Medical care
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Randomized Controlled Trial Clinical Trial
Ethical issues in administrative continuous improvement. Applying the concept of prior notification to the conduct of firm trials.
Consensus exists concerning the distinctions to be drawn between clinical practice and research. When the latter is undertaken, established regulations require that protocols including plans for obtaining subjects' informed consent be submitted to Institutional Review Boards for approval. Less consensus or codification exists concerning evaluations conducted by managers in health care settings. ⋯ Accordingly, the history of firm trials from an ethical perspective is reviewed. At the University of Washington, participants of such studies are informed through the process of prior notification, an adaptation of procedures employed widely to inform patients that records or specimens may be used in epidemiologic or biomedical research. Prior notification appears to be a useful refinement of the firm system methodology, one that may have application to managerial manipulations in other arenas.