The ethical review of health care quality improvement initiatives: findings from the field.

Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, and Berman Institute of Bioethics at the Johns Hopkins University, USA.
Commonwealth Fund Issue Briefs 08/2010; 95:1-12.
Source: PubMed


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.

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Available from: Nancy Kass, Oct 06, 2015
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    ABSTRACT: The publication of insights from a quality improvement project recently precipitated a ruling by the lead federal regulatory agency that regulations providing protection for human subjects of research should apply. The required research review process did not match the rapid changes, small samples, limited documentation, clinician management, and type of information commonly used in quality improvement. Yet quality improvement can risk harm to patients, so some review might be in order. The boundaries and processes are not clear. Efforts have been made to determine what constitutes "research", but this has proved difficult and often yields irrational guidance with regard to protection of patients. Society needs a workable way to separate activities that will improve care, on the one hand, and those that constitute research, on the other. Practitioners who lead both quality improvement and research projects claim that those which rapidly give feedback to the care system that generated the data, aiming to change practices within that system, are "quality improvement" no matter whether the findings are published, whether the project is grant funded, and whether contemporaneous controls do not have the intervention. This criterion has not previously been proposed as a possible demarcation. The quandaries of which projects to put through research review and how to ensure ethical implementation of quality improvement need to be resolved.
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