Belmont Report – The Three Benchmark Rules
Ethical Principles and Guidelines for the Protection of Human Subjects was published in 1979. It provides the philosophical underpinnings for current laws governing research with human subjects. Unlike the Nuremberg Code and the Helsinki Declaration, which set forth “guidances” or “rules,” the Belmont Report establishes three fundamental ethical principles: respect for persons, beneficence, and justice.
Ethical Principles and Guidelines for the Protection of Human Subjects of Research
On July 12, 1974, National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research created Belmont Report to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and to develop guidelines which should be followed in accordance with those principles
The Commission was directed to consider: I. The boundaries between biomedical and behavioral research and the accepted and routine practice of medicine, II. The role of assessment of risk-benefit criteria in the determination of the appropriateness of research involving human subjects, III. Appropriate guidelines for the selection of human subjects for participation in such research and IV. The nature and definition of informed consent in various research settings
Part A. Boundaries between Practice and Research:-
The Belmont Report necessitates the separation and differentiation of the definitions of practice and research. • Practice-Refers to a practitioner adjusting or slightly deviating from the standard protocol of treatment to help an individual client or patient. • Research-Refers to a rigidly designed protocol that needs to be tested or is being tested. The goal is to develop a hypothesis and to contribute to the body of knowledge in field
• The distinction between practice and research is blurred; often because they occur together.
• The IRB must ensure that the researcher (and the participant) distinguishes practice from research in both social science and biomedical research.
• Minimize the potential for therapeutic misconception when one believes the purpose of clinical research is to treat rather then to gain knowledge.
The Belmont Principles
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.
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. 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.
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.
Applications
Respect for Persons principle directly pertains to Informed Consent (IC) and explains why IC must encompass 3 components:
Information
Comprehension
Voluntariness.
Selection of Subject
Belmont relies on the principle of Justice (equality of treatment) to focus on injustice in two senses:
(a) The injustice of keeping persons from receiving what they deserve.
(b) Imposing undue burdens on emotionally, socially, and economically disadvantaged persons.
Justice is relevant to the selection of subjects of research at two levels: the social and the individual.
➢ Social justice requires that distinction be drawn between classes of subjects that should and should not participate in any particular kind of research.
➢ 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.
Reference
Laura Lee Swisher PT, PhD, Catherine G. Page PT, MPH, PhD, in Professionalism in Physical Therapy, 2005
https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html
https://www.sciencedirect.com/topics/medicine-and-dentistry/belmont-report
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