September 27, 2016 - West Virginia School of Osteopathic Medicine

Michael D. Adelman, DO, JD
West Virginia School of Osteopathic Medicine
400 North Lee Street
Lewisburg, WV 24901

Human Research Protections under Federalwide Assurance FWA-7632
Dear Dr. Adelman:
Thank you for your August 11, 2015 report in response to our July 7, 2015 request that the West Virginia School of Osteopathic Medicine (WVSOM) investigate allegations of noncompliance with Department of Health and Human Services (HHS) regulations for the protection of human research subjects (45 CFR Part 46).  We appreciate your investigation into the matter outlined in our request. 
A.  Determination:
A complainant alleged that WVSOM did not have written institutional review board (IRB) procedures, as required by HHS regulations at 45 CFR 46.103(a) and (b)(4)-(5). Specifically, it was alleged that WVSOM accepted HHS funding for research in 2012 without written IRB procedures being in place. 
Based on your report, WVSOM‘s research human research portfolio consists of approximately 27 active IRB-reviewed protocols, and 22 exempt protocols.  Research activities at WVSOM focus primarily on basic bench science, educational research, and rural or community health research. Since 2012, WVSOM has been a collaborative partner and sub-award recipient with West Virginia University in the development of the West Virginia Clinical and Translational Science Institute (WVCTSI), which is funded by the National Institutes of Health (IDEA-CTR Award 1U54GM104942-01). 
Based on our review of the documentation provided by WVSOM, written IRB procedures have been in place since 2007, and have been revised twice since then.  The current written IRB procedures are posted on WVSOM’s web site ( ).  We have determined that there is no violation of the regulatory requirements with regard to the complainant’s allegation.
At this time, there should be no need for further involvement by our office in this matter. 
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. 
Lisa Buchanan, MAOM
Division of Compliance Oversight
1101 Wootton Parkway, Suite 200
Rockville, Maryland 20852
Telephone: 240-453-8298
FAX: 240-453-6909
Dr. Jandy B. Hanna, IRB Chairperson, WVSOM
Dr. Joanne Less, Food and Drug Administration
Dr. Sherry Rodger, National Institutes of Health (NIH) 
Dr. Michelle Bulls, Director of OPERA, Office of Extramural Research, NIH
Ms. Sarah Carr, Office of Science Policy, NIH
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