Continuing review might have gone away for many studies, but a research protection program’s responsibilities have not. This is why many IRBs have devised an alternative annual review process that combines workflow efficiency with enhanced research protection.
One model for this regular review is an annual status report (ASR), says Sandra Meadows, MPH, CIP, program manager, Office of Responsible Research Practices (ORRP) at The Ohio State University. Minimum risk, expedited review, and some additional studies do not need to go through the annual continuing review by the IRB, but they can be monitored through an ASR.
The ASR process requires 70% less staff time on pre-review than the continuing review process. ASR screens take an average of nine minutes, compared with an average of 30 minutes for an initial continuing review screen.1 ORRP first devised an ASR process five years ago, anticipating changes to the Common Rule, says Erin M. Odor, MA, CIP, quality improvement specialist.
“When the Notice of Proposed Rulemaking [NPRM] came out in 2015, we took that opportunity to do a pilot project for research that is not subject to federal regulations to see if the [ASR] system might work,” Odor explains. “We knew we could work out the kinks before the revised Common Rule went into effect.”
They used the flexibility of non-federally funded research to loosen the pathway by performing a yearly administrative check instead of a formal continuing review, Meadows says. After the Common Rule’s deadline in January 2019, the organization rolled out the ASR to eligible federally funded research. “This only applied to new studies,” she notes.
ORRP took these five steps in implementing the ASR:
- Assessed the NPRM’s proposed regulations and an accreditation organization’s requirements;
- Established criteria for annual status report eligibility;
- Developed an ASR option in the electronic IRB system;
- Revised policies, trained staff, and implemented the ASR application;
- Evaluated how the ASR affected staff resources and investigator burden, comparing ASR to continuing review over a three-year period.1
To ensure the process was consistent and expedient, they worked with information systems staff to implement the review pathway in the electronic system.
“When a new study comes in for annual review, our system will automatically put it into one of two places: the annual status report or the continuing review application,” Odor says. “Our system makes the decision; our staff makes sure the decision is correct, based on investigator responses.”
Odor created a decision tree that is used to determine whether a study is sent to the IRB for continuing review or ASR. The first question is whether the study is FDA regulated. If so, then it is subject to a continuing review. If not, then there are additional questions, including whether the study is federally funded, whether the study was approved prior to Jan. 21, 2019, or whether a reliance agreement stipulates continuing review by the IRB. (The ORRP decision tree can be found at: http://bit.ly/2wdiVkN.)
“It has a lot of complicated criteria,” Odor says. “There are many ways to get to the annual status review option.”
While the electronic decision tree process works well, sometimes the IRB needs to ask investigators for more information. “A tiny percentage of submissions for annual status review were not eligible,” Meadows says. “It had a high accuracy rate — greater than 90% — for the routing.”
The ASR includes these features:
• Four research status questions. For example, the second question asks, “What is the status of participant recruitment?” It includes checkboxes next to each of the two possible answers: “Recruitment is ongoing,” and “Recruitment has been completed.”
• Research progress summary. Investigators are instructed to summarize the progress of their research, including any interim findings.
• Questions about approved amendments since last review. It also features questions about changes made to research that have not been reported and approved by the IRB.
• Questions about participant enrollment, and other comments.
The ASR saves time on both ends of its use — with investigators completing the form, and with the IRB in reviewing it.
“Occasionally, there are inconsistent items in the status report, and we have to go back to the investigator for clarification,” Odor says. “But that happens much more often with continuing review applications.”
About 80% of the annual status report applications were complete when they were submitted. They were renewed automatically, without any questions for investigators, Odor says.
“For continuing review submissions, only 11% were complete when they came in. Most of those had to go back to investigators before the IRB reviewed the continuing review,” she adds.
The electronic system sends investigators annual renewal reminders 90 days before expiration. It also sends reminders at 45 days, 14 days, and seven days before the study expires, Odor says.
“One of the suggestions we are considering is to reduce the annual renewal notice from 90 days to 60 days or less because it doesn’t take as long to renew studies as it used to with the annual review status report,” Odor adds.
Investigators are far less likely to let an ASR expire because it can be completed so quickly, Meadows notes. “Before, it would take weeks for some continuing reviews to get approved, while 63% of annual status reports are approved within five days of receipt,” she says.
“We didn’t see many continuing reviews expiring previously, but it was causing a lot of stress,” Odor adds. “I think I can say, anecdotally, that we’re not up against the clock as often now.”
Use of ASRs reduced staff resources by 11 hours per week in 2019. This is expected to increase to 13 hours per week in 2020.1 “It gives us more flexibility in how fast we can turn it around and who can look at it,” Meadows says. “We have a number of these approved on the same day, and that’s a huge win for everyone.”
While it is true that the revised Common Rule does not require IRBs to create an ASR-like process for studies that are not required to go through continuing review, it also is true that many research institutions want to have some oversight, Meadows notes.
“We have a monthly conference call with the other Big Ten institutions, allowing us a check with peer institutions about how things are going,” she explains. “The Common Rule had very little guidance associated with it, so we felt more comfortable having those conversations with each other, and gauging where they’re going with this flexibility. The vast majority of the Big Ten schools elected to have some kind of annual check-in with their investigators.”
- Meadows S, Odor EM. Haven’t heard from you lately: A burden-reducing alternative to annual IRB review. Presented at the 2019 PRIM&R Advancing Ethical Research Conference, Nov. 17-20, 2019, Boston. Poster: 57.