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Improving oversight of international studies
Report advises IRBs to get creative
The report prepared for the University of Michigan about international research conducted there lays out a series of recommendations that can aid other institutions' investigators and IRBs.
Author Terry VandenBosch, PhD, senior research compliance associate with the university's Office of Human Research Compliance Review, says that among the most important steps an institution can take to help improve human subjects protections international research is in its informed consent process.
She says the U.S. model of consent — requiring a written form and a subject's signature — is cumbersome and ill-adapted to many cultures. She'd like to see IRBs show some flexibility in encouraging innovative techniques to better educate subjects around the world.
"We should think more creatively about how to get information across," she says, pointing to an example of research conducted in Guatemala, where investigators use newsprint with pictures to go through the informed consent process.
"At our IRB council, we said, let's post examples of creative uses of the informed consent process for other investigators," VandenBosch says. "We did a search of the literature to see if we could find something on informed consent other than [relying on] the written document or verbal script, and we found what we think is the same Guatemalan study. That's it."
She says guidances and templates don't promote creativity in the process, "so investigators don't even realize that it would be supported by the IRB for them to do that."
The report recommends that investigators make use of more visual materials, especially with low-literacy populations; that IRBs provide them with examples of fresh approaches; and that UM consider a demonstration project of alternative methods to written signatures to document informed consent.
"It's possible that to ask for a signature could be offensive to someone, because their culture relies on verbal contracts," VandenBosch says.
Training, collaborating key
Other recommendations from the UM report include:
• Cross cultural training: The report recommends providing human subjects protection training in a number of languages for international co-investigators, study staff and students conducting research overseas. In addition, U.S. and international investigators should know applicable human subjects laws and guidance in the study countries, using resources such as the Office for Human Research Protections and the International Compilation of Human Research Standards. Investigators should maintain close and open relationships with international collaborators.
IRBs should promote the use of the Collaborative Institutional Training Initiative (CITI) human subjects courses, which are available online in several languages.
• IRB collaboration: When working with an IRB in another country on a sensitive ethical issue, a U.S. IRB should educate itself about the other IRB's membership and processes. They can use faculty members to serve as consultants about various areas of the world in which studies are being conducted.
Consider investing in capacity building for international investigators and IRBs where the university has ongoing collaborative relationships.
• Enlisting technology: The report notes several areas where technology may make it easier for investigators and IRBs to communicate across borders and oceans.
It recommends that IRBs dealing with difficult ethical issues consider using tools such as Skype to talk to each other "face to face." The university could create a web portal that can guide investigators to necessary documents and guidance. VandenBosch says there's been discussion of creating mobile applications for IRB submissions.
"It also would be possible, if our collaboration was with an English-speaking country, that we could actually open up our submissions system and with a different set of confidentiality protections, we could actually help run the electronic submission system for an IRB in another university in another country," she says. "I don't know at what point or if there will be a sharing of that electronic capability across countries, but it would be possible."
She says it's also important for IRBs and investigators to recognize the potential for them to be working at cross-purposes because of lack of information. VandenBosch says she became aware of this problem when interviewing both investigators and IRB officials for her report.
She says investigators she interviewed told her that IRBs often ask about unimportant issues and don't ask about important ones. IRBs told her they didn't have enough information from investigators to determine the risks of research in another country.
"How can an IRB be up to date on the cultural aspects of 86 different countries? No wonder they ask questions, and they're going to ask questions that flow from our culture. The PI is going to have more general information about the [study] culture. That chasm needs to have more examination."