Co-design and implementation research: challenges and solutions for ethics committees
Co-design and implementation research: challenges and solutions for ethics committees
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DOI：
10.1186/s12910-015-0072-2
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发表时间：
2015-11-16
影响因子：
2.7
通讯作者：
Greenhalgh, Trisha
中科院分区：
文献类型：
--
作者：
Goodyear-Smith, Felicity;Jackson, Claire;Greenhalgh, Trisha
背景：实施科学研究，特别是在使用参与式和共同设计方法时，给研究伦理委员会带来了独特的挑战。这些挑战可能很难通过为更传统的研究方法（例如随机对照试验）开发的批准和治理机制来解决。讨论：实施科学通常涉及研究人员和利益相关者的合作，试图理解和鼓励采用已完成或试点的研究。共同创造方法涉及研究人员和最终用户从一开始就在问题框架、研究设计和交付以及影响策略方面进行合作，而实施和更广泛的传播策略是其从酝酿阶段的设计的一部分。共同创造的一个决定性特征是其突发性和适应性，使得干预措施和结果衡量的详细预先规范变得不可能。这种方法与伦理委员会的协议不一致，该协议要求精确预先定义干预措施、实施方式、结果测量和研究参与者的角色。但伦理委员会制定严格的（有些人会说是僵化的）要求是为了保护参与者免受伤害并帮助确保研究的严谨性和透明度。我们提出了一些指导原则来帮助解决这个问题。首先，伦理委员会应该承认并庆祝研究方法的多样性，无论是正式的（通过培训）还是非正式的（通过促进辩论和讨论）；如果没有积极支持，其成员可能不会理解或重视参与式设计。其次，应为协同设计应用制定基本规则（例如如何判断“咨询”或“参与”何时成为研究）并传达给委员会成员和利益相关者。第三，应该认识到权力分享的好处，并赞扬可能支持这一重要目标的措施，特别是在针对弱势社区的研究中。例如，在涉及新西兰、澳大利亚和加拿大土著人民的研究中，协同设计被认为是最佳实践。
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.Discussion: 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.