IRB develops non-research QI templates
Policy charges IRB with determination
Academic and medical research institutions and their IRBs often have to deal with study proposals that fall between research and quality improvement (QI). The solution is an initiative that addresses QI projects separately, experts say.
This issue was particularly difficult at one major university where nurses often conducted QI projects that they tried to fit into the research template.
Nurses were trying to put their QI projects into a research-based template and then they'd submit these proposals to the IRB, explains Marilyn Hockenberry, PhD, RN, PNP, FAAN, Bessie Baker professor of nursing, professor of pediatrics, and IRB chair at Duke University in Durham, NC.
"The IRB chairs would evaluate them and find all kinds of things wrong with them because they were quality improvement projects and not research," Hockenberry adds.
"There has been a great debate about that slippery slope of QI and research, and we've spent many hours of discussions about this gray area," Hockenberry says. "So it's opened up a dialogue across the campus, and it's caused great awareness and lots of interest."
The result is a new policy about QI activities in healthcare vs. research, which states that a QI project does not need to be submitted to the IRB. The policy also states that Duke students, trainees, and faculty who are conducting QI projects must submit to the IRB for an authoritative determination of whether the activity meets the definition of research with humans.
When investigators have a QI project, they can apply for an exemption from further IRB review. The IRB created a QI vs. research checklist to assist them with identifying QI activities. (See checklist box, below.)
In light of a national trend to clear IRB agendas of non-research submissions, the IRB initiated a project to help students and faculty determine which projects could be classified as quality improvement and which were research proposals that needed to be submitted to the IRB.
"This was a problem for many of our graduate students at Duke who wanted to do QI projects," says June Walker, MS, MSCR, CIP, IRB compliance specialist at Duke University Health System IRB.
The problem was that IRB submission forms were not asking the right questions, and not well-suited to distinguishing between nontraditional research and QI projects, Walker notes.
Tackling this problem began with gathering IRB leaders to discuss making a change, Hockenberry says.
IRB leaders readily agreed to consider making changes, she notes.
"It helped tremendously to have the Hastings published report last year," Hockenberry says. "Once everyone said 'yes,' we had more facilitating meetings, and we decided to draft a proposed policy."
The Hastings Center's IRB: Ethics & Human Research journal published an article in the fall about differentiating between clinical research and quality improvement.1
The result was a template, which was piloted in January 2013. It's a Word document that is attached to an applicant's electronic submission to the IRB. They start by picking up the template from the IRB website. Then they complete the form and submit it electronically in the university's e-IRB electronic submission system. Applicants have to select the pathway for an exemption review, and the IRB makes an exempt determination, Walker says.
"You submit it to be exempt, but the IRB decides if it's exempt," Hockenberry says.
The QI template asks for a letter of support or administrative approval from the clinical site where the project will occur, and it requests this information:
- project title and clinical site;
- statement of the problem;
- evidence — literature review and synthesis;
- project aims;
- project methods;
- data collection plan;
- evaluation plan;
- protected health information; and
- privacy, data storage and confidentiality.
An instruction sheet offers explanations for each of the items on the form. For instance, under the project aims, the instructions say, "Identify the purpose of this project and list specific aims or goals to be accomplished. The aims should clearly support that the project is to implement evidence into clinical practice (quality improvement) and that it will not produce new knowledge (research)."
The instructions also ask applicants to describe how the QI project will be evaluated and what statistical measures will be used.
"We piloted it for three months with graduate students," Hockenberry says.
A senior IRB chair reviewed the completed templates to catch mistakes, she adds.
The IRB's goal was for the template to be used appropriately — with exempt QI projects, she says.
It appeared to achieve that goal, so they rolled it out systemwide. Anecdotally, feedback indicates that students find it easy to use, Hockenberry says.
"Everyone says it's so easy to use because it works," she adds.
Duke's residents are also interested in the process, Walker notes.
"Young physicians commonly do QI projects, and the medical students in our medical school often conduct QI projects in their third year of medical school," she adds.
While this project started out as a solution for the nursing school, it's now used across the Duke campus, Hockenberry says.
"I think it's a time saver for the IRB," she adds. "It still has to come to the chair, but I think what happens is you don't spend so much time trying to get them to reword things because we're trying to fit it into a research study. It's now straightforward, and they're much more easy to review, evaluate, and identify an exemption."
- Solomon MZ, Bonham AC, et al. Ethical oversight of learning health care systems. IRB: Ethics & Human Research, Hastings Center Report. 2013;43(1-Suppl):1-48.