They note, for example, questions that were raised in 2001 about a project on end-stage renal disease that was funded by the Centers for Medicaid & Medicare Services. While CMS considered the project to be a quality improvement initiative, the Office for Human Research Protection (OHRP) determined it was human subject research and that it should have been reviewed by an institutional review boards (IRB) prior to implementation.
And, in 2007, an anonymous whistleblower accused the leaders of a project in Michigan (funded by the Agency for Healthcare Research and Quality) to reduce life?threatening infections in intensive care units—through the use of checklists—of not having received proper ethical review. Questions were raised about whether the project constituted research and if informed consent should have been obtained from all patients who were involved.
The authors found that "despite myriad proposals" regarding the ethical oversight of quality improvement, "surprisingly little empirical research" has been reported on the review and oversight of quality improvement initiatives.
To get a better understanding of where this issue is now, they carried out two surveys. One was conducted in collaboration with the Institute for Healthcare Improvement (IHI) in April 2009 of quality improvement practitioners that had participated in IHI's "100.000 Lives Campaign."
The majority of IHI respondents in the study self-identified as managers either in a quality improvement/safety department or other hospital department. Most of the respondents (83%) indicated that quality improvement initiatives conducted by their faculty and staff were subject to some type of review prior to implementation; most of those (85%) reported that the review is conducted most of the time or always.