Giovanni Piedimonte, MD
Vice President for Research
1440 Canal Street, Suite 2400
Mail Stop #8401
New Orleans, LA 70112
Dear Dr. Piedimonte:
Thank you for your September 1, 2016, August 8, 2017, October 2, 2019 and October 17, 2019 responses to our July 29, 2016, July 6, 2017, October 2, 2019 and October 16, 2019 requests that Tulane University (Tulane) evaluate allegations of non-compliance with Department of Health and Human Services (HHS) regulations for the protection of human research subjects.
It is our understanding that the activities described in this letter were initiated prior to January 21, 2019, and remain subject to the pre-2018 Requirements (the requirements published in the 2016 edition of the Code of Federal Regulations at 45 CFR part 46, Subpart A). Please note that regulatory sections listed below refer to sections in the pre-2018 Requirements.
Based on our review of the documents Tulane provided in its report, including the institutional review board (IRB) records, standard operating procedures (SOP), and other pertinent information, we make the following determinations.
The complainant alleged that the Chair of the Biomedical IRB, who is also the Director of the Clinical Trials Unit (CTU), does not regularly recuse herself from voting on trials which are conducted through the CTU. Further, it was alleged that this Chair’s direct employees at CTU also serve as members on the Biomedical IRB and also do not recuse themselves from voting on trials or studies that are conducted through the CTU. In response to OHRP’s inquiry, Tulane provided a copy of a draft Policy 2.8.1 IRB Member Conflict of Interest which stated (in part):
"No IRB Member may participate in the review (initial, continuing, or modification) of any Research project in which the member has a Conflict of Interest (“COI”), except to provide information as requested. It is the responsibility of each IRB member to disclose any COI in a study submitted for review and recuse him/herself from the deliberations and vote by leaving the room.
IRB members may find themselves in any of the following COI when reviewing Research:
1. Where the member or consultant is involved in the design, conduct, and reporting of the Research (for example, if member is involved in the Research through the member’s affiliation with the Tulane Clinical Translational Unit (CTU)). . ."
Upon further inquiry, Tulane provided evidence that the policy initially provided and quoted above was a draft version of Tulane’s Policy 2.8 that had never been approved. The draft policy had been included in error in its response. Tulane, recognizing its error, then provided a copy of the approved policy 2.8 IRB Member Conflict of Interest which omits the CTU example.
OHRP does not consider an IRB member’s affiliation with a CTU as an automatic conflict of interest. Tulane provided evidence demonstrating that the IRB Chair /CTU Director and staff regularly recused themselves from votes to avoid potential conflicts of interest in accordance with 45 CFR 46.107(e) of the pre-2018 Requirements. Therefore, we determine that this allegation is unproven.
The complainant further alleged that two members of the IRB were inappropriately categorized as non-scientific members on the IRB roster in violation of section 46.107(c) of the pre-2018 Requirements, which requires at least one member whose role is in a non-scientific area.
The complainant alleged that one of the people categorized as a non-scientist was pursuing a Ph.D. in Global Community Health and Behavioral Sciences and should be categorized as a scientist for the purposes of IRB review. In addition, it was further alleged that she was employed as a regulatory administrator and has an M.P.H., so she has a scientific background and was working in that capacity.
Based on a review of the documentation provided, the member was appointed as a non-scientific member to the IRB prior to her enrollment into a Ph.D. program. Upon enrollment in the Ph.D. program, the member’s designation was properly changed to that of a scientific alternate member.
Regarding the second non-scientific member, Tulane reported that although the second member holds a Bachelor of Science degree, she is employed in a non-scientific position at Tulane in an area that does not require or utilize scientific training. She is currently employed as a Senior Regulatory Compliance Specialist, an administrative rather than scientific position. Tulane reports that this position views research activities from a non-scientific standpoint.
Therefore, we find that the two members of the IRB were appropriately categorized in accordance with section 46.107(c) of the pre-2018 Requirements and that these allegations are unproven.
B. Tulane’s Response:
As a result of its investigation and audit, Tulane took the following actions:
- Appointed a new Chair, unaffiliated with the CTU, for the Tulane Biomedical IRB. This person reportedly has extensive IRB experience, regulatory expertise, and experience as a clinical investigator performing human subjects research;
- Appointed additional IRB members to strengthen the range of expertise and capacity;
- Streamlined the pre-review process conducted by the HRPO staff;
- Implemented the use of a new electronic IRB submission system; and
- Developed a new Compliance Work Group to review and investigate potential instances of serious or continuing non-compliance identified by the IRB.
OHRP commends Tulane for these efforts taken in support of its human subjects protection program. 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. Please feel free to contact me if you have any questions.
Lisa Buchanan, MAOM
Director, Division of Compliance Oversight
Ms. Roxanne R. Johnson, Director, Human Research Protection Office, Tulane University
Dr. Joanne Less, Food and Drug Administration
Dr. Griffin P. Rodgers, Director, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health (NIH)
Dr. Michelle Bulls, Director, OPERA, Office of Extramural Research, NIH
Dr. Pamela Kearney, Director, Division of Human Subjects Research, Office of Extramural Research, NIH
Dr. Adam Berger, Director, Division of Clinical and Healthcare Research Policy, Office of Science Policy, NIH
Mr. Taunton Paine, Office of Science Policy, NIH