April 17, 2025 – New York State Psychiatric Institute

Study Title: L-DOPA vs. Placebo for Depression and Psychomotor Slowing in Older Adults

Dear Dr. Smith:

The Office for Human Research Protections (OHRP) is closing its investigation related to allegations of noncompliance with the U.S. Department of Health and Human Services (HHS) regulations (45 CFR part 46) (hereinafter referred to as the “HHS regulations”) involving the above referenced study, other research conducted by the principal investigator for this study, and the New York State Psychiatric Institute’s (NYSPI) human research protections program (HRPP).

Background: On August 23, 2021, NYSPI submitted to OHRP a report of serious noncompliance involving the death by suicide of a subject enrolled in the above study. The study sponsor, the National Institute of Mental Health (NIMH), noted that NYSPI’s report to OHRP may not have included sufficient details regarding the event.

OHRP, in collaboration with NIMH, conducted an on-site investigation of the above-referenced principal investigator’s studies and NYSPI’s HRPP and OHRP continued its investigation until the date of this letter closing our investigation. The on-site portion of this investigation occurred from November 29, 2021, to December 3, 2021.

While this investigation was initiated in response to concerns related to the suicide of a research subject, further inspection revealed potential systemic and serious noncompliance with the HHS regulations such that, on June 23, 2023, OHRP restricted NYSPI’s Federalwide Assurance (FWA).

In response to the potential noncompliance OHRP observed, NYSPI took commendable action and paused all its research involving human subjects, regardless of funding sources. OHRP acknowledges that since OHRP restricted NYSPI’s FWA, NYSPI restructured its HRPP to demonstrate its commitment to protecting the rights and welfare of participants who enroll in research. Most notably, NYSPI has:

1. Created and revised HRPP and IRB standard operating procedures and policies.
2. Hired an external research compliance consulting firm to audit and monitor multiple aspects of NYSPI’s HRPP.
3. Hired several subject matter experts for key positions throughout NYSPI’s HRPP.
4. Transferred review of all their studies to an external IRB, resuming oversight over non- exempt human subjects research after NYSPI’s IRB members and staff received additional training on HHS regulations.

At this time, OHRP is closing its investigation, with the understanding that NYSPI will continue to provide OHRP with monthly reports about the implementation of their corrective actions at least through December 2026. Resources permitting, OHRP intends to conduct a follow-up site visit in the future to assess NYSPI’s progress in restructuring its HRPP.

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,

Julie A. Kaneshiro, M.A.
Acting Director, OHRP

cc: (email only)
Dr. Ann Sullivan, Commissioner, New York State Office of Mental Health
Dr. Karya Ottey, Director of the New York State Office of Mental Hygiene, Office of Human Research Protections Program
Dr. Winifred Meeker-O’Connell, Director, Office of Clinical Policy, FDA
Ms. Theresa Jarosik, Chief Grants Management Officer, National Institutes of Health (NIH) National Institute of Mental Health
Dr. Michelle Bulls, Director, OPERA, Office of Extramural Research, NIH
Dr. Pamela Kearney, Director, Division of Human Subjects Research, Office of Extramural Research, 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

January 10, 2025 – New York State Psychiatric Institute

June 23, 2023 – New York State Psychiatric Institute