When we began our careers as psychiatrists in the 1970s, the primary locus of psychiatric research (especially psychopharmacology) was in academic-affiliated “research units.” Most medical school psychiatry departments, major state and VA hospitals, and prestigious private institutions dedicated some inpatient beds and clinic space to research. Most research units specialized in specific psychiatric diagnoses: major depression, schizophrenia, bipolar disorder, OCD, borderline personality disorder, anxiety, or eating disorders. At major institutions, there was often an affiliated pre-clinical research program (usually animal research), which added a basic sciences component.

The vast majority of the research was “investigator-initiated.” The primary investigators (PIs) proposed the hypotheses, designed the methodology, managed the paperwork, collected, analyzed, and interpreted the data, and presented and published the findings. Funding usually came through competitive grants from federal and state governments or national and local foundations.

When I (FWP) started clinical research training at the NIMH, there was no formal human subjects or scientific oversight, other than review by my immediate boss. External checks involved the competitive funding process, and later, pre-publication peer-review of the findings. By the time I left 20 years later (1999), there was a highly structured, independent review of the ethical and scientific issues for all human subjects, human tissue, and animal research.

That regulatory structure and intensive scrutiny have only increased by another order or two of magnitude in the quarter century since. Indeed, as I talk with colleagues and former mentees, they tell me that the extraordinary difficulties in obtaining adequate grant funding and the enormous paperwork and administrative burdens of conducting investigator-initiated research have........

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