ike many IRBs, the Virginia Commonwealth University IRB has been on a mission recently to streamline its processes, decrease approval time, and improve IRB member training.

Hand-in-hand with the IRB consolidating its four panels into one, 40-member IRB that meets weekly, the IRB office has created a 67-page IRB Member Handbook that provides comprehensive training material for new members. It also serves as a resource for experienced members.

“The reason we created the handbook is because we had six new members come on, and we saw the need — especially for non-scientists,” says Meghan Wright, MEd, IRB training manager. Wright is the lead author of a poster on the handbook resource.1

“We don’t have constant turnover, but we felt it was a good investment to train members,” Wright adds. “We also give it to current members to use as a resource during reviews.”

The IRB’s mission to improve processes began with the handbook, which Wright began to write in the summer of 2015. It also includes this past summer’s consolidation.

With a goal of increasing consistency and decreasing time to approval, the IRB office took its three biomedical panels and one social-behavioral panel and combined them into one IRB that can handle all studies. The IRB membership was cut by 40%, and a chair and vice-chair were selected to head the new 40-member IRB. The chair and vice-chair attend each of the weekly meetings, but other members attend about one meeting per month, Wright explains.

When studies are submitted, the IRB staff pre-screen them and assign them to primary and secondary reviewers, based on their expertise.

“If we get social-behavioral research, it’s assigned to a social-behavioral reviewer, but the study also can have the benefit of having biomedical members reviewing it at the meeting,” Wright says.

The new member handbook resource is divided into three sections, including member information, a guide to reviewing a submission, and guidance for full board meetings. (See samples from IRB Member Handbook in this issue.)

For example, meeting guidance covers details about how an IRB member can make a motion, detailing the motions for approval, approval with conditions, and table. It notes that motions for disapproval, suspension, and termination are rarely used. It also discusses how to amend a motion and withdraw a motion. Details also outline the four voting options of “yes,” “no,” “abstain,” and “recuse.”

Wright wrote the book over several months, with editing assistance from IRB staff.

“I did research online, although there wasn’t a lot available for public use,” she says. “One university had a full training guide, but it didn’t have the content I sought.”

Wright pulled from various internal and external sources and created the guide in a PowerPoint, eventually merging into one PDF document.

The handbook is available in print and PDF format, listed on the IRB members’ private folder. It’s not available to the public. The PDF version has links to the IRB’s electronic system.

The PowerPoint version makes it easy to create visual items and charts, she notes.

“We give all new members an electronic copy and a bound copy, so they can take notes on it,” Wright says.

“I used to be a teacher, and I know that sometimes if a resource is too content-heavy or overwhelming, it won’t be used at all,” Wright says. “So I made this user-friendly and visually appealing.”

The PDF also has color-coded charts and flowcharts, including a page that helps new members navigate the electronic submission system. Key words are outlined in color rectangles.

“The goal was to make it visually easy to read as a reference,” Wright says. “We picked up the relevant things like reporting, consent waivers, compliance, HIPAA, and FDA, and also created some flowcharts for subparts.”

When various human research protection regulatory changes occur, the handbook also will be updated, she adds.

Results of an IRB member survey suggest the handbook has been a success. About 86% of members said they used the handbook while completing a study review, and about half of the IRB members said they had referenced the handbook in an IRB meeting. All of those surveyed said they liked the handbook’s format and layout, and 92% of members said they found the most useful section to be the one about reviewing a submission.1

REFERENCE

  1. Wright M, Davison C. IRB member comprehensive handbook resource. Abstract submitted to PRIM&R’s 2016 Advancing Ethical Research Conference, held Nov. 13-16, 2016, in Anaheim, CA. Poster 13