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Special Coverage: 2003 PRIM&R/ARENA Conference
U.S., international IRBs forming partnerships
International organization offers model
As more research heads for underdeveloped countries, there are greater challenges and opportunities for research institutions and IRBs located in the United States that may be connected to the research done in these countries through sponsorship or multisite clinical trials.
"We do a lot of work in developing countries, and more and more research is heading to those parts of the world," says David Borasky, CIP, associate director of the Office of International Research Ethics at the Family Health International (FHI) in Research Triangle Park, NC.
He spoke about building IRB capacity in developing nations at the PRIM&R/ARENA conference, held Dec. 5-7, 2003, in Washington, DC. The annual conference included its strongest focus yet on international research and IRBs, Borasky says.
"A lot of these [third-world trials] require IRB review that follows U.S. standards," he says. "Following the terms of a federal assurance is easy to sign your name to, but actually implementing it has been a real challenge to a lot of international institutions."
Institutions that work with an international country for particular research may benefit from helping to develop an IRB or research partner in that region, Borasky suggests.
And these types of international IRB relationships likely will increase as global technologies make it easier to communicate and teleconference, he notes. "Even in developing countries, most folks have e-mail, and some have cell phones."
When there is a research connection that may involve multiple studies or long periods of time, it may well be worth the financial resources it would take to mentor the foreign IRB and help IRB members learn the same skills used by their U.S. counterparts, Borasky says.
"It’s a little trickier if you have a study here and a study there, because it’s tough to find the funding to do capacity building for the IRBs," he adds. "The groups that should look more into this are the sponsors of research; groups like the Office of Human Research Protections will be doing more of this."
FHI has received a National Institutes of Health grant to identify and assist international institutions that need some IRB support. These institutions include the College of Medicine at the University of Malawi in Balntyre, Malawi, and the University of Zambia in Lusaka, Zambia, Borasky reports.
"We identified the institutions and got their verbal commitment to participate in the project, and we’ll spend a year trying to get them up to speed for what they agreed to do in their federalwide assurance," he explains. "We’ll help them meet the goals of that assurance by going over there, visiting IRBs, spending a week at each site, and looking at their operations from top to bottom."
For U.S. IRBs that often are challenged with finding enough financial and staff resources to meet all regulatory and caseload requirements, it is easy to understand how an IRB at an institution that has far fewer financial resources can struggle meeting U.S. regulatory standards.
"They don’t feel like they have the financial capability to do things the Western way," Borasky says. "There is the burden of overhead; they don’t have large pots of money sitting around to be spent, so it’s tough to make the IRB a financial priority for an institution."
Also, foreign IRBs may find it difficult to figure out how to meet the U.S. federalwide assurance, as there is no instruction or guidebook describing strategies for doing so, he adds.
Through the mentoring program, FHI will observe how the foreign IRBs work and hopefully learn some strategies for assisting these IRBs with improving their processes, Borasky adds.
Here is what the mentoring program will involve:
"We’ll see what barriers they’ve encountered in trying to achieve their goals, and will look for funds to continue the program," Borasky says. "Both sites are enthusiastic about it, and representatives from both sites attended the PRIM&R conference."