Informed consent in randomised controlled trials: development and preliminary evaluation of a measure of Participatory and Informed Consent (PIC).

2.50
Hdl Handle:
http://hdl.handle.net/11287/620448
Title:
Informed consent in randomised controlled trials: development and preliminary evaluation of a measure of Participatory and Informed Consent (PIC).
Authors:
Wade, J.; Elliott, D.; Avery, K N L; Gaunt, D.; Young, G. J.; Barnes, R.; Paramasivan, S.; Campbell, Bruce; Blazeby, J. M.; Birtle, A. J.; Stein, R. C.; Beard, D. J.; Halliday, A. W.; Donovan, J. L.
Abstract:
Informed consent (IC) is an ethical and legal prerequisite for trial participation, yet current approaches evaluating participant understanding for IC during recruitment lack consistency. No validated measure has been identified that evaluates participant understanding for IC based on their contributions during consent interactions. This paper outlines the development and formative evaluation of the Participatory and Informed Consent (PIC) measure for application to recorded recruitment appointments. The PIC allows the evaluation of recruiter information provision and evidence of participant understanding.
Citation:
Informed consent in randomised controlled trials: development and preliminary evaluation of a measure of Participatory and Informed Consent (PIC). 2017, 18 (1):327 Trials
Publisher:
BioMed Central
Journal:
Trials
Issue Date:
17-Jul-2017
URI:
http://hdl.handle.net/11287/620448
DOI:
10.1186/s13063-017-2048-7
PubMed ID:
28716064
Additional Links:
https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-017-2048-7
Note:
This article is freely available via Open Access. Click on the Additional Link above to access the full-text via the publisher's site.
Type:
Journal Article
Language:
en
ISSN:
1745-6215
Appears in Collections:
Vascular Surgery; 2017 RD&E publications

Full metadata record

DC FieldValue Language
dc.contributor.authorWade, J.en
dc.contributor.authorElliott, D.en
dc.contributor.authorAvery, K N Len
dc.contributor.authorGaunt, D.en
dc.contributor.authorYoung, G. J.en
dc.contributor.authorBarnes, R.en
dc.contributor.authorParamasivan, S.en
dc.contributor.authorCampbell, Bruceen
dc.contributor.authorBlazeby, J. M.en
dc.contributor.authorBirtle, A. J.en
dc.contributor.authorStein, R. C.en
dc.contributor.authorBeard, D. J.en
dc.contributor.authorHalliday, A. W.en
dc.contributor.authorDonovan, J. L.en
dc.date.accessioned2017-10-13T15:08:17Z-
dc.date.available2017-10-13T15:08:17Z-
dc.date.issued2017-07-17-
dc.identifier.citationInformed consent in randomised controlled trials: development and preliminary evaluation of a measure of Participatory and Informed Consent (PIC). 2017, 18 (1):327 Trialsen
dc.identifier.issn1745-6215-
dc.identifier.pmid28716064-
dc.identifier.doi10.1186/s13063-017-2048-7-
dc.identifier.urihttp://hdl.handle.net/11287/620448-
dc.description.abstractInformed consent (IC) is an ethical and legal prerequisite for trial participation, yet current approaches evaluating participant understanding for IC during recruitment lack consistency. No validated measure has been identified that evaluates participant understanding for IC based on their contributions during consent interactions. This paper outlines the development and formative evaluation of the Participatory and Informed Consent (PIC) measure for application to recorded recruitment appointments. The PIC allows the evaluation of recruiter information provision and evidence of participant understanding.en
dc.language.isoenen
dc.publisherBioMed Centralen
dc.relation.urlhttps://trialsjournal.biomedcentral.com/articles/10.1186/s13063-017-2048-7en
dc.rightsArchived with thanks to Trials. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.en
dc.subjectWessex Classification Subject Headings::Patients. Primary care. Medical profession. Forensic medicineen
dc.titleInformed consent in randomised controlled trials: development and preliminary evaluation of a measure of Participatory and Informed Consent (PIC).en
dc.typeJournal Articleen
dc.identifier.journalTrialsen
dc.description.noteThis article is freely available via Open Access. Click on the Additional Link above to access the full-text via the publisher's site.en
dc.type.versionPublisheden
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