Abstract
BackgroundImplementation 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.DiscussionImplementation 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.
Highlights
Implementation science research, especially when using participatory and co-design approaches, raises unique challenges for research ethics committees
The current system of research ethics in biomedicine emerged partly as a response to international scandals such as the infamous experiments on prisoners under the Nazi regime and the Tuskeegee syphilis study [18]
Banks et al, writing about community-based participatory research (CBPR, a type of co-creation research linked to community development and the quest for social justice), point out that whereas conventional research ethics is principle-based and focused primarily on ensuring rule-following to meet regulatory requirements, CBPR is value-based and focused on relationships and the distribution of power between ‘researchers’ and ‘researched’ [28]
Summary
Challenges in gaining ethics committee approval in co-creation research Research involving human participants puts people at risk, largely for the benefit of the researchers [17]. Banks et al, writing about community-based participatory research (CBPR, a type of co-creation research linked to community development and the quest for social justice), point out that whereas conventional research ethics is principle-based and focused primarily on ensuring rule-following to meet regulatory requirements, CBPR is value-based and focused on relationships and the distribution of power between ‘researchers’ and ‘researched’ (and acknowledging that the boundaries between these groups may be blurred) [28] With these caveats in mind, and assuming that cocreation approaches will continue to be assessed by existing systems of research governance, we offer four principles to guide ethics committees when considering applications. Collecting and assessing such data could be a role for organisations such as the National Research Ethics Service ( part of the Health Research Authority) in the UK, and the Health and Disability Ethics Committee in New Zealand, which are charged with ensuring that the rights and safety of research participants are protected, and ethical research of potential benefit to science and society is conducted
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