Staff training that includes a thorough focus on each employee’s job description and expectations, along with staff engagement, can be crucial to improving an IRB office’s workflow and efficiency.
Consistency also is key. One person should not receive more training than another person, says Angela Brown, REEGT, IRB Panel A administrator in the office of research subjects protection at Virginia Commonwealth University (VCU) of Richmond, VA.
The change has resulted in a 13% decrease in time to approval, and there’s a 3% increase in general satisfaction of the IRB.1
Brown offers the following suggestions for how IRBs can improve their staff training and education:
• Discuss with staff their perceived strengths. When the VCU IRB changed from having four separate medical IRBs that each met monthly to having one IRB that meets each week, the staff administrators for each board were suddenly working together. Their jobs and responsibilities were adjusted, as well.
“We met with our director to determine our strengths and weaknesses,” Brown says.
The director asked:
- Did we prefer one study over another?
- How did we prepare for a meeting?
- What work do we like to do best?
• Modify job descriptions. As job descriptions were modified to fit the new, more collaborative IRB administrator model, there was a focus on improving training of how to write minutes and becoming more proficient, Brown says.
IRB leaders consulted with staff to learn more about their strengths.1
“There were different goals set for us individually,” she says. “Management rewrote our job descriptions and told us what we needed to be doing.”
• Engage staff to identify ways to modify workflow. Managers and staff looked at each person’s strengths and role for meetings.
“Before we switched to a single board review, we had worked independently,” Brown says. “Now the three of us work well together as a team, and it’s a team effort.”
Administrators helped their teammates manage the new workflow and tasks. “We were overwhelmed in the beginning — it’s a fairly busy office,” she says.
For instance, when there were four IRBs, administrators would take more time — maybe a week — to turn around meeting minutes. With the new, weekly meeting schedule, they are supposed to have their meeting minutes completed the next day, Brown explains.
“Now there are three of us writing up 12 submissions,” she says. “Management wanted the minutes done in a day; investigators are anxious to get started, and we don’t send out letters until the minutes are done.”
Other workflow changes include:
- IRB staff use new review checklists, tracking documents, and templates to assist with study reviews;
- new workflow deadlines;
- the IRB office meets weekly to discuss meeting agendas prior to the IRB meeting.1
The workflow is more manageable for investigators, and the time to review turnaround is faster.
“We’re not just getting our minutes done faster, but we’re getting approval letters out to investigators more quickly, so they can make the study changes needed and get it back to us,” Brown says. “That was really what was the deciding factor to get everything reduced, getting research approved faster.”
Another workflow change involved the time to add studies to the agenda. Previously, investigators could submit a study at the beginning of the month and wait a few weeks to get it on the board agenda. Now, they don’t have to wait more than a week, Brown says.
“The workflow is more manageable this way,” she says. “In the beginning, it was more overwhelming because it was just trying to get through things in a faster period of time.”
• Create comprehensive IRB minutes training with staff participation. “We had IRB minutes training that involved self-paced, once-a-week topics that lasted about six weeks,” Brown says. “It was in Google Docs and had a quiz at the end.”
The topics included:
- regulatory requirements of minutes;
- summarizing versus transcribing;
- organization of a discussion;
- clarifying panel decisions;
- drafting and editing;
- correcting mistakes and problems;
- substantive versus administrative issues;
- documenting unspoken parts of an IRB discussion.
“These helped us complete the minutes more efficiently,” Brown says. “We have a manager who looks at our minutes, and in the beginning there were changes sent back to us that needed to be made, and now, across the team, we usually don’t have many revisions to make in our minutes.”
• Collect IRB staff feedback on what’s working. Managers met informally with administrators to see which changes worked and which did not.
“We didn’t make a lot of changes once we started the process,” Brown says. “We thought about changing things and having one administrator at each meeting, but we decided not to do that, so we have all three go to each meeting.”
Managers had their own expectations of how administrators would handle their workflow, but they were open to adjusting these when something did not work well, she adds.
“In the end, all three of us came together as a team,” Brown says. “If someone was not feeling well and couldn’t make it to the meeting, someone would pick up their slack.”
• Engage staff in a comprehensive training and competency assessment process. “We had a 50-page training packet that covered a lot,” Brown says. “They wanted to know that we understood FDA regulations and different types of studies.”
The training and competency assessment process included information about humanitarian devices, informed consent, and reviewing the submission process. “We wanted to make sure all requirements were included with that submission.”
A checklist helps them account for all items. Also, the competency training was based on the meeting minutes and the amount of time necessary to complete the work, Brown says.
“It also was preparing for minutes and our taking quizzes,” she adds.
1. Hicks S, Haywood N, Brown A. The professionalism of IRB staff members. Poster presented at PRIM&R’s 2017 Advancing Ethical Research Conference, Nov. 5-8, 2017, San Antonio. Poster: 35.