Institutional Review Boards (IRBs) are charged with ensuring the protection of humans enrolled in research. IRB activities are governed by the United States Office for Human Research Protections, which does not clearly differentiate quality improvement from research. More clear standards are needed so that the protection of human subjects (including their right to privacy) can be ensured and health care providers can efficiently meet their objective of improving patient care through quality improvement efforts. While past commentaries on this subject have provided some guidance, no standard definitions exist that distinguish "quality improvement" from "research."
We conducted a national survey of IRBs serving academic medical centers to determine whether local guidelines exist that make this distinction, and if so, what criteria are used to guide decision making.
On the basis of the findings of our survey, we propose a decision algorithm to guide IRBs and quality improvement oversight committees as they define local policies that distinguish research projects from quality improvement efforts.
The decision algorithm should result in greater ability to conduct quality improvement work in an efficient manner without compromising the protection of human subjects. The criteria identified are consistent with, but clearer than, the exemption standards provided in the common rule.
[Show abstract][Hide abstract] ABSTRACT: Since the advent of formal, data-driven quality improvement programs in health care in the late 1980s and early 1990s, there are have been questions raised about requirements for ethical committee review of quality improvement activities. A form of consensus emerged through a series of articles published between 1996 and 2007, but there is still significant variation among ethics review committees and individual project leaders in applying broad policies on requirements for committee review and/or written informed consent by participants. Recent developments in quality management, particularly the creation and use of multi-site disease registries, have raised new questions about requirements for review and consent, since the activities often have simultaneous research and quality improvement goals. This article discusses ways in which policies designed for local quality improvement projects and data bases may be adapted to apply to multi-site registries and research projects related to them.
[Show abstract][Hide abstract] ABSTRACT: Questions have been raised about whether and how health care quality improvement (QI) initiatives ought to be reviewed to address possible ethical issues associated with them. These questions have focused primarily on whether some QI initiatives meet the regulatory criteria for human subject research and should therefore be regulated and reviewed as such. Based on surveys of health care system professionals conducting QI initiatives and hospital CEOs, this issue brief finds that QI initiatives are routinely reviewed by a variety of internal mechanisms prior to implementation, although rarely through an institutional review board or another independent body charged specifically with ethical oversight of QI initiatives. Further research, the authors say, is needed to achieve a better understanding of how review mechanisms for QI initiatives are structured, including information on who reviews these activities, how they are reviewed, and whether such processes include an ethical assessment of the proposed QI initiative.
[Show abstract][Hide abstract] ABSTRACT: Quality improvement (QI) activities are an important part of residency training. National studies are needed to inform best practices in QI training and experience for residents. The impact of the Institutional Review Board (IRB) process on such studies is not well described.
This observational study looked at time, length, comfort level, and overall quality of experience for 42 residency training programs in obtaining approval or exemption for a nationally based educational QI study.
For the 42 programs in the study, the time period to IRB approval/exemption was highly variable, ranging from less than 1 week to 56.5 weeks; mean and median time was approximately 18 weeks (SD, 10.8). Greater reported comfort with the IRB process was associated with less time to obtain approval ( = -.50; < .01; 95% CI, -0.70 to -0.23). A more positive overall quality of experience with the IRB process was also associated with less time to obtain IRB approval ( = -.60; < .01; 95% CI, -0.74 to -0.36).
The IRB process for residency programs initiating QI studies shows considerable variance that is not explained by attributes of the projects. New strategies are needed to assist and expedite IRB processes for QI research in educational settings and reduce interinstitutional variability and increase comfort level among educators with the IRB process.
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