October 13, 2010

Regulatory Investigation Results in Good News for UC Berkeley

In August 2006, the Vice Chancellor for Research received a letter from the Office for Protection of Human Subjects (OHRP), the federal oversight agency for human subjects research. OHRP had been sent a whistle-blower complaint about UCB, and what ensued was over a year and a half of extensive investigation, including questions and responses by OPHS on behalf of CPHS, UCB, and our researchers. We satisfactorily addressed their concerns and that phase of the investigation was wrapped up by May 2008, but OHRP promised us a site visit would follow. Subsequently, in June 2010, OHRP did conduct an on-site visit of UCB’s human subjects research program. OHRP officials reviewed exempt and non-exempt protocols, recent amendments, two years worth of meeting minutes, CPHS Policies and Procedures, and the CPHS web site. In addition, they met with OPHS staff, the CPHS Chairs and members, NIH-funded investigators, and senior administrators.

In their post-visit letter of July 15, 2010, OHRP noted in their letter to Graham Fleming, Vice Chancellor for Research and our Institutional Official:
During the OHRP site visit, the IRB chairs, members, and administrative staff displayed an enthusiastic and sincere concern for the protection of human subjects. In addition, we noted that investigators demonstrated a culture of respect for the IRB process. Moreover, as we indicated during the exit interview with you and others, we have observed that over the last few years there have been significant improvements in the UCB human subjects protection program…. We applaud UCB for these improvements.
Then, on October 12, 2010, we were officially notified that OHRP had made no regulatory findings or determinations as a result of their visit and that we had addressed their remaining concerns. This letter stated, “As a result, our evaluation of the University of California, Berkeley (UCB) human subject protection program has been completed. We appreciate your institution’s continued commitment to the protection of human research subjects.”

OPHS staff would like to say a big thank-you to all UCB investigators and especially to the CPHS Chairs, Professor Jane Mauldon and Professor Bill Jagust, as well as their respective committees, for working with us to improve UCB’s human subject protection program. We also wish to acknowledge the support we’ve received from Vice Chancellor for Research Graham Fleming (and Beth Burnside before him) for the resources necessary to truly make this an outstanding program reflective of Berkeley’s premier status!

Rebecca D. Armstrong, DVM, PhD
Director, Research Subject Protection