Ethical conflict in providing informed consent for clinical trials: a problematic example from the gynecologic cancer research community.
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.
Markman
Maurie
M
Department of Hematology/Medical Oncology, The Cleveland Clinic Foundation, Cleveland, Ohio 44195, USA. markmam@ccf.org
D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage / Q000627:therapeutic use*; D017326:Clinical Trials, Phase III as Topic / Q000941:ethics*; D018450:Disease Progression; D005260:Female; D006801:Humans; D007258:Informed Consent / Q000941:ethics*; D028681:Moral Obligations; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000473:pathology; D017239:Paclitaxel / Q000008:administration & dosage / Q000627:therapeutic use*; D010353:Patient Education as Topic / Q000941:ethics*; D018579:Patient Selection / Q000941:ethics; D016032:Randomized Controlled Trials as Topic / Q000941:ethics*; D018570:Risk Assessment; D012941:Social Responsibility; D016019:Survival Analysis
D000972:Antineoplastic Agents, Phytogenic; D017239:Paclitaxel