CITI Training Practice Exam 2025 - Free CITI Training Practice Questions and Study Guide

Question: 1 / 400

What is required of the IRB/IEC per FDA guidelines concerning consent forms?

To review and approve the consent form.

The correct answer is A. The IRB/IEC, or Institutional Review Board/Independent Ethics Committee, is required to review and approve consent forms in order to ensure that the form adequately informs research subjects of their rights and any potential risks or benefits associated with participating in the study. Option B is incorrect as the IRB/IEC does not typically handle the distribution of consent forms. Option C is also incorrect as the IRB/IEC is responsible for reviewing and approving the form, not just filing it. Option D is incorrect as review by the IRB/IEC is required by FDA guidelines.

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To distribute consent forms to subjects.

Only to file the consent form with no review.

Review is not required.

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