CITI Training Practice Exam

Question: 1 / 400

Under what conditions can ICH allow subjects who cannot consent for themselves to be enrolled?

If the subjects can indirectly benefit from the study.

If the study objectives cannot be met without these subjects, risks are low, and the study is not illegal.

Possible explanation

ICH guidelines state that subjects who cannot consent for themselves may be enrolled in a study only if the study objectives cannot be met without them, the risks are low, and the study is not illegal. This means that both options A and D are incorrect because the subjects' indirect benefit or a general approval for all subjects do not fulfill all these conditions. Option C is also incorrect because it only mentions the role of a legal guardian, while the ICH guidelines specify the requirements that must be met in addition to a legal guardian's consent. Therefore, the correct answer is B.

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Only if a legal guardian gives consent.

Regardless of study objectives or risks.

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