In 2021, the federal office charged with ensuring that the vast research enterprise bankrolled by the Department of Health and Human Services keeps study participants safe, received a report of a death by suicide involving a person enrolled in a study testing a treatment for depression and reduced mobility.
Once the Office of Human Research Protections started looking into the death at the New York State Psychiatric Institute, it found problems that spread far beyond that one study, including failures in how the institute’s ethics board reviews proposed research. “We saw, holy smokes, this whole institution has issues,” said Lisa Buchanan, then director of the OHRP’s compliance division. The investigation became all-consuming. “It was probably 60-70% of our time,” she said.
The Food and Drug Administration got involved, as did the National Institutes of Health, which had provided grant funding to support the study. OHRP put a hold on all HHS-funded clinical research being conducted at NYSPI, and shortly after, the NIH suspended all grants for human subject research at the institute. Such severe actions are rare in the world of biomedical research.
In the months that followed, NYSPI developed a comprehensive corrective action plan that included restructuring its human research protections program under new leadership, implementing additional mandatory training for scientists, and establishing new methods for reporting potential problems. As it began implementing these safeguards, OHRP dropped the ban on human research in October 2024. Two months later, NYSPI signed an agreement with HHS, promising that it would continue to follow through on its plan. HHS in turn agreed to monitor its progress — through reviews of monthly reports and by sending staff from HHS, NIH, and OHRP to conduct at least one on-site visit in the first year of the agreement, according to a copy obtained by STAT.
