Evaluation of interventions for informed consent for randomised controlled trials (ELICIT): developing a core outcome set

Kate Gillies; Cynthia Fraser; Vikki Entwistle; Shaun Treweek; Paula Williamson; Marion Campbell

doi:10.1186/1745-6215-16-S2-P53

Evaluation of interventions for informed consent for randomised controlled trials (ELICIT): developing a core outcome set

Kate Gillies, Cynthia Fraser, Vikki Entwistle, Shaun Treweek, Paula Williamson, Marion Campbell^* (Corresponding Author)

^*Corresponding author for this work

Research output: Contribution to journal › Conference article › peer-review

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Abstract

The process of obtaining informed consent for participation in randomised controlled trials (RCTs) was established as a mechanism to protect participants against undue harm from research and allow people to recognise any potential risks, or benefits, associated with the research. A number of interventions have been put forward to improve this process. Outcomes reported in trials of interventions to improve the informed consent process for decisions about trial participation tend to focus on ‘understanding’ of trial information and recruitment to the parent study. Yet there is a lack of clarity regarding whether these are the ‘right’ outcomes to measure and which outcomes matter (to whom) and why.

Original language	English
Article number	P53
Number of pages	1
Journal	Trials
Volume	16
Issue number	Supplement 2
DOIs	https://doi.org/10.1186/1745-6215-16-S2-P53
Publication status	Published - 16 Nov 2015
Event	3rd International Clinical Trials Methodology Conference - Glasgow, United Kingdom Duration: 16 Nov 2015 → 17 Nov 2015

Keywords

Systematic Literature Review
Informed Consent Process
Healthcare Intervention
Systematic Methodology
Delphi Study

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10.1186/1745-6215-16-S2-P53Licence: CC BY

Trials_Gillies_et_al_Evaluation_of_interventions_VoR
© 2015 Gillies et al. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 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.
Final published version, 285 KBLicence: CC BY

Cite this

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title = "Evaluation of interventions for informed consent for randomised controlled trials (ELICIT): developing a core outcome set",

abstract = "The process of obtaining informed consent for participation in randomised controlled trials (RCTs) was established as a mechanism to protect participants against undue harm from research and allow people to recognise any potential risks, or benefits, associated with the research. A number of interventions have been put forward to improve this process. Outcomes reported in trials of interventions to improve the informed consent process for decisions about trial participation tend to focus on {\textquoteleft}understanding{\textquoteright} of trial information and recruitment to the parent study. Yet there is a lack of clarity regarding whether these are the {\textquoteleft}right{\textquoteright} outcomes to measure and which outcomes matter (to whom) and why.",

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AU - Williamson, Paula

AU - Campbell, Marion

N1 - Poster presentation.

PY - 2015/11/16

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N2 - The process of obtaining informed consent for participation in randomised controlled trials (RCTs) was established as a mechanism to protect participants against undue harm from research and allow people to recognise any potential risks, or benefits, associated with the research. A number of interventions have been put forward to improve this process. Outcomes reported in trials of interventions to improve the informed consent process for decisions about trial participation tend to focus on ‘understanding’ of trial information and recruitment to the parent study. Yet there is a lack of clarity regarding whether these are the ‘right’ outcomes to measure and which outcomes matter (to whom) and why.

AB - The process of obtaining informed consent for participation in randomised controlled trials (RCTs) was established as a mechanism to protect participants against undue harm from research and allow people to recognise any potential risks, or benefits, associated with the research. A number of interventions have been put forward to improve this process. Outcomes reported in trials of interventions to improve the informed consent process for decisions about trial participation tend to focus on ‘understanding’ of trial information and recruitment to the parent study. Yet there is a lack of clarity regarding whether these are the ‘right’ outcomes to measure and which outcomes matter (to whom) and why.

KW - Systematic Literature Review

KW - Informed Consent Process

KW - Healthcare Intervention

KW - Systematic Methodology

KW - Delphi Study

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Evaluation of interventions for informed consent for randomised controlled trials (ELICIT): developing a core outcome set

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Keywords

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