Report shows challenges of international research
Protection of participants requires extra care
As institutions seek to expand their international research portfolios, IRBs face increasing challenges — differing regulations in different countries, cultural distinctions that may lead to unexpected risks and the difficulties of oversight at such a distance.
The University of Michigan in Ann Arbor is an example of a global research player, with human subjects research projects — ranging from minimal-risk social-behavioral studies to biomedical research — going on in more than 80 countries.
"Here at the University of Michigan and I think at many of our peer institutions as well, there's been a big uptick in interest in international research and international scientific partnerships," says Ron Maio, DO, MS, director of UM's Office of Human Research Compliance Review (OHRCR).
With a new push to expand research relationships with China, Maio says UM officials decided to take a closer look at international research — what the university is doing now, what risks are involved and what the expectations are of researchers and IRBs.
The resulting report lays out a series of recommendations to aid the university in enhancing human subjects protections overseas in areas ranging from informed consent and IRB procedures to possible technological aids to investigators.
In developing the report, Terry VandenBosch, PhD, RN, senior research compliance associate with the OHRCR, first set out to catalog the current international research being conducted on behalf of UM. She says that process revealed some surprising facts.
"I had thought that there would be more studies being overseen by the IRB than there were," she says. "I especially thought there would be fuller committee reviews. In working with people from [UM's] behavioral science IRB and Center for Global Health I found that, in fact, a number of the international studies aren't subject to IRB oversight. A large number of them are low-risk or exempt or they're in areas other than human subjects research."
Dealing with range of regulations
VandenBosch says that the vast majority of international human subjects research being conducted by the university is minimal risk, with its behavioral science IRB handling 62% of the studies.
But there are risks associated with social and behavioral studies, risks that can be complicated by the different cultures and governments in which research is being conducted, according to Maio and VandenBosch.
"Looking at the bucket of low-risk studies, they aren't all the same," VandenBosch says. "It could be that there may be political consequences for the subjects if the data are known. If confidentiality protections aren't put in place as they should be, it could bring more risk to the subjects or to the students who are conducting some of the studies and aren't covered in the regulations."
She says students conduct a number of low-risk studies, although only 20% are international research, often in the countries of their origin. The report notes that only 50% of UM student investigators stated that their departments had an effective mentoring program that helped them to understand the ethical obligations of conducting human subjects research. Seventy-five percent reported that their faculty advisors helped them in this area.
Investigators and IRBs also must cope with an array of levels of regulation at research sites.
The country with the greatest number of UM research studies was Michigan's northern neighbor Canada, where there is strong regulatory oversight.
In what VandenBosch calls "middle-resource developing countries" — China, for example, or Brazil or India — governments are creating regulations, but she says they haven't been tested in the way that the United States' regulatory system has.
"We don't always know exactly how to interpret the regulations because they're written broadly, to fit many different kinds of situations," she says. "But that means that agencies put out guidance frequently, as to what the regulations mean, as issues occur."
In "low-resource developing countries" such as some African countries, there may not be research regulations and guidance, or the information may not be available in English on a website, VandenBosch says. She does note that the Office of Human Research Protection's (OHRP's) International Compilation of Human Research Standards guidance is helpful.
In addition to that, "you have to rely on your collaborative relationships," VandenBosch says. "And I think one of the things we're looking at is what does a collaborative relationship look like, so that we know we can rely on the information that we're getting?
"Investigators are the ones that have those relationships, so the burden will probably be on them in terms of what information they're getting," she says. "And they need help."
IRB relationships
VandenBosch says it's also important for IRBs to find out what they can about the regulations and oversight in the countries in which U.S. investigators are carrying out projects. Because IRBs can't be experts on regulatory oversight in 80-plus countries, that process requires some care and thought, not a one-size-fits-all approach. Particularly in behavioral science, investigators are working in some areas with no IRBs whatsoever.
She says the university may base a decision about whether to cede to a foreign IRB on whether it had a Federalwide Assurance (FWA), whether it was accredited by the Association for Accreditation of Human Research Protection Programs (AAHRPP) and whether OHRP has determined that the foreign institution has equivalent human research protections in place.
Meanwhile, university officials are seeking more long-term relationships with IRBs in places where they plan to conduct many studies. Maio notes that UM has begun a research collaboration with Peking University in Beijing, one that has involved the two universities' IRB officials.
"Right from the start, the regulatory component of that relationship was something everybody wanted to make sure we understood and got straight," he says. "We have actually met with their people face to face, as well as through some teleconferencing to talk to their IRB people and to figure out how to do things that will be efficient and will maximize human subjects protection."
VandenBosch would like to see some mechanism for U.S. institutions that have these types of international collaborations to network with each other to help facilitate research. For example, she notes that UM is doing a great deal of research in Ghana, and has strong relationships with IRBs there.
"It would be useful, if another school of public health is sending students to Ghana, for them to contact our IRB and get some information about it," she says.
Other institutions have similar strengths in various areas of the world, but currently, VandenBosch says, it's very difficult to find out where they are.
"There's no place where IRBs can get that information, other than to put a post on the IRB Forum and hope that someone there has worked in that country," she says. "We need some kind of international perspective to help IRBs work with each other, more than just how to do an international study with your IRB."
To read the UM report, "International Human Subjects Research Risks, visit http://ohrcr.umich.edu/reports/.
As institutions seek to expand their international research portfolios, IRBs face increasing challenges differing regulations in different countries, cultural distinctions that may lead to unexpected risks and the difficulties of oversight at such a distance.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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