Tiny HHS office tasked with protecting research participants’ safety is running on fumes

Article excerpt

The federal Office of Human Research Protections, tasked with safeguarding participants in HHS-funded studies, is severely understaffed and under-resourced. The office discovered systemic problems at New York State Psychiatric Institute after investigating a suicide death in a depression treatment trial in 2021, issues that extended well beyond that single study. With a tiny budget and skeleton crew overseeing a massive research enterprise, the office struggles to conduct adequate inspections and enforce safety standards across thousands of federally funded studies.