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Panel lays a framework for ethical conduct in QI
Determine if project is QI, human research, or both
A wide-ranging group of experts convened by The Hastings Center has put forth some general understandings of quality improvement — what it is, what role it plays in health care, and how ethical conduct can be ensured in QI projects. Their conclusions are reported in a new paper in the Annals of Internal Medicine.1
The panel, which included ethicists, clinician leaders, experienced managers, regulators, and noted authors, defined QI as "systematic, data-guided activities designed to bring about immediate improvements in health care delivery in particular settings." They further concluded that: QI is an intrinsic part of health care operations; both clinicians and patients have an ethical responsibility to participate in QI, provided that it complies with specified ethical requirements; and that most QI activities are not human subjects research and should not undergo review by an institutional review board (IRB), but rather, appropriately calibrated supervision of QI activities should be part of professional supervision of clinical practice.
"QI as a method and topic was sort of in the backwaters of healthcare until the last 10 to 15 years," notes Joanne Lynn, MD, recently a quality improvement leader and researcher with the Rand Corp. and lead author of the article. "We've developed a mode of research without paying much attention to the use of data in guiding system design and management decisions, and more and more we want and need that."
In addition, she explains, there is often a perceived overlap between QI and research that needs to be addressed, as it has impacted the research review enterprise "in ways those people never imagined."
Thus, she continues, this paper is "both an expression of the 'growing up' of the field of QI and to ask how we do this in more or less ethical ways, and when we ought to undergo research review and when it should be kept apart from that process."
Too much rigidity
In most instances it is advantageous that QI not be treated as research, says Lynn, "because the mode of research review has become pretty rigid and it can impose lots of delays and costs [on QI]."
One of the principles of QI, she emphasizes "is to make changes when you can make changes; you try something, and if it works you go to it the next day." In that context, she observes, "the mode of review for research does not fit QI very well."
Ethics, however, demand that QI be reviewed, Lynn notes. "But not in the way that is put together for research."
To try to come up with some answers, the panel drew from "quite an array of perspectives," in the aforementioned group sponsored by the Agency for Healthcare Research and Quality (ARHQ). "We drew upon the experiences and insights of the group. We had a listserv; we sent information out to the field and got comments back," Lynn reports.
Don't separate QI
In addressing the most significant conclusions of the panel, Lynn noted, "We felt QI has to be seen as an intrinsic part of health care, not separate like research is."
In other words, she explains, research is optional; anyone can opt out. "For reasons of ethics, all participants have to be associated with the research voluntarily," she says. "But for QI, you can't have people opting out; you would double or triple your costs. Also, everyone has an interest in the system running well and working well, so all parties should want to be involved."
A second important conclusion, says Lynn, is that clinicians involved in QI should not be protected from outcomes like they are in research. "If QI shows your job needs redoing, or you are not doing a good job, no review should protect you from having to improve your quality," she asserts.
Thirdly, says Lynn, there are a number of situations in which research and QI overlap, and where you may want to treat the project as both. "That may take some special attention, like building a special research review mechanism for QI," she says. In fact, the authors call upon federal agencies to help develop such a mechanism.
They outlined the following characteristics they say could prove helpful in defining activities as both QI and human subject research:
Learn about issue
Lynn predicts that more and more quality managers are going to run into the problem of separating QI and research, "and they should be knowledgeable about this problem."
While the mere fact that you are doing a QI project and publishing your results does not necessarily make it research, "you should be attentive to making sure your QI projects remain ethical," she advises. The science in this area is not yet good enough, Lynn maintains, and that could put patients at risk.
"That's why one of the strongest things we say is that QI has to be done ethically; you can't just assume that because you are trying to fix things you can't go wrong."
She recommends that quality managers approach IRBs in the areas they are looking at. "Go over the paper with the chairperson and work out procedures for that setting."
1. Lynne J, Baily MA, Bottrell M, Jennings B, et al. The Ethics of Using Quality Improvement Methods in Health Care. Ann Intern Med 2007; 146:666-673.
For more information, contact:
Joanne Lynn, MD. Phone: (202) 297-9773.