The Regulation and Governance of Clinical Trials: Past and Present Considerations to Ensure Ethical Treatment of Human Participants

Title
The Regulation and Governance of Clinical Trials: Past and Present Considerations to Ensure Ethical Treatment of Human Participants
Publication Date
2021-03
Author(s)
Borsellino, Grace
Foong, Patrick
Allan, Sonia
( author )
OrcID: https://orcid.org/0000-0002-8770-6430
Email: sallan23@une.edu.au
UNE Id une-id:sallan23
Type of document
Journal Article
Language
en
Entity Type
Publication
Publisher
Lawbook Co
Place of publication
Australia
UNE publication id
une:1959.11/56674
Abstract

Clinical trials are crucial in determining whether novel medical interventions are effective and safe. The use of human participants in such trials is also vital, as animal testing and computer simulation are no substitutes for testing people. Regulation aimed to ensure ethical and safe practices when using human participants, had its beginnings at a global level in response to World War II atrocities. Since that time, there has been an exponential rise of clinical trials, driven mostly by large pharmaceutical companies and for-profit contract research organisations motivated to find preventions and cures for illness and disease, and profit. In turn, there is an ever-growing demand for clinical trial human participants. This article considers historical and contemporary instances of when such trials have gone wrong, and examines the development, and importance of comprehensive, robust, and responsive regulation and governance of clinical trials at both international and domestic levels of which researchers must be aware.

Link
Citation
Journal of Law and Medicine, 28(2), p. 421-438
ISSN
1320-159X
Pubmed ID
33768749
Start page
421
End page
438

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