Ethical oversight in quality improvement and quality improvement research: new approaches to promote a learning health care system

BMC Medical Ethics

Gbenga Ogedegbe¹  Hua He⁵  Jennifer K. Carroll⁴  Jonathan N. Tobin³  Kevin Fiscella² 

[1] Department of Population Health, Center for Healthful Behavior Change, New York University Langone Medical Center, New York, NY, USA;Family Medicine Research, 1381 South Ave, Rochester 14620, NY, USA;The Rockefeller University Center for Clinical and Translational Science, New York, NY, USA;Department of Family Medicine, University of Colorado, Denver, USA;Department of Biostatistics, University of Rochester Medical Center, Rochester, NY, USA

关键词: Learning health care systems;    Waiver of informed consent;    Informed consent;    Ethics, clinical;    Quality improvement research;    Quality improvement;    Health services research;    Ethics, committees research;    Research subjects;    Ethics, Research;   

Others  :  1228243
DOI  :  10.1186/s12910-015-0056-2

 received in 2015-03-10, accepted in 2015-09-07,  发布年份 2015

【 摘 要 】

Background

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. Neither of these criteria holds up upon scrutiny. Rather, this apparently false dichotomy may foster under-protection of participants in QI projects and over-protection of participants within QIR.

Discussion

Minimal risk projects should entail minimal oversight including waivers for informed consent for both QI and QIR projects. Minimizing the burdens of conducting QIR, while ensuring minimal safeguards for QI projects, is needed to restore this imbalance in oversight. 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. 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.

Summary

We argue that QI and QIR are not reliably distinguishable. 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.

【 授权许可】

   
2015 Fiscella et al.

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