Litigation in Clinical Research: Malpractice Doctrines Versus Research Realities

Human clinical research trials, by which corporations, universities, and research scientists bring new drugs, devices, and procedures into the practice and marketplace of medicine, have become a huge business. The National Institutes of Health (NIH) doubled its spending over the past five years, whi...

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Bibliographic Details
Published in:The Journal of law, medicine & ethics medicine & ethics, 2004-09, Vol.32 (3), p.474-484
Main Author: Morreim, E. Haavi
Format: Article
Language:English
Subjects:
Causality
Clinical trials
Clinical Trials as Topic - legislation & jurisprudence
Company business management
Company legal issue
Disclosure - legislation & jurisprudence
Government regulation
Health technology assessment
Human experimentation in medicine
Human medical experimentation
Human subjects
Humans
Informed Consent - legislation & jurisprudence
Law
Laws, regulations and rules
Litigation
Malpractice
Malpractice - legislation & jurisprudence
Management
Medical malpractice
Medical personnel
Research Subjects - legislation & jurisprudence
Self-experimentation in medicine
Terminology as Topic
United States
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Summary:Human clinical research trials, by which corporations, universities, and research scientists bring new drugs, devices, and procedures into the practice and marketplace of medicine, have become a huge business. The National Institutes of Health (NIH) doubled its spending over the past five years, while in the private sector the top twenty pharmaceutical companies have more than doubled their investment in research and development over a roughly comparable period. To date, some twenty million Americans have participated in clinical research trials that now are as common in the private practice setting as in academia. For many years human clinical trials received relatively little public attention. In the wake of several well-publicized research abuses, Congress created in 1974 the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to formulate recommendations to protect human research subjects. The Commission’s 1979 Belmont Report helped to guide the Institutional Review Boards (IRBs) that review the ethics of federally funded research.
ISSN:1073-1105
1748-720X
DOI:10.1111/j.1748-720X.2004.tb00160.x