March 13, 2025 – Leland Stanford Junior University

Study Titles: Early Intervention for Youth at Risk for Bipolar Disorder-Family Focused Treatment (“FFT”); and Brain Connectivity and Mindfulness Training in Youth with Bipolar Disorder Not Otherwise Specified (“BCMT”)

Dear Dr. Studdert,

The Office for Human Research Protections (OHRP) investigated the allegations lodged against Leland Stanford Junior University (Stanford)’s Human Research Protections Program (HRPP). OHRP acknowledges that Stanford has taken appropriate corrective actions to address the alleged noncompliance that occurred in the above referenced research studies. OHRP makes no determinations of noncompliance with the U.S. Department of Health and Human Services (HHS) regulations for the protection of human research subjects.

Background: In July 2015, OHRP received allegations against Stanford of noncompliance with HHS regulations for the protection of human research subjects (45 CFR part 46). It is our understanding that the research activities listed above were initiated prior to January 21, 2019, and are subject to subparts A-D of 45 CFR part 46 as they existed at that time.

In summary, the complainant alleged inadequacies in the solicitation and documentation of parental permission and assent; improper adherence to the Institutional Review Board (IRB)-approved protocol; and concerns about data integrity and validity.

OHRP reviewed documentation provided by the complainant and Stanford, including: the IRB application for FFT, a summary report of internal compliance audits of the FFT and BCMT studies, IRB records related to the study, informed consent forms, Good Clinical Practice (GCP) audit reports (both studies), and the National Institute of Mental Health Interim Monitoring Visit Report (FFT only).

Corrective actions taken by Stanford included:

• hiring an independent consulting group to conduct comprehensive GCP audits of the involved research activities;
• development and implementation of corrective action plans;
• instituting quarterly audits during the interventional phase of the research;
• correcting gaps in source documentation, including seeking informed consent again for the collection and use of data as needed; and
• independent review of data integrity of the Stanford dataset by another PI of the study.

Based on our review of the provided materials, OHRP determines that Stanford has taken appropriate actions to investigate and address the alleged noncompliance with the HHS regulations for the protection of human research subjects.

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,

Lisa Buchanan, MAOM, CIP
Director, Division of Compliance Oversight

CC (email only):

• Dr. Ann Johnson, PhD, MPH, Human Protections Administrator, Leland Stanford Junior University
• 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