December 11, 2013 - Washington University, St. Louis

Dear Dr. Kharasch:

The Office for Human Research Protections (OHRP) conducted an on-site evaluation of the human subjects protection program (HRPP) at Washington University (WU) from September 17-19, 2013. The evaluation was conducted as part of our program to evaluate human subjects protection programs of institutions that receive Department of Health and Human Services (HHS) support for research in compliance with 45 CFR Part 46.

The evaluation, conducted by five OHRP staff and two expert consultants, included interviews with senior HRPP officials, seven institutional review board (IRB) Chairs, forty-five IRB members, thirty Human Research Protections Office (HRPO) staff and fifteen principal investigators who conduct HHS-supported research. The site-visit team reviewed IRB files for over 40 HHS-supported research studies, IRB meeting minutes for the past year, IRB written procedures and observed an IRB meeting.
Based on our observations, the senior institutional officials were approachable, appear to be highly vested in providing excellent resources for the HRPP and were supportive of the IRBs’ role and responsibilities. The HRPO leadership, IRB chairs, IRB members and HRPO staff displayed an enthusiastic and sincere concern for, and an exceptional commitment to, the protection of human research subjects at WU.  

We note that HRPO’s pre-IRB administrative reviews of protocol submissions appear to be rigorous, IRB records in the “MyIRB” protocol submission and tracking system were well-organized, regulatory guides and charts appear to be useful to IRB members during IRB meetings, and the HRPO offered impressive training initiatives for IRB members, staff and researchers (e.g. training videos shown at the beginning of each IRB meeting, the “buddy system” used to bring new members up to speed on how to review research protocols, and chat rooms to aid researchers with submissions to the IRB).

At this time, there should be no need for further involvement by our office in this matter. Please notify us if you identify new information which might alter this conclusion.
We appreciate the continued commitment of your institution to the protection of human research subjects. Please do not hesitate to contact me should you have any questions.

Sincerely,

Lisa Buchanan, MAOM
Division of Compliance Oversight
1101 Wootton Parkway, Suite 200
Rockville, Maryland 20852
Telephone: 240-453-8298
FAX: 240-453-6909
E-mail: Lisa.Buchanan@HHS.gov

cc:
Martha, Jones, Human Protections Administrator, Washington University (WU)
Dr. Jonathan Green, MD, Executive Chair, IRB, WU
Ms. Denise McCartney, Assoc. Vice Chancellor for Research Administration, WU
Dr. Margaret Hamburg, Commissioner, Food and Drug Administration (FDA)
Dr. Joanne Less, FDA
Dr. Michelle Bulls, Director of OPERA, Office of Extramural Research, National Institutes of Health (NIH)
Ms. Sarah Carr, Office of Science Policy, NIH