title: 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.
authors.affiliation: College of Medicine, Swansea University, Swansea, Wales, UK. b.a.evans@swansea.ac.uk
authors.forename: Bridie Angela
authors.initials: BA
authors.lastname: Evans
authors.forename: Emma
authors.initials: E
authors.lastname: Bedson
authors.forename: Philip
authors.initials: P
authors.lastname: Bell
authors.forename: Hayley
authors.initials: H
authors.lastname: Hutchings
authors.forename: Lesley
authors.initials: L
authors.lastname: Lowes
authors.forename: David
authors.initials: D
authors.lastname: Rea
authors.forename: Anne
authors.initials: A
authors.lastname: Seagrove
authors.forename: Stefan
authors.initials: S
authors.lastname: Siebert
authors.forename: Graham
authors.initials: G
authors.lastname: Smith
authors.forename: Helen
authors.initials: H
authors.lastname: Snooks
authors.forename: Marie
authors.initials: M
authors.lastname: Thomas
authors.forename: Kym
authors.initials: K
authors.lastname: Thorne
authors.forename: Ian
authors.initials: I
authors.lastname: Russell
mesh_terms: D002986:Clinical Trials as Topic / Q000592:standards*; D003256:Community Participation; D003299:Cooperative Behavior; D003661:Decision Support Techniques; D017408:Guidelines as Topic; D006801:Humans; D033183:Interdisciplinary Communication; D016730:Program Development; D012107:Research Design / Q000592:standards*; D012108:Research Personnel / Q000592:standards*; D035842:Research Subjects; D014852:Wales