The ethics of ongoing randomization trials. Investigation among intimates.

Precisely because firm trials employ experimental designs, it is important that attention be paid to the rights and welfare of the human subjects of these evaluations. This report reviews how administrative firm trials, those that do not directly interfere in the practice of medicine, can be ethically conducted. However, because spiraling health costs are increasing pressures on managers to determine which medical practices are the most cost-effective, we also consider how clinical firm trials comparing accepted diagnostic or therapeutic modalities might be performed. Both of these types of trials require that patients agree to join clinical communities whose routine practice has been redefined to include some level of minimal-risk experimentation. Consequently, it may be appropriate for firm systems formally to adopt a new paradigm of investigation among intimates, one that encourages the participation of patients in all aspects of the research endeavor.