HHS Office of Human Research Protections faces staff shortages, jeopardizing participant safety oversight

In 2021 the Office of Human Research Protections (OHRP) received a report of a participant suicide during a depression and mobility study at the New York State Psychiatric Institute. The incident prompted OHRP to launch a deep investigation into the study and the institute's oversight processes.

The probe uncovered widespread problems with the institute's ethics board reviews, leading OHRP staff to devote the majority of their time-estimated at 60‑70%-to the case. The findings suggested systemic issues beyond the single trial.

The Food and Drug Administration and the National Institutes of Health became involved, and OHRP placed a hold on all HHS‑funded clinical research at the institute. Shortly after, NIH suspended all grants for human‑subject research there, actions that are rarely taken in biomedical research oversight.