Clinical trials in crisis situations : Ethical issues
Authors
Ramiro Avilés, Miguel ÁngelPublisher
Springer
Date
2019Embargo end date
2029-12-31Bibliographic citation
D. P. O'Mathúna, I. de Miguel Beriain (eds.), Ethics and Law for Chemical, Biological, Radiological, Nuclear & Explosive Crises. Springer, 2019, p. 117-133
Keywords
Public health crisis
Clinical trials
Research ethics
Rights
Double standard
Mandatory participation
Document type
info:eu-repo/semantics/bookPart
Version
info:eu-repo/semantics/publishedVersion
Rights
Attribution 4.0 International (CC BY 4.0)
@ Springer Nature Swirzerland AG
Access rights
info:eu-repo/semantics/embargoedAccess
Abstract
The implementation of a clinical trial within a crisis situation – including chemical, biological, radiological, nuclear and explosive (CBRNE) events triggered by natural causes or bioterrorist attacks – raises issues related to the balance between public health and human rights. In such a scenario we need to ponder ethical principles and legal rules, especially when the agents causing illness or death in people, animals or plants do not respond to current standard of care or no approved treatments exist. Public health crises complicate ethical concerns common to clinical research and pose challenges to the way ethical principles for human subjects research are interpreted and applied. It is necessary to give careful thought to which normative requirements (both legal and ethical) should be satisfied in order to carry out a clinical trial in a public health crisis. Double normative standards and mandatory participation are issues of particular importance to the design and implementation of clinical trials in pubtic health crises.
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clinical_ramiro_ethics_2019.pdf | 4.589Mb |
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Files | Size | Format |
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clinical_ramiro_ethics_2019.pdf | 4.589Mb |
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