Belmont Report

The Belmont Report.

The Belmont Report is an influential, eight-page document that identifies basic ethical principles and corresponding applications for the conduct of research involving human subjects; its issuance in 1978 is considered a major milestone in research ethics. The Belmont Report, and its three core ethical principles—respect for persons, beneficence, and justice—continues to provide an essential reference and guidance document for researchers and for Institutional Review Boards that review research.

Research with human subjects is an essential tool for advances in human welfare and health. However, historically, such research has been fraught with unethical acts, egregious crimes, and researchers' abuse of power. Highly publicized cases of human cruelty committed under the guise of research include the Nazi human experiments; the biological and chemical warfare research of Unit 731, and the United States Public Health Services Tuskegee Syphilis Study. The Belmont Report was developed to advance protection of human subjects and came on the foundation of such documents as the Nuremberg Code and the World Medical Association's Declaration of Helsinki.

The full title is the Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.

Summary of Belmont Report

The Belmont Report is organized into three parts. Fundamental to the statement is "Part B: Basic Ethical Principles," which details three ethical principles, which are considered to be "comprehensive" and "general prescriptive judgements that are relevant to research involving human subjects." The report further notes that these three principles "are stated at a level of generalization that should assist scientists, subjects, reviewers and interested citizens to understand the ethical issues inherent in research involving human subjects." The relatively short "Part A: Boundaries Between Practice & Research" addresses distinction between biomedical and behavior research with the practice of accepted therapy. "Part C: Applications" deals with practical utilization of the three ethical principles identified in Part B.

At the heart of the Belmont Report are the three ethical principles: (1) Respect for Persons; (2) Beneficence; and (3) Justice.

Respect for Persons

The concept of respect for persons refers to the fact that each individual has the right to autonomy and self-determination. That is, each person has the right to decide whether or not to participate in the research and to withdraw at any time without penalty. The concept also includes the conviction that those individuals with diminished autonomy are to be accorded extra protection.

Examples of vulnerable subjects with diminished autonomy, according to the Report, are children and prisoners, the first because of their intellectual development and legal status and the second because they have forfeited certain liberties. Others may be considered to have diminished autonomy if they lack the capacity to understand their situation well enough to decide whether or not to participate in a research study. Such individuals deserve special protection to prevent exploitation. They may be excluded from the research or possibly included on the basis of consent from a properly motivated and capable surrogate decision maker.

The principle of "respect for persons" leads to the following essential conditions:

1. Voluntary consent to participate in research
2. The right to withdraw from research at any time without penalty
3. Informed consent
4. Protection of privacy and confidentiality

It is important that individuals not be coerced to participate in the research or to be stopped or pressured from withdrawing. Individuals are to understand the implications of their decision to participate. Subjects are to have a level of protection from an invasion of privacy and breach of confidentiality; such could have implications for their reputation, financial and legal status, lead to discrimination, and so forth.

Beneficence

The concept of beneficence deals with the conviction that research is to be designed to maximize potential benefits and minimize potential risks. The proposed research is to take into account the potential risks and their magnitude and the potential benefits and their magnitude and assure that there is a favorable benefit-to-risk ratio. in other words, the risks must be justified by the potential benefits. (Note that generally benefits accrue to society at large, while risks are assumed by the research subjects.)

In minimizing risks, it is important that the research design maximizes the quality of the science, including the qualifications and training of the investigators and the methods employed. It is also important to manage conflicts of interest, as any resultant bias on research decisions could mean that risks are not being minimized.

In general, this principle means that researchers should be kind to their research subjects and treat them as they would like to be treated.

Justice

The concept of justice deals with how the risks are distributed. The Belmont Report defines this principle as follows: "The potential risks of research should be borne equally by the members of our society who are likely to benefit from it." In other words, it deals with the question of fairness in distribution in terms of who ought to receive the benefits and who ought to bear its burdens.

The Report notes that it is important that the human subjects not be selected simply because of the ease of their availability or for other reasons unrelated to the problem being studied, such as selecting on the basis of being a particular minority, or welfare patients, or incarcerated, or those easily manipulated. The concept of justice means that a person should not be denied benefit without good reason or bear a burden unjustly. For example, it would go against the principle of justice for the risk primarily to fall to the poor and benefits to the rich.

The Belmont Report notes: "Justice is relevant in the selection of subjects in research at two levels: the social and the individual. Individual justice in the selection of subjects would require that researchers exhibit fairness: thus, they should not offer potentially beneficial research only to some patients who are in their favor or select only 'undesirable' persons for risky research. Social justice requires that distinction be drawn between classes of subjects that ought, and ought not, to participate in any particular kind of research, based on the ability of members of that class to bear burdens or on the appropriateness of placing further burdens on already burdened persons."

Applications

In Part C, the Belmont Report specifically notes three categories of applications related to the three principles: informed consent; assessment of risk and benefits, and selection of subjects.

Informed consent. The Belmont Report notes that the principle of 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." The report addresses the issue of what this means in terms of specific items that should be disclosed so that the subjects are provided sufficient information. It also addresses those special cases where disclosure of some pertinent information may impair the validity of the study. Further discussed are provisions for cases where subjects' comprehension may be limited, such as due to "immaturity or mental disability" (such as infants, young children, terminally ill, comatose, mentally disabled patients). The issue of coercion and undue influence is also examined, such as improper rewards for participating or individuals in positions where those in authority may place unjustifiable pressure on them.

Assessment of risks and benefits. The Belmont Report notes that the principle of beneficence bears a close relation to "the requirement that research be justified on the basis of a favorable risk/benefit assessment." It notes "risk/benefit assessments are concerned with the probabilities and magnitudes of possible harm and anticipated benefits." Among possible risks are physical, legal, psychological, social, economic, and so forth. The report addresses the issue of assessing risks and benefits. it notes that "brutal or inhumane treatment of human subjects is never morally justified" and that "risks should be reduced to those necessary to achieve the research objective," and that one must consider whether it is necessary at all to use human subjects.

Selection of subjects. The Belmont Report notes that the principle of justice leads to the an application that the selection of research subjects be done in a fair manner. For example, as noted above, one "should not offer potentially beneficial research only to some patients who are in their favor or select only 'undesirable' persons for risky research." The application of the principle of justice leads to the need to protect vulnerable subjects from selection simply for such reasons as administrative convenience or because of the ease of being manipulated because of being economically disadvantaged or ill or institutionalized or a racial minority.

The Belmont Report summarizes the applications of its three principles in this manner:

Just as the principle of respect for persons finds expression in the requirements for consent, and the principle of beneficence in risk/benefit assessment, the principle of justice gives rise to moral requirements that there be fair procedures and outcomes in the selection of research subjects.

History and Importance of the Belmont Report

History and Importance

On July 12, 1974, the National Research Act was signed into law by United States President Richard M. Nixon. The United States Congress had passed this law in response to concerns regarding the exploiting and harming of human subjects in medical, biomedical, and social science research. This Act both established the modern system of Institutional Review Boards (IRBs) and created the National Commission for Protection of Human Subjects of Biomedical and Behavior Research. This commission, which had the goal of identifying ethical guidelines for human subject research, would be the one that issued the Belmont Report.

The National Commission for Protection of Human Subjects of Biomedical and Behavioral Research issued a number of reports between 1975 and 1978 dealing with the conduct of research in various populations, such as research involving children, prisoners, pregnant women, and people with dementia. In February 1976, the commission met over a four-day period at the Smithsonian Institute’s Belmont Conference Center. The commission continued to deliberate monthly after this initial summit to expound upon and revise the concepts discussed at that summit. Finally, in 1978, the commission issued the Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, with the title of the statement deriving from the initial meeting site.

The three principles identified in the Belmont Report are widely used to guide human subject research. Furthermore, they are key resources for IRBs that regulate research involving human subjects. The National Research Act of 1974 directed that human subject research be reviewed and approved by IRBs. Following the direction of the National Research Act, the main IRB regulations were established by diverse government departments and agencies. In 1981, the United States Department of Health and Human Services (HHS) promulgated its principal IRB regulations, and in 1991, HHS regulations regarding human subject research were published in Title 45, Part 46 of the Code of Federal Regulations (45 CFR Part 46). Also in 1991, fourteen other federal agencies adopted identical rules to those of the HHS, including the Department of Energy and the Department of Defense. Other departments and agencies followed the same regulations on the basis of executive order or statutory mandate. As noted by Amdur and Bankert (2022), "because these regulations are common to most federal agencies, the HHS regulations are referred to as the Common Rule." The Common Rule was subsequently revised, with final revisions to the Common Rule published in the Federal Register in 2017, and then further amended and finalized in 2018. This revised Common Rule began to be referred to as "revised Common Rule," "2018 requirements" or "2018 Rule," while the earlier version as the "pre-2018 requirements" (Hautala-Bateman and White 2019). (See Common Rule History.)

The Common Rule is published in the Code of Federal Regulations (CFR). For the Department of Health and Human Services, the Common Rule refers to subpart A of 45 CFR, part 46 of the HHS regulations. There are five subparts, the others dealing with protections for pregnant woman, human fetus, neonates (subpart B), prisoners (subpart C), children (subpart D), and requirements for IRB registration (subpart E). Each agency that has signed onto the Common Rule has identical section numbers and language in its own chapter of the Code of Federal Regulations to those of the HHS codification at subpart A of 45 CFR, part 46 (HHS 2021).

The Common Rule specifically notes the need to be "consistent with the principles of the Belmont Report."

Historical Antecedents

The Belmont Report itself cites the importance of the Nuremberg Code, which was drafted in response to horrifying abuses of human subjects in biomedical experiments conducted by Nazi scientists and physicians, as detailed during the Nuremberg War Crime Trials. The Code was produced as part of the prosecutors case to argue that the the Nazi defendants had violated fundamental ethics with respect to research on human subjects. The Nuremberg Code details key requirements that should be part of human subject research.

Amdur and Bankert (2022) note several other important historical events/documents of importance for the production of the Belmont Report. Among these are:

• Declaration of Helsinki, produced by the World Medical Association in 1964 (and revised numerous times since), building on the Nuremberg Code, to detail standards relative to medical research.
• Tuskegee Syphilis Study. A U.S. Public Health Service funded study conducted between 1932 and 1972 which became infamous in terms of exploitation of research subjects—poor, black sharecroppers in Alabama—and led to public outrage. Amdur and Bankert (2022) state: "this study was the main reason that the principle of justice was developed in the Belmont Report." They further state: "Public reaction to the Tuskegee study also catalyzed a series of events that led to passage of the National Research Act of 1974."
• 1973 Congressional Hearings on the Qualify of Health Care and Human Experimentation. There were "a series of congressional hearings in response to public concern about ethical problems in the way medical research was being conducted" (Amdur and Bankert 2022).

See also

• Common Rule
• Declaration of Helsinki
• Human subject research
• Informed consent
• Nuremberg Code
• Tuskegee Syphilis Study

References

ISBN links support NWE through referral fees

• Amdur, Robert J., and Elizabeth A. Bankert. 2022. Institutional Review Book: Member Handbook, 4th Edition. Burlington, MA: Jones & Bardett Learning.
• Hautala-Bateman, C., and L. White. May 14, 2019. Changes to the Common Rule. PowerPoint Presentation to the Central Department of Energy Institutional Review Board Meeting of May 14, 2019.
• National Commission for the Protection of Human Subjects of Biomedical and Behavior Research. April 18, 1979. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Retrieved July 23, 2021.
• US Department of Health and Human Services (HHS). 2021. Federal Policy for the Protection of Human Subjects ('Common Rule'). Retrieved July 23, 2021.

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