Abstract

http://ssrn.com/abstract=2143200
 


 



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


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

September 1, 2012

Journal of Law, Medicine, and Ethics, Forthcoming
Virginia Public Law and Legal Theory Research Paper No. 2012-54

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.

Number of Pages in PDF File: 24

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

Accepted Paper Series


Download This Paper

Date posted: September 9, 2012 ; Last revised: May 24, 2014

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: http://ssrn.com/abstract=2143200

Contact Information

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

Feedback to SSRN


Paper statistics
Abstract Views: 574
Downloads: 74
Download Rank: 191,167

© 2014 Social Science Electronic Publishing, Inc. All Rights Reserved.  FAQ   Terms of Use   Privacy Policy   Copyright   Contact Us
This page was processed by apollo1 in 0.297 seconds