Belmont Revisited: Ethical Principles for Research with Human Subjects

April 12, 2010 • Posted in Book Reviews

The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was created in 1974 and, after much deliberation (including four days at the Smithsonian Institution’s Belmont Conference Center), released its recommendations in April, 1979. The Belmont Report, after 25 years, is reconsidered in this book by authors prominent in bioethics, economics, law, medicine, medical ethics, philosophy, public health, public policy, and sociology. Three of these authors — Albert R. Jonsen, Patricia King, and Karen Lebacqz — served as members of the National Commission, while Tom L. Beauchamp was assigned the task of writing the original document.

The authors of the Belmont Report described three principles that should govern research with human subjects: respect for persons, beneficence, and justice. Are these all that should be required of human research? Are these three the most important considerations in conducting human research now? The authors, in stand-alone chapters, have a variety of views.

Jonsen and Beauchamp provide the historical context for the Belmont Report, as well as a good number of details regarding its creation. Beauchamp takes pains to describe the work he and James F. Childress did in delineating their four principles of medical ethics and how they differ from the work of the Commission. He concludes that the Belmont Report is both principlist and casuist.

Chapters by Capron; Faden, Mastroianni, and Kahn; and Shapiro and Meslin reflect on the use (or lack of use) of Belmont by subsequent government-appointed bodies: the President’s Commission, the Advisory Committee on Human Radiation Experiments, and the National Bioethics Advisory Commission.

Eric J. Cassell offers a thoughtful essay on how both medicine and the Belmont principles have changed over 25 years. He concludes with the case of a 49-year-old woman who dies of recurrent breast cancer even while the wound for her hip surgery is healing and her kidneys are ‘doing well.’

Lebacqz calls for modifying autonomy with covenant, and including the requirement for ‘attention to power differentials and to the liberation of the oppressed’ (105-7). Churchill would prefer a re-formulation of autonomy as the guiding first principle, built on a base of ‘respect for persons.’ (117) Levine tackles beneficence, while justice is addressed by King.

Susan Sherwin, using her feminist lens to critique Belmont, declares, ‘Only when research programs are made accountable to all segments of the population can we be confident that subjects and citizens are treated ethically.’ (162) She then contradicts herself by stating in her last note that her call for diversity only extends so far: ‘. . . it allows specific exclusion of those who are committed to discriminatory social programs, as they do not support the underlying ethical principles at issue.’ (164)

Reducing bodies to organ systems may make information more manageable; reducing ethics to principles may make distributive justice more transparent. Yet, according to Evans, many scholars feel such reductionism in ethics does not capture the moral life. The Belmont Report is a good place to begin as well as to revisit, but we do not have to live there forever.

James F. Childress, Eric M. Meslin, and Harold T. Shapiro, Editors. Washington, D.C.: Georgetown University Press, 2005.

ISBN 978-1-58901-062-8, 279 PAGES, PAPER $29.95

Reviewed by D. Joy Riley, MD, MA (Bioethics) who serves as the Executive Director of the Tennessee Center for Bioethics & Culture in Brentwood, TN, USA.

Originally published Spring 2009

Reprinted with kind permission of Ethics & Medicine: An International Journal of Bioethics