CITI Training Practice Exam

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Master CITI Training with our comprehensive practice exam. Boost your research skills, ensure compliance, and excel in your field. Start now for success!

Each practice test/flash card set has 50 randomly selected questions from a bank of over 500. You'll get a new set of questions each time!

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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.
Only if a legal guardian gives consent.
Regardless of study objectives or risks.

The correct answer is: 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.