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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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Summary<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s11883-026-01454-8","type":"journal-article","created":{"date-parts":[[2026,8,28]],"date-time":"2026-08-28T09:10:47Z","timestamp":1787908247000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Modernizing the Institutional Review Board Process for Implementation Science \u2013 A Narrative Review of Barriers and Ethical Considerations"],"prefix":"10.1007","volume":"28","author":[{"given":"Abhishek","family":"Bazaz","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Caroline","family":"Plott","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francoise A.","family":"Marvel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Allison W.","family":"Peng","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stacey","family":"Schott","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Benjamin M.","family":"Scirica","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jessica M.","family":"Pe\u00f1a","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ankeet","family":"Bhatt","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laney K.","family":"Jones","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Seth S.","family":"Martin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,8,28]]},"reference":[{"issue":"3","key":"1454_CR1","doi-asserted-by":"publisher","first-page":"221","DOI":"10.1007\/s10552-020-01376-z","volume":"32","author":"S Khan","year":"2021","unstructured":"Khan S, Chambers D, Neta G. 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Dr. Caroline Plott has nothing to disclose. Dr. Francoise A. Marvel, MD is a co-founder and equity holder in Corrie Health, and reports personal consulting fees from Apple, Amgen, Novartis, Kaneka, and New Amsterdam Pharma. Dr. Allison Peng has received research support from NewAmsterdam Pharma. Dr. Stacey Schott is a consultant to the American College of Preventive Medicine. Dr. Benjamin M. Scirica has received institutional research grants to Brigham and Women\u2019s Hospital from Better Therapeutics, Boehringer Ingelheim, Merck, NovoNordisk, and Pfizer; he also has received consulting fees from Abbvie (DSMB), AstraZeneca (DSMB), Boehringer Ingelheim, Better Therapeutics, Bristol Myers-Squibb, Elsevier Practice Update Cardiology, Esperion, Hanmi (DSMB), Lexeo (DSMB), Lexicon, NovoNordisk, and has equity in Health [at] Scale and Doximity. Dr. Jessica Pe\u00f1a is coinvestigator on a grant from the National Institute of Neurological Disorders and Stroke (R01 NS104364-02), serves as section editor at Current Atherosclerosis Reports, and reports honoraria from National Kidney Foundation, Novo Nordisk, Novartis, Cleerly Inc., Springer Publishing. National Association of Continuing Medical Education, Vindico CME, and consulting fees from Turning Point HealthCare. Dr. Ankeet Bhatt has received research grant support to his institution from National Institutes of Health\/National Heart, Lung, and Blood Institute, National Institutes of Health\/National Institute on Aging, American College of Cardiology Foundation, American Heart Association, Sanofi Pasteur, Abiomed, and the Centers for Disease Control and Prevention and consulting fees from Heart Health Leaders, Sanofi Pasteur, Merck, Amgen, AstraZeneca, Esperion, Bayer, Cytokinetics, and Novo Nordisk. Dr. Laney K. Jones is an Amgen employee and owns stock. Dr. Seth S. Martin has received research grant support to his institution from the National Institutes of Health\/National Heart, Lung, and Blood Institute, American Heart Association, Patient-Centered Outcomes Research Institute, American College of Cardiology Foundation, Google, and Merck, philanthropic support from the David and June Trone Family Foundation, the Pollin Digital Innovation Fund, Sandra and Larry Small, is a co-founder and equity holder in Corrie Health, serves on the Advisory Board for Care Access, and reports personal consulting fees from Amgen, Bain Capital, AstraZeneca, Heartflow, Kaneka, Merck, New Amsterdam, Novartis, and Regeneron.","order":1,"name":"Ethics","label":"Conflict of interest","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"No animals were used in this study. All studies with human subjects are published in peer-reviewed journals.","order":2,"name":"Ethics","label":"Human and Animal Rights","group":{"name":"EthicsHeading","label":"Declarations"}}],"article-number":"84"}}