In Plain Sight: A Solution to a Fundamental Challenge in Human Research

Journal of Law, Medicine, and Ethics, Forthcoming

Virginia Public Law and Legal Theory Research Paper No. 2012-54

24 Pages Posted: 9 Sep 2012 Last revised: 24 May 2014

Lois L. Shepherd

University of Virginia Center for Biomedical Ethics and Humanities; University of Virginia School of Law

Margaret Foster Riley

University of Virginia School of Law

Date Written: September 1, 2012

Abstract

The conflict of interest created when physician-researchers combine medical research and treatment is a long-standing and widely recognized ethical challenge of clinical research that has thus far eluded satisfactory solution. A researcher’s obligation to the scientific enterprise not only provides the temptation to ignore the medical needs of subjects in a study, it may provide an obligation, short of actually endangering subjects, to override their medical needs or preferences. Expecting research subjects to protect themselves through informed consent processes is unrealistic, as is expecting physician-researchers to internally navigate this conflict simply by being virtuous. The problem is a structural one that requires a structural solution. People who are receiving medical treatment need a doctor devoted to their care to provide the independent, individualized judgment and advice expected of a physician outside of research. Reliance on other, existing protective mechanisms — institutional review boards, data safety monitoring boards, medical monitors or even the new research subject advocacy programs — falls short, as indeed each of those mechanisms assumes that the subject will be protected and advised by the local investigators, a role they cannot fulfill. For these reasons, we propose that in much clinical research, each research subject should have a doctor independent from the research study.

Keywords: conflict of interest, research, physician, investigator, medical monitors, institutional review boards, research ethics, research subject advocate, clinical research, biomedical research, clinical trials, therapeutic misconception, informed consent, patient-subject, Belmont Report, risk/benefit

Suggested Citation

Shepherd, Lois L. and Riley, Margaret Foster, In Plain Sight: A Solution to a Fundamental Challenge in Human Research (September 1, 2012). Journal of Law, Medicine, and Ethics, Forthcoming; Virginia Public Law and Legal Theory Research Paper No. 2012-54. Available at SSRN: https://ssrn.com/abstract=2143200

Lois L. Shepherd (Contact Author)

University of Virginia Center for Biomedical Ethics and Humanities ( email )

Box 800758
Charlottesville, VA 22901
United States
434-982-3970 (Phone)

University of Virginia School of Law

580 Massie Road
Charlottesville, VA 22903
United States

Margaret Foster Riley

University of Virginia School of Law ( email )

580 Massie Road
Charlottesville, VA 22903
United States

HOME PAGE: http://www.law.virginia.edu

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