The New England Journal of Medicine
e-mail icon  FREE NEJM E-TOC    HOME   |   SUBSCRIBE   |   CURRENT ISSUE   |   PAST ISSUES   |   COLLECTIONS   |    Advanced Search
Sign in | Get NEJM's E-Mail Table of Contents — Free | Subscribe
 
Health Law, Ethics, and Human Rights
PreviousPrevious
Volume 356:2737-2743 June 28, 2007 Number 26
NextNext

Compact versus Contract — Industry Sponsors' Obligations to Their Research Subjects
Michelle M. Mello, J.D., Ph.D., M.Phil., and Steven Joffe, M.D., M.P.H.

Since this article has no abstract, we have provided an extract of the first 100 words of the full text and any section headings.

 Sign up for free e-toc
 

This Article
-Full Text
- PDF
-PDA Full Text
-Purchase this article

Tools and Services
-Add to Personal Archive
-Add to Citation Manager
-Notify a Friend
-E-mail When Cited
-E-mail When Letters Appear

More Information
Public unease about industry's influence over clinical research has never been greater. Recent events have elevated concerns about financial ties among investigators, academic medical centers, and industry sponsors,1,2,3,4 and disquieting findings have emerged about the legal relationships these entities form to conduct clinical trials.5,6,7,8 Tort litigation brought by injured research subjects has accentuated the legal dimensions of clinical research relationships.9,10,11

These areas of focus converged in Abney v. Amgen, an important case decided in March 2006 by the U.S. Court of Appeals for the Sixth Circuit.12 The dispute centered on the legal obligation of an industry sponsor to provide clinical-trial . . . [Full Text of this Article]

The GDNF Clinical Trial

Plaintiffs' Claims and Court's Findings

Legal Context

Ethical Considerations

Recommendations for Academic Medical Centers


Source Information

From the Harvard School of Public Health (M.M.M.) and the Dana–Farber Cancer Institute, Children's Hospital, and Harvard Medical School (S.J.) — all in Boston.


This article has been cited by other articles:



HOME  |  SUBSCRIBE  |  SEARCH  |  CURRENT ISSUE  |  PAST ISSUES  |  COLLECTIONS  |  PRIVACY  |  HELP  |  beta.nejm.org

Comments and questions? Please contact us.

The New England Journal of Medicine is owned, published, and copyrighted © 2008 Massachusetts Medical Society. All rights reserved.