Jeffrey Pokorak, J.D.
Vice Provost for Faculty and Curriculum
8 Ashburton Place, Boston MA 02108
Boston, MA 02108
Dear Dr. Jeffrey Pokorak,
Thank you for your November 6, 2015 and March 8, 2016 reports in response to our October 2, 2015 letter to Suffolk University (Suffolk) regarding allegations of noncompliance with the 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 your institution’s system for protecting human subjects
1) The complainant alleged and we determine that the institution did not have written institutional review board (IRB) procedures that adequately described the following activities, as required by HHS regulations at 45 CFR 46.103(a) and 46.103(b)(4) and (5):
a. Procedures for ensuring prompt reporting of serious or continuing noncompliance with 45 CFR Part 46 or the requirements or determinations of the IRB. Your institutional procedures stated “Federal regulations require that any serious or continuing non-compliance with DHHS human subjects regulations of the determinations of the IRB must be promptly reported to the Office of Human Research Protections (OHRP)” and had procedures for Investigating Allegations of Non-Compliance, IRB Review of Noncompliance, reporting serious or continuing noncompliance to the institutional official, the funding agency and OHRP, but did not have any procedures for how the institution ensures that such noncompliance is reported to the IRB.
b. Procedures for ensuring prompt reporting of unanticipated problems involving risks to subjects or others to the head of the sponsoring Federal department or agency. Your institutional procedures stated “Federal regulations require the prompt reporting by [principal investigators] of ‘any adverse event or unanticipated problems involving risk to subjects or others’” and had procedures for reporting unanticipated problems to the IRB, institutional official, and OHRP, but did not have any procedures for reporting unanticipated problems to the funding agency.
Corrective Action: Suffolk has provided OHRP with written procedures that address the regulatory requirements noted above. You added procedures for reporting unanticipated problems involving risks to subjects or others to the sponsor, and defined sponsor as the funding agency. You also added procedures for forwarding any allegations or concerns about noncompliance to the IRB.
2) The complainant also alleged the following:
a) There was a failure to report serious and continuing noncompliance to the IRB, institutional officials, and OHRP, contrary to HHS regulations at 45 CFR 46.103(a) and 46.103(b)(5).
b) Minutes of IRB meetings are inadequate, contrary to HHS regulations at 45 CFR 46.115(a)(2).
Based on the documentation provided in your December 19, 2014 correspondence, we have determined that there is no violation of the regulations regarding these allegations. No evidence was presented to us indicating that serious and continuing noncompliance was not reported to the IRB, institutional officials, and OHRP or that the minutes of IRB meetings are inadequate.
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 your institution’s continued commitment to the protection of human research subjects.
Kristina C. Borror, Ph.D.
Director, Division of Compliance Oversight
1101 Wootton Parkway, Suite 200
Rockville, Maryland 20852
Mr. Michael Mullahy, Assistant Vice Provost, Office of Research and Sponsored Programs, Suffolk
Dr. Michael Suvak Ph.D., IRB Chair, Suffolk
Dr. Joanne Less, Food and Drug Administration (FDA)