Belmont report


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Belmont report

  1. 1. The Belmont Report: An Ethical Framework for Protecting Research Subjects Janet F. Zimmerman, MS, RN, Clinical Research Training Consultant, Newtown, PAI NTRODUCTION Twenty years ago, a select group of 11 American men and women were in the midst of a congressional assignment. The assignment was to “identify the basic ethical principles that should underlie the conduct of biomedical and behavioralresearch involving human subjects and to develop guidelines which should be followed toassure that such research is conducted in accordance with those principles.” 1 In 1979,these principles were published in what is commonly known as The Belmont Report.While never formally adopted, The Belmont Report has become the primary ethical framework forprotecting human research subjects in the United States. Most of us have some knowledge of BACKGROUND two international codes were adoptedthe U.S. Food and Drug Administration At its basic level, the U.S. Congress for physicians and scientists conduct-(FDA) statutes, which are published is an agent of change, enacting laws as ing research with human Title 21 of the Code of Federal Reg- a response to events or problems They were The Nuremberg Code inulations (CFR), or those of U.S. Public requiring national uniformity. On July 1947 and the Declaration of HelsinkiHealth Service (PHS) which are pub- 12, 1974, Congress passed the in 1964, which has since been revisedlished in Title 45 CFR. However, we National Research Act, primarily in and updated. At the time, each ofmay be less familiar with non-regula- response to the USPHS-sponsored these international standards delin-tory guidelines, such as The Belmont syphilis studies that were conducted eated ethical principles for informedReport, that have importance in on indigent African-American males consent and medical care of researchresearch involving human subjects. in Tuskegee, Alabama from 1932 to subjects, both of which were disre-Our goal is to briefly explain some of 1972. When the story broke, the garded in the syphilis studies. Forthe historical events that led to The tragic events of these studies were whatever reasons, the United StatesBelmont Report and to provide an widely reported in the press. In fact, government continued to sponsoroverview of the Belmont principles the syphilis studies are still newswor- research in humans that should haveand the underlying message of the thy as exemplified by the made-for- been guided by the Nuremberg andreport. television movie, Miss Evers’ Boys, Helsinki principles. While the United broadcast on HBO earlier this year. It is interesting to note that during the 40 years of the syphilis studies, the monitor s summer 1997
  2. 2. States was the primary sponsor of The became the basis for future DHHS THE BELMONT REPORTNuremberg Code, the United States laws. In 1981, Congress enacted three The objective of The Belmontwas not a signatory to the Declaration DHHS statutes that demonstrated a Report “is to provide an analyticalof Helsinki. remarkable collaborative effort within framework that will guide the resolu- However, codes and principles are DHHS. They are FDA regulation 21 tion of ethical problems arising fromnot regulations, and therefore are not CFR Part 50 and PHS regulation 45 research involving human subjects.” 2enforceable by law. With the 1974 CFR Part 46, both titled Protection of The framework of The Belmont ReportNational Research Act, Congress Human Subjects. The third 1981 is presented in three discussionmandated the establishment of insti- statute is FDA regulation 21 CFR Part topics: boundaries between practicetutional review boards (IRBs) to 56, titled Institutional Review Boards. and research, basic ethical principles,review all federally funded human and applications.research. Until this time, hospital orinstitutional review of research activi- 1. Boundaries Between Practiceties for purposes of protecting humansubjects was voluntary, informal, and “ Technically, and Research Practice refers to interventionswithout established criteria. that are intended to solely improve the the United States The National Research Act also well being of the patient. They arecreated the National Commission for accepted standards that have a reason-the Protection of Human Subjects of does not have a able expectation of success. The goalBiomedical and Behavioral Research. of practice is to provide a diagnosis,The 11 members of the Commission, preventive treatment, or therapy that national policy forwho represented science, law, ethics, will enhance the patient’s wellness. Inand society, published several state- most cases, practice standards arements or reports on various aspects of protecting research supported by research findings.research with human subjects. These Research refers to activities thatreports outlined recommendations to are designed to develop or contribute subjects.”the Secretary of the Department of to the general body of knowledge.Health, Education, and Welfare General knowledge includes theories,(DHEW), now known as the Depart- principles, and relationships.ment of Health and Human Services Since neither Congress or DHEW Research activities test a hypothesis,(DHHS). (now DHHS) moved to formally adopt are validated by statistical measures, One of the Commission’s statements The Belmont Report in its entirety, and allow conclusions to be drawn.was The Belmont Report: Ethical Prin- arguably, the United States does not Research is written in a formalciples and Guidelines for the Protection have a national policy for protecting protocol that can be reviewed andof Human Subjects of Research com- research subjects. Yes, there are the replicated by others. In research, ben-monly referred to as The Belmont aforementioned DHHS statutes, but efits are not always known nor areReport. The Commission recommended these are mandates too restrictive and they assured. Because harm mayto the DHEW Secretary that The Bel- inflexible to be used as a dynamic result during research, the protectionmont Report be adopted in its entirety, foundation for evolving biomedical of subjects is paramount.representing DHEW policy. While The ethics. It is not uncommon to have practiceBelmont Report was never officially Despite the lack of endorsement and research occur simultaneously inendorsed, many of the Commission’s by either DHEW or Congress, The clinical trials, particularly if the safetyrecommendations in this statement Belmont Report is indeed alive. It is and efficacy of the investigational recognized by many, albeit quietly, as treatment are being evaluated. During the United States’ contribution to the the informed consent process, short list of international guidelines for protecting human subjects involved in research. the monitor s summer 1997
  3. 3. subjects must clearly know which efforts to improve an individual’s well activities: informed consent, assess-study activities are standard practice being. The principle of beneficence is ment of risks and benefits, and selec-and which are research. firmly embedded in the ethical tradi- tion of research subjects. tion of medicine as defined by Hip-2. Basic Ethical Principles pocrates: “As to diseases, make a a. Informed Consent The Belmont Report identifies three habit of two things — to help, or at The first Belmont principle,fundamental principles that underlie least to do no harm.” However, in respect for persons, requires thatall research involving human subjects: order to help and avoid harm, we must research subjects be given the oppor-respect for persons, beneficence, and first learn what is harmful. tunity to decide what will or will notjustice. For research that will benefit soci- happen to them. This opportunity ety, subjects may be exposed to a risk occurs during the informed consenta. Respect for Persons of harm with no personal benefit. In process, which contains three compo- Respect for persons includes two research, an ethical dilemma occurs in nents: information, comprehension,ethical presumptions. The first is that deciding when it is proper to pursue and voluntariness.persons should be treated as certain benefits despite the risks Information. When presentingautonomous individuals, capable of involved, and when the benefits information, it is essential for subjectsmaking their own decisions. should be foregone because of known to understand the research is neitherAutonomous individuals possess the or potential risks to the subject. necessary for their well being nor arecapacity for self-determination. We the effects of the research fully knowndemonstrate our respect for persons c. Justice or understood. Understanding this,when we encourage and accept an Justice is the third basic principle subjects can decide if they wish toindividual’s opinions and choices. We identified in The Belmont Report. Jus- participate in the research for the pur-show a lack of respect for persons tice requires that each person is treat- pose of contributing to general knowl-when we withhold information and ed fairly, equitably, and given what he edge. If a direct benefit to subjects isdeny individuals the freedom to make or she is due. There is an equal distri- expected, they should clearly under-an informed decision. bution of benefits as well as burdens. stand the range of risks. The second presumption is that not An injustice occurs when a benefit to The minimum information requiredevery person is capable of self-deter- which a person is entitled is denied to be provided to subjects is found inmination. The capacity for self-deter- without good reason or when an exces- 21 CFR 50.25 for FDA reviewedmination develops during a person’s sive burden is imposed. research and 45 CFR 46.116 for alllife. Therefore, the very young have In clinical research, we should federally funded research. These sec-diminished autonomy. Additionally, always be mindful that certain classes tions contain the 14 elements ofsome individuals may lose the capacity of persons, e.g., the indigent, ethnic informed consent. While these regula-for self-determination because of groups, or the institutionalized may be tions pertain to DHHS activities, theyphysical illness, mental disabilities, or selected because of their availability, have become a framework for prepar-situations that restrict personal free- dependence, or because they are easy ing and reviewing informed consentsdom, such as prisons and the military. to manipulate rather than for reasons in all types of research involvingRespect for persons who are immature, related to the problem being studied. human subjects.incapacitated, or restricted requires These classes are frequently referred Comprehension. Another compo-that we provide them protection as to as “vulnerable populations” and nent of informed consent is compre-human subjects. require protection as human subjects. hension. Comprehension is the capacity to understand. The informa-b. Beneficence 3. Applications tion provided to a subject must be in a The second basic ethical principle We can gain an understanding of language and at a level that he or sheis beneficence. Beneficence is the the Belmont principles by applying can comprehend. Informed consent ispractice of doing good, making all them to some of the steps in the invalid if the consentor does not clinical research process. The Belmont Report singles out the following the monitor s summer 1997
  4. 4. understand the information upon beneficence, is applied in the assess- never officially adopted or endorsed,which the consent was based. Investi- ment of risks and benefits. Risk refers The Belmont Report has served as angators are responsible for determining to the possibility that harm may occur. ethical framework for protectingthat a subject has comprehension of Benefit refers to something of positive research subjects in the United Statesthe information. value related to well being. Assess- for nearly 20 years. Many of its Voluntariness. Voluntariness is ment of risks and benefits deals with recommendations have been incorpo-the third component of informed con- the probabilities and magnitudes of rated into Title 21 CFR Parts 50 andsent. The informed consent process possible harms and anticipated bene- 56, and Title 45 CFR Part 46.must be free of coercion, undue influ- fits. In general, risks to the subject To gain a full appreciation of Theence, and unjustifiable pressures. should be outweighed by the sum of Belmont Report, readers are encour-Coercion is the threat or intention of anticipated benefits to the subject and aged to obtain a copy of the statementharm by one person to another in to society in the form of new knowl- and to review it in its entirety. Theorder to gain compliance. For exam- edge. It is commonly stated that risks Belmont Report and the Declaration ofple, the subject may be denied med- and benefits should be “balanced.” Helsinki can be found in the Marchical care unless the subject enrolls in Unfortunately, there are few quantita- 1996 edition of the FDA’s Informationthe study. tive measures available to provide this Sheets for Institutional Review Boards Undue influence is an offer of an kind of objective assessment for and Clinical Investigators. The Decla-excessive or unwarranted reward in investigators or IRBs. ration of Helsinki may also be found inorder to gain compliance. An example 21 CFR 312.120(c)(4); Foreign clini-of this might be the amount of money c. Selection of Subjects cal studies not conducted under anoffered to healthy subjects who parti- The third Belmont principle is jus- IND.cipate in Phase 1 trials, or making tice and this is applied during thecompensation contingent upon the selection of subjects. Justice in the The author wishes to thank Carolsubject completing the study. selection of subjects occurs at two Saunders, RN, editor of Research Unjustifiable pressure occurs levels: individual justice and social Nurse, for her thoughtful review of thewhen a person in a position of author- justice. Individual justice requires the manuscript.ity urges a course of action for the investigator to consistently demon-subject. This may occur with the strate fair procedures in selecting Referencesinvestigator as well as with any mem- subjects. For example, investigators 1ber of the investigator’s team, when should not offer potentially beneficial The National Commission for the Protec-presenting the informed consent to the research to their favored patients tion of Human Subjects of Biomedical and Behavioral Research: The Belmont Report:subject. The dilemma is to recognize while offering riskier studies to less Ethical Principles and Guidelines for thewhen objective discussion of the favored patients. Protection of Human Subjects of Research.research study becomes unjustifiable Societal justice is based on a fair DHEW Publication No. (OS) 78-0012,pressure to participate. and equitable selection of subjects Washington, 1978, p. 2. across economic, ethnic, and gender 2b. Assessment of Risks and Benefits classes. No class of subjects should Ibid. p. 3. The second Belmont principle, bear the burdens of research particu- larly if disabilities, restrictions, or a Copyright ©1997 Janet F. Zimmerman, MS, RN hostile social environment already Janet F. Zimmerman, MS, RN Reprinted with President burdens them. permission from T IMPAC P.O. Box 1364 The Monitor, a quarterly Newtown, Pa 18940 SUMMARY USA publication of the The Belmont Report, which was (215) 579-7694 Association of Clinical Fax (215) 860-8942 published in 1979, was a directCONSULTING GROUP Research Professionals. response to the notorious syphilis studies that were conducted by the Innovative Methods for Providing Advanced Clinical Training USPHS from 1932-1972. While it was the monitor s summer 1997