May 16, 2025 – Texas A&M University

Research Project: Telehealth Counseling Clinic (TCC)

Dear Dr. Georghiades,

The Office for Human Research Protections (OHRP) investigated allegations lodged in 2016 regarding the conduct of the above-referenced study. While the research referenced above was not supported by U.S. Department of Health and Human Services (HHS), at the time of the alleged noncompliance, Texas A&M University (TAMU)’s Federalwide Assurance (FWA) applied 45 CFR part 46, subparts A – D to all research conducted at the institution regardless of the source of support. OHRP acknowledges that TAMU has taken appropriate corrective actions to address the alleged noncompliance that occurred in the study. OHRP makes no determinations of noncompliance with the HHS regulations for the protection of human research subjects, and this investigation is closed.

All events related to these allegations occurred prior to January 21, 2019, and were subject to the Common Rule as it existed at that time (the “Pre-2018 Requirements”). Therefore, all citations in this letter refer to the Pre-2018 Requirements.

Background: In September 2016, OHRP received allegations of noncompliance with the Pre-2018 Requirements. In summary, the complainant alleged that the TCC study was initiated prior to the investigator obtaining institutional review board (IRB) review and approval, and that once the study was approved, the study was not conducted as described in the IRB-approved protocol.

In 2016 TAMU investigated the above referenced allegations of noncompliance with the Pre-2018 Requirements, and implemented the following corrective actions:

• Revised policies and procedures to increase investigator and student knowledge of the activities and require submission to the IRB for a determination.
• Updated IRB standard operating procedures to contain detailed descriptions of activities and submission requirements.
• Revised the eIRB system to facilitate determinations of when an activity is considered human subjects research and thus when a full IRB application is needed.
• Developed guidance to assist students and researchers in evaluating what constitutes human subjects research.
• Updated standard operating procedures in the telehealth counseling clinic to ensure that patients are adequately notified of the extent to which their clinical data could be used in research.
• Enhanced the privacy and confidentiality protections in place at the telehealth counseling clinic to better safeguard the privacy and confidentiality of potential research subjects that also receive clinical care at the clinic.
• Implemented a training program within the TCC program to ensure staff and volunteers can differentiate clinical services and human subjects research activities.

We regret the amount of time it has taken to close this investigation. The corrective actions developed and implemented by TAMU adequately address the allegations presented.

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 Kelly, MPH
Compliance Specialist
Division of Compliance Oversight

CC (email only):

Ms. Jane Aliese Seawright, Human Protections Administrator, TAMU
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