Clinical Research and the Physician–Patient Relationship

15 April 2003 | Volume 138 Issue 8 | Pages 669-672

All practicing physicians should be prepared to respond to requests from patients for advice about participating in clinical trials research. Even physicians who choose not to conduct clinical trials but rather devote their practice to clinical care may have patients who consider volunteering for research. In advising patients about clinical research, physicians enhance the physician–patient relationship and contribute to the overall goals of evidence-based medicine. We discuss several ethical and practical challenges facing physicians who wish to help their patients make decisions about volunteering for clinical trials. In addition, we suggest how preparation for advising patients about clinical research participation can be incorporated into the medical education process.

Author and Article Information

From the National Institute of Mental Health, National Institutes of Health, Bethesda, Maryland.

Disclaimer: The opinions expressed are those of the authors and do not necessarily reflect the opinions or policies of the National Institutes of Health, the Department of Health and Human Services, or the federal government.

Acknowledgments: The authors thank Bradford Worrall, MD; Maria Merritt, PhD; Davina Chen, JD; Marion Danis, MD; and Ezekiel Emanuel, MD, PhD, for their advice during the preparation of this manuscript.

Grant Support: This project was supported by National Institute of Mental Health Intramural Research Program funds as part of a Fellowship in Bioethics and Consultation–Liaison Psychiatry cosponsored by the Office of the Clinical Director, National Institute of Mental Health, and the Department of Clinical Bioethics, National Institutes of Health.

Potential Financial Conflicts of Interest: Honoraria: D.L. Rosenstein (Foundation for Advanced Education in the Sciences and College of Psychiatric and Neurologic Pharmacists).

Requests for Single Reprints: Donna T. Chen, MD, MPH, Department of Clinical Bioethics, National Institute of Mental Health, National Institutes of Health, 10 Center Drive, Room 10/1C118, Bethesda, MD 20892-1156; e-mail, dochen{at}cc.nih.gov.

Current Author Addresses: Dr. Chen: Department of Health Evaluation Sciences, PO Box 800717, Hospital West Complex, Multistory Building, 3rd Floor, Room 3181, Charlottesville, VA 22908-0717.

Dr. Miller: Department of Clinical Bioethics, National Institute of Mental Health, National Institutes of Health, 10 Center Drive, Room 10/1C118, Bethesda, MD 20892-1156.

Dr. Rosenstein: Office of the Clinical Director, National Institute of Mental Health, National Institutes of Health, 10 Center Drive, Room 10/3N242, Bethesda, MD 20892-1277.