PRIM&R takes IRB training to international sites
Workshops held in Africa, Mexico
The rapid growth in international research is providing challenges for human subjects protection in other countries, many of which lack the resources that American IRBs have.
The Public Responsibility In Medicine and Research (PRIM&R) program is gearing up to help these countries improve their means of reviewing research and collaborating with U.S. institutions.
PRIM&R already has participated in two conferences in Africa on human subjects protection practices, says PRIM&R Executive Director Joan Rachlin, JD, MPH, in Boston, MA.
She says that at the most recent conference, held last year in Durban, South Africa, PRIM&R introduced an REC Administration 101 program, adapted from PRIM&R's existing "IRB Administration 101" program offered in the United States (Many countries outside the U.S. refer to their IRBs as research ethics committees, or RECs).
PRIM&R and its REC Administration 101 workshop in Durban were selected recently for an honorable mention in the 2006 Associations Make A Better World Awards.
Rachlin and others involved in the program say the goal of their continuing efforts to provide IRB training in other countries is to provide the U.S. perspective on human subjects protection — not to impose a set of U.S. practices on the rest of the world.
"The main thing we made clear was we weren't there to tell them what to do, we were there to tell them how we do it — they have to figure out how they want to do it," says Elizabeth Bankert, MA, IRB administrator at Dartmouth College, Hanover, NH. Bankert was one of two people who presented the REC Administration 101 program at the Durban conference, and presented a similar program in Mexico City this past summer.
"I go overboard to make sure I come in with that attitude that we're here to work with you — that it's your perspective that's the most important. These are your people and your country, you need to teach us," Bankert says.
Building capacity
Rachlin says PRIM&R's goal is human subjects protection capacity building in parts of the world such as Africa, which has seen a tremendous increase in clinical research.
"PRIM&R has been very committed to trying to help those who are doing research internationally, particularly in under-resourced or resource-scarce countries," she says. "We want to ensure that they have access to both the materials and the information necessary to develop strong human protection programs.
"It's a very significant challenge because of the technological limitations. Quite often people in resource-scarce countries don't have the access to technology, or it's insufficient for the kinds of electronic training that we take for granted here."
Rachlin says PRIM&R had participated two years ago in a conference in Malawi, in southern Africa. Last year, the organization was invited to a second conference in Durban, at which research professionals from 14 African nations were represented.
"We decided that since we were going to be part of the conference, perhaps it would be helpful to bring one of our short courses over, and give it free of charge to those who were coming for this broader ethics consortium," Rachlin says.
For content, Rachlin turned to the IRB Administration course developed by Ada Sue Selwitz, MA, director of the Office of Research Integrity at the University of Kentucky, and Susan Kornetsky, MPH, CIP, director of clinical research compliance at Children's Hospital in Boston. Selwitz and Kornetsky worked with the two women who would be presenting the program in Durban — Bankert and Karen Hansen, director of the Institutional Review Office of the Fred Hutchinson Cancer Research Center in Seattle, WA — to adapt the program for use at the African conference.
IRBs or RECs in other countries still are bound by U.S. regulations if federal funding is used for a clinical trial, so much of that content was kept for the African version.
Bankert says the chief issue in adapting the program was recognizing the different level of resources available to the African RECs.
"They're still looking at the one-person or no-person IRB office, they're not yet looking at it at an institutional level," she says. "We try to work with them at the point where they are, starting with getting policies and procedures written down. We could have stayed with them another day and just sat with them and written policies and procedures, because many of them didn't have those."
Bankert says she also believes that African RECs work under different pressures from those experienced by IRBs in the U.S.
"The Ministry of Health and the institutions really need money so badly," she says.
She noted that some RECs were struggling with decisions over whether to allow Phase IV "post-marketing surveillance" studies, which some U.S. institutions won't do.
"Some people really consider it a marketing study," Bankert says. "It can bring in some money to an institution, but is that really the mission of a research academic medical institution?
"There was one institution in Johannesburg that had been asked to do Phase IV studies and it bothered them, because they're not even sure that their population would ever actually use the drug. So they knew they were doing it for the funding, not necessarily for the long-term population. That was troubling to them."
Rachlin enthused about the work the four women did to create a curriculum that served its international audience.
"It was adapted to be as responsive as it could be to the needs of those on the continent of Africa," she says. "It was not just taking a canned curriculum, exporting it to Durban and saying, 'Well, here you are, hope you like it, hope most of it helps.' It was a very different process and one we're very, very proud of."
Bankert and Rachlin say they were impressed by the enthusiasm of the REC professionals, as well as their understanding of the international regulations that apply to human research.
The Durban conference has led to the creation of an African professional society, the Partnership for Enhancing Human Research Protections — Africa (PEHRP-A). That organization has its own newsletter, and hopes to hold another conference next year, Rachlin says. She plans for PRIM&R to participate in that one, as well.
In the meantime, Bankert gave a similar presentation in Mexico City this past summer. She says the experience was different from the one in Africa, most notably because the African participants were more conversant in English, whereas she required a translator in Mexico.
Bankert says her international experiences have changed her own understanding of international research, and she'd like to see more collaboration between U.S. IRBs and the RECs in countries where research is conducted. Currently, she says, she's found that these boards rarely are in contact.
Rachlin says PRIM&R will work to set up more workshops in various parts of the world, and continue its program of bringing human subjects protection professionals from other countries to attend conferences in the United States.
Currently, PRIM&R has been funding these efforts from its own reserves, but hopes to apply for grant money to expand the program.
"We do expect that within the next year, we're going to start advertising our willingness and ability to teach this in other international countries and we're very excited about that," Rachlin says.
In each case, though, she says the organization wants to proceed carefully, to provide the most useful program for the international audience.
"We want to make sure we have the right partners, the right stakeholders, the right curriculum, the right teachers," Rachlin says. "We want to make sure that the case studies we use aren't Western-centric. So it's a fairly long preparatory process. But the Durban session was such an exciting, well-received, toe-in-the-water effort, we're truly excited about next steps and we'll hopefully engage in this work for a long time to come."
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