The Limits of Disclosure as a Response to Financial Conflicts of Interest in Clinical Research

36 Pages Posted: 6 Dec 2010

See all articles by Kathleen Boozang

Kathleen Boozang

Seton Hall School of Law; Seton Hall University - Center for Health & Pharmaceutical Law & Policy

Carl H. Coleman

Seton Hall University School of Law

Kate Greenwood

affiliation not provided to SSRN

Simone Handler-Hutchinson

Center for Health & Pharmaceutical Law & Policy; Seton Hall School of Law

Catherine Finizio

Seton Hall University - Center for Health & Pharmaceutical Law & Policy

Date Written: December 5, 2010

Abstract

While allowing that transparency should be one of the tools employed to manage clinical researchers' conflicts of interest, this paper disagrees with the numerous recommendations that such information become part of the informed consent process. Empirical research in several areas suggests that the provision of this information to prospective trial participants will too often cause information overload; further, few research participants understand the relevance of the information to them once provided. Because many clinical trial participants do not have viable alternatives to trial participation, the information is not facilitating exit from participation. In short, we conclude that embedding this complicated information will ultimately do more harm than good for most recipients.

Keywords: conflicts of interest, clinical trials, informed consent, transparency

Suggested Citation

Boozang, Kathleen M. and Coleman, Carl H. and Greenwood, Kate and Handler-Hutchinson, Simone and Finizio, Catherine, The Limits of Disclosure as a Response to Financial Conflicts of Interest in Clinical Research (December 5, 2010). Available at SSRN: https://ssrn.com/abstract=1720564 or http://dx.doi.org/10.2139/ssrn.1720564

Kathleen M. Boozang (Contact Author)

Seton Hall School of Law ( email )

One Newark Center
Newark, NJ 07102-5210
United States

Seton Hall University - Center for Health & Pharmaceutical Law & Policy ( email )

One Newark Center
Newark, NJ 07102-5210
United States

Carl H. Coleman

Seton Hall University School of Law ( email )

One Newark Center
Newark, NJ 07102-5210
United States
201-204-9512 (Phone)
973-642-8194 (Fax)

HOME PAGE: http://law.shu.edu/Faculty/fulltime_faculty/Carl-Coleman.cfm

Kate Greenwood

affiliation not provided to SSRN

Simone Handler-Hutchinson

Center for Health & Pharmaceutical Law & Policy ( email )

One Newark Center
Newark, NJ 07102-5210
United States

Seton Hall School of Law ( email )

One Newark Center
Newark, NJ 07102-5210
United States

Catherine Finizio

Seton Hall University - Center for Health & Pharmaceutical Law & Policy ( email )

United States

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