SWAT! project provides support to investigators

IRB’s best practice is popular with PIs

IRBs searching for highly effective ways to improve protocol submissions and enhance education and training efforts might check out the SWAT! program at Washington University in St. Louis.

SWAT! — Staff With Answers Today! — provides just-in-time education and an ongoing training program for IRB and research staff. Seven members of the IRB’s 28-member staff are trained to provide expedited reviews, and they also serve on the IRB.

They spend two days a week in the university’s psychology building and at the biomedical campus, meeting with investigators who have questions or studies that might need expedited reviews, says Martha Jones, MA, CIP, executive director of the human research protection office. SWAT! received a 2012 Award of Excellence in Human Research Protection from the Health Improvement Institute.

“We wanted to be of service,” Jones says. “We have expedited reviewers on staff, and they have authority to do approvals through the expedited review process.”

Since opening the onsite office hours more than 18 months ago, the program has been well received. Every month, between 10 and 20 investigators visit each satellite office, she notes.

“We provide a more efficient way for studies to get approval through the expedited review process,” Jones says.

The program also has a dedicated staff position for answering researchers’ phone calls or responding quickly to online chat questions as they complete the protocol submission form electronically. These, as well as the staffed satellite offices, are available during weekday office hours, she adds.

SWAT! has grown to 300 to 450 monthly phone calls and its visits from biomedical researchers has increased by nearly 40% from a year ago, says Mike Leary, MA, CIP, education and compliance specialist in the human research protection office of WUSL.

How it works

Here are some details about how the SWAT! program works:

Offer in-person consultation: The HRPO SWAT! team offers in-person consultation on myIRB submissions to any researchers who ask for help. The team staffs offices at the biomedical campus and behavioral science campus, each for several hours twice a week.

“The IRB office sits three to four blocks from the main medial campus,” Jones says. “So we identified a computer center directly on the medical campus where we could hold in-person office hours twice a week.”

Investigators can meet with the IRB experts and work on their IRB submissions at a computer in the offices.

“We keep a combination of expertise available, depending on what kind of questions come through the door,” Jones says.

IRB experts staffing the offices also are trained to serve on the IRBs and provide expedited reviews, providing a more efficient expedited review process, she notes.

“Typically, these are people who have research experience, and we train them in regulatory criteria for expedited review, which is what they do on a full-time basis,” she explains. “They attend board meetings with other IRB members, and we take the approach that their job is to reflect what the full board would be doing.”

Provide on-call service: HRPO professionals take turns staffing the on-call lines between 8 a.m. and 4 p.m. weekdays.

“Researchers can call the staff person to ask any questions and get help with their applications by phone,” Jones says. “This is available weekdays so they can get the same kind of help they would in person.”

The IRB office has one staff member dedicated to the on-call service and chat service in the mornings and a different person dedicated to them in the afternoons, she says.

The idea is to offer different areas of expertise during the day.

“One person might have expertise in full board reviews, so if an investigator has a full-board question, there is someone available to consult with,” Jones says.

If the on-call expert doesn’t have an answer, the expert will research the question and get back to the caller within the four-hour shift window whenever possible, she adds.

Make online chat service available: The same HRPO employee who is staffing the on-call service also will answer investigators’ questions through the live support chat service. Investigators can access the chat service through myIRB where a chat icon appears on the top right side of the screen. They can click on the link and then click on the “join chat” button.

The goal of having an online chat service is to provide more flexibility in the online application process with real-time answers to investigators’ questions as they are completing electronic forms, Jones says.

The live chat service is not available at night or on weekends, Jones says.

Collect metrics on what kind of questions and issues arise: “We’re looking at metrics on whether SWAT! decreases time to approval,” Leary says.

The IRB also has collected information about investigators’ questions and trends that might point to educational needs.

“We record names, role at the university, what kind of questions they ask us, and we keep data on how long it takes us to get a response,” Leary says. “We’re able to demonstrate that if you come to SWAT! the approval time is less than if you went through the usual process.”

The IRB can check data in each department to see how many visits they’ve had with SWAT! and what kinds of questions they’re asking IRB staff. This helps Leary and the IRB determine what each department’s educational needs are.

For example, in recent years the university has had a rapid increase in biobanking, and data collected through SWAT! suggest this was a frequent topic of discussion and questions, Leary says.

“We didn’t have standardized advice for investigators, and it’s a complex issue,” he explains. “We found that a lot of people at the medical school would have pre-submission questions about biobanking and want to sit down and talk with us about their studies and ideas,” he says. “We can help them set up their study and application on the spot, since they do that in collaboration with us, and this reduces their approval time considerably.”

Leary reviews data regularly and looks for trends that might require additional educational materials or sessions.

“We have developed a lot of educational materials just for SWAT! that we didn’t previously have,” he says. “We can sit down with the research community and say, ‘Here is the beating pulse of your questions.’”

The SWAT! program has changed the IRB’s culture and interactions with stakeholders, Leary notes.

“This is a way to create more transparency for the IRB process,” he says. “In many institutions, the IRB is a black box, and people don’t know how it works; with SWAT! you can walk people through the process over the phone or in person.”

SWAT! increases the IRB’s mission of protecting human subjects, and it fosters collaboration with IRB staff, researchers, and faculty members. Plus, it’s an affordable model that IRBs small and large could employ, he adds.

“It fosters a sense that we’re in this together,” Leary says.