Modernizing the Institutional Review Board Process for Implementation Science - A Narrative Review of Barriers and Ethical Considerations.

PURPOSE OF REVIEW: This review highlights the barriers and facilitators that implementation science studies face in the institutional review board (IRB) approval pathway and provides recommendations on how to potentially streamline this process.

RECENT FINDINGS: Significant gaps persist between evidence-based recommendations and real-world clinical practice. Implementation science projects investigate how to promote uptake of evidence-based and guideline-recommended practices. Regulatory ambiguity may arise because implementation science involves aspects of traditional research and quality improvement. Currently, there is a lack of well-delineated processes to determine the optimal review pathway for implementation science projects. Current research review pathways do not facilitate efficient approval for implementation science projects due to ambiguous IRB submission guidelines, limited exposure to implementation science, and recent integration of digital tools. In this review, we suggest further development of expedited review pathways for low-risk projects, creation of tools for researchers to determine IRB application category, and further investment in digital health-focused implementation science projects and approval pathways to prepare for the emerging wave of implementation science and maximize the positive impact on patient health outcomes.