The Belmont Report Essay

8855 Words Jun 19th, 2013 36 Pages
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
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Subpart E – Registration of Institutional Review Boards (effective July 14, 2009)

Requirements for Federal Support of Human Subjects Research
The HHS regulations (45 CFR 46.120) require that Federal Departments and Agencies that conduct or support human subjects research must evaluate all applications for research using the following criteria: • Risks to the subjects • Adequacy of protection against these risks • Potential benefits of the research to the subjects and others • Importance of the knowledge gained or to be gained

Equivalent Protections for International Research
When research covered by the HHS regulations takes place in countries other than the United States, the HHS regulations (45 CFR 46.101(h)) allow a department or agency head to approve the substitution of alternative polices, codes, or regulations to protect human subjects in lieu of the requirements of 45 CFR 46 as long as the alternatives afford protections that are at least equivalent to those provided in 45 CFR 46.
In a Federal Register Notice on July 7, 2006, HHS clarified that the requirements of the HHS regulations (45 CFR 46) must be satisfied for all HHS-conducted or -supported research covered by the Federalwide Assurance, regardless of whether the research is conducted domestically or internationally. As of the publication of that Notice, HHS had not deemed any other procedural

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