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Involving service users in trials: developing a standard operating procedure.

Abstract：

BACKGROUND:Many funding bodies require researchers to actively involve service users in research to improve relevance, accountability and quality. Current guidance to researchers mainly discusses general principles. Formal guidance about how to involve service users operationally in the conduct of trials is lacking. We aimed to develop a standard operating procedure (SOP) to support researchers to involve service users in trials and rigorous studies. METHODS:Researchers with experience of involving service users and service users who were contributing to trials collaborated with the West Wales Organisation for Rigorous Trials in Health, a registered clinical trials unit, to develop the SOP. Drafts were prepared in a Task and Finish Group, reviewed by all co-authors and amendments made. RESULTS:We articulated core principles, which defined equality of service users with all other research team members and collaborative processes underpinning the SOP, plus guidance on how to achieve these. We developed a framework for involving service users in research that defined minimum levels of collaboration plus additional consultation and decision-making opportunities. We recommended service users be involved throughout the life of a trial, including planning and development, data collection, analysis and dissemination, and listed tasks for collaboration. We listed people responsible for involving service users in studies and promoting an inclusive culture. We advocate actively involving service users as early as possible in the research process, with a minimum of two on all formal trial groups and committees. We propose that researchers protect at least 1% of their total research budget as a minimum resource to involve service users and allow enough time to facilitate active involvement. CONCLUSIONS:This SOP provides guidance to researchers to involve service users successfully in developing and conducting clinical trials and creating a culture of actively involving service users in research at all stages. The UK Clinical Research Collaboration should encourage clinical trials units actively to involve service users and research funders should provide sufficient funds and time for this in research grants.

journal_name

Trials

journal_title

Trials

authors

Evans BA,Bedson E,Bell P,Hutchings H,Lowes L,Rea D,Seagrove A,Siebert S,Smith G,Snooks H,Thomas M,Thorne K,Russell I,West Wales Organisation for Rigorous Trials in Health (WWORTH).

doi

10.1186/1745-6215-14-219

subject

Has Abstract

pub_date

2013-07-17 00:00:00

pages

219

issn

1745-6215

pii

1745-6215-14-219

journal_volume

pub_type

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Involving service users in trials: developing a standard operating procedure.