The Belmont Report

Ethical Principles and Guidelines for the Protection of Human Subjects

Government document

By: United States Department of Health, Education, and Welfare. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research

Date: April 18, 1979

Source: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Washington, D.C.: U.S.G.P.O., 1979.

About the Author: Congress passed the National Research Act of 1974 in the wake of negative publicity for both the government and the scientific community regarding the cruel treatment of some medical research subjects. Among the consequences of this act was the Department of Health, Education, and Welfare (DHEW) creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which met at the Belmont House in Elkridge, Maryland, beginning in February 1976.

INTRODUCTION

In the 1960s, the concept of human individual autonomy rose to the forefront of political discourse throughout the Western world. One part of this discourse that continues its crescendo at the beginning of the twenty-first century concerns the rights of patients and biomedical research subjects. Two gradual disclosures in the late 1960s and early 1970s were the major impetus for passing the National Research Act, for founding the Office for Protection from Research Risks (OPRR) in 1972, and ultimately for writing the Belmont Report.

From 1932 to 1972, the United States Public Health Service (USPHS) studied the full natural course of syphilis among 399 poor African American men in Tuskegee, Alabama. The USPHS lied to these men about the purpose of the study, deceived them about the nature of their disease, and deliberately withheld curative treatment from them even after penicillin was proved effective against syphilis in the 1940s. From 1955 to 1972, New York State sponsored experiments on hepatitis among mentally retarded children at Willowbrook State School for the Retarded, Staten Island. These incompetent research subjects were exploited without the informed consent of their parents or legal guardians. Shortly after the press published these stories, the federal government took decisive action to prevent the further undermining of public trust in science and medicine.

PRIMARY SOURCE

ETHICAL PRINCIPLES AND GUIDELINES FOR THE PROTECTION OF HUMAN SUBJECTS OF RESEARCH

Part B: Basic Ethical Principles The expression "basic ethical principles" refers to those general judgments that serve as a basic justification for the many particular ethical prescriptions and evaluations of human actions. Three basic principles, among those generally accepted in our cultural tradition, are particularly relevant to the ethics of research involving human subjects: the principles of respect of persons, beneficence and justice.

1. Respect for Persons. Respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection. The principle of respect for persons thus divides into two separate moral requirements: the requirement to acknowledge autonomy and the requirement to protect those with diminished autonomy.

An autonomous person is an individual capable of deliberation about personal goals and of acting under the direction of such deliberation. To respect autonomy is to give weight to autonomous persons' considered opinions and choices while refraining from obstructing their actions unless they are clearly detrimental to others. To show lack of respect for an autonomous agent is to repudiate that person's considered judgments, to deny an individual the freedom to act on those considered judgments, or to withhold information necessary to make a considered judgment, when there are no compelling reasons to do so.

However, not every human being is capable of self-determination. The capacity for self-determination matures during an individual's life, and some individuals lose this capacity wholly or in part because of illness, mental disability, or circumstances that severely restrict liberty. Respect for the immature and the incapacitated may require protecting them as they mature or while they are incapacitated.

Some persons are in need of extensive protection, even to the point of excluding them from activities which may harm them; other persons require little protection beyond making sure they undertake activities freely and with awareness of possible adverse consequences. The extent of protection afforded should depend upon the risk of harm and the likelihood of benefit. The judgment that any individual lacks autonomy should be periodically reevaluated and will vary in different situations.

In most cases of research involving human subjects, respect for persons demands that subjects enter into the research voluntarily and with adequate information. In some situations, however, application of the principle is not obvious. The involvement of prisoners as subjects of research provides an instructive example. On the one hand, it would seem that the principle of respect for persons requires that prisoners not be deprived of the opportunity to volunteer for research. On the other hand, under prison conditions they may be subtly coerced or unduly influenced to engage in research activities for which they would not otherwise volunteer. Respect for persons would then dictate that prisoners be protected. Whether to allow prisoners to "volunteer" or to "protect" them presents a dilemma. Respecting persons, in most hard cases, is often a matter of balancing competing claims urged by the principle of respect itself.

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

The Hippocratic maxim "do no harm" has long been a fundamental principle of medical ethics. Claude Bernard extended it to the realm of research, saying that one should not injure one person regardless of the benefits that might come to others. However, even avoiding harm requires learning what is harmful; and, in the process of obtaining this information, persons may be exposed to risk of harm. Further, the Hippocratic Oath requires physicians to benefit their patients "according to their best judgment." Learning what will in fact benefit may require exposing persons to risk. The problem posed by these imperatives is to decide when it is justifiable to seek certain benefits despite the risks involved, and when the benefits should be foregone because of the risks.

The obligations of beneficence affect both individual investigators and society at large, because they extend both to particular research projects and to the entire enterprise of research. In the case of particular projects, investigators and members of their institutions are obliged to give forethought to the maximization of benefits and the reduction of risk that might occur from the research investigation. In the case of scientific research in general, members of the larger society are obliged to recognize the longer term benefits and risks that may result from the improvement of knowledge and from the development of novel medical, psychotherapeutic, and social procedures.

The principle of beneficence often occupies a well-defined justifying role in many areas of research involving human subjects. An example is found in research involving children. Effective ways of treating childhood diseases and fostering healthy development are benefits that serve to justify research involving children—even when individual research subjects are not direct beneficiaries. Research also makes it possible to avoid the harm that may result from the application of previously accepted routine practices that on closer investigation turn out to be dangerous. But the role of the principle of beneficence is not always so unambiguous. A difficult ethical problem remains, for example, about research that presents more than minimal risk without immediate prospect of direct benefit to the children involved. Some have argued that such research is inadmissible, while others have pointed out that this limit would rule out much research promising great benefit to children in the future. Here again, as with all hard cases, the different claims covered by the principle of beneficence may come into conflict and force difficult choices.

3. Justice. Who ought to receive the benefits of research and bear its burdens? This is a question of justice, in the sense of "fairness in distribution" or "what is deserved." An injustice occurs when some benefit to which a person is entitled is denied without good reason or when some burden is imposed unduly. Another way of conceiving the principle of justice is that equals ought to be treated equally. However, this statement requires explication. Who is equal and who is unequal? What considerations justify departure from equal distribution? Almost all commentators allow that distinctions based on experience, age, deprivation, competence, merit and position do sometimes constitute criteria justifying differential treatment for certain purposes. It is necessary, then, to explain in what respects people should be treated equally. There are several widely accepted formulations of just ways to distribute burdens and benefits. Each formulation mentions some relevant property on the basis of which burdens and benefits should be distributed. These formulations are (1) to each person an equal share, (2) to each person according to individual need, (3) to each person according to individual effort, (4) to each person according to societal contribution, and (5) to each person according to merit.

Questions of justice have long been associated with social practices such as punishment, taxation and political representation. Until recently these questions have not generally been associated with scientific research. However, they are foreshadowed even in the earliest reflections on the ethics of research involving human subjects. For example, during the nineteenth and early twentieth centuries the burdens of serving as research subjects fell largely upon poor ward patients, while the benefits of improved medical care flowed primarily to private patients. Subsequently, the exploitation of unwilling prisoners as research subjects in Nazi concentration camps was condemned as a particularly flagrant injustice. In this country, in the 1940's, the Tuskegee syphilis study used disadvantaged, rural black men to study the untreated course of a disease that is by no means confined to that population. These subjects were deprived of demonstrably effective treatment in order not to interrupt the project, long after such treatment became generally available.

Against this historical background, it can be seen how conceptions of justice are relevant to research involving human subjects. For example, the selection of research subjects needs to be scrutinized in order to determine whether some classes (e.g., welfare patients, particular racial and ethnic minorities, or persons confined to institutions) are being systematically selected simply because of their easy availability, their compromised position, or their manipulability, rather than for reasons directly related to the problem being studied. Finally, whenever research supported by public funds leads to the development of therapeutic devices and procedures, justice demands both that these not provide advantages only to those who can afford them and that such research should not unduly involve persons from groups unlikely to be among the beneficiaries of subsequent applications of the research.

Part C: Applications Applications of the general principles to the conduct of research leads to consideration of the following requirements: informed consent, risk/benefit assessment, and the selection of subjects of research.

1. Informed Consent. Respect for persons requires that subjects, to the degree that they are capable, be given the opportunity to choose what shall or shall not happen to them. This opportunity is provided when adequate standards for informed consent are satisfied. While the importance of informed consent is unquestioned, controversy prevails over the nature and possibility of an informed consent. Nonetheless, there is widespread agreement that the consent process can be analyzed as containing three elements: information, comprehension and voluntariness.

Information. Most codes of research establish specific items for disclosure intended to assure that subjects are given sufficient information. These items generally include: the research procedure, their purposes, risks and anticipated benefits, alternative procedures (where therapy is involved), and a statement offering the subject the opportunity to ask questions and to withdraw at any time from the research. Additional items have been proposed, including how subjects are selected, the person responsible for the research, etc.

However, a simple listing of items does not answer the question of what the standard should be for judging how much and what sort of information should be provided. One standard frequently invoked in medical practice, namely the information commonly provided by practitioners in the field or in the locale, is inadequate since research takes place precisely when a common understanding does not exist. Another standard, currently popular in malpractice law, requires the practitioner to reveal the information that reasonable persons would wish to know in order to make a decision regarding their care. This, too, seems insufficient since the research subject, being in essence a volunteer, may wish to know considerably more about risks gratuitously undertaken than do patients who deliver themselves into the hand of a clinician for needed care. It may be that a standard of "the reasonable volunteer" should be proposed: the extent and nature of information should be such that persons, knowing that the procedure is neither necessary for their care nor perhaps fully understood, can decide whether they wish to participate in the furthering of knowledge. Even when some direct benefit to them is anticipated, the subjects should understand clearly the range of risk and the voluntary nature of participation.

A special problem of consent arises where informing subjects of some pertinent aspect of the research is likely to impair the validity of the research. In many cases, it is sufficient to indicate to subjects that they are being invited to participate in research of which some features will not be revealed until the research is concluded. In all cases of research involving incomplete disclosure, such research is justified only if it is clear that (1) incomplete disclosure is truly necessary to accomplish the goals of the research, (2) there are no undisclosed risks to subjects that are more than minimal, and (3) there is an adequate plan for debriefing subjects, when appropriate, and for dissemination of research results to them. Information about risks should never be withheld for the purpose of eliciting the cooperation of subjects, and truthful answers should always be given to direct questions about the research. Care should be taken to distinguish cases in which disclosure would destroy or invalidate the research from cases in which disclosure would simply inconvenience the investigator.

Comprehension. The manner and context in which information is conveyed is as important as the information itself. For example, presenting information in a disorganized and rapid fashion, allowing too little time for consideration or curtailing opportunities for questioning, all may adversely affect a subject's ability to make an informed choice.

Because the subject's ability to understand is a function of intelligence, rationality, maturity and language, it is necessary to adapt the presentation of the information to the subject's capacities. Investigators are responsible for ascertaining that the subject has comprehended the information. While there is always an obligation to ascertain that the information about risk to subjects is complete and adequately comprehended, when the risks are more serious, that obligation increases. On occasion, it may be suitable to give some oral or written tests of comprehension.

Special provision may need to be made when comprehension is severely limited—for example, by conditions of immaturity or mental disability. Each class of subjects that one might consider as incompetent (e.g., infants and young children, mentally disable patients, the terminally ill and the comatose) should be considered on its own terms. Even for these persons, however, respect requires giving them the opportunity to choose to the extent they are able, whether or not to participate in research. The objections of these subjects to involvement should be honored, unless the research entails providing them a therapy unavailable elsewhere. Respect for persons also requires seeking the permission of other parties in order to protect the subjects from harm. Such persons are thus respected both by acknowledging their own wishes and by the use of third parties to protect them from harm.

The third parties chosen should be those who are most likely to understand the incompetent subject's situation and to act in that person's best interest. The person authorized to act on behalf of the subject should be given an opportunity to observe the research as it proceeds in order to be able to withdraw the subject from the research, if such action appears in the subject's best interest.

Voluntariness. An agreement to participate in research constitutes a valid consent only if voluntarily given. This element of informed consent requires conditions free of coercion and undue influence. Coercion occurs when an overt threat of harm is intentionally presented by one person to another in order to obtain compliance. Undue influence, by contrast, occurs through an offer of an excessive, unwarranted, inappropriate or improper reward or other overture in order to obtain compliance. Also, inducements that would ordinarily be acceptable may become undue influences if the subject is especially vulnerable.

Unjustifiable pressures usually occur when persons in positions of authority or commanding influence—especially where possible sanctions are involved—urge a course of action for a subject. A continuum of such influencing factors exists, however, and it is impossible to state precisely where justifiable persuasion ends and undue influence begins. But undue influence would include actions such as manipulating a person's choice through the controlling influence of a close relative and threatening to withdraw health services to which an individual would otherwise be entitled.

SIGNIFICANCE

The Belmont Report prompted much new legislation and regulation in the decades following. In 1991, the Department of Health and Human Services (DHHS) codified the "Federal Policy for the Protection of Human Subjects." This policy is called the "Common Rule" because, even though created by DHHS, it applies equally to all federal departments and agencies that grant money for scientific research that involves human subjects. Among other provisions, it strengthened the 1974 mandate that every institution receiving federal funds for research must have its own Institutional Review Board (IRB) to approve all research protocols. In 2000, the OPRR, now within DHHS, became the Office for Human Research Protections (OHRP).

Legal and ethical issues surrounding informed consent and informed refusal remain in a state of flux and continue to be a major concern of the federal government. In 1998, the National Bioethics Advisory Commission issued a report called Research Involving Persons with Mental Disorders that may Affect Decisionmaking Capacity. Abuses, carelessness, and deaths still occur, even at the most prestigious American academic research institutions. Eighteen-year-old Jesse Gelsinger died during experimental gene therapy for his rare metabolic disease in 1999 at the University of Pennsylvania. Twenty-four-year-old Ellen Roche, a healthy volunteer, died of a reaction to an experimental medication for asthma in 2001 at Johns Hopkins University. In such cases federal agents immediately intervene, scrutinizing the IRB, the principal investigator, and the protocols. The government retains the authority to suspend funding and even to shut down the whole research enterprise of the institution.

FURTHER RESOURCES

Books

Berg, Jessica W., Paul S. Appelbaum, Charles W. Lidz, and Lisa S. Parker. Informed Consent: Legal Theory and Clinical Practice. 2nd edition. New York: Oxford University Press, 2001.

Doyal, Len, and Jeffrey S. Tobias, eds. Informed Consent in Medical Research. London: BMJ Books, 2001.

Getz, Kenneth, and Deborah Borlitz. Informed Consent: The Consumer's Guide to the Risks and Benefits of Volunteering for Clinical Trials. Boston: CenterWatch, 2003.

Periodicals

Beauchamp, Tom. "The Legacy and the Future: 30 Years after the Belmont Report." Protecting Human Subjects. vol. 10 (2004): 1-3.

Cassell, Eric J. "The Principles of the Belmont Report Revisited: How Have Respect for Persons, Beneficence, and Justice Been Applied to Clinical Medicine?" Hastings Center Report. vol. 30, no. 4 (July-August 2000): 12-21.

Web sites

Georgetown University. "The Birth of the Belmont Report." 〈http://www.georgetown.edu/research/nrcbl/nbac/transcripts/jul98/belmont.html〉 (accessed January 15, 2006).

Kent State University. "ISB National Research Act." 〈http://www.kent.edu/rags/Compliance/IRB-National-Research-Act.cfm〉 (accessed January 15, 2006).

National Institutes of Health. "Regulations and Ethical Guidelines." 〈http://ohsr.od.nih.gov/guidelines/belmont.html〉 (accessed January 9, 2006).

United States Department of Health and Human Services. "Code of Federal Regulations, Title 45, Public Welfare, Part 46, Protection of Human Subjects, Revised June 23, 2005, Effective June 23, 2005." 〈http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm〉 (accessed January 9, 2006).

United States Department of Health and Human Services, Office for Human Research Protections. "Belmont Report." 〈http://www.hhs.gov/ohrp/belmontArchive.html〉 (accessed January 9, 2006).

United States Department of Health and Human Services, Office for Human Research Protections. "Policy Guidance." 〈http://www.hhs.gov/ohrp/policy/〉 (accessed January 9, 2006).