Clinical research in the private office setting--ethical issues.

A new model for performing clinical investigations has emerged in the United States which utilizes networks of physicians practicing in private office settings. This arrangement has sparked much controversy because of the potential conflicts of interest inherent in the dual roles of physician as clinician and investigator as well as the significant direct financial gains reported by some physicians which might impact on the interests of research subjects. We describe some of the ethical concerns and propose some procedural guidelines to safeguard the interests of research subjects participating in clinical trials in private physician offices. These safeguards include: requiring education of all investigators in research ethics, limiting financial incentives, disclosure to subjects of potential conflicts and financial arrangements, creation of an independent resource available to subjects to discuss concerns and answer questions, and development of educational materials to inform all potential subjects about important issues related to clinical research.