The Belmont Report

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The Belmont Report Following the public outrage over the Syphilis Study at Tuskegee, Congress established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1974. The National Commission was charged with: • Identifying the ethical principles to guide all research involving human subjects • Developing guidelines for the conduct of ethical research involving human subjects The Belmont Report identified three principles essential to the ethical conduct of research with humans: • Respect for persons • Beneficence • Justice The principle of respect for persons can be broken down into two basic ideas: 1. Individuals should be treated as autonomous agents 2. Persons with…show more content…
• IRBs are committees that consist of 5 or more members with varying expertise and diversity that are responsible for reviewing and approving human subjects research activities on behalf of institutions. The Common Rule specifies: • IRB membership (45 CFR 46.107) • IRB functions & operations (45 CFR 46.108) • IRB review of research (45 CFR 46.109 and 45 CFR 46.110) • Criteria for IRB approval of research (45 CFR 46.111) And more! The roles and responsibilities of IRBs are discussed extensively in the module on Beneficence. Exemptions The HHS regulations describe categories of human subjects research that may be exempt from requirements described in the HHS regulations including IRB oversight. Studies proposing only research that falls under one or more of the exempt categories of research do not require IRB review and approval, but the HHS Office for Human Research Protections (OHRP) has stated that:
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