New findings from Johns Hopkins suggest that most quality-improvement (QI) initiatives in U.S. hospitals are reviewed internally before they are conducted, but there is not routine consideration of the ethical issues associated with them.
Most of these QI initiatives are reviewed internally: by a management team or office, clinicians leading the effort, or an institution-wide advisory board. But, according to a new study that appears online in the journal Quality and Safety in Health Care, most of those are not routinely submitted to an institutional review board (IRB)—committees with the responsibility of assuring that the rights and welfare of human subjects in biomedical and behavioral research are protected.
There is no question that some aspects of QI efforts, such as cost and administration should be scrutinized, says study leader Holly Taylor, Ph.D., M.P.H., a core faculty member of the Johns Hopkins Berman Institute of Bioethics.
But, she says, "a lingering concern is that arguably at least some of these initiatives ought to be overseen to ensure that ethical issues are considered and addressed. It is important to assure that ethical principles such as minimizing risk, protecting privacy, and concerns about conflicts of interest are adequately addressed prior to implementation."
In 2007, the federal Office of Human Research Protection (OHRP) ordered a stop to a Johns Hopkins initiative in which a network of hospitals in Michigan implemented checklists in their intensive-care units to see if the protocol would reduce catheter-related bloodstream infections.
The halt was ordered because the IRBs at each of the participating hospitals had not been asked to grant approval for the initiative. When the group presented Hopkins' IRB with the plan for the initiative, the board exempted it from evaluation and it commenced, without necessitating approval from the participating hospitals' IRBs.
Patient-safety experts and hospital associations alike called the OHRP action misguided—especially given that the checklist included important, non-controversial instructions for physicians, such as washing their hands and cleaning a patient's skin before catheter insertion. The debate also raised the basic question of how QI initiatives are reviewed.
That's what Taylor and a couple of professors from the Johns Hopkins University School of Medicine sought to clarify through their study. Her co-authors are Jeremy Sugarman, M.D., M.P.H., the Berman Institute's deputy director for medicine, and Peter Pronovost, M.D., Ph.D., the medical director of the Center for Innovation in Quality Patient Care and the physician behind the Michigan catheter study.
In 2008, a study led by Nancy Kass, Sc.D., the Berman Institute's deputy director for public health, along with Sugarman and Institute Director Ruth Faden, Ph.D., M.P.H., raised questions about the necessity of oversight for patient-safety projects, and whether or not such initiatives should be reviewed as if they were human subject research.
Collectively, the authors — including Pronovost and several of his colleagues in the Department of Anesthesiology and Critical Care Medicine — voiced concern that regulatory uncertainty could discourage more patient-safety efforts from going forward, and that clarity was needed.
"Even though there has been a lot of attention to the potential problems associated with reviewing QI initiatives as if they are research, we realized that there were virtually no systematic data about what kind of review is used for QI initiatives," Sugarman says. "We thought that gathering such data would be a critical step in developing sound policy."
The co-authors of this study surveyed more than 100 QI practitioners affiliated with the Institute for Healthcare Improvement "100,000 Lives" Campaign. The majority of those surveyed were managers in QI or safety departments.
Overall, responses showed that most QI initiatives are subject to some form of review prior to launch. The three most commonly cited mechanisms were internal — a QI management team, clinicians leading the initiative or an advisory board.
"One tenet of ethical review is that the review is independent of those in charge of implementing the initiative," says Taylor, who is also an assistant professor in the Department of Health Policy and Management at the Johns Hopkins Bloomberg School of Public Health.
She added that, while most QI initiatives are reviewed regularly, it is unclear whether an ethical review is routinely conducted — and to what extent.
The study found that a vast majority of those surveyed recognized that important considerations were relevant to the ethical conduct of QI initiatives. The three ethical goals that received the strongest agreement among respondents were minimizing risk to patients, protecting privacy and confidentiality, and assessing established practices.
But while more than two-thirds of those surveyed indicated that the review mechanisms at their institutions do a good job of considering ethical issues, only one-third of the respondents indicated that they had training in ethics.
Taylor said future studies might focus on the actual process by which QI initiatives are reviewed, to identify ways in which attention to ethical issues could be introduced. Once more is known about what happens in practice, discussions about the most appropriate mechanism for ethical oversight can begin.
"We are not ready to develop a national policy," Taylor said. "But we are one step closer than when we had no data."
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