VIDENCE-BASED MEDICINE PRESCRIBES THAT CLINICAL practice should be guided by the results of rigorous research. The close connection between clinical research and patient care, coupled with the need for researchtobeconductedbyphysician-investigatorswithpatients who participate in research (patient-participants), makes it difficult to appreciate how the ethical obligation of investigators differ from those of physicians. Moreover, clinicalresearchcreatesethicaltensionsbyexposingpatientparticipants to risks of harm for the sake of generating scientific knowledge. This has been obscured and assuaged by the prominent tendency to view the ethics of clinical research through the lens of the patient-physician relationship. 1 According to this therapeutic orientation, physicianinvestigatorsretainafiduciarydutyofloyaltytothemedical best interests of patients, characteristic of clinical practice, in the context of conducting clinical research. In contrast, this fiduciary loyalty does not cohere with the socially valuable enterprise of clinical research. To be sure, researchers owe significant and extensive ethical obligation to patientparticipants. However, the ethics of clinical practice does not provide an accurate account of the dual obligations of investigators to promote valuable science and protect human research participants. Unquestionably, research participants place trust in physician-researchers. For example, patient-participants trust investigators to assess their eligibility for a protocol, to explain clearly the study’s risks and potential benefits, to keep private information confidential, and to monitor their wellbeing. Moreover, some patients who participate in research are especially vulnerable to exploitation because of illness. Accordingly, physician-researchers owe these patients significant duties, although the scope of these duties must be evaluated. Can these duties to patients be defined by fiduciary loyalty, akin to the physician’s relationship to patients, requiring the researcher to promote each patientparticipant’s best interests? Or do these duties need separate elucidation? Widelyacceptedaspectsofclinicalresearchwouldbeunethical if physician-researchers’ duties to patientparticipants were identical to those of physicians in clinical care. These research practices are tied to the distinctive goal of research, ie, producing generalizable knowledge. In the medical care setting, treatments and diagnostics must beprescribedbasedoneachpatient’sindividualneeds.However, because controlled experimentation is necessary for valid scientific results, treatments within clinical trials are limited by protocols, not personalized. Moreover, valid scientific results often require that nontherapeutic procedures pose some risk to patient-participants without being offset by individual benefits. For example, performing a biopsy, lumbar puncture, and imaging procedure is justified in clinical care only if the procedure contributes to diagno
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