Conflicts of Interest in Clinical Research: Advocating for Patient-Subjects

Abstract

A version of this paper was first delivered March 15, 2001 at a symposium on legal and ethical issues and conflicts of interest in clinical research at Widener University School of Law. It is intended for lawyers, physicians, clinical scientists, and others interested in human subject research. The article begins by stating broadly that there is a conflict of interest whenever researchers or an institution stand to benefit financially from the enrollment of patients in a clinical trial. The first part of the article offers a brief history of the protections offered to human subjects of research from the 1940s to the present, setting forth the premise that clinical research, although improved, still presents ethical problems and that conflicts of interest play a significant role. The second section looks at the doctor-patient relationship and the notion of informed consent, noting that the consent process for clinical trials is plagued by misconceptions and confusions on the part of patients. Regarding patients' awareness and understanding of conflicts of interest, the article points out that even if a researcher's conflict of interest were disclosed to patient-subjects, which such conflicts generally are not, most patient-subjects would not be able to reasonably assess the impact the conflict might have on subject enrollment or subsequent treatment. The third section focuses on the limitations of Institutional Review Boards, and the limits of institutional policies. The fourth section proposes some first steps to solve the conflict of interest problem, and asserts that until steps are taken to correct the current situation, clinical research will proceed in an ethically problematic atmosphere.