Abstract

Expedited review is usually conducted by the IRB chairperson or by 1 or more experienced IRB members designated by the IRB chairperson. An expedited reviewer will refer any research protocol that the reviewer would have disapproved to the full IRB committee for review. Whether expedited or full board review is warranted, it is imperative that all studies are of sound scientific design. Risks should always be reasonable in relation to whatever benefit can be expected. Participant selection must be equitable. Privacy and confidentiality should be maintained to the greatest degree possible. Subjects must be made aware that their participation is always voluntary, without undue coercion or influence, and they have a right to withdraw at any time.

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