Do IRB members read protocol review folders before meetings?

Regulatory compliance is at risk

In days not so long ago, when all IRB members received heavy stacks of paper packets containing protocol submissions before each meeting, research institutions and regulatory compliance officials never questioned whether they would read the work before meetings. It was assumed they would be well-prepared for discussions.

Then technological change made it both possible and easy to find out if they actually do take a look at their packets prior to meetings. With submissions in electronic format, it’s very easy to see if the electronic documents have been viewed.

And as a recent study shows, the answer can be surprising: At one institution, fewer than half of the documents IRB members were supposed to review were even opened electronically for viewing.1

Everyone, including the IRB members themselves, was surprised by the findings, says Melissa Schlenker, MS, CCRC, CIP, an IRB and clinical trials manager at WellSpan Health in York, PA.

Schlenker and Tara Moore, quality assessment specialist for research at WellSpan, published a study about their findings and quality improvement project to increase compliance at the Public Responsibility In Medicine and Research (PRIM&R) Advancing Ethical Research Conference, held Dec. 4-6, in San Diego.

When they discussed their paper with other PRIM&R attendees, they found that most of their IRB peers were startled by the study.

“We questioned whether we should take this [study] out to a national venue, but we felt like the benefits of identifying a problem and finding a way to correct it were important,” Schlenker says. “Some of the comments at PRIM&R were, “I never thought about assessing whether our members are preparing for meetings.’”

From the IRB office’s perspective, this was an IRB compliance issue that needed to be addressed and corrected, Schlenker says.

WellSpan Health’s IRB members are volunteers who are uncompensated for their time. Many have professional careers and may work for the organization in other full-time roles, so being an IRB member is a big time commitment, Schlenker notes.

“They’re doing this on their administrative time, and we appreciate their commitment to doing that work,” she adds.

The IRB’s membership mostly is stable, and members are well-trained, Schlenker and Moore say.

“I think we were very fortunate in the members we have on our board,” Moore says.

There were some signs, however, that members sometimes attended the meetings with less than ideal preparation for the studies being discussed, Schlenker notes.

“Sometimes you’d get the impression from their questions that they didn’t read the packets,” she says. “We also had some trouble with IRB members’ documentation, completing their reviews on time.”

The IRB began to receive their submission and review packets electronically, and this change made it possible to check whether they were opening their packets prior to the meetings.

They found that out of five documents the members would receive, they’d open one or two, Schlenker says.

“We had a review checklist, and we tried to make sure the members came to the meeting prepared to have a meaningful discussion,” she explains. “But when we saw the results, the light bulb came on.”

They realized it was a compliance issue that could be addressed through a Lean Training methodology process and quality improvement project.

Moore met with members of the IRB, thanked them for doing a good job, and asked if they had any concerns, suggestions, or comments. Since she is a long-time member of WellSpan’s staff, the IRB members reacted without defensiveness when she discussed the report about their opening files.

“There was not one person who responded negatively,” Moore recalls. “I received a lot of feedback from that.”

The IRB members mostly wanted to know what they could do to improve their scores, Schlenker says.

“We had discussions with the IRB and said, ‘Here are the things that need to be reviewed,’ and we showed the list to them,” she adds. “We had a discussion about what was preventing them from opening the file.”

Chief issues included time and being too busy, not knowing which files needed to be reviewed most carefully, and even computer illiteracy, Moore says.

“Some people didn’t realize they could scroll down to the bottom of the page,” she explains. “They just saw the cursor on the screen and thought that was it.”

The quality improvement project has resulted in improvements in the quality of IRB discussions and in the percentage of documents opened, although the study’s target goal of having 95% of the documents opened has not yet been reached.1

Most members now open 100% of their monthly review documents, but for a couple of people this has remained a challenge, Schlenker notes.

The change has also improved the IRB meetings qualitatively, she says.

“IRB members are better prepared for meetings,” Schlenker says. “It’s been a shared responsibility to improve the performance of our IRB members, make sure they have access to the tools they need, and it’s been a positive experience for IRB staff and members.”

Reference

  1. Moore T, Schlenker M. A performance improvement approach to increasing IRB member regulatory compliance. Poster presented at PRIM&R’s Advancing Ethical Research Conference, held Dec. 4-6, 2012, San Diego, CA.