Conflicts of Interest in Clinical Trial Recruitment & Enrollment: A Call for Increased Oversight

White Paper for the Center for Health & Pharmaceutical Law & Policy, Seton Hall Law School

62 Pages Posted: 3 Dec 2009 Last revised: 11 Feb 2014

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

Tracy E. Miller

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

Kate Greenwood

affiliation not provided to SSRN

Valerie Gutmann Koch

University of Chicago - MacLean Center for Clinical Medical Ethics; New York State Task Force on Life and the Law; DePaul University - College of Law

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: November 30, 2009

Abstract

This White Paper makes several policy recommendations to eliminate or manage the conflicts of interest that arise pursuant to the compensation arrangements between investigators and their institutions with drug and medical device manufacturers as they affect the recruitment and enrollment of human research subjects in clinical trials. The paper seeks to accomplish overall financial neutrality as between treatment and research, so that physicians' decisions regarding inclusion of patients in clinical trials is unaffected by their own financial interests.

Keywords: conflict of interest, pharmaceutical, clinical trials

Suggested Citation

Boozang, Kathleen and Coleman, Carl H. and Miller, Tracy E. and Greenwood, Kate and Koch, Valerie Gutmann and Handler-Hutchinson, Simone and Finizio, Catherine, Conflicts of Interest in Clinical Trial Recruitment & Enrollment: A Call for Increased Oversight (November 30, 2009). White Paper for the Center for Health & Pharmaceutical Law & Policy, Seton Hall Law School. Available at SSRN: https://ssrn.com/abstract=1515762 or http://dx.doi.org/10.2139/ssrn.1515762

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

Tracy E. Miller

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

United States

Kate Greenwood

affiliation not provided to SSRN

Valerie Gutmann Koch

University of Chicago - MacLean Center for Clinical Medical Ethics ( email )

5841 S Maryland Ave
Chicago, IL 60637-1470
United States

New York State Task Force on Life and the Law ( email )

90 Church Street
New York, NY 10007
United States

DePaul University - College of Law ( email )

25 E. Jackson Blvd.
Chicago, IL Cook County 60604-2287
United States

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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