical harm, legal harm, social harm and economic harm and the corresponding benefits.15While the most likely types

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 of the individual subjects, and society at large (or specialgroups of subjects in society).Previous codes and federal regulationshave required that risks to subjects be outweighed by the

The Belmont Report is the outgrowth of an intensive four-day period of discussions that were held in February 1976 at the Smithsonian Insti- tution's Belmont Conference Center and the monthly Commission's deliberatio