Managing conflicts of interest in the conduct of clinical trials.
The interaction between medical research and for-profit corporations is not new, but it has expanded considerably in recent years. Some of the recent trends may accelerate the research process, particularly when large clinical trials are required. However, a renewed commitment to the application of high ethical standards is essential to ensure that societal trust in research is not eroded, subjects enrolled in trials do not become merely a means to an end, and medical research is efficiently translated into clinical advances that will benefit future patients. This article focuses on the analysis of conflicts of interest in the conduct of clinical trials in both academic and community-based settings. Specifically, it discusses how the roles of research scientists and clinical practitioners differ and the importance of ensuring that participants' consent to enroll in clinical trials is not the result of confusion about the goals of an experimental treatment that may resemble clinical care. The article also discusses the potential conflicts of interest that can arise when clinicians stand to gain from enrolling their own patients as subjects in clinical trials and examines various instances in which disclosure of information regarding funding and compensation may serve to minimize such conflicts. This article emphasizes that to preserve the integrity of research and to protect the welfare of human subjects who enroll in trials, physicians should have adequate training in the conduct of research and be familiar with the ethics of research. When a physician has treated or continues to treat a patient who is eligible to enroll as a subject in a clinical trial conducted by the same physician, someone other than the treating physician should obtain the participant's informed consent. Finally, the article addresses disclosure of financial incentives and related funding issues.
Morin
Karine
K
Council on Ethical and Judicial Affairs, Ethics Standards Group, American Medical Association, 515 N State St, Chicago, IL 60610, USA. Karine_Morin@ama-assn.org
Rakatansky
Herbert
H
Riddick
Frank A
FA
Morse
Leonard J
LJ
O'Bannon
John M
JM
Goldrich
Michael S
MS
Ray
Priscilla
P
Weiss
Matthew
M
Sade
Robert M
RM
Spillman
Monique A
MA
D035843:Biomedical Research; D001709:Biotechnology; D002986:Clinical Trials as Topic / Q000191:economics / Q000592:standards*; D016265:Conflict of Interest; D003284:Contract Services; D003299:Cooperative Behavior; D030881:Disclosure; D004345:Drug Industry; D026724:Ethical Review; D005378:Financial Support; D019981:Health Care Sector; D006801:Humans; D007258:Informed Consent; D018579:Patient Selection; D010819:Physician's Role; D035842:Research Subjects; D012109:Research Support as Topic; D035844:Researcher-Subject Relations