Review board focuses on children, pregnant women

Decision to divide based on increasing research

When an institution's study portfolio gets large enough, its review board 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 review board or one devoted to social-behavioral studies.

At Orlando Health, Inc., in Florida, review board 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 review board for research involving children, infants, and pregnant women.

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

"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 (Institutional Review Board) at PRIM&R's (Public Responsibility in Medicine & Research) recent Advancing Ethical Research Conference.

New specialists

Lin says that on the original Orlando Health review board, 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) review board has added more specialists, including a 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 review board experience.

Adult research is now handled by the original review board, 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 review board, 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.