Use experts wisely to improve IRB review time, efficiency, and quality

"Content experts" serve as IRB-PI liaison

Major research institutions can improve their IRBs' efficiency and protocol review quality by making the best use of a resource they have in abundance: expert professors and scientists.

Calling such staff "content experts," an IRB chair at Nova Southeastern University in Fort Lauderdale, FL, finds that professors are in a much better position to look at protocols' content and to understand studies from researchers' perspective.

"Nova has a system where the entry point for protocols for IRB review is an individual who is generally a faculty member within the academic unit," says Jaime A. Arango, EdD, assistant director for education for human subjects protection at the University of Miami (FL). Arango also is with the CITI program at the University of Miami. Arango was an author of a study on using professors as content experts.1

The goal is for faculty members who are content experts in the same field as a particular study to work with investigators and help them identify systemic or design issues that could be resolved prior to the formal IRB protocol review, Arango explains.

Content experts help educate investigators and student researchers about the IRB review process, answering their questions much earlier than would occur without the experts' help, he adds.

"They have a similar background to the researchers and understand the methodology people in that profession typically use," says Ana Imia Fins, PhD, associate professor at the Center for Psychological Studies and IRB chair at Nova Southeastern University.

"We have at Nova 16 academic units or centers, as we call them," Fins explains. "Each of these centers has either a dean or director, and that person selects from faculty someone we refer to as a center representative for the IRB."

Each center representative serves as a liaison between the IRB office and the center, facilitating submissions from faculty and staff, and serving as a voting IRB member, she adds.

Most centers have one center representative and one alternative person, she says.

When protocols are submitted to the IRB office for expedited or full review, the center representative is the first contact from the IRB office that the principal investigator will contact, Fins says.

"The PI submits the protocol the center representative, who reviews it and gives feedback to the PI, asking for clarification, revision, and so on," Fins says. "It's an informal process and can be done verbally."

Each center representative can provide this feedback in a way that works best for him or her. This might entail a center representative meeting with a principal investigator before the protocol is given to them to have questions answered.

"I've been a center representative, and many times I'd have a student with questions about the IRB protocol who would ask to meet with me," Fins says. "I'd give them a heads up on what the IRB was looking for so they could make sure everything was addressed in the protocol."

This proactive educational process helps to improve the quality of submitted protocols and can result in greater IRB review efficiency and reduced turnaround time.

Center representatives also serve as a less intimidating liaison or point person for IRB offices, Fins notes.

"It's nice to have someone at your own center and who is identified as an IRB person who can answer your questions," she adds.

There is a significant benefit for researchers to have someone who speaks their own language and understands their own area of study bridging the gap between investigators and IRB staff, Arango notes.

"They helped improve protocol submissions," he adds. "I definitely think they were helping investigators polish their submissions to get them ready for the next stage of the IRB."

When center representatives are asked a question they cannot answer they can call the IRB director or chair for assistance. The point is that they will help to facilitate a conversation, using their own expertise in the researcher's field to improve communication, Fins explains.

Nova Southeastern University appoints center representatives to three year terms, and they attend monthly IRB meetings during their terms. Their presence at meetings can help improve education throughout departments as they learn about protocol submission trends and issues and then take this information back to faculty and students conducting research.

"Center representatives can go back to investigators and say, 'Focus more on these aspects of your protocol: make sure these are areas you describe well and can hopefully reduce revisions that occur,'" Fins says.

Reference:

  1. Arango J, Fins A, Hamill T. Professors as content experts: the first line of IRB review. Poster presented at the 2010 Advancing Ethical Research Conference, held Dec. 6-8, 2010 in San Diego, CA.