‘If a clinician tries a new therapy with the idea of studying it carefully, evaluating outcomes, and publishing the results, he or she is doing research. The subjects [sic] of such research are thought to be in need of special protection. The protocol must be reviewed by an Institutional Review Board (IRB) [equivalent to a research ethics committee in Europe]. The informed consent form will be carefully scrutinised and the research may be forbidden.
On the other hand, a clinician may try this new therapy without any intention of studying it, merely because he believes it will benefit his patients. In that situation, trying the new therapy is not research, the trial does not need IRB approval, and consent may be obtained in a manner governed only by the risk of malpractice litigation.
It would seem that the patients in the second situation (non research) are at much higher risk than are the patients in the first situation (being part of formal clinical research). Furthermore, the physician in the first situation seems more ethically admirable. The physician in the first situation is evaluating the therapy, whereas the physician in the second situation is using the therapy based on his or her imperfect hunches.
Nevertheless, because ethical codes that seek to protect patients focus on the goal of creating generalizable knowledge, they regulate the responsible investigator but not the irresponsible adventurer.’
Lantos J. Ethical issues – how can we distinguish clinical research from innovative therapy? American Journal of Pediatric Hematology/Oncology 1994;16:72-75.
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