IRBs can ensure smoother, more effective collaboration between institutions and pave the way for reliance agreements through the use of an IRB working group.

For instance, about 20 people representing a dozen research institutions meet regularly with the University of Texas at Arlington, which formed the working group.

The group has grown to include hospitals, academic institutions, and a private university.

“We didn’t have 12 institutions at the very beginning, but some members suggested more groups to join the working group,” says Alyson Stearns, CIP, regulatory services manager at the University of Texas at Arlington.

The working group members are diverse from an IRB perspective. Some have many clinical trials and a large IRB office structure, and others were new — just setting up their programs.

“Some might have a large portfolio regulated by the Food and Drug Administration, and another might have solely behavioral research,” Stearns says.

The working group meets quarterly or every other month. It started with monthly meetings, which helped members discuss and share information about following requirements of the new Common Rule, says Kirstin Morningstar, CIP, CPIA, director of regulatory services at the University of Texas at Arlington.

The meetings are flexible in scheduling and length, depending on the agenda. The first project the working group began involved creating a to-do list for the revised Common Rule. (See to-do list in this issue.)

The revised Common Rule necessitated changes to IRB offices’ standard operating procedures (SOPs), and representatives from each institution contributed to the to-do list.

“We came up with a checklist of items to think about in preparing for the new rule and institutions’ SOPs,” Morningstar says. “One of the best things that came out of it was a shared resource database.”

This box account — a web-based, secure location for folders and documents — made it possible for each institution to share information and examples by uploading tools or data from their institutions.

“It’s been helpful to us to have all that shared information,” Morningstar notes.

“Another positive thing was some institutions opened up their educational opportunities to all working group members,” she says. “That was a real benefit.”

For instance, one university hired a consultant to provide training in a day-long workshop, and the institution made the workshop free and available to other organizations represented in the working group, Morningstar adds.

The University of Texas at Arlington also shared some educational sessions with others in the working group, Stearns says.

“We have a mini-conference in fall and spring semesters, and we opened some of these to other institutions — available for free,” she adds.

The group discussed recruitment and training for new staff, but that was more of an issue for larger institutions that did not have the one-on-one training as did smaller organizations, Morningstar says.

“We shared resources on training and how we provide one-on-one training for new staff members, talking about our own experiences and what works for us,” she adds.

At least one working group member was open to institutions assisting with cross-training, Stearns notes.

A big focus of the working group involved forming reliance agreements, Morningstar says. One of the working group members was knowledgeable about reliance agreements and presented information to the group.

“We also discussed how we each handle reliance agreements in our offices,” she adds.

The group’s institutions began to execute agreements with each other as a result of the education on reliance agreements, Stearns says.

The group developed a shared contact list that is kept up to date with contact information of each group member.

“If a member has a question, they can send it out and get replies on the same day,” Stearns says. “We requested assistance for finding a new IRB representative to do prisoner studies, and one member volunteered someone, who worked out for our IRB.”

That was only one example of how well the resource worked, she notes.

“People were asking questions all the time about how does your institution do this,” Stearns says.

The working group’s ability to facilitate collaboration and share resources has made it so successful that the individual members plan to continue it indefinitely. In an anonymous feedback survey, 91% of respondents said they had already implemented changes to their human research protection programs as a result of the IRB working group, or they said they planned to make changes in the future.1

“There was one member who liked the IRB working group so much she’s taken the idea and is doing a working group for other goals, including a federal compliance perspective that is not just about the IRB,” Stearns notes.

All members said their participation in the working group had definitely or probably improved communication and collaboration with other local IRB offices.1

The survey found that working group members ranked these as their top reasons for participating in the working group:

• sharing and access to resources;

• personal education;

• networking and personal communication with colleagues;

• staying current on other local IRB policies and personnel.1

Stearns and Morningstar also attribute the group’s success to its flexibility and engagement with its members.

“I think now there is a new kind of camaraderie between us and other IRB offices,” Stearns says.

“As time went on, people were a lot more willing to volunteer their own ideas for what to put on the agenda for the working group meeting and also to just reach out to each other,” she adds. When the IRB receives a call from a working group member who has a quick question about what a researcher wants to do that might involve both institutions, these discussions are much quicker because of the group, Stearns says.

“It’s satisfying to have a group of people who know you,” Morningstar says.

“This is your group,” she adds. “We have the support of other members of the group, and we know we can rely on the other members, which is helpful.”

REFERENCE

1. Stearns A, Morningstar K, Lybrand MC. The North Texas IRB Working Group — A model for collaboration and communication between regional IRBs. Poster presented at PRIM&R Advancing Ethical Research Conference, Nov. 14-17, 2018, San Diego. Poster: 47.