Build efficiencies into your IRB practice
Collect data about own practices
There are a number of innovative practices IRBs can employ to improve their office's efficiency and work quality.
"These innovative practices work for some people and should be considered by others," says Daniel Nelson, MS, CIP, an associate professor of social medicine and pediatrics at the University of North Carolina, Chapel Hill. Nelson has spoken about improving IRB office efficiencies at national human subjects protection conferences.
One mistake IRB directors often make is to err on the side of being overly strict in their interpretation of federal regulations, Nelson notes.
"IRBs should be making use of the flexibility regulations provide," Nelson says. "I think it's human nature to think that if a little bit is good, then a lot must be better."
In fact, Nelson says he used to be in the camp of thinking that it's better to err on the side of having more review in every case, but he now believes that's not always true.
"For example, if an IRB always takes every action to the full IRB, even when it involves eligibility for expedited review or an exemption, or if they never give consideration to an alteration or waiver of consent or cooperative review arrangements, when circumstances might warrant these, the IRB is doing a disservice to research participants, research communities, and their own institutions," Nelson says.
"Ultimately, it becomes a research issue, and the sheer weight of over-applying this in every circumstance puts bulk in the system, diverts attention, resources, money, time, and effort away from places that are truly value-added," Nelson says. "We see more and more people now thinking a bit more critically at an administrative level, and it's not always value added to take everything to the highest level of processing."
The goal is to not shortchange important things, but to recognize that with limited resources, it's not necessary to do everything to the extreme, Nelson adds.
With this goal in mind, Nelson makes the following suggestions for building greater efficiencies into the IRB process:
- Create checklist tool: "We increasingly see this as a helpful aid," Nelson says.
"The regulations lay out eight criteria that must be satisfied before an IRB can approve a study," Nelson says. "My experience is that many IRB members don't approach each review with those firmly in mind, but approach it with what feels right in mind."
Increasingly, IRBs are using checklists as their framework for a review, and these are helpful for guiding the discussion and ensuring consistency, Nelson says.
"These shouldn't be used in a lock-step mentality to just check off things, but they are helpful," he adds.
With a checklist, an IRB can make sure its review is rigorous and less subjective, and it reminds IRB members of the most essential regulatory elements, Nelson says.
It also forces IRB members to be analytical in their protocol review, he says.
- Use evidence-based IRB practice: "A positive development that, increasingly, we're looking for and expecting is evidence-based IRB practice," Nelson says.
"By that I mean, it's just like a medical practice that's informed by data and experience," he explains. "Obviously, we now have people asking more critical questions and gathering data to support questions like 'How many IRBs do we need?'"
Other questions that can be asked as part of data gathering are:
- We only have one protocol per meeting, so are we meeting too often?
- Do our meetings run too long, and so should we split the board into two?
- How much staff are needed to properly handle the workload?
- Do all the consent form edits that IRBs typically require really improve understanding?
"This is an area where I think there's been a lot of supposition and personal references and pet peeves," Nelson says. "Everyone has their own consent form they look for, and there's a growing body of literature that analyzes this in a more rigorous scientific manner to see what is value-added."
The IRB field needs to be more analytical and critical about its own practices and processes, subjecting them to study, he adds.
"So much of IRB practice has been informed by a seat-of-the-pants feel," Nelson says.
Individual IRBs could institute a best practice by simply tracking their own data about how long meetings are taking and how many protocols are being reviewed at each meeting, he suggests.
"How much staff will there be for each protocol action, and how many actions per full time equivalent is an even better way to say it?" he says.
IRBs increasingly are moving into the direction of collecting their own data and analyzing their own results for evidence-based best practices, he notes.
"For many years, I have had a bar chart that I add to each year to show our workload and the number of actions we've taken, and we update that annually and check the data as the year progresses to see how the workload is growing or shrinking," Nelson says.
As more institutions collect their own data and share it with others through informal networking or formal quality improvement initiatives, it results in benchmarking data that will give IRBs an idea of what is working at other institutions.
Also, many IRB directors have reached out to peers to conduct an informal survey of their own practices, Nelson says.
- Seek accreditation: "Growing efforts like accreditation for programs and certification for individuals are in essence benchmarking efforts and are a positive evolution in the field," Nelson says. "These are built around best practices in the sense of how standards are set."
National organizations set these standards and benchmarks that institutions and individuals can seek to achieve as a way of measuring their own performance, he says.
Accreditation and certification in the field are relatively new, but there has been an increase in the number of organizations and individuals who have sought to measure their own performances against these standards, he says.
"That has had a positive impact on the field as a whole," Nelson says. "Until these came along, IRBs were left to kind of wondering to themselves about what is adequate and whether they are doing something right or wrong."
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