SOCRA CCRP Practice Exam

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What FDA guideline lists the basic elements of informed consent?

21 U.S.C. 355
21 CFR 50
10 CFR 20
45 CFR 46

The correct answer is: 21 CFR 50

The Food and Drug Administration (FDA) sets guidelines and regulations for medical research involving human subjects to ensure their safety and rights are protected. The basic elements of informed consent, which include information about the study, potential risks and benefits, and the voluntary nature of participation, are outlined in FDA's Code of Federal Regulations (CFR) section titled "Protection of Human Subjects" or 21 CFR 50. This is why option B is the correct answer. Option A, 21 U.S.C. 355, refers to the U.S. Code section about new drug applications, and option C, 10 CFR 20, pertains to radiation protection standards. These have no direct relation to informed consent in medical research. Option D, 45 CFR 46, is the correct code for the Department of Health and Human Services' regulations for human subjects research. However, this code is not