title: Co-design and implementation research: challenges and solutions for ethics committees.
abstract: BACKGROUND
  Implementation science research, especially when using participatory and co-design approaches, raises unique challenges for research ethics committees. Such challenges may be poorly addressed by approval and governance mechanisms that were developed for more traditional research approaches such as randomised controlled trials.
  
  
  CONCLUSIONS
  Implementation science commonly involves the partnership of researchers and stakeholders, attempting to understand and encourage uptake of completed or piloted research. A co-creation approach involves collaboration between researchers and end users from the onset, in question framing, research design and delivery, and influencing strategy, with implementation and broader dissemination strategies part of its design from gestation. A defining feature of co-creation is its emergent and adaptive nature, making detailed pre-specification of interventions and outcome measures impossible. This methodology sits oddly with ethics committee protocols that require precise pre-definition of interventions, mode of delivery, outcome measurements, and the role of study participants. But the strict (and, some would say, inflexible) requirements of ethics committees were developed for a purpose - to protect participants from harm and help ensure the rigour and transparency of studies. We propose some guiding principles to help square this circle. First, ethics committees should acknowledge and celebrate the diversity of research approaches, both formally (through training) and informally (by promoting debate and discussion); without active support, their members may not understand or value participatory designs. Second, ground rules should be established for co-design applications (e.g. how to judge when 'consultation' or 'engagement' becomes research) and communicated to committee members and stakeholders. Third, the benefits of power-sharing should be recognised and credit given to measures likely to support this important goal, especially in research with vulnerable communities. Co-design is considered best practice, for example, in research involving indigenous peoples in New Zealand, Australia and Canada.
authors.affiliation: Department of General Practice & Primary Health Care, University of Auckland, PB, 920919, Auckland, New Zealand. f.goodyear-smith@auckland.ac.nz.
authors.forename: Felicity
authors.initials: F
authors.lastname: Goodyear-Smith
authors.affiliation: Centre for Primary Care Reform Research Excellence, School of Medicine, University of Queensland, Brisbane, Australia. c.jackson@uq.edu.au.
authors.forename: Claire
authors.initials: C
authors.lastname: Jackson
authors.affiliation: Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK. trish.greenhalgh@phc.ox.ac.uk.
authors.forename: Trisha
authors.initials: T
authors.lastname: Greenhalgh
mesh_terms: D001315:Australia; D002170:Canada; D055812:Community-Based Participatory Research / Q000941:ethics* / Q000639:trends*; D003299:Cooperative Behavior; D028744:Ethics Committees, Research / Q000592:standards; D006801:Humans; D009520:New Zealand; D017063:Outcome Assessment, Health Care; D012107:Research Design / Q000592:standards / Q000639:trends; D012108:Research Personnel / Q000941:ethics*; D035842:Research Subjects