Human Research Subject Protections – The Crisis at New York State Psychiatry Institute

From 1974 to 2000, we relied on institutional review boards (IRBs) to protect human subjects participating in research in the U.S. However, due to the tragic deaths of Jesse Gelsinger in 1999 and Ellen Roche in 2001, we implemented human research protection programs in 2001 to improve our system of human research subject protections. However, there has been no evidence in the literature demonstrating that the human research protection program system provides better protections than the IRB system. Here I report a case of death by suicide of an elderly patient with depression who participated in a randomized clinical trial involving the administration of carbidopa/levodopa (L-DOPA) vs. placebo for depression and psychomotor slowing in older adults at the New York State Psychiatry Institute in 2021. A comparison of these three cases revealed similar egregious noncompliance by the institutions, IRBs, and investigators involved. I suggest using human research subject protection performance metrics data in a continuous quality improvement program to prevent similar incidents from happening in the future.