Our current regulatory systems to protect the subjects of human research seem misguided in many ways. If clinicians try a new therapy with the idea of studying it carefully, evaluating out-comes, and publishing the results, they are doing research. Research is thought to be risky, and the subjects of the research are thought to be in need of special protection. Therefore an institutional review board will review the protocol, the informed consent form will be carefully scrutinized, and the research may be forbidden. If the study is permitted, every adverse event will be carefully documented and scrutinized. If, however, clinicians try the same new therapy without any intention of studying it, simply because they believe it will benefit their patients, it is not research and does not need institutional review board approval, con-sent may be obtained in a manner governed only by the risk of malpractice litigation, and adverse events may not necessarily be noticed or analyzed. It would seem that the patients in the second situation are at much higher risk than the patients in the first. After all, the physicians in the first situation are carefully evaluating the therapy, whereas the physicians in the second situation are using the therapy based on imperfect hunch.
Lantos, J. D. (1999). The “incision benefit” in clinical trials. Journal of Pediatrics, 134(2), 130–131. https://doi.org/10.1016/S0022-3476(99)70400-2