Assessing the bioethical integrity of a clinical trial in surgery.

leagues in the June 2004 Canadian Journal of Surgery (volume 47, pages 200–208) nicely takes readers through the process of assessing the value of a randomized clinical trial (RCT) in surgery. These steps are based on the invaluable work of the Evidence-Based Medicine Working Group (EBMWG). Considerable effort has also gone into standardizing reportage of RCTs. Thoma’s article has 35 references, of which 2 touch on ethical aspects of clinical research. This same discordance in attention between the scientific and ethical dimensions of clinical research is reflected in the emphases of EBMWG and CONSORT, the Consolidated Standards of Reporting Trials Group. Ethical issues are nonetheless assuming greater prominence in the conduct and interpretation of clinical research. Although most researchers are virtuous and well-meaning, it is easy to transgress proper ethical boundaries, just as it is easy for a surgeon untrained in trial design to transgress proper methodology. Some ethical dimensions are extremely obvious by common sense, common practice, or common law, such as the need to submit an RCT to one’s institutional research ethics board (REB). Others are subtle and nuanced, such as the nonfinancial conflicts of interest experienced by clinical investigators. Most of the literature on ethical conduct of research is commentary or theoretical analysis. Although a few papers have attempted to formulate usable frameworks, only 1 was written by a surgeon. Herein is offered a simple, practical, and surgically oriented framework for assessing the bioethical integrity of clinical research (Box 1).