South Korean research controversy raises questions about oversight
IRBs have little control over research fraud here or abroad
As the story developed in headlines from around the world it grew from questions about ethical lapses on the part of a South Korean stem cell researcher to his admission of fake data. South Korean Hwang Woo Suk’s research problems were front-page news because he was considered a pioneer in stem cell research, which is one of the more controversial areas of investigation, particularly in the United States.
While many saw this as a very rare event, another shocking report in mid-January told the story of a Norwegian cancer researcher who fabricated data in a study of anti-inflammatory drugs and their use in reducing the risk of oral cancer. The Lancet, which published the study last year, announced in January that it was based on fabricated data.
The study’s principal author was Jon Sudbo, a researcher at the Norwegian Radium Hospital in Oslo. There were five co-authors from the United States. Sudbo’s transgressions were less widely publicized, but possibly could have an even greater impact on U.S.-foreign research collaborations.
The South Korean scientist had made international headlines earlier in 2005 after announcing he created the world’s first cloned dog, and he had claimed to have invented the technology necessary for cloning human embryos. Light first was shed on Hwang’s ethical issues when American researcher Gerald P. Schatten of the University of Pittsburgh announced that he was suspending ties with Hwang and his team because of possible ethical violations in the way oocytes were collected for research. Hwang later admitted to paying women for their oocytes, although earlier he had said they were donated, and he used oocytes donated by some of his research assistants, which raised questions of subject coercion.
The issue raises some general questions about what, if anything, IRBs can do to prevent such ethical lapses, particularly when research involves international collaborations.
"Every now and then in the United States, we have problems too, but they’re maybe not as big or newsworthy," says J. Mark Waxman, JD, a partner with Foley & Lardner in Boston. Waxman is a member of the IRB Advisor editorial advisory board.
"This one happens to be particularly noteworthy because it’s in a very hot area, it seemed to be a kind of break-through effort, and it was overseas," he notes.
"Certainly the problem was exacerbated by the type of research involved," says David Borasky, CIP, an associate director in the Office of International Research Ethics at Family Health International (FHI) of Research Triangle Park, NC. "Given the sensitivity we have in the states about that kind of research, it’s no wonder it blew up."
Hwang’s national fame within South Korea might have contributed to an atmosphere that enabled him to take liberties that led to data fabrication and his resignation from Seoul National University of Seoul, South Korea.
IRBs are inclined to give the benefit of doubt to researchers who have an established track record with the IRB, Borasky says. "These are the people to whom it’s difficult to say things are not going as they should, and we need to think about doing something about it," Borasky says. "Whether working domestically or internationally, no institution wants to call regulatory officials about their own investigator because they feel they can’t get the job done themselves."
While the South Korean stem cell research debacle is an unfortunate cautionary tale for international research, it’s debatable whether it will have a far-reaching impact on IRBs and the research industry.
"Whenever these things happen it’s a black eye, not just for that investigator, but for clinical trials generally," Waxman says. "It makes people edgy about participating in trials."
And for stem cell researchers, who already are embroiled in a volatile public debate, it could move discussions about stem cell research away from science and into another realm, Waxman adds. Still, it’s possible the damage will be limited.
"I guess for those people in favor of stem cell research it doesn’t have an impact, and for those against stem cell research, it does have an impact, but I’m not sure that it has an impact beyond that," says Robert Nelson, MD, PhD, an associate professor of anesthesiology and critical care in the Department of Anesthesiology and Critical Care Medicine at the University of Pennsylvania School of Medicine and the Children’s Hospital in Philadelphia. Nelson is a member of the editorial advisory board of IRB Advisor.
While any news of research misconduct may raise questions about oversight by IRBs and research compliance offices, IRBs are limited in what they can do about such problems, Nelson says.
IRBs often have no oversight in private research involving oocytes collected for research purposes, notes Jeremy Sugarman, MD, MPH, MA, a Harvey M. Meyerhoff professor of bioethics and medicine, Phoebe R. Berman Bioethics Institute and department of medicine at Johns Hopkins University in Baltimore. Sugarman also is a member of the editorial advisory board of IRB Advisor.
"That’s one of the concerns that’s been raised domestically — that IRBs don’t have purview over all research," Sugarman says.
"The issues raised by the South Korean case in the press are different," Sugarman says. "IRBs have not traditionally paid as much attention to responsible conduct of research." Other institutional mechanisms are designed for that task, Sugarman explains.
"The IRB is not a fraud detection agency," Waxman says.
"Unless IRBs want to police the actual conduct of research, there is a limited role in what they can do," Nelson says. "The only way to ascertain fraud is to get into audits and data audits and that’s a highly intensive range of monitoring."
The four main issues raised by the South Korean research fraud are as follows, Sugarman says:
- The distinction between research ethics and responsible conduct of research or research misconduct
- International collaboration among IRBs.
- A lack of complete coverage for the role of human subjects in in-vitro fertilization and other uses of eggs.
- A lack of embryonic stem cell research oversight committees.
On issue 1, Sugarman says, "Every academic institution that receives federal funds has to have a mechanism in place to deal with scientific misconduct." Regarding issue 4, he explains, "The fourth issue is being addressed with the new National Academy of Sciences’ guidelines toward developing escrows, embryonic stem cell research oversight committees that will be charged with looking at questions of eggs themselves or where stem cells come from."
This problem is not just an IRB issue, although IRBs need to be aware of the other institutional approaches that are in place, including an institution’s approach to dealing with research misconduct, Sugarman adds.
IRBs also could refer to the detailed guidelines expressed in the National Bioethics Advisory Commission report on international research ethics,1 Sugarman says.
For example, the report’s recommendation 3.7 is as follows: "Researchers should strive to ensure that individuals agree to participate in research without coercion or undue inducements from community leaders or representatives."
IRBs and research institutions could check a foreign site’s references and try to understand the environment in which the trials will take place, Waxman suggests.
"Since the IRB isn’t there, it can’t guarantee everything but at least in the protocol design and reporting, it can look very carefully," Waxman says. "And in controversial areas where there may be issues, it can seek outside expert review."
IRBs could go so far as to seek comments from colleagues or others in the field who are knowledgeable about that environment and who could alert the IRB to any potential special problems, Waxman adds.
Reference:
- Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries. Volume I, Report and Recommendations by the National Bioethics Advisory Commission, Bethesda, MD, April 2001:1-154. Web site: http://www.georgetown.edu/research/nrcbl/nbac/clinical/Vol1.pdf.
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