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What is defined as 'Assent' in clinical trials?

  1. The agreement from the trial sponsor.

  2. Legal consent from a guardian.

  3. The agreement of someone who cannot legally consent for themselves.

  4. 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.