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SOCRA CCRP Exam - Topic 3 Question 7 Discussion
Topic #: 3
Which document was created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and summarizes the basic ethical principles and guidelines for the conduct of research involving human subjects?
The Belmont Report (1979), issued by the U.S. National Commission, identifies three core ethical principles guiding human subject research:
Respect for Persons (informed consent, autonomy, protection of vulnerable populations).
Beneficence (maximize benefits, minimize harms).
Justice (fairness in subject selection and treatment).
The Nuremberg Code (1947) was developed post-WWII to prevent unethical experiments.
The Declaration of Helsinki (1964, updated) is a World Medical Association document guiding international physician research ethics.
The ICH Guidelines (1996) outline harmonized regulatory requirements for good clinical practice.
Only the Belmont Report fits the description of a U.S.-based, principle-driven framework for human research ethics.
Thus, the correct answer is D (The Belmont Report).
The Belmont Report (1979), National Commission for the Protection of Human Subjects.
45 CFR 46 (Human Subject Protections).
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