Consent form violations found in 78% of OHRP site visits, half in initial review process. (Informed consent).

About 78% of the IRB site visits conducted by the Office of Human Research Protections (OHRP) in recent fiscal years had problems with consent forms, and nearly half of the deficiencies are in either the initial review process or in informed consent, an OHRP official told the Food & Drug Law Institute in Washington Oct. 12.

Kristina Borror, Ph.D., compliance oversight coordinator for OHRP, told the meeting that the data was compiled for an Institute of Medicine report released last month (See October issue, page one).

While fewer than 100 cases come to OHRP each year and only seven or eight result in on-site visits, according to Deputy Director Melody Lin …