Healthy Skepticism Library item: 1982
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: Journal Article
Morin K, Rakatansky H, Riddick FA Jr, Morse LJ, O'Bannon JM 3rd, Goldrich MS, Ray P, Weiss M, Sade RM, Spillman MA.
Managing conflicts of interest in the conduct of clinical trials.
JAMA 2002 Jan 2; 287:(1):78-84
http://jama.ama-assn.org/cgi/content/full/287/1/78
Abstract:
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.
Keywords:
Biomedical Research
Biotechnology
Clinical Trials/economics
Clinical Trials/standards*
Conflict of Interest*
Contract Services
Cooperative Behavior
Disclosure
Drug Industry
Ethical Review
Financial Support
Health Care Sector
Humans
Informed Consent
Patient Selection
Physician's Role*
Research Subjects
Research Support
Researcher-Subject Relations
*analysis
United States
American Medical Association
Council on Ethical and Judicial Affairs
clinical trials
drug company sponsored research
bioethics
relationship between medical profession and industry
relationship between researchers, academic institutions and industry
private physicians
conflict-of-interest
safety of participants
informed consent
reimbursement to doctors
declaration of interests
ETHICAL ISSUES IN PROMOTION: ETHICS OF TRIALS
ETHICAL ISSUES IN PROMOTION: PAYMENTS IN STUDIES
INFLUENCE OF PROMOTION: OUTCOME OF CLINICAL TRIALS
PROMOTION DISGUISED: CLINICAL TRIALS
SPONSORSHIP: RESEARCH
