The Office for Human Research Protections (OHRP)—which is responsible for overseeing compliance with the Department of Health and Human Services’ regulations governing research with humans—reports on a review of 235 compliance oversight determination letters issued to 146 institutions between August 1, 2002, and August 31, 2007. This report provides comparison to a similar report of compliance oversight determination letters issued to 155 institutions between October 1, 1998, and June 20, 2002. Although the time period covered in this analysis is greater than that in our previous analysis (60 vs. 44 months), OHRP made fewer citations of noncompliance and deficiencies during this time period (762 vs. 1,120), fewer determination letters were issued (235 vs. 269), and fewer institutions were cited for noncompliance or deficiencies (133 vs. 142). The most common areas of noncompliance and deficiency involved informed consent documents and procedures (34%) and the process for IRB initial review of research protocols (20%).

Key words/concepts: human subjects research, research ethics, DHHS regulations, OHRP, compliance oversight, institutional review board (IRB).