March 12, 2025 – Virginia Commonwealth University

Dear Dr. Rao:

The Office for Human Research Protections (OHRP) is unable to substantiate the allegations lodged against the Virginia Commonwealth University’s (VCU) Human Research Protections Program (HRPP) and makes no determination of noncompliance with the U.S. Department of Health and Human Services (HHS) regulations for the protection of human research subjects.

Thank you for your May 23, 2022, September 12, 2022, March 9, 2023, and May 16, 2023, responses to our corresponding requests that further allowed OHRP to evaluate these allegations.

Background: OHRP conducted an investigation of VCU’s HRPP in response to allegations of noncompliance with the HHS regulations for the protection of human research subjects (Subpart A, 45 CFR part 46). Complainants alleged that institutional leadership inappropriately interfered in the research oversight of VCU’s HRPP, specifically allowing an investigator’s (hereinafter referred to as “the PI”) noncompliance with institutional policies and HHS regulations to go unaddressed.

Specifically, a complainant alleged that VCU’s HRPP audit of the PI’s research was “being subverted and hindered… by the Institutional Official, the VCU Health System (including the CEO), and various deans and department chairs in the School of Medicine.” Further, it was alleged that this PI and their study team “appear to be engaged in willful ongoing noncompliance.”

It was also alleged that the Signatory Official on the FWA “refuse[d] to take action that might impact the approximately $26 million in research grants brought to the institution by this PI.”

Based on OHRP’s on-site investigation of these allegations and our review of the documents provided by VCU on May 16, 2023, and the responses to the questions and concerns provided on March 9, 2023, OHRP is unable to substantiate these allegations.

OHRP’s investigation included observation of two Institutional Review Board (IRB) meetings on June 7, 2022, and June 10, 2022, and an onsite investigation from June 14, 2022, to June 17, 2022. OHRP reviewed IRB records for approximately 30 active studies (primarily those of the PI), IRB written procedures and checklists, IRB meeting minutes, reliance agreements, Post-Approval Monitoring and Quality Improvement Program (PAMQuiP) reports, investigation audit reports, and appeal documents related to the allegations. In addition, OHRP conducted multiple interviews with VCU’s HRPP officials, institutional leadership, IRB Chairs, IRB members and staff, quality assurance (QA) staff, and other staff with responsibilities key to the HRPP’s operations, as well as with the PI and their study team.

OHRP acknowledges that VCU established routine briefing meetings with the Institutional Official to strengthen their engagement in the HRPP, allocated resources to support the proposed changes, including a redesign of the HRPP by incorporating a consulting firm’s tool kit to support compliance and additional training for HRPP staff and IRB members. This additional support includes ongoing continuing education for HRPP staff and IRB members through an annual HRPP conference and enhancing the VCU’s electronic records management system. In addition, VCU revised standard operating procedures for quality assurance monitoring and reliance agreement processes.

Regarding the allegations pertaining to the PI’s noncompliance, VCU provided oral and written counseling for the PI regarding responsible and ethical conduct of research and ensured adequate training of the PI’s study team to assure compliance with obtaining informed consent, and adherence to HRPP policies and IRB requirements.

This investigation is closed. We appreciate your institution’s continued commitment to the protection of human research participants. Please feel free to contact me if you have any questions.

Sincerely,

Crystal M Kelly, MPH
Program Specialist
Division of Compliance Oversight

CC (email only):
Ms. Lisa Ballance, Human Protections Administrator, VCU
Ms. Winifred Meeker-O’Connell, Director, Office of Clinical Policy, Food and Drug Administration (FDA)
Dr. Michelle Bulls, Director, OPERA, Office of Extramural Research, National Institutes of Health (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
Ms. Lydia Kline, Team Lead, Clinical Research Policy, Division of Clinical and Healthcare Research Policy, Office of Science Policy, NIH
Center for Devices and Radiological Health (CDRH) IRB: BIMO-CDRH@fda.hhs.gov
Center for Biologics Evaluation and Research (CBER): CBERBIMONotification@fda.hhs.gov
Office of Regulatory Affairs (ORA): orabimoinspectionpoc@fda.hhs.gov
Center for Drug Evaluation and Research (CDER): BIMO-CDEROSI@fda.hhs.gov