OHRP Compliance Oversight Letters: An Update (Report‪)‬

In this article, we describe our review of 23 5 compliance oversight determination letters that the Office for Human Research Protections (OHRP) issued to 146 institutions between August 1, 2002, and August 31, 2007. Our previous review of 269 determination letters issued to 155 institutions between October 1, 1998, and June 20, 2002, appeared in the September-October 2003 issue of this journal. (1) As a component of the Department of Health and Human Services (HHS), OHRP is responsible for overseeing compliance with the HHS regulations governing research with human subjects. An institution engaged in nonexempt human subjects research conducted or supported by HHS must submit to OHRP written assurance that it will comply with the HHS regulations. This is now called a Federalwide Assurance (FWA). OHRP may also have jurisdiction over research not conducted or supported by HHS if an institution elects to extend its FWA to all nonexempt human subjects research at that institution, regardless of the source of funding.