Modern medicine has provided physicians and medical researchers with opportunities to enhance significantly their financial interests through entrepreneurial adventures. There has been much discussion of financial conflicts of interest in the medical and legal literature, and many professional societies are in the process of developing policies to deal with them. Governmental regulations and laws concerning conflicts of interest do not encompass requirements that are proscriptive regarding the types of financial interest that may be held. Institutional policy requirements vary. There is no current, comprehensive document or policy guidance for those engaged in health care, medical research, or policy making to review concerning the appropriate means by which to handle conflicts of interest. The challenge is to develop mechanisms whereby the new pressures, motivations, and incentives introduced in medical research and clinical practice can be reconciled with traditional scientific principles and ethical values that promote the public well-being. This is the focus of the proposed project and distinguishes it from previous work. The project will divide conflicts of interest faced by physicians and biomedical researchers into two categories - A) those occurring in research settings and B) those found in clinical practice. Within each of the two areas, there will be: 1) an in-depth exploration of reported cases and existing literature involving conflicts of interest from all sources; 2) a thorough analysis and critique of the approach the medical community has taken to deal with those conflicts, including governmental regulations and legislation, as well as guidelines set out by professional organizations; 3) a legal analysis of the foundations of the relationships among patients, physicians, and researchers, both in terms of existing jurisprudence and legislative and regulatory remedies; and 4) ethical review and analysis of existing rules and regulations and guidelines. Change in existing laws, regulations and guidelines will be proposed. Final products resulting Ct from the research will include peer reviewed journal articles and a book intended for a university press.
