Healthy Volunteer Registries and Ethical Research Principles

The dual enrolling of phase I volunteers is a potential risk to subjects. It can also distort study results, threaten study validity, and possibly cause harm to future patients. Existing subject registries differ in structure, funding, and governance. Although the choice of the ideal system is drive...

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Bibliographic Details
Published in:Clinical pharmacology and therapeutics 2012-06, Vol.91 (6), p.965-968
Main Authors: Kupetsky-Rincon, E A, Kraft, W K
Format: Article
Language:English
Subjects:
Altruism
Costs and Cost Analysis
Ethics, Research
Humans
Motivation
Personal Autonomy
Registries - ethics
Research Subjects - psychology
Research Subjects - supply & distribution
Risk Assessment
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Summary:The dual enrolling of phase I volunteers is a potential risk to subjects. It can also distort study results, threaten study validity, and possibly cause harm to future patients. Existing subject registries differ in structure, funding, and governance. Although the choice of the ideal system is driven by the scope of the risk and the funding mechanism, and is ultimately a value judgment of freedom versus paternalism, none of the registries significantly impinges on the tenets of ethically based research. Clinical Pharmacology & Therapeutics (2012); 91 6, 965–968. doi:10.1038/clpt.2012.32
ISSN:0009-9236
1532-6535
DOI:10.1038/clpt.2012.32