CITI Training Practice Exam

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What is defined as 'Assent' in clinical trials?

The agreement from the trial sponsor.
Legal consent from a guardian.
The agreement of someone who cannot legally consent for themselves.
The refusal of a participant to continue in the trial.

The correct answer is: The agreement of someone who cannot legally consent for themselves.

Assent is defined as the agreement of someone who cannot legally consent for themselves, such as a minor or person with a cognitive impairment. This is different from legal consent, which is obtained from a guardian or sponsor. Option A is incorrect because the trial sponsor is responsible for organizing and funding the trial, not for providing assent. Option B is incorrect because it implies that legal consent and assent are interchangeable terms, when in fact they are distinct concepts. Option D is incorrect because it refers to refusal, which is the opposite of assent. Therefore, only option C correctly defines assent in clinical trials.