SOCRA CCRP Practice Exam

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What is one of the most important points to consider when consenting patients according to 21 CFR 50?

  1. No person can participate without their or LAR consent

  2. Patients must be over 18

  3. Consent must be verbally given

  4. Patients must consent on the same day as enrollment

The correct answer is: No person can participate without their or LAR consent

One of the most important points to consider when consenting patients according to 21 CFR 50 is that no person can participate without their or their legally authorized representative's consent. This is because informed consent is a key principle in protecting patient rights and ensuring their autonomy in medical decision-making. Options B, C, and D are incorrect because they do not fully encompass all aspects of informed consent. Option B is incorrect because age alone does not determine an individual's ability to give informed consent. Option C is incorrect because consent must be given in writing, not just verbally. Option D is incorrect because there is no specific timeframe for when consent must be given, as long as it is obtained before the patient begins participating in the study.

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