How are a participants rights and safety protected? safety, How, participants, protected

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How are a participant's rights and safety protected?

　

The FDA is the governing agency that develops the policies and guidelines for all medical research, regardless of manufacturer, study phase, or drug type. There are also independent Institutional Review Boards (IRB) that review and approve all study-related documents, such as protocols, Informed Consent forms, physician credentials and eligibility, and patient recruitment materials, such as print advertisements and public service announcements. (See "Protocol" and "Informed Consent" in the Common Terms Used in Clinical Trials section.)