How does the IRB ensure compliance?
Audit As a requirement of our institutional Federal Wide Assurance with the Office Human Research Protections (OHRP) and to maintain compliance with FDA guidelines, the IRB Office conducts audits designed to assure that both investigators and the IRB are in compliance with federal as well as institutional requirements for the protection of human subjects. In addition, because our IRB reviews and approves research involving investigational drugs and devices, the FDA conducts audits of IRB records and procedures at least every five years. The purpose of these audits is to identify, report, and correct any deficiencies and/or material breaches in uniformly protecting the rights and welfare of human subjects. Complaints Any research subject, staff member, or member of the community may make a complaint regarding a failure to comply with federal or institutional policy regarding the protection of human research subjects. Examples include, but are not limited to, failure to submit a protocol
