Kennedy Institute of Ethics journal
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Kennedy Inst Ethics J · Jun 2003
Intrinsic conflicts of interest in clinical research: a need for disclosure.
Protection of human subjects from investigators' conflicts of interest is critical to the integrity of clinical investigation. Personal financial conflicts of interest are addressed by university policies, professional society guidelines, public standards, and government regulation, but "intrinsic conflict of interest"--conflicts of interest inherent in all clinical research--have received relatively less attention. Such conflicts arise in all clinical research endeavors as a result of the tension among professionals' responsibilities to their research and to their patients and both academic and financial incentives. These conflicts should be disclosed to research subjects and managed as assiduously as are financial conflicts of interest.
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When may a physician legitimately offer enrollment in a randomized clinical trial (RCT) to her patient? Two answers to this question have had a profound impact on the research ethics literature. Equipoise, as originated by Charles Fried, which we term Fried's equipoise (FE), stipulates that a physician may offer trial enrollment to her patient only when the physician is genuinely uncertain as to the preferred treatment. Clinical equipoise (CE), originated by Benjamin Freedman, requires that there exist a state of honest, professional disagreement in the community of expert practitioners as to the preferred treatment. ⋯ FE articulates conditions under which the fiduciary duties of physician to patient may be upheld in the conduct of research. CE sets out a standard for the social approval of research by institutional review boards. Viewed this way, FE and CE are not necessarily competing notions, but rather address complementary moral concerns.
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The attack on the United States by terrorists on 9/11 and the war with Iraq have raised new ethical questions for the military and for military physicians (Herman 2002; Elshtain 2003). How and when attacks may occur now is less predictable. Planes have been hijacked, and persons dressed as civilians may carry bombs to blow themselves and others up. ⋯ One of the most difficult ethical question raised for the military and military doctors by these developments is what interrogation methods are permissable when questioning captured terrorists. The licitness of different interrogation practices is, however, only one of the ethical problems potentially encountered by military physicians now having to treat terrorists and POWs. The following discussion presents the major concerns regarding this and other issues.