Self-certification Tool Formalizes Process to Decide Between QI and Research
Submissions dropped dramatically
IRB officials at the University of Wisconsin-Madison realized seven years ago that the IRB was receiving too many requests for review of quality improvement (QI) or other projects that did not meet the Common Rule’s definition of human subjects research.
“Because of the volume of these requests, we knew we needed a formal way to make these determinations, and there weren’t any other groups at the university that had the expertise,” says Gretchen Anding, MA, assistant director for the health sciences IRB at the school of medicine and public health at University of Wisconsin-Madison.
“It fell to the IRB to make determinations about whether something needed oversight or not,” she adds. “As the requests grew, we started to wonder whether we were using resources in the best way.”
The IRB was burning through staff resources. Handling these determinations required a full-time staff reviewer.
“We felt we were using resources to cover people in the eventuality that they might publish or present at some point in the future, even though it wasn’t part of their current plan,” Anding says. “It seemed like we could be devoting our resources to other things.”
Many of the determinations were straightforward. Those determinations seemed to be a waste of IRB resources, she notes.
“We were not using the project person’s time well, either. They were not familiar with our electronic system and had never submitted before,” Anding says. “So these kinds of factors led us to think that maybe there’s another way we could do this.”
The solution was to create a tool that would weed out the straightforward quality improvement projects and program evaluation initiatives from research.
Starting in 2012 and piloting the tool in 2013, the IRB provided submitters with a self-certification document. (See sample questions from the self-certification tool in this issue.)
Four years later, the IRB switched to a different electronic platform and was able to track some basic information about who’s using the tool and where they get information in completing the certification.
Use of the tool led to a stunning drop in formal IRB submissions. In the first year, the number of submissions dropped 30%. In the second year, it dropped another 30%.
“The tool has significantly reduced the formal submissions coming to our office,” Anding says. “It’s enabled us to use staff reviewer time for exemptions and to devote additional staff time to expedited reviews.”
The following is how the IRB created and initiated the tool:
- Create a guidance chart. “For a long time, we had been talking about the characteristics of research and quality improvement,” Anding says.
A chart that compared the characteristics of research with QI projects was on the website for guidance purposes.
“We took that chart and developed it into questions in the decision tool,” Anding says. “And that’s what we piloted and released in 2013.”
- Start a process for questioning project leaders. “We created a process in our office for asking specific questions of project leaders, to see how they were doing,” Anding says.
“I took what we had been using orally to help people through this decision-making process and turned it into a structured decision tree,” she says.
Anding sent it out for review and feedback, then revised the questions.
“We also sent it to our legal counsel and had multiple conversations to make sure people were comfortable with the idea of taking decision-making out of the IRB’s hands and putting it into the tool,” she explains.
“After discussions and recognition of how many requests were coming in, our legal counsel and others felt the tool was worth pursuing because it seemed like an appropriate use of resources to switch this process and put it in the hands of people conducting research,” Anding says. “It also provided an indication of our trust in our researchers and project leaders on campus.”
- Assess its use. Most people are able to use the tool appropriately. Those who have questions or who have a complicated project can come to the IRB office for assistance, she notes.
“We did an IRB analysis and felt there were a lot of benefits and low risk, based on what we had seen from the pilot and the submissions coming to our office,” Anding says.
So far, the tool has received uniformly positive feedback. Many people have used it for quality improvement projects, she says.
“We’ve been told it is very easy to use and understandable,” Anding says. “We have comprehensive guidance for the tool and, so far, it’s been positively received.”
There were a few times when people misinterpreted the questions, saying they had QI projects that actually were research projects, she says.
“They didn’t get very far because another office stopped them and sent them back to us to get on the right process,” Anding says.
“When those situations happen, we take a look the tool’s questions to see at which point the person got confused or misinterpreted the questions,” she explains. “It’s a good quality check for us, too. It allows us to make improvements to the tool.”
IRB officials at the University of Wisconsin-Madison realized seven years ago that the IRB was receiving too many requests for review of quality improvement or other projects that did not meet the Common Rule’s definition of human subjects research.
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