Ethical dilemmas in medical innovation and research: distinguishing experimentation from practice.

The words research and experimentation continue to have the power to evoke fear in potential subjects. But much of standard practice, particularly in critical care settings, involves interventions of unknown efficacy and safety. Innovation also abounds in practice settings, typically unchecked by prospective or retrospective review. Historical attention has focused on the conflict of interest of the physician/investigator, but contemporary safeguards have reduced the risks of research and increased the likelihood that the patient/subject will have the opportunity to make an informed choice. Innovation and untested interventions in practice, in contrast, are often unknown to the patient and lack institutional safeguards. Some common cliches that suggest that research is more to be feared than standard practice will be examined, leading to the following conclusions: defining an intervention as experimental may be less important in ethical terms than the quality of prospective and retrospective review and the standards for informed consent, and the concerns that led to regulation of research should now be directed toward unproven interventions and innovation in the practice setting.