Institutional, QI projects may require IRB review

Institutions should have policies in place

As awareness of IRBs and human subjects research protection increases among the public and staff at institutions, IRB members sometimes are asked to consider new gray areas regarding studies that typically haven’t made it to the IRB’s radar screen.

For instance, do certain types of surveys conducted at colleges or hospitals qualify as research, or are they exempt from consideration by an IRB?

The short answer is that if a study contributes to generalizable knowledge, then it’s subject to an IRB review and federal regulations, says Dale Hammerschmidt, MD, FACP, associate professor of medicine at the University of Minnesota Medical School in Minneapolis. Hammerschmidt is a member of an IRB and has chaired IRBs for 10 years.

But this simplistic approach creates some problems, including the question of who makes the decision that it doesn’t meet the regulatory definition of contributing to generalizable knowledge, he notes.

"Most institutions don’t have a very clear policy on this," Hammerschmidt says. "Federal assurances require an institution to have a system for designating when research is exempt."

However, these regulations apply to studies that already meet the definition of qualified research and also meet one of the categories of research that is so low-risk that it doesn’t need an IRB review, he explains.

"And most commonly the mechanism is to have a screening for exempt status done through the IRB office," Hammerschmidt says. "But if the study doesn’t even meet the threshold for research, then institutions usually don’t have specific policies, and people get confused."

In the process of updating information about its IRB and research guidelines, members of the Institutional Review Board: Human Subjects and Research at Colby College in Waterville, ME, came across the issue of institutional research, says Bob McArthur, chair of the IRB.

Traditionally, research at Colby College has been behavioral research, and the projects come from the psychology, education, sociology, and political science departments, he says.

"Our institutional research office, which is relatively new, does research of the standard kind on our student population," McArthur says. "So the question that has developed within our IRB is whether or not such projects should be themselves come before the IRB for review, and what sort of authority the IRB would have over such projects."

Charting new territory

IRBs may not have grappled with these questions before because certain types of studies and data collection were never sent to IRBs for consideration or review, notes Lawrence H. Muhlbaier, PhD, assistant research professor at the department of biostatistics and bioinformatics in the Duke University School of Medicine in Durham, NC.

For example, there are lots of activities in medical centers that use the scientific method, but are not considered research, such as quality assurance activities that include collecting data from charts about infections, he says.

"Our hospital and many hospitals are expected to survey their patients about satisfaction with their care, and that’s also not considered research," Muhlbaier adds. "The report goes through the hospital to help us do a better job, but it never is published, and I think very few IRBs or institutions would consider it research."

Most quality improvement activities are not submitted to an IRB unless the staff person involved in the project is considering publishing the information, he notes.

"I think that’s typical of many academic medical centers," Muhlbaier says. "And just as a note, a lot of QI activities are done by staff rather than faculty who would typically be considered researchers because it is a hospital activity rather than a school of medicine activity."

However, it may be an issue with IRBs when institutions conduct studies and quality improvement services that don’t meet the federal definition of research, but carry the same sort of risks for research, Hammerschmidt says.

"Institutions have different ways of handling this," he adds. "It seems that someone should be looking out for loose cannons."

When is QI really research?

Some quality improvement activities can create risk that is comparable to research, says Hammerschmidt. "If you look at hospice patients sent home to die, they’re every bit as inconvenienced by telephone calls at home where someone calls to see how happy they were with their hospital stay as they would be if someone called them for an outcome study," he explains. "One would be under the IRB, and one would not."

Likewise, studies conducted by colleges and institutions for the purposes of understanding client problems and issues can pose risks that are comparable to research studies.

For example, suppose the institutional research office or a dean of students’ office at a college is engaged in a project to understand alcohol use among students, including underage students, McArthur says. "The activity being researched is an illegal activity at some level, so there are major privacy and confidentiality concerns that the institution has and that individuals who are subjects have."

The exact same study could be proposed by the college’s psychology department, and there would be no question that it would be subject to an IRB review, so should it be reviewed by an IRB when it’s conducted by the institution for institutional purposes only, he poses.

"If the nature of the study is essentially the same, with the same instruments, the same population, then should there be an exemption just because the source is different," McArthur says. "The faculty is doing the research in one case while the institutional research office is doing research in the other, and we’d just say that because the source is different, it’s not clear to us that the ethical concerns are any different."

In fact, some aspects of the research would appear to pose a greater risk to subjects if the institution rather than a psychology department does it. For instance, the institution that is conducting the research is a college that may have a responsibility to report crimes when these are detected, and students have privacy concerns, particularly with regard to their college, he says.

"This kind of study in the climate of understanding undergraduate alcohol use is going on all across the country," McArthur says. "And it’s the sort that could easily transgress the concerns we have about privacy and confidentiality."

If an IRB were to review this study, IRB members would want to know who has access to the identify of the subjects and what would be the standard protections afforded the subjects, he adds.

"We would be very concerned that the identities of subjects of research would not be available, and we would be worried even if the director of research knew the identities," McArthur says. "But we also would be worried about anyone else having access to the identities."

Hammerschmidt suggests that a solution to these sorts of problems would be to have an institutional policy that states that any quality assurance or institutional research is reviewed by some board.

"It would be better for it not to be the IRB in some cases because IRBs are already overburdened, and in a lot of circumstances, the federal regulations would not have to apply," he says. "On the other hand, the board would need a member who knows what an IRB review is so that studies that really are research could be punted to the IRB."

The real problem is that an institution’s staff may not be aware of the IRB’s role in protecting human subjects of research, and so these gray areas may never come under discussion when studies are conducted that entail some risk but do not meet the federal definition of what is considered research.

An IRB is passive in the sense that it receives proposals for review and does not solicit them, so often there is no general education of staff about what constitutes research and human subjects protection, McArthur says.

"If the nature of a study raises ethical questions regarding human subjects, then our IRB’s question is whether or not the content is a trigger for an IRB review," he says.

"Our IRB is looking at this issue," McArthur adds. "And we’re collecting information and are having a discussion about it with the college administration, and we hope to make a recommendation to the administration by the end of the year."