IRB focuses on children, pregnant women

Decision to divide based on increasing research

When an institution's study portfolio gets large enough, its IRB must decide: Is it time for a new board? And if so, how do you divide the work? At many institutions, that division is based on methodology — studies are assigned to either a biomedical IRB or one devoted to social-behavioral studies.

At Orlando Health Inc. in Florida, IRB officials looked to the growing number of studies being generated by two of its affiliated hospitals — the Arnold Palmer Hospital for Children and the newly opened Winnie Palmer Medical Center for Women and Babies — and created a dedicated IRB for research involving children, infants and pregnant women.

IRB Manager Jonathan Lin, MHSE, CCRP, says the idea was to provide more comprehensive review of these studies by bringing to the board members with different pediatric specialties.

"We thought there needed to be more of a precise review from different types of expertise among the pediatric realm," Lin says. He discussed the development of this new IRB at PRIM&R's recent Advancing Ethical Research Conference.

New specialists

Lin says that on the original Orlando Health IRB, members included an obstetrician-gynecologist and a pediatric cardiologist, because the Arnold Palmer Hospital has a strong pediatric cardiac care program.

The newly-formed Arnold Palmer Medical Center (APMC) IRB has added more specialists, including second OB-GYN, a neonatologist, a pediatric pharmacy specialist and a pediatric emergency physician.

"They're all bringing in their backgrounds and providing their perspectives within the review," Lin says. He says the members all have extensive research experience and previous IRB experience.

Adult research is now handled by the original IRB, renamed the Orlando Regional Medical Center IRB.

In creating the new IRB, Lin says he looked to existing IRBs at children's hospitals.

"I consulted with a few IRB managers or IRB representatives from those institutions," he says. "They definitely provided a lot of guidance. They directed me to their policies and procedures, and I'd see how those matched up with our state law and our institutional policies."

He says the process required creating new forms for the new IRB, including an assent form for pediatric research written in appropriate language for children.

But the biggest change was in the way studies are reviewed, Lin says.

"We provide consistent review between both IRBs, but the new IRB is very specific in addressing and documenting the reviewers' determinations with regards to the subject population," he says. "There's a lot more discussion on the APMC IRB than when the IRBs were [combined], because people are bringing their backgrounds to the table and bringing different concerns that were not previously missed, but maybe not emphasized in these [combined] IRB meetings."

He says the research conducted with pregnant women hasn't raised many new issues because it tends to consist of minimal risk studies, such as surveys and chart reviews.

Balancing workload

When the APMC IRB was created in September 2010, 98 studies out of the existing load of 350 were transferred to it. Currently, Lin says, there are still more adult studies being handled than pediatric and pregnant women studies, but the workload is balancing out more.

Operationally, the addition of a new IRB has helped the office run smoothly, he says.

"We've tried to have the turn-around remain the same or even shorter," Lin says, noting that he can move IRB members from one board to another in to help maintain a quorum if a member can't attend.

An institution considering creating a new board should focus on two key factors, he says:

Choosing members:The roster should well represent the various specialties the IRB commonly will be encountering in review.

Creating forms: This can be time-consuming, Lin says, but is important, as the forms must document all of the additional safeguards and regulatory requirements involved in research with vulnerable populations. "I saw it as a way of investing up front rather than having to change forms later," he says. "If we create forms and then change them constantly, we lose trust."