Although considered safe, no studies evaluated the pharmacokinetics of high-dose ropivacaine infiltration in simultaneous bilateral TKA. Ropivacaine is commonly used in local infiltration anaesthesia (LIA) as pain management after total knee arthroplasty (TKA). The group recommended a period of innovation and evaluation to refine the framework for ethical conduct of QI and to integrate that framework into clinical practice. The group formulated a framework that would use key characteristics of a project and its context to categorize it as QI, human subjects research, or both, with the potential of a customized institutional review board process for the overlap category. Most QI activities are not human subjects research and should not undergo review by an institutional review board rather, appropriately calibrated supervision of QI activities should be part of professional supervision of clinical practice. Both clinicians and patients have an ethical responsibility to participate in QI, provided that it complies with specified ethical requirements. The group defined QI as systematic, data-guided activities designed to bring about immediate improvements in health care delivery in particular settings and concluded that QI is an intrinsic part of normal health care operations. The Hastings Center convened leaders and scholars to address ethical requirements for QI and their relationship to regulations protecting human subjects of research. Quality improvement (QI) activities can improve health care but must be conducted ethically. We advocate for approaches that improve protections for QI participants while minimizing over-protection for participants in QIR through reasonable ethical oversight that aligns risk to participants in both QI and QIR with the needs of a learning health care system. We argue that QI and QIR are not reliably distinguishable. Standards for such ethical review and training in these standards, coupled with rapid review cycles, could facilitate an appropriate level of oversight within the context of creating and sustaining learning health care systems. Potentially, such ethical oversight could be provided by the integration of Institutional Review Boards and Clinical Ethical Committees, using a more integrated and streamlined approach such as a two-step process involving a screening review, followed by a review by committee trained in QIR. Minimizing the burdens of conducting QIR, while ensuring minimal safeguards for QI projects, is needed to restore this imbalance in oversight. ![]() Minimal risk projects should entail minimal oversight including waivers for informed consent for both QI and QIR projects. ![]() Rather, this apparently false dichotomy may foster under-protection of participants in QI projects and over-protection of participants within QIR. Neither of these criteria holds up upon scrutiny. Institutional review boards (IRBs) distinguish health care quality improvement (QI) and health care quality improvement research (QIR) based primarily on the rigor of the methods used and the purported generalizability of the knowledge gained.
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