January 10, 2013 - Boston University Medical Center

Dear Dr. Moore:

Thank you for your April 13, 2012 report in response to our February 10, 2012 request that Boston University Medical Center (BUMC) evaluate allegations of noncompliance with Department of Health and Human Services (HHS) regulations for the protection of human research subjects (45 CFR part 46).  Based on review of your response, we make the following determinations:

Determinations regarding the above-referenced research:

The complainant alleged that grant award monies are being released to investigators prior to institutional review board (IRB) review and approval.  Based on information received in connection with our evaluation of this allegation, we have determined that non-exempt human subjects research was conducted without IRB review or approval, in contravention of HHS regulations at 45 CFR 46.103(b) and 46.109(a).  Specifically, you acknowledged that a research project conducted by a trainee under the grant award 2T32HL007035 (Biology of the Lung:  A Multidisciplinary Program”) was begun prior to IRB review and approval.  We acknowledge that there is no evidence that any of the other studies noted above were conducted prior to IRB review and approval.  

Corrective action:  We acknowledge your institution’s plan to notify all T32 directors and research mentors to underscore that they are responsible for assuring that all trainees’ human research has IRB approval.  We also acknowledge your plan for clarifying the difference between conditional and final approval, which appears to have been the problem which lead to the regulatory violation.  In addition, you noted that both BUMC and Boston University’s grants office will create monthly reports describing the number of awards that are allowing access to funds but do not yet have IRB approval and the results of the review of charges against those grants, and send those reports to your office, as Institutional Official.

We determine that the corrective actions adequately address the determinations.  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 determination.

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,

Kristina C. Borror, Ph.D.
Director, Division of Compliance Oversight
1101 Wootton Parkway, Suite 200
Rockville, Maryland  20852
Telephone: 240-453-8132
FAX: 240-453-6909
E-mail: Kristina.Borror@hhs.gov

cc:
Ms. Mary A. Banks, IRB Director, Boston University Medical Center (BUMC)
Dr. Lynn Borgatta, IRB Chairperson, Boston U Med Ctr IRB - Green
Dr. James Feldman, IRB Chairperson, Boston U Med Ctr IRB – Blue
Dr. Sanford Auerbach, IRB Chairperson, Boston U Med Ctr IRB – Purple
Dr. David Kaufman, IRB Chairperson, Boston U Med Ctr IRB – Orange
Dr. Howard Cabral, Associate Professor, Biostatistics, Boston University School of Public Health
Dr. Christine Chaisson, Research Assistant Professor, SPH Data Coordinating Ctr, BU
Dr. Andrew C. Wilson, Assistant Professor, Cntr Med--Pulmonary Center, BU
Dr. David Center, Professor, Cntr Med--Pulmonary Center, BU
Dr. Mei-Yu Hsu, Principal Investigator, Clin—Dermatology, BU

Dr. Margaret Hamburg, Commissioner, Food and Drug Administration (FDA)
Dr. Joanne Less, FDA
Dr. Sherry Mills, National Institutes of Health (NIH)
Mr. Joseph Ellis, NIH
Dr. Harold Varmus, Director, National Cancer Institute, National Institutes of Health (NIH)
Dr. Susan Shurin, Director, National Heart, Lung, and Blood Institute, NIH
Dr. Nora D. Volkow, Director, National Institute on Drug Abuse, NIH