Protecting subjects from 5,000 miles away
IRB Series: Overseeing studies overseas:
[Editor’s note: This story is part of a series about how IRBs are handling international research studies. In the November issue of IRB Advisor, there were stories about how universities are focusing more on international research, and stories about best practices and guidelines for international research. This story on collaborations and human subjects protection of international study participants concludes the series.]
Collaborations can help grow research overseas
A first step in protecting human subjects in an international study is to ask researchers to discuss their motivation, preparation, and knowledge involving research in foreign countries, experts say.
"What do they say prepares them to conduct research in that location and with that subject population?" says Michelle Watkinson, IRB administrator at Rutgers, The State University of New Jersey, in New Brunswick.
"What are their attitudes and cultural sensitivities?" she adds. "In today’s world it’s about connections."
IRBs will also want to know about oversight, including having someone provide oversight for a graduate student who is initiating research overseas, she says.
"Who does the researcher know in that country, and what consultants have they gotten to do the work?" Watkinson asks.
A research protection office might provide some education about research in international settings to an institution’s faculty. The IRB also might seek input from experienced international researchers when creating new educational and training materials and programs, she suggests.
"We provide educational outreach and sessions," Watkinson says. "Last year we did a session for [the global affairs department] for international students, telling them what they needed to do to go through the IRB process."
Those kinds of programs are helpful in improving research compliance with international research rules, she adds.
Another strategy might be to speak with experienced researchers about ways to improve reviews of international studies. This can help create better submissions and reduce the time it takes to complete the review process, Watkinson says.
"It allows for reviewers and committee members to review things effectively and to know what their resources are if they have any concerns," she says.
The Rutgers IRB has guidance for international studies that addresses these questions. IRB Guidance and Procedures: Evaluation of the Local Research Context for International Studies provides guidance for handling both research involving greater than minimal risk to subjects, and research involving no greater than minimal risk to subjects.
For example, one guideline involves the use of consultants, and states that it is not acceptable for a consultant to be a friend or collaborator on protocols or grants with the investigator, or anyone who has personal or professional ties with the protocol investigator that would preclude him or her from speaking independently and objectively about the research project.
"This is because of objectivity," Watkinson explains. "We want a consultant who is knowledgeable, but objective."
Overseas consultants must understand the needs of the population, as well as have research knowledge and experience, but they cannot be connected to the investigator, she adds.
Domestic researchers could find a researcher at the international setting and ask to collaborate with him or her, says Richard L. Sneed, PhD, director of the Office of Research Compliance, University of Central Oklahoma in Edmond.
Working with consultants and collaborators also is a good strategy for conducting international research on a limited budget, he notes.
"We encourage collaborations, and one way we do that is to try to find more local universities or find universities with pre-existing relationships in those places," Sneed says.
"Given the global nature of education, if I want to talk with a researcher in Singapore, I can do it at a mouse click," Sneed says. "We can identify local researchers, ask them to collaborate, and then initiate a system of collaboration between our research endeavors and what the local researchers have in place."
Once an institution establishes a record of success, it can write about its track record in grant applications for international research, Sneed adds.
When the IRB is able to contact a consultant who is knowledgeable and objective, IRB members will be able to trust the consultant’s input as they make a decision about the study, he says.
