CLINICAL TRIALS LITIGATION: PRACTICAL REALITIES AS SEEN FROM THE TRENCHES

Litigation involving human clinical research trials has escalated rapidly in the past few years. Whereas these suits raise many important theoretical questions, they also have important practical and human dimensions of which many people are unlikely to be aware until, by some unfortunate turn, they...

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Bibliographic Details
Published in:Accountability in research 2005, Vol.12 (1), p.47-67
Main Author: Morreim, E. HAAVI
Format: Article
Language:English
Subjects:
Bioethics
Clinical Trials as Topic - adverse effects
Clinical Trials as Topic - economics
Clinical Trials as Topic - legislation & jurisprudence
Compensation and Redress - legislation & jurisprudence
Conflict of Interest
Contracts - legislation & jurisprudence
Ethics Committees, Research - legislation & jurisprudence
Heart, Artificial - adverse effects
Hospitals
Humans
Implants, Experimental - adverse effects
Implants, Experimental - economics
Industry - legislation & jurisprudence
Informed Consent - legislation & jurisprudence
Insurance, Liability - economics
Insurance, Liability - legislation & jurisprudence
Jurisprudence
Lawyers
Liability, Legal
Malpractice - legislation & jurisprudence
Mass Media
Patient Advocacy
Prosthesis Implantation
Research Personnel - legislation & jurisprudence
Research Subjects
Therapeutic Human Experimentation - legislation & jurisprudence
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Summary:Litigation involving human clinical research trials has escalated rapidly in the past few years. Whereas these suits raise many important theoretical questions, they also have important practical and human dimensions of which many people are unlikely to be aware until, by some unfortunate turn, they must live the reality. From the vantage of a fairly close view on one recent lawsuit, this article offers some ground-level observations and reflections that, it is hoped, may be of use to people in clinical research who might one day find themselves in a similar position.
ISSN:0898-9621
1545-5815
DOI:10.1080/08989620590918934