September 27, 2016 - George Washington University

Dear Ms. Garrity,

The Office for Human Research Protections (OHRP) conducted an on-site not-for-cause evaluation of the human research protections program (HRPP) at George Washington University in Washington, DC on June 28 through 30, 2016.  The site visit is part of our program of assessing compliance with 45 CFR Part 46 by routinely evaluating human subjects protection programs of institutions that receive Department of Health and Human Services (HHS) support for research.

This site evaluation included interviews with the Institutional Official, the interim Associate Vice-President for Research, IRB Director, institutional review board (IRB) Chairs, IRB members, IRB staff, and investigators who conduct HHS-supported research. Your human subject research portfolio consists of approximately 450 active studies.  The site-visit team reviewed IRB files for 35 HHS-supported research studies, IRB meeting minutes for the past six months, IRB written procedures. In addition, two site team members attended an IRB meeting.

We are pleased to note that we observed a robust human research protections program.  Based on our observations, GWU officials, IRB chairpersons, staff, and researchers conveyed a sincere commitment to and concern for the protection of human research subjects.  We would like to highlight the essential role your IRB administrator and analysts play in successfully carrying out the daily operations of your Office for Human Research (OHR).  Your IRB administrator demonstrated comprehensive knowledge of HHS regulations.  The entire OHR staff seems to be a collegial and capable team.  We also note that the IRB written procedures are thorough and clear and the use of checklists and worksheets are a helpful support for IRB members and staff by providing them with useful references and templates for recording their reviews.

The records maintained by IRB staff (a paper-based system) are complete and extremely organized. Folders for protocols included copies of minutes from meetings at which each protocol submission was discussed, making it easy to see what determinations were made by the IRB and why, including any controverted issues.

Recommendations:

GWU management indicated plans to fill the regulatory affairs position that has been vacant for two years.  This person would be responsible for monitoring ongoing projects to ensure that they are being conducted in accordance with IRB requirements and determinations.  We agree that this function could be a critical piece of the program and recommend that you move forward with plans to fill this position.  

At this time, there should be no need for further involvement by our office in this matter.  We appreciate your institution’s continued commitment to the protection of human research subjects.

Please do not hesitate to contact me should you have any questions.

cc:
Ms. Carley Emerson, GWU Human Protections Administrator
Dr. Joanne Less, Food and Drug Administration
Dr. Sherry Rodgers, National Institutes of Health (NIH)
Dr. Michelle Bulls, Director of OPERA, Office of Extramural Research, NIH
Ms. Sarah Carr, Office of Science Policy, NIH