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dc.contributor.authorAndrews, Joseph E
dc.contributor.authorMoore, J Brian
dc.contributor.authorWeinberg, Richard B
dc.contributor.authorSissine, Mysha
dc.contributor.authorGesell, Sabina
dc.contributor.authorHalladay, Jacquie
dc.contributor.authorRosamond, Wayne
dc.contributor.authorBushnell, Cheryl
dc.contributor.authorJones, Sara
dc.contributor.authorMeans, Paula
dc.contributor.authorKing, Nancy M P
dc.contributor.authorOmoyeni, Diana
dc.contributor.authorDuncan, Pamela W
dc.contributor.authoron behalf of COMPASS investigators and stakeholders,
dc.date.accessioned2019-09-25T17:03:50Z
dc.date.available2019-09-25T17:03:50Z
dc.date.created2018-07-28 23:20
dc.date.issued2018-08-01
dc.identifieroai:open-archive.highwire.org:medethics:44/8/560
dc.identifierhttp://jme.bmj.com/cgi/content/short/44/8/560
dc.identifierhttp://dx.doi.org/10.1136/medethics-2017-104478
dc.identifier.urihttp://hdl.handle.net/20.500.12424/364275
dc.description.abstractCluster randomised clinical trials present unique challenges in meeting ethical obligations to those who are treated at a randomised site. Obtaining informed consent for research within the context of clinical care is one such challenge. In order to solve this problem it is important that an informed consent process be effective and efficient, and that it does not impede the research or the healthcare. The innovative approach to informed consent employed in the COMPASS study demonstrates the feasibility of upholding ethical standards without imposing undue burden on clinical workflows, staff members or patients who may participate in the research by virtue of their presence in a cluster randomised facility. The COMPASS study included 40 randomised sites and compared the effectiveness of a postacute stroke intervention with standard care. Each site provided either the comprehensive postacute stroke intervention or standard care according to the randomisation assignment. Working together, the study team, institutional review board and members of the community designed an ethically appropriate and operationally reasonable consent process which was carried out successfully at all randomised sites. This achievement is noteworthy because it demonstrates how to effectively conduct appropriate informed consent in cluster randomised trials, and because it provides a model that can easily be adapted for other pragmatic studies. With this innovative approach to informed consent, patients have access to the information they need about research occurring where they are seeking care, and medical researchers can conduct their studies without ethical concerns or unreasonable logistical impediments. <sec><st>Trial registration number</st> <inter-ref locator="https://clinicaltrials.gov/ct2/show/NCT02588664" locator-type="url">NCT02588664</inter-ref>, recruiting. This article covers the development of consent process that is currentlty being employed in the study. </sec>
dc.format.mediumtext/html
dc.languageen
dc.language.isoeng
dc.publisherBMJ Publishing Group Ltd
dc.rightsCopyright (C) 2018, Institute of Medical Ethics
dc.subjectResearch ethics
dc.titleEnsuring respect for persons in COMPASS: a cluster randomised pragmatic clinical trial
dc.typeTEXT
ge.collectioncodeEC
ge.dataimportlabelOAI metadata object
ge.identifier.legacyglobethics:14840970
ge.identifier.permalinkhttps://www.globethics.net/gel/14840970
ge.lastmodificationdate2018-07-28 23:20
ge.lastmodificationuseradmin@pointsoftware.ch (import)
ge.submissions0
ge.oai.exportid148650
ge.oai.repositoryid1568
ge.oai.setnameHighWire Press
ge.oai.setnameBMJ Publishing Group Ltd
ge.oai.setspecHighWire
ge.oai.setspecBMJ-PG
ge.oai.streamid2
ge.setnameGlobeEthicsLib
ge.setspecglobeethicslib
ge.linkhttp://jme.bmj.com/cgi/content/short/44/8/560
ge.linkhttps://dx.doi.org/10.1136/medethics-2017-104478


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