The Markingson Case and the Ethics of Institutional Proceduralism
in Trudo Lemmens and Bernadette J. Richards, "Recent Developments: Investigating research and Accessing Reproductive Material" (2014) 11(1) Bioethical Inquiry 11-16 DOI 10.1007/s11673-013-9503-2
9 Pages Posted: 31 Mar 2014 Last revised: 7 Apr 2014
Date Written: March 29, 2014
Abstract
This article discusses the controversy surrounding the 2004 suicide of Dan Markingson in a clinical trial at a University of Minnesota hospital. It explains the rationale behind a recent initiative by a group of more than 170 international scholars to request a publicly accountable inquiry into the events surrounding the suicide and into the lack of proper investigation by the University and several other agencies (including the FDA and professional regulators) mandated to protect patients and research subjects. The case raises serious and ongoing concerns about the enrollment of vulnerable psychiatric patients in research, coercion and undue influence, the impact of conflicts of interest on the behavior of clinical investigators and university administrators, the qualifications of research personnel, and the integrity of medical research at major medical schools. The arguments invoked by various institutional players to reject a further investigation shows how existing research ethics review procedures may result in superficial assessments that can easily be employed as a protective shield. Instead of promoting better ethical standards in research, they may sometimes become tools to hide abuse.
Keywords: clinical trials; undue inducement; coercion; IRB; FDA; research subject protection
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