{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,9]],"date-time":"2026-07-09T12:35:38Z","timestamp":1783600538838,"version":"3.55.0"},"reference-count":19,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2025,7,31]],"date-time":"2025-07-31T00:00:00Z","timestamp":1753920000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2025,7,31]],"date-time":"2025-07-31T00:00:00Z","timestamp":1753920000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Learning Health Systems"],"published-print":{"date-parts":[[2025,10]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>A learning health system (LHS) strives to improve clinical practice and outcomes through applied research and quality improvement (QI). However, distinguishing between research and QI has been a persistent challenge. While research involving human subjects is highly regulated, QI remains largely unregulated, lacking in comparable oversight. With confusion and uncertainty surrounding this distinction and little practical guidance for QI activities, Denver Health's LHS developed a model of practice for reviewing QI projects.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>In 2018, Denver Health, an integrated academic safety\u2010net delivery system, established the Quality Improvement Review Committee (QuIRC) as a practical approach for distinguishing between QI and human subjects research. We describe the institutional structure and processes, from identifying the problem to establishing the committee and charter, to obtaining institution support, and finally implementation and improvement, ensuring transparency and protections of disseminated QI work.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Over 7\u2009years, the QuIRC has reviewed 379 submissions, with 78% approved as QI (non\u2010human subjects research), 8% referred to the Colorado Multiple Institutional Review Board, and 13% requiring clarification or being withdrawn. A standardized review process, clear charter, broad organizational representation, executive sponsorship, and IRB collaboration enhanced transparency and engagement. The QuIRC has facilitated QI dissemination, supporting the LHS framework and increasing recognition of the impact of QI on clinical care and patient outcomes.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The QuIRC framework has improved clarity and oversight of QI activities at Denver Health. These practical approaches can be adapted by other health care systems, contributing to broader efforts to establish national guidance for QI oversight.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/lrh2.70030","type":"journal-article","created":{"date-parts":[[2025,7,31]],"date-time":"2025-07-31T08:55:08Z","timestamp":1753952108000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["From ethical guidance to practice: Oversight of quality improvement activities at Denver Health, a learning health system"],"prefix":"10.1002","volume":"9","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6009-3569","authenticated-orcid":false,"given":"Romana","family":"Hasnain\u2010Wynia","sequence":"first","affiliation":[{"name":"Office of Research Denver Health and Hospital Authority  Denver Colorado USA"},{"name":"Department of Medicine, School of Medicine University of Colorado  Aurora Colorado USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4899-9768","authenticated-orcid":false,"given":"Rachel","family":"Everhart","sequence":"additional","affiliation":[{"name":"Department of Medicine, School of Medicine University of Colorado  Aurora Colorado USA"},{"name":"Ambulatory Care Services Department Denver Health and Hospital Authority  Denver Colorado USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6116-9016","authenticated-orcid":false,"given":"Nancy","family":"Wittmer","sequence":"additional","affiliation":[{"name":"Office of Research Denver Health and Hospital Authority  Denver Colorado USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura J.","family":"Podewils","sequence":"additional","affiliation":[{"name":"Office of Research Denver Health and Hospital Authority  Denver Colorado USA"},{"name":"Department of Epidemiology, School of Public Health University of Colorado  Aurora Colorado USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas D.","family":"MacKenzie","sequence":"additional","affiliation":[{"name":"Office of Research Denver Health and Hospital Authority  Denver Colorado USA"},{"name":"Department of Medicine, School of Medicine University of Colorado  Aurora Colorado USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,7,31]]},"reference":[{"key":"e_1_2_8_2_1","volume-title":"Best Care at Lower Cost: the Path to Continuously Learning Health Care in America","author":"Committee on The Learning Health Care System In America; Institute Of Medicine","year":"2013"},{"key":"e_1_2_8_3_1","unstructured":"National Academy Of Medicine.Learning Health System Shared Commitments. [Online]. Available:https:\/\/nam.edu\/programs\/value-science-driven-health-care\/lhs-core-principles\/Accessed November 18 2024."},{"key":"e_1_2_8_4_1","unstructured":"U.S. Department Of Health And Human Services.Protection of Human Subjects 45 CFR Part 46 [Online]. Electronic Code of Federal Regulations. Available:https:\/\/www.ecfr.gov\/current\/title-45\/subtitle-A\/subchapter-A\/part-462024Accessed November 18 2024."},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.7326\/0003\u20104819\u2010146\u20109\u2010200705010\u201000155"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/hast.134"},{"key":"e_1_2_8_7_1","unstructured":"Centers For Medicare & Medicaid Services.Quality Measurement and Quality Improvement. [Online]. Available:https:\/\/www.cms.gov\/Medicare\/Quality-Initiatives-Patient-Assessment-Instruments\/MMS\/Quality-Measure-and-Quality-Improvement-Accessed November 18 2024)."},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmjoq\u20102021\u2010001497"},{"key":"e_1_2_8_9_1","unstructured":"Agency For Healthcare Research And Quality.Learning Health System Competencies: Training the Next Generation of Researchers [Online]. Rockville MD. Available:https:\/\/www.ahrq.gov\/funding\/training-grants\/summary.htmlAccessed July 9 2025."},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMp0800372"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.31486\/toj.19.0087"},{"key":"e_1_2_8_12_1","unstructured":"US Department of Health And Human Services Office For Human Research Protections.Quality Improvement Activities FAQs [Online]. Available:https:\/\/www.hhs.gov\/ohrp\/regulations\u2010and\u2010policy\/guidance\/faq\/quality\u2010improvement\u2010activities\/index.htmlAccessed November 18 2024."},{"key":"e_1_2_8_13_1","first-page":"S21","article-title":"Improving compliance with the dialysis prescription as a strategy to increase the delivered dose of hemodialysis: an ESRD network 4 quality improvement project","volume":"7","author":"Palevsky PM","year":"2000","journal-title":"Adv ren Replace Ther"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa061115"},{"key":"e_1_2_8_15_1","unstructured":"GostinLO.HHS shuts down Michigan patient safety study [Online]. Available:https:\/\/amednews.com\/article\/20080204\/profession\/302049965\/6\/Accessed February 4 2008."},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1201\/b17564"},{"key":"e_1_2_8_17_1","unstructured":"Agency For Healthcare Research And Quality.Denver Health: How a Safety Net System Maximizes Its Value [Online]. Available:https:\/\/www.ahrq.gov\/sites\/default\/files\/wysiwyg\/lhs\/lhs_case_studies_denver_health.pdfAccessed December 12 2024."},{"key":"e_1_2_8_18_1","unstructured":"Us Department Of Health And Human Services.Summary of the HIPAA Privacy Rule. [Online]. Available:https:\/\/www.hhs.gov\/hipaa\/for-professionals\/privacy\/laws-regulations\/index.htmlAccessed July 9 2025."},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.acap.2020.11.026"},{"key":"e_1_2_8_20_1","doi-asserted-by":"publisher","DOI":"10.1093\/jpids\/piad065"}],"container-title":["Learning Health Systems"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/lrh2.70030","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/lrh2.70030","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/lrh2.70030","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,1,31]],"date-time":"2026-01-31T01:21:04Z","timestamp":1769822464000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/lrh2.70030"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,7,31]]},"references-count":19,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2025,10]]}},"alternative-id":["10.1002\/lrh2.70030"],"URL":"https:\/\/doi.org\/10.1002\/lrh2.70030","archive":["Portico"],"relation":{},"ISSN":["2379-6146","2379-6146"],"issn-type":[{"value":"2379-6146","type":"print"},{"value":"2379-6146","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,7,31]]},"assertion":[{"value":"2025-04-04","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-07-16","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-07-31","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70030"}}