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Under which circumstance does the FDA allow verbal consent prior to participation in a research study?

  1. The study involves multiple international sites

  2. The study is minimal risk

  3. Consent is obtained remotely

  4. The study requires emergency intervention

The correct answer is: The study is minimal risk

Verbal consent is allowed by the FDA in minimal risk studies. Minimal risk studies are those that only present a small degree of risk and do not expose participants to potential harm or discomfort. This option differs from the other choices because the other options do not mention minimal risk. A, C, and D do not specify the level of risk involved in the study, therefore verbal consent may not be appropriate in those circumstances. Additionally, option A mentions multiple international sites, which could pose language barriers and make verbal consent more difficult to obtain. Option D mentions emergency intervention, which may require immediate written consent in order to properly inform the participant of the risks involved.