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Do quality improvement projects require IRB approval?

Journal of Perinatology volume 41, pages 1209–1212 (2021)Cite this article

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The past two decades have seen an increasing number of publications related to quality improvement (QI) and quality assurance (QA). Several pediatric journals now offer a special category of publication for quality improvement reports while others are exclusively devoted to pediatric quality and safety articles. Such publications complement traditional research publications and offer clinicians working in quality and safety methods to gain academic credit and a channel to disseminate their work. A recent article [1] provides a comprehensive general overview of how to write and publish QI manuscripts. Based on our experience serving as peer reviewers for articles on quality improvement submitted to various journals, and serving in editorial roles for different journals, we have encountered variation in descriptions of how authors of submitted manuscripts verified that their project was a QI project not needing formal review by an institutional body that reviews proposals and ensures protection of human subjects. There is also variation in the terminology used to describe the studies. For example, authors have used terms such as ‘quality improvement prospective equivalence study’ and ‘observational time series’ in manuscripts we have reviewed. This leads us to conclude that some clinicians involved in QI lack clarity about when their project constitutes ‘pure’ QI, when it is traditional research, and when it may contain elements of both. Obtaining such clarity helps health professionals decide when they must obtain institutional review board (IRB) approval, include specific language in manuscripts when submitting for publication, and select appropriate journals for manuscript submission. This commentary will address two practical questions for members of QI teams: [1] When should Institutional Review Board / Research Ethics Committee approval be obtained for a project? [2] What information about IRB approval and consent / permission should a QI manuscript include?

A default policy of submitting all projects to the IRB might be simple and clear but would create onerous burdens on QI teams, delay the launch and timely completion of QI projects, and increase the workload of IRBs. Therefore, a balanced approach that simultaneously ensures protection of patients and their privacy, enables the success of QI projects, and avoids needless burden on IRBs is required. Several articles have elaborated on the differences between research and QI projects [2,3,4] and these differences are depicted in the Table 1. A project that is clearly a QI project does not constitute human subjects research and does not require formal review by an IRB. However, irrespective of how a project is classified, all necessary precautions should always be taken to ensure that patient safety, confidentiality and privacy are protected, and that in the US, Health Insurance Portability and Accountability Act regulations are not violated. Subjects involved in QI deserve the same protection of their privacy and from unintended harm as research subjects [5, 6].

Table 1 Characteristics of quality improvement projects and research projects.
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Authors and Affiliations

  1. Baylor College of Medicine, Houston, TX, USA

    Kanekal S. Gautham

  2. Sidney Kimmel College of Medicine of Thomas Jefferson University, Philadelphia, PA, USA

    Stephen Pearlman

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KG reviewed the literature, wrote the initial draft of the manuscript, revised the manuscript, and contributed to final approval of the version. SP helped to write and revise the manuscript, and contributed to final approval of the version to be published.

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Correspondence to Kanekal S. Gautham.

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Gautham, K.S., Pearlman, S. Do quality improvement projects require IRB approval?. J Perinatol 41, 1209–1212 (2021). https://doi.org/10.1038/s41372-021-01038-1

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