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The Oncologist, Vol. 10, No. 8, 636-641, September 2005; doi:10.1634/theoncologist.10-8-636
© 2005 AlphaMed Press

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Informed Consent for Medical Treatment and Research: A Review

Marcela G. del Carmena, Steven Joffeb

a Division of Gynecologic Oncology, Vincent Obstetrics and Gynecology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA; b Department of Pediatric Oncology, Dana-Farber Cancer Institute, Children’s Hospital, Harvard Medical School, Boston, Massachusetts, USA

Correspondence: Marcela G. del Carmen, M.D., Gillette Center for Women’s Cancers, 55 Fruit Street, Cox Building, 5th Floor, Boston, Massachusetts 02114, USA. Telephone: 617-724-4800; Fax: 617-724-6898; e-mail: mdelcarmen{at}partners.org

The practice of informed consent has historical roots in various disciplines, including medicine, moral philosophy, and the law. It is closely tied to philosophical notions of respect for persons and respect for individual autonomy. Consent to treatment is rooted in case law. Consent to research, in contrast, has its basis in ethical codes, statutes, and administrative regulations, with the courts playing a lesser role. In this article, we define the elements of informed consent in the treatment setting, outline its ethical and legal foundations, and explore some of its limitations. We contend that informed consent plays a critical role in clinical medicine but that other models of decision making deserve consideration under particular circumstances. We also delineate the current federal regulatory schemes guiding human subject research in the U.S., highlight how consent to research differs from consent to treatment, and explore the difficulties that arise in research involving cancer patients and certain vulnerable populations.

Key Words. Informed consent • Treatment • Autonomy • Ethics • Law






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