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Ethical Conflict in Providing Informed Consent for Clinical Trials: A Problematic Example from the Gynecologic Cancer Research Community

Department of Hematology/Medical Oncology, The Cleveland Clinic Foundation, Cleveland, Ohio, USA

Correspondence: Maurie Markman, M.D., Department of Hematology/Medical Oncology (R35), The Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, Ohio 44195, USA. Telephone: 216-445-6888; Fax: 216-444-9464; e-mail: markmam{at}ccf.org

The principle of respect for patient autonomy and the importance of informed consent are well established in the conduct of clinical research. However, in actual clinical practice, how one applies this concept is not always clear. The provocative results of a randomized trial examining "consolidation/maintenance" therapy in women with advanced ovarian cancer who achieved a clinically defined complete response to primary chemotherapy have raised difficult issues for clinicians and clinical investigators regarding their obligations to provide patients with information that may interfere with the conduct of ongoing or future research studies.

Key Words. Ovarian cancer • Paclitaxel • Randomized trials • Informed consent in clinical research

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