Breaking down OHRP Assurance

Authors

• RY Cox
• LB Hoopengardner
• E Annum
• SM Simpson
• S Vogel
• J Pierson
• B Baseler

Abstract

As a result of various historical, unethical research events that occurred in the United States and internationally, the importance of understanding ethical standards, policies and regulations as well as the entities that ensure compliance is key to the success of research studies. The Office of Human Research Protection (OHRP) was re-established (as it was formally known as the Office for Protection from Research Risk) to provide leadership in the protection of the rights, welfare, and wellbeing of subjects involved in research conducted or supported by the US Department of Health and Human Services (HHS) and ensure compliance with Title 45 CFR 46. As part of their oversight responsibilities, OHRP evaluates all written substantive allegations or indications of noncompliance with the HHS regulations. Therefore, an institution (domestically and internationally) engaged in nonexempt human subject’s research conducted or supported by federal funds must submit to OHRP written assurance that it will comply with the HHS regulations, known as a Federal Wide Assurance (FWA). In addition to the requirement for an FWA, OHRP requires that all human subjects research must be reviewed by an Institutional Review Board (IRB) with knowledge of the local research context. Subsequently, OHRP maintains a list of all sites under an FWA, IRB organizations and individual IRB registrations. The objective of this poster is to provide insight into the purpose and requirements of each entity as well as illustrate how they relate to each other. Funded by the NCI Contract No. HHSN261200800001E

Scientific Focus Area: Research Support Services

This page was last updated on Friday, March 26, 2021