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Survey shows QI projects do get some oversight
However, ethics training, independence lacking
When the federal Office of Human Research Protections raised questions about a quality improvement (QI) initiative to reduce catheter infections in Michigan hospitals in 2007, it reignited a debate over the line between QI and human subjects research necessitating IRB review.
The project, an assessment of infection control practices in hospital ICUs, had been granted exempt status by the IRB at Johns Hopkins School of Medicine in Baltimore, MD, where the project was developed. But OHRP initially ruled that IRBs at all the participating hospitals should have reviewed it and that informed consent should have been obtained from patients.
Although the project eventually was allowed to continue, the incident left QI advocates concerned that they face increased IRB review requirements for their work. They say such reviews will hamper their efforts to protect patients using interventions that already have been proven successful and thus, aren't really human subjects research.
In an effort to move the discussion along, a team from Johns Hopkins wanted to see exactly what review QI projects currently undergo – by IRBs, by QI departments or by other institutional entities. What ethical considerations are examined? What ethical training do QI practitioners have?
The results, published in a recent issue of the journal Quality and Safety in Health Care show that while QI projects generally have some sort of oversight, they often are not reviewed by someone with ethical training or who is independent of those conducting the intervention.
Holly Taylor, PhD, MPH, a core faculty member at the John Hopkins Berman Institute of Bioethics, says there's not enough information yet about the practice of QI to know what kinds of policy recommendations should be made for the ethical review of these projects.
"Our goal was to describe what we know about what happens," she says. "We wanted to find out whether quality improvement initiatives were systematically reviewed in any way, period."
Asked about effectiveness
Taylor's group surveyed 132 quality improvement practitioners from hospitals and healthcare systems.
Respondents were asked about oversight mechanisms used at their institutions, their opinions about the effectiveness of those mechanisms and factors that they thought were relevant to the ethical review of QI:
Type of review – 83% of all respondents said that QI initiatives at their institutions were subject to some kind of review prior to implementation.
Among that group, the most common QI oversight mechanisms reported were (in order): review by the QI management team; oversight by the clinical leadership conducting the QI intervention; and review by an advisory board set up specifically to look at QI initiatives.
Only 15% of QI practitioners who reported any kind of review said that their IRBs were involved in the review of QI.
Quality of review For each mechanism, almost all respondents reported that they believed it to be either 'very' or 'somewhat' effective.
Nearly 70% of the respondents said their QI oversight mechanisms identified and considered ethical issues either 'well' or 'very well.'
Ethical considerations When asked what considerations were important to the ethical conduct of QI, respondents listed human subjects protection issues – minimal risk to patients and privacy and confidentiality – as most important.
Taylor says that despite their differences, the ethical review of QI is closely related to the ethical review of human subjects research.
"Both groups would recognize their responsibility to protect the welfare of their patients and participants," she says. "For example, they both clearly recognize the importance of privacy and confidentiality. The culture in health care is such that privacy and confidentiality are always a concern."
At the same time, however, only a third of the 102 respondents who answered demographic questions had completed any course in the ethics of human subjects research.
Taylor says there still are a lot of unanswered questions about the role that ethical considerations play in the review of QI initiatives. The role of special QI advisory boards, for example could be fleshed out more, comparing their work to the work of IRBs, especially since they're set up to be independent of those actually carrying out the QI interventions.
She says that while conflict of interest questions may be slightly different for QI professionals than they are for typical researchers, the existence of an independent body may be a good approach to review of QI projects.
"The question is still open as to whether that's the best mechanism," she says. "If I was making a recommendation, a next good step would be to answer the question of how do these advisory boards operate? How are the ethics of it looked at in the review of the project?"
In the meantime, Taylor says, IRBs should take the opportunity to reach out to quality improvement professionals at their institutions and find how QI initiatives are handled there.
"If I were an IRB administrator or an IRB chair, I might want to pursue a conversation with them about whether there's a way we can work together," she says.
"Say an investigator submits a project that really looks like quality improvement or practice improvement. The IRB isn't really an expert in that. If I had a contract with someone who does this every day, I could pick up the phone and say, 'We have a project we think is QI – can you look at it.' If there is such a mechanism for review."
Likewise, she says, a quality improvement officer could look at a proposed QI intervention and see a potential for patient risk. "Then, they can reach out to the IRB chair," Taylor says.
Taylor says she would not want to see a requirement that any intervention labeled as quality improvement be reviewed by an IRB.
"My worry would be that IRBs would be overwhelmed and that QI staff would choose not to collect data because they do not want to go through that process," she says. "It would stymie their ability to make progress. We want to facilitate moving the agenda forward."