Quality improvement (QI) is an important function of learning health systems, and public policy should promote QI activities. Use of systematic methodologies in QI has prompted substantial confusion regarding when QI is human subjects research under the Common Rule, and this confusion persists with the revised Rule. Difficulty distinguishing research from QI imposes costs on the quality improvement process. I offer guidance to IRBs to mitigate these costs and suggest a new regulatory exclusion for minimal risk quality improvement activities.
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References
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M. A.Bailyet al., “The Ethics of Using QI Methods to Improve Health Care Quality and Safety,”The Hastings Center Report36, no. 4 (2006): S1-40; C. E. Goldstein et al., “Accommodating Quality and Service Improvement Research within Existing Ethical Principles,” Trials 19, no. 1 (2018): 334-340; N. Kass et al., “Controversy and Quality Improvement: Lingering Questions about Ethics, Oversight, and Patient Safety Research,” Joint Commission Journal on Quality and Patient Safety 34, no. 6 (2008): 349–353; K. Fiscella et al., “Ethical Oversight in Quality Improvement and Quality Improvement Research: New Approaches to Promote a Learning Health Care System,” BMC Medical Ethics 16, no. 1 (2015): 63-69.
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J.A.Hirschet al., “PQRS and the MACRA: Value-Based Payments Have Moved from Concept to Reality,”American Journal of Neuroradiology37, no. 6 (2016): 2195-2200. Inpatient acute care is a partial exception to fee-for-service. Care is bundled under the DRG system. However, even there, hospitals have flexibility to use different DRGS of varying reimbursement and intensity of services.
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45 C.F.R. 46.114 (2018).
19.
This same definition is used for other federal regulations that affect QI activities, including the definition in Health Insurance Portability and Accountability Act of 1996. 45 CFR 164.501 (2018). The definition of research is unchanged, but the revised CR definition includes a set of activities that are not research. 45 C.F.R. 46.102(l) (2018).
20.
Id. The most important is an exemption for secondary analysis of identifiable health information regulated by the HIPAA privacy rule. 45 C.F.R. 46.104(d)(4)(iii) (2018). This category of exemption does not require a limited IRB review. However, certain requirements, such as informed consent, may still apply under the privacy rule, and involve a similar inquiry into the application of the definition of research.
21.
See Rolnick et al., supra note 11; Pierce and McKinney, “Opportunities Missed and Created by the New Common Rule,”17, no. 7 (2017): 36.38; See Baily et al., supra note 5, at 37.
22.
Applying the generalizability standard is not a unique problem for QI, but QI is an important example of the problems.
23.
45 C.F.R. 46.102(l) (2018).
24.
Case 1 may involve evaluation of an untested intervention, and therefore not QI. I would dispute that a historical record of testing is what distinguishes QI from research. Many changes to systems practice will be untested, and their contextual nature means that any local system change is, in a sense, untested. Regardless, the point here is to illustrate that generalizability does not by itself lead to ethical harms that would justify independent review.
25.
Quality Improvement Activities FAQs, United States Department of Health and Human Services, Office for Human Research Protections, available at <http://www.hhs.gov/ohrp/policy/faq/quality-improvement-activities/index.html> (last visited Jan. 1, 2019). It is unclear how OHRP is distinguishing the quality of care from patient outcomes, or why measurement of patient outcomes rather than other endpoints (e.g. a process measure) should determine whether an evaluation of an untested intervention is research under the Rule.
26.
45 C.F.R. 46.102(b) (2018).
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D.Whicheret al., “The Views of Quality Improvement Professionals and Comparative Effectiveness Researchers on Ethics, IRBs, and Oversight,”Journal of Empirical Research on Human Research Ethics10, no. 2 (2015): 132–144, at 138.
28.
The Common Rule only applies to “all research involving human subjects conducted, supported, or otherwise subject to regulation by any Federal department or agency.” 45 C.F.R. 46.101(a) (2018). However, as a practical matter, funded institutions are likely to apply it to any research activities, regardless of direct funding source.
29.
Infectious Diseases Society of America, “Grinding to a Halt: The Effects of the Increasing Regulatory Burden on Research and Quality Improvement Efforts,”Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America49, no. 3 (2009): 328–335.
