Public preferences on written informed consent for low-risk pragmatic clinical trials in Spain

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dc.contributor.author Dal-Ré, Rafael
dc.contributor.author Carcas, Antonio J.
dc.contributor.author Carné, Xavier
dc.contributor.author Wendler, David
dc.contributor.other UAM. Departamento de Farmacología es_ES
dc.contributor.other Instituto de Investigación Sanitaria Hospital Universitario de La Paz (IdiPAZ) es_ES
dc.contributor.other UAM. Departamento de Medicina Preventiva y Salud Pública y Microbiología es_ES
dc.contributor.other Instituto de Investigación Sanitaria Fundación Jiménez Díaz (ISS-FJD) es_ES
dc.date.accessioned 2017-11-28T14:41:21Z
dc.date.available 2017-11-28T14:41:21Z
dc.date.issued 2017-01-01
dc.identifier.citation British Journal of Clinical Pharmacology 83.9 (2017): 1921-1931 en_US
dc.identifier.issn 0306-5251 (print) es_ES
dc.identifier.issn 1365-2125 (online) es_ES
dc.identifier.uri http://hdl.handle.net/10486/680527
dc.description.abstract Aims: Pragmatic randomized clinical trials (pRCTs) collect data that have the potential to improve medical care significantly. However, these trials may be undermined by the requirement to obtain written informed consent, which can decrease accrual and increase selection bias. Recent data suggest that the majority of the US public endorses written consent for low-risk pRCTs. The present study was designed to assess whether this view is specific to the US. Methods: The study took the form of a cross-sectional, probability-based survey, with a 2 × 2 factorial design, assessing support for written informed consent vs. verbal consent or general notification for two low-risk pRCTs in hypertension, one comparing two drugs with similar risk/benefit profiles and the other comparing the same drug being taken in the morning or at night. The primary outcome measures were respondents' personal preference and hypothetical recommendation to a research ethics committee regarding the use of written informed consent vs. the alternatives. Results: A total of 2008 adults sampled from a probability-based online panel responded to the web-based survey conducted in May 2016 (response rate: 61%). Overall, 77% of respondents endorsed written consent. In both scenarios, the alternative of general notification received significantly more support (28.7–37.1%) than the alternative of verbal consent (12.7–14.0%) (P = 0.001). Forty per cent of respondents preferred and/or recommended general notification rather than written consent. Conclusions: The results suggested that, rather than attempting to waive written consent, current pRCTs should focus on developing ways to implement written consent that provide sufficient information without undermining recruitment or increasing selection bias. The finding that around 40% of respondents endorsed general notification over written consent raises the possibility that, with educational efforts, the majority of Spaniards might accept general notification for low-risk pRCTs en_US
dc.description.sponsorship This work was supported in part by the Victor Grifols i Lucas Foundation (Barcelona, Spain:http://www.fundaciogrifols.org/en/web/fundacio/home). The present work was funded in part by intramural research funds of the US NIH Clinical Center en_US
dc.format.extent 11 pag. es_ES
dc.format.mimetype application/pdf en
dc.language.iso eng en
dc.publisher Wiley-Blackwell Publishing Ltd. en_US
dc.relation.ispartof British Journal of Clinical Pharmacology en_US
dc.rights © 2017 The Authors en_US
dc.subject.other Clinical trial regulation en_US
dc.subject.other General notification en_US
dc.subject.other Low-risk en_US
dc.subject.other Pragmatic trials en_US
dc.subject.other Verbal informed consent en_US
dc.subject.other Written informed consent en_US
dc.title Public preferences on written informed consent for low-risk pragmatic clinical trials in Spain en_US
dc.type article en
dc.subject.eciencia Medicina es_ES
dc.relation.publisherversion https://doi.org/10.1111/bcp.13305 es_ES
dc.identifier.doi 10.1111/bcp.13305 es_ES
dc.identifier.publicationfirstpage 1921 es_ES
dc.identifier.publicationissue 9 es_ES
dc.identifier.publicationlastpage 1931 es_ES
dc.identifier.publicationvolume 83 es_ES
dc.type.version info:eu-repo/semantics/publishedVersion en
dc.rights.cc Reconocimiento – NoComercial es_ES
dc.rights.accessRights openAccess en
dc.authorUAM Carcas Sansuan, Antonio Javier (259090)


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