Toni L Denison, Kristyn U Sorensen, Michael P Blanton, Lara Johnson, Theresa Byrd, Steven E Pass, Lacy Philips, Joyce Miller, Lance R McMahon, Barbara Cherry
{"title":"The Quality Improvement Review Board: An Innovative Approach to Oversight of Projects That Do Not Meet Criteria of Human Subject Research.","authors":"Toni L Denison, Kristyn U Sorensen, Michael P Blanton, Lara Johnson, Theresa Byrd, Steven E Pass, Lacy Philips, Joyce Miller, Lance R McMahon, Barbara Cherry","doi":"10.1097/QMH.0000000000000446","DOIUrl":null,"url":null,"abstract":"<p><p>This article describes the development of an institutional quality improvement review board (QIRB) as an effective and efficient method for reviewing and overseeing institutional quality improvement (QI) initiatives. QI projects involve the systematic collection and analysis of data and the implementation of interventions designed to improve the quality of clinical care and/or educational programs for a distinct population in a specific setting. QI projects are fundamentally distinct from human subjects research (HuSR); however, the differences between them are subtle and highly nuanced. Determining whether a project meets the definition of QI or qualifies as HuSR, thus requiring institutional review board (IRB) review, can be confusing and frustrating. Nevertheless, this distinction is highly consequential due to the heavy regulatory requirements involved in HuSR and IRB oversight. Making the correct determination of a project's regulatory status is essential before the project begins. Project leaders may not realize that their work meets the definition of HuSR and, therefore, might conduct the project without appropriate IRB review. Therefore, best practices dictate that project leaders should not decide which type of institutional review is appropriate for their projects. In addition, when QI project teams attempt to disseminate the results of their work, documentation of formal review and approval is generally required by peer-reviewed journals and professional organizations. However, institutional review mechanisms are rarely available. Projects that do not meet the definition of HuSR fall outside the purview of IRBs and most institutions do not have an alternative review body. This creates frustration for both project leaders and IRB administrators. Apart from IRB review, a separate process for reviewing QI projects offers several benefits. These include (1) relieving the burden on busy IRB staff; (2) promoting scholarly activity; (3) protecting the institution, project leaders, and participants from HuSR conducted outside of appropriate IRB review; and (4) promoting rigorous QI methods.</p>","PeriodicalId":20986,"journal":{"name":"Quality Management in Health Care","volume":null,"pages":null},"PeriodicalIF":1.2000,"publicationDate":"2024-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Quality Management in Health Care","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1097/QMH.0000000000000446","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"HEALTH CARE SCIENCES & SERVICES","Score":null,"Total":0}
引用次数: 0
Abstract
This article describes the development of an institutional quality improvement review board (QIRB) as an effective and efficient method for reviewing and overseeing institutional quality improvement (QI) initiatives. QI projects involve the systematic collection and analysis of data and the implementation of interventions designed to improve the quality of clinical care and/or educational programs for a distinct population in a specific setting. QI projects are fundamentally distinct from human subjects research (HuSR); however, the differences between them are subtle and highly nuanced. Determining whether a project meets the definition of QI or qualifies as HuSR, thus requiring institutional review board (IRB) review, can be confusing and frustrating. Nevertheless, this distinction is highly consequential due to the heavy regulatory requirements involved in HuSR and IRB oversight. Making the correct determination of a project's regulatory status is essential before the project begins. Project leaders may not realize that their work meets the definition of HuSR and, therefore, might conduct the project without appropriate IRB review. Therefore, best practices dictate that project leaders should not decide which type of institutional review is appropriate for their projects. In addition, when QI project teams attempt to disseminate the results of their work, documentation of formal review and approval is generally required by peer-reviewed journals and professional organizations. However, institutional review mechanisms are rarely available. Projects that do not meet the definition of HuSR fall outside the purview of IRBs and most institutions do not have an alternative review body. This creates frustration for both project leaders and IRB administrators. Apart from IRB review, a separate process for reviewing QI projects offers several benefits. These include (1) relieving the burden on busy IRB staff; (2) promoting scholarly activity; (3) protecting the institution, project leaders, and participants from HuSR conducted outside of appropriate IRB review; and (4) promoting rigorous QI methods.
期刊介绍:
Quality Management in Health Care (QMHC) is a peer-reviewed journal that provides a forum for our readers to explore the theoretical, technical, and strategic elements of health care quality management. The journal''s primary focus is on organizational structure and processes as these affect the quality of care and patient outcomes. In particular, it:
-Builds knowledge about the application of statistical tools, control charts, benchmarking, and other devices used in the ongoing monitoring and evaluation of care and of patient outcomes;
-Encourages research in and evaluation of the results of various organizational strategies designed to bring about quantifiable improvements in patient outcomes;
-Fosters the application of quality management science to patient care processes and clinical decision-making;
-Fosters cooperation and communication among health care providers, payers and regulators in their efforts to improve the quality of patient outcomes;
-Explores links among the various clinical, technical, administrative, and managerial disciplines involved in patient care, as well as the role and responsibilities of organizational governance in ongoing quality management.