Developing ethical standards for dissemination and implementation research: a roadmap for consensus and guidance

BACKGROUND: As a relatively new field, dissemination and implementation research has not been included as a separate study design category for ethical consideration compared with clinical and social/behavioral research, yet it should be based on unique study designs, targets of intervention, and corresponding risks. MAIN TEXT: Research teams conducting dissemination and implementation research have raised important questions related to the responsible conduct of research such as collecting informed consent, site monitoring, identifying and mitigating risks of unintended consequences, and adverse event ascertainment and reporting in dissemination and implementation research. In this commentary, we highlight the need for guidance and consensus standards on ethical issues in dissemination and implementation research and describe some ethical domains and relevant questions in dissemination and implementation research. Additionally, we propose a process for conceptual development and a research agenda to create consensus standards for the responsible conduct of research for dissemination and implementation research. CONCLUSION: Thorough research is needed to understand the depth of ethical issues in dissemination and implementation research. A consensus-seeking process will be needed to develop new bioethical standards that carefully identify, measure, and mitigate unintended consequences in dissemination and implementation research.