How are a participant’s rights safely protected?

The FDA is the governing agency that develops the policies and guidelines for all clinical research, regardless of manufacturer, study phase or drug type. There are also independent Institutional Review Boards (IRB) at institutions 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” Form in the “Common Terms Used in Clinical Trials” section.)