Best Practices Spotlight

IRB's submission flowchart makes PI decisions easier

Sometimes an IRB's caseload grows so big and complex that new processes have to be implemented or the workload is unmanageable.

When this proved to be the case for the institutional review board at the University of Tennessee Graduate School of Medicine in Knoxville, the IRB developed a submission flow chart that helped cut down on time and IRB office effort.

The IRB handles a wide array of study submissions, including reviewing studies from the university health system, the medical school, and from individual physicians, faculty, residents, and staff.

"We also have faculty from the University of Tennessee on the main campus submitting," says Reni Leslie, CIM, IRB associate director.

"It got to the point where we had to have a process that would expedite the approval process," she says.

The IRB office and institution's compliance officer met and decided a submission flowchart would be the best solution, Leslie says.

"I spent time online looking at the processes of other IRBs, pulling samples from different sites," she explains.

The result is a colorful, one-page flow chart that provides simple, concise instructions on what level of submission and which forms are needed.

Here are some sample items on the flow chart:

• Projects of non-GSM/non-UHS investigators must be approved by UHS director of research compliance;

• Exempt Review(may be submitted any time):

– Less than "minimal risk" to human subjects; Example:

– Anonymous response survey, focus group or questionnaire, case reports;

– Working with a completely de-identified (anonymous) secondary data set;

• Expedited Review(may be submitted any time):

– "Minimal risk" to human subjects; Examples: Prospective or retrospective chart review, surveys/questionnaires collecting limited personal identifiers or health information, any intervention or interaction with the subject;

• Full Review (see the IRB meeting schedule for pre-review and submission deadlines for full board reviews):

– More than "minimal risk" to participants):

– Any research project involving human subjects not covered under any other review categories;

– Contact with vulnerable populations;

– Working with data that can be traced or linked to individual participants;

– Interventions involving physical or emotional discomfort.

The submission flowchart also contains information about CITI training, definitions of minimal risk and vulnerable populations and details about the forms and copies that need to be submitted.

"We put the flowchart on our website, and it's basically self-explanatory," Leslie says.