SOCRA Certified Clinical Research Professional (CCRP) CCRP Question # 27 Topic 3 Discussion
CCRP Exam Topic 3 Question 27 Discussion:
Question #: 27
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?
TheBelmont Report (1979), issued by the U.S. National Commission, identifiesthree core ethical principlesguiding 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).
TheNuremberg Code (1947)was developed post-WWII to prevent unethical experiments.
TheDeclaration of Helsinki (1964, updated)is a World Medical Association document guiding international physician research ethics.
TheICH 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 isD (The Belmont Report).
[References:, The Belmont Report (1979), National Commission for the Protection of Human Subjects., 45 CFR 46 (Human Subject Protections)., ]
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