QI initiatives and ethical oversight

Study sought "systematic data"

In light of "substantial attention in both professional and popular literature" regarding ethical oversight of quality improvement initiatives, researchers at Johns Hopkins University sought systematic data on this topic — and they believe that's what they found.

The resulting study was published online in Quality and Safety in Health Care on May 27.1

"The . . . contemporary history that led us to this was there's been, probably over the last 10 years, a strain of debate in the literature about what is quality improvement practice — is there a subset of that that we ought to be considering human subject research?" says Holly A. Taylor, PhD, MPH, assistant professor, Department of Health Policy and Management, Bloomberg School of Public Health and Berman Institute of Bioethics, Johns Hopkins University in Baltimore. Taylor is a co-author of the study.

The debate over whether QI initiatives should be considered human subject research heated up when Peter Pronovost, MD, another co-author of this paper, did a study in the ICUs in Michigan, which involved the implementation of a checklist of procedures. While most considered that checklist standard practice, "It was not clear that all [of the steps] were used systematically every time," she says.

"Their hypothesis was: If we do have a checklist that everybody follows, every time, maybe we can reduce the likelihood of hospital-based infections," Taylor explains. "and then they showed in this project that that was, indeed, true — that they were able to radically reduce the number of hospital-acquired infections in the ICU by implementing the checklist."

Once the results of that research were published in the New England Journal of Medicine, someone forwarded that study to the Office of Human Research Protection, she says. However, that project had already been reviewed by the institutional Review Board at Johns Hopkins, which considered the QI research project exempt from IRB review, according to Taylor.

But the ensuing controversy sparked in the researchers the question of whether QI initiatives and research actually do meet the criteria for human subject research, which always requires approval and oversight by an IRB, she says.

"If you imagine a . . . diagram [where] on one side of the circle is labeled human subject research and the other side is labeled quality improvement initiative — there may be some overlap in the center, where the quality improvement activity does meet the criteria for human subject research, and would be reviewed, or re-reviewed, or overseen, according to [OHRP] regulations," Taylor tells Medical Ethics Advisor.

"But there's lots of quality improvement work that goes on that doesn't meet that criteria," she notes. "But we were interested in how that body of work is reviewed, if it's reviewed, and whether, in that review process, ethics is brought to the table, as it were, in the review of that initiative."

In the paper's introduction, the authors note, "there are no systematic data regarding the institutional mechanisms currently in place to review the conduct of QI initiatives or the ethical considerations that guide quality improvement practitioners (QIP) in their efforts. This is unfortunate, as attempts to develop policy regarding the ethical review and oversight of QI initiatives ought to be evidence-based."1

Survey of QIPs conducted

First, the researchers conducted a focus group of "QI stakeholders," which included patient safety officers, QI program managers, and IRB chairs or administrators from urban, suburban, and rural community hospitals.

Focus group members identified that QI practitioners "seek approval from an IRB," among other factors, due to "an absence of an alternative institutional oversight body that is available to review and ensure that QI initiatives are ethically acceptable.

"In addition, focus group participants indicated a number of ethical considerations they believe guide their work in QI, including transparency, minimal risk to patients, and patient privacy," the article states.

Ultimately, the study was conducted, and 132 QIPs responded, with a 26% response rate.

According to the abstract, "Respondents strongly agreed that ensuring minimal risk to patients, and privacy and confidentiality are relevant ethical considerations for QI initiatives conducted at their institution. A majority of respondents also agreed that assessing established practices, scientifically sound design, transparency, and the identification of minimization of potential conflicts are relevant ethical considerations for QI initiatives."1

The survey found that 83% of QI projects are routine reviewed, meaning that "some oversight . . . is happening," according to Taylor.

"What we also found is that a lot of the oversight is happening by the team, either the medical team that is implementing the project, or perhaps if the institution has a quality improvement team," Taylor says. "That's good, right . . . but one piece of oversight is that it's important to have some independence."

That's how the IRB became the default oversight body in these circumstances, because such initiatives should have oversight from "someone other than the investigator, who may have a vested interest in the project itself; there ought to be an independent review of that project before it goes into the field," Taylor says.

Conclusions drawn

"What we're saying is: Not all of that quality improvement work that's happening must go to the IRB, but we wanted to say, 'Given that oversight is routine, are there ways in the future that we could contribute to finding out more about how that happens, how ethics might be incorporated, could ethics be incorporated; and if it was, what sort of principles would one interested in maximizing the likelihood that the patients, or the physicians for that matter, that are involved are protected . . .,'" Taylor says.

For example, one of those principles might be: Physicians participating in a QI study should not be compromised in delivering the standard of care they would like to their patients, she says. From a patient perspective, a principle might be: Any initiative should not compromise the physician-patient relationship.

While the principles involve "very basic things . . . there is general consensus about the types of principles that [survey respondents] already believe are in place at their institutions," Taylor says.

Such principles could serve as "standards that they might promote as what's guiding their decisions in whether or not to adopt a particular quality improvement initiative in their institution," she notes.


  1. Taylor HA, Pronovost, P, Sugarman, J. "Ethics, oversight, and quality improvement initiatives." Qual Saf Health Care(2010).


  • Holly A. Taylor, PhD, MPH, assistant professor, Department of Health Policy and Management, Bloomberg School of Public Health and Berman Institute of Bioethics, Johns Hopkins University, Baltimore. E-mail: htaylor@jhsph.edu.