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The Proceedings of the American Thoracic Society 4:171-175 (2007)
© 2007 The American Thoracic Society
doi: 10.1513/pats.200701-012GC
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Framing the Forum

Medical Ethics in Large-Scale, Interventional Respiratory Clinical Trials

Gerard J. Criner1

1 Temple University School of Medicine, and Temple University Hospital, Division of Pulmonary and Critical Care Medicine, Temple Lung Center, Philadelphia, Pennsylvania

Correspondence and requests for reprints should be addressed to Gerard J. Criner, M.D., FCCP, Division of Pulmonary and Critical Care Medicine, Temple Lung Center, Temple University Hospital, 777 Parkinson Pavilion, 3401 North Broad Street, Philadelphia, PA 19140. E-mail: crinerg{at}tuhs.temple.edu

ABSTRACT

Clinical research can create a conflict between the quest for science and the quest for individualized best patient care. The researcher must balance the degree of uncertainty about a particular treatment with the risk of patient exposure to control therapy. This is known as clinical equipoise. Clinical research and clinical care are intricately linked, yet they differ significantly from each other. This is an important distinction to make for both patients and physicians. This overview of ethics in clinical research will discuss some of the key contentious issues: informed consent (including payment for participation in a clinical trial, use of a placebo, and defining "standard of care"), research in critically ill patients, dissemination of study results, race issues, and financial disclosure. More research is being conducted by more investigators, in more organizations, in more disciplines than ever before. While this environment creates enormous opportunities for advances in healthcare, it also poses numerous challenges to the ethical conduct of clinical trials and raises numerous heretofore unconsidered issues.

Key Words: ethics • clinical trial • race • financial disclosure • informed consent






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