Tips for IRBs overseeing international research
Pre-trial preparation is one key element
The recent headlines and controversy over the resignation of a South Korean investigator who admitted to ethical lapses and fraudulent data have raised concerns among IRBs and others in the research industry.
While IRBs aren’t in a position to detect fraud, there are some safeguards they could take that might such problematic collaborations from taking place here.
For IRB members and staff who are concerned about encountering ethical lapses involving international research, here are some suggestions for preventing problems:
• Handle international research as much like a U.S. study as possible: "I think the closer you handle it to a U.S. study the better," says J. Mark Waxman, JD, a partner with Foley & Lardner in Boston.
"U.S. studies typically are in an environment where people are not able to act entirely unilaterally," he adds.
While some researchers and research administrators think everything is different when studies are done overseas, it’s a good policy to act as though there is no difference, says David Borasky, CIP, an associate director in the Office of International Research Ethics at Family Health International (FHI) of Research Triangle Park, NC.
At FHI, where most of the research is conducted internationally, the foreign sites and foreign investigators are treated the same as domestic-based investigators, Borasky says.
"We wouldn’t entertain the excuse that we couldn’t do the study the right way because the site doesn’t have the capability to do so," Borasky says. "If a site is incapable of conducting research, then our IRB’s first recommendation is to shut down that site."
• Require pre-trial site preparation: When done correctly, pre-trial preparations could reveal an international site’s potential ethical and data quality problems, Borasky says.
"The only thing you can have control over is how you select and identify collaborators and, then, what level of cooperation you put into that site," Borasky says.
IRBs and research offices should look at an international site’s history and whether they have a compliance program, Waxman suggests.
"If someone is going to defraud you, it’s very difficult to detect without independently verifying what it is they did," Waxman says.
If the international site has a compliance office that will monitor the trial, it will provide some assurance to an IRB that any intentional or unintentional data fraud will be detected.
"We have to take exceptional care to make sure we’re selecting good investigators and sites that are capable of implementing good research, whether it’s a clinical trial or a behavioral study," he adds. "That sometimes involves a significant amount of pre-trial investigation of the site, but that’s the only time you have total control over things."
• Establish a monitoring plan: Once a study starts, research offices and IRBs are dependent on the investigator doing what he or she was asked to do, but this can be complemented with monitoring, Borasky notes. "One thing our IRB looks for in protocols is the monitoring plan for any given study," Borasky says.
"We require a monitoring plan for all studies, whether it’s a clinical trial or a qualitative study, and that monitoring plan should be commensurate with the nature of the research."
For instance, in a large clinical trial, clinical monitors will go out to sites according to a predetermined schedule, such as monthly or quarterly, he says.
These are complemented by good clinical practice (GCP) audits by the regulatory affairs staff, which are conducted separately and a little differently from the monitors’ audits, Borasky explains.
Monitoring plans are important particularly in cases where FHI staff believe there is a lot at stake ethically for a trial and when there would be a lot of potential downside if something went wrong, Borasky says.
Borasky makes additional oversight trips that are conducted by the IRB. "We do want to make sure we’re staying on top of that site for whatever reason," he says.
• Gain trust of foreign collaborators and request misconduct reports: "If your collaboration is really with the institution and not simply the investigator then you’re likely to have more support in working through and dealing with any alleged misconduct," Borasky says.
"Whereas, if your whole relationship is really with one investigator and you don’t have a good understanding of the institution and its inner workings, then you have your work cut out for you because you have only one point of access to it."
FHI stresses collaboration, and even the organization’s IRB office works to improve that, Borasky says.
"One of our new goals is for every new study, once approvals are in place, we contact the local IRB and let them know that if we’re aware of any problems, we’ll inform them," Borasky explains. "And, hopefully, if they have any issues they think FHI should be aware of they’ll notify us."
U.S. research administrators and IRBs should be sensitive to the reality that many IRBs in host countries may experience pressure to approve studies, and some of this pressure can come from the United States side, he notes.
"So we give the IRBs an opportunity to let us know if they have any concerns," Borasky says.
Fortunately for IRBs and research institutions, misconduct and ethical lapses on the scale of what happened in South Korea are very rare, Borasky says.
"Most researchers and sponsors of research want to do a good job, and, by and large, people are putting in appropriate time to find proper sites and to make sure they are capable of doing a study before they get going," Borasky says.
The recent headlines and controversy over the resignation of a South Korean investigator who admitted to ethical lapses and fraudulent data have raised concerns among IRBs and others in the research industry.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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