March 8, 2022 – University of Texas Southwestern Medical Center

Dear Dr. Peterson:

The Office for Human Research Protections (OHRP) conducted an on-site evaluation of the University of Texas Southwestern Medical Center’s (UTSW) human research protections program on May 31 through June 2, 2017. The evaluation was conducted as part of OHRP’s program to evaluate, for compliance with 45 CFR Part 46, Human Research Protections Programs (HRPPs) of institutions and institutional review boards (IRBs) that review research receiving Department of Health and Human Services (HHS) support.

The evaluation included meetings and interviews with institutional officials, institutional review board (IRB) chairpersons and members, the IRB staff, and multiple investigators who receive HHS funding for their research. We also interviewed the Reliance Program Manager and the Regulatory Monitoring Analyst. Your human subject research portfolio consisted of approximately 3,500 active human research studies, of which approximately 300 were HHS supported. During our visit, we reviewed over 35 active HHS-supported studies, IRB written procedures, IRB meeting minutes and various IRB forms and checklists.

We were pleased to observe a well-organized HRPP. Based on our observations, UTSW officials, IRB chairpersons, staff, and researchers conveyed a sincere commitment to and concern for the protection of human research subjects. We would like to highlight the essential role your IRB administrators and analysts play in successfully carrying out the daily operations of your Office for Human Research (OHR). The HRPP Director demonstrated comprehensive knowledge of HHS regulations and appeared to be highly engaged in all aspects of the program. After our evaluation, OHRP sent UTSW as questions and concerns letter (dated June 6, 2018) outlining concerns related to UTSW’s HRPP. Based on the information provided in your response, these concerns were resolved.

Resolved Concern:

During our site visit, we questioned IRB members, staff, and researchers about the process of reporting serious and continuing non-compliance and unanticipated problems to the IRB and OHRP, and they appeared to lack understanding of which incidents needed to be reported to OHRP. Aside from the Human Research Protections Program Office (HRPPO) staff acknowledgement of certain events, we found no indication that the IRB receives, and reviews reports of unanticipated events and serious or continuing noncompliance. Further, in our review of the IRB written procedures, we did not locate a description of the types of events that are forwarded to the IRB for assessment, and or the types of events that would be reported to OHRP.

UTSW response and corrective actions: Per your response to this concern, UTSW reviewed its records and found that the policy and procedure documents in place at that time required a Senior IRB Coordinator to review all events reported to the IRB to determine whether they met prompt reporting criteria. If that person determined that the event met prompt reporting criteria, then it would be forwarded to an IRB Chair who would schedule the event for review by the IRB Executive Committee (IEC). The IEC would review the event and corrective action plan and determine whether the event required reporting to OHRP. If the Senior IRB Coordinator determined the event did not meet prompt reporting criteria (not possibly serious or continuing noncompliance or not an unanticipated problem involving risks to subjects or other (UPIRSO), then the event was “acknowledged” in the eIRB system. The eIRB system at that time did not allow the user to enter a comment describing the rationale for the determination and the procedures did not require a rationale. Since the OHRP site evaluation, the HRPPO has undergone numerous changes and improvements.

The HRPPO revised and issued a 335-page HRPP Policy and Procedure. Based on our review of the revised policies and procedures, we acknowledge that these written procedures define which events must be reported promptly and describe the requirements for timely submission of reportable events to the HRPP Office. The policies describe the review in the HRPPO by a designated reviewer; the subsequent review by a subcommittee to further investigate events and planned corrective actions; and finally, the convened IRB review of possible serious/continuing noncompliance and/or possible unanticipated problems involving risks to subjects or others and proposed corrective actions. According to the policies, when reviewing the event, the IRB considers the appropriateness of the corrective and preventative action (CAPA) plan (or requires additional modifications to the plan).

The revised policy also explains the process for reporting serious or continuing noncompliance, unanticipated problems involving risks to subjects or others, IRB suspensions and terminations to appropriate institutional officials (at UTSW and affiliates) and appropriate federal agencies, including OHRP when funded by HHS.

Lastly, these revisions led to numerous training sessions of IRB members and researchers.

The corrective actions that UTSW has taken adequately addresses OHRP’s concerns. 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 that 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.

Sincerely,

Lisa Buchanan, MAOM
Director
Division of Compliance Oversight

cc:
Ms. Rhonda Oilepo, Human Protections Administrator, UTSW
Ms. Ann Meeker-O’Connell, Director, Office of Clinical Policy, Food and Drug Administration (FDA)
Dr. Quynh-Van Tran, Center for Drug Evaluation and Research, FDA
Dr. Michelle Bulls, Director, OPERA, Office of Extramural Research (OER), National Institutes of Health (NIH)
Dr. Pamela Kearney, Director, Division of Human Subjects Research, OER, 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