Abstract

http://ssrn.com/abstract=2393127
 


 



Shadows Amid Sunshine: Regulating Financial Conflicts of Interest in Medical Research


Richard S. Saver


University of North Carolina (UNC) at Chapel Hill - School of Law

October 3, 2103

145 CHEST 379 (2014)
UNC Legal Studies Research Paper No. 2393127

Abstract:     
The controversial Physician Payments Sunshine Act (Sunshine Act) makes public a wide range of financial relationships between industry, physicians, and teaching hospitals. A response in part to increasing concern about financial conflicts arising in clinical trials, the Sunshine Act applies quite broadly in the research setting. This article considers the implications of the Sunshine Act for medical research. It also identifies important unresolved issues and implementation challenges that still lie ahead with the rollout of the legislation underway. Among reasons to question the law's effectiveness, some public reporting can likely be avoided through restructuring of financial relationships with greater participation by allied health professionals and distributors in place of physicians and manufacturers. Of even greater concern, the Sunshine Act primarily depends upon disclosure as a regulatory strategy, making its long-term impact open to question. Disclosure in the research context may have limited utility given uncertainty about who the intended recipients are and their ability to use the information effectively. Apart from the insufficiency of transparency, this article further explores how proportionality, fairness, and accountability considerations make optimal regulation of financial conflicts in medical research quite challenging.

Number of Pages in PDF File: 7

Keywords: Physician Payments Sunshine Act, disclosure, medical research, financial conflicts, regulation

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Date posted: February 11, 2014  

Suggested Citation

Saver, Richard S., Shadows Amid Sunshine: Regulating Financial Conflicts of Interest in Medical Research (October 3, 2103). 145 CHEST 379 (2014); UNC Legal Studies Research Paper No. 2393127. Available at SSRN: http://ssrn.com/abstract=2393127

Contact Information

Richard S. Saver (Contact Author)
University of North Carolina (UNC) at Chapel Hill - School of Law ( email )
Van Hecke-Wettach Hall, 160 Ridge Road
CB #3380
Chapel Hill, NC 27599-3380
United States

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