Ethical Acceptability of Postrandomization Consent in Pragmatic Clinical Trials | Zendy

David Miller | Zendy; Scott Y. H. Kim | Zendy; Xiaobai Li | Zendy; Neal W. Dickert | Zendy; James Flory | Zendy; Carlisle P. Runge | Zendy; Clare Relton | Zendy

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Ethical Acceptability of Postrandomization Consent in Pragmatic Clinical Trials

Author(s) -

David Miller,

Scott Y. H. Kim,

Xiaobai Li,

Neal W. Dickert,

James Flory,

Carlisle P. Runge,

Clare Relton

Publication year - 2018

Publication title -

jama network open

Language(s) - English

Resource type - Journals

SCImago Journal Rank - 3.278

H-Index - 39

ISSN - 2574-3805

DOI - 10.1001/jamanetworkopen.2018.6149

Subject(s) - clinical trial , psychology , informed consent , political science , epistemology , medicine , philosophy , alternative medicine , pathology

Key Points Question What are the opinions of the general public on the ethics of pragmatic trial designs in which specific informed consent is obtained after randomization from only the active arm of the trial? Findings In this online survey study of 2004 members of the US general public, most participants (75.4%) would recommend approval of the ethics of the trial design, although personal involvement in such trials had a lower approval rate. Better understanding of the postrandomization consent design was associated with a higher rate of approval. Meaning Although controversial, postrandomization consent for pragmatic trials may be ethically acceptable to the public, and education may increase its acceptance.

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