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For enrolling an adult who is unable to consent for themselves, what does ICH require?

  1. Only consent from their legal guardian.

  2. Assent along with permission from their Legal Authorized Representatives (LARs).

  3. No assent is required.

  4. Assent from their primary care physician.

The correct answer is: Assent along with permission from their Legal Authorized Representatives (LARs).

When enrolling an adult who is unable to consent for themselves, ICH requires both assent and permission from their Legal Authorized Representatives (LARs). Option A is incorrect because only consent from their legal guardian is not enough, both assent and permission from the LARs are needed. Option C is incorrect because even though the adult is unable to consent for themselves, their assent is still required and cannot be waived. Option D is incorrect because the approval of the primary care physician is not sufficient for enrolling an adult unable to consent, assent and permission from the LARs are still required.