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IRB Overreach?

IRB Overreach?
March 18, 2011

An associate professor of education has sued Brown University for barring her from using her own data because she paid her human research subjects different amounts of money based on their economic status.

Jin Li, an associate professor of education and human development at Brown, alleges that the university’s Institutional Review Board overstepped its jurisdictional bounds, failed to have minority members on its panel and denied her due process. “Should the IRB ruling stand,” reads Li’s complaint, which was filed last month in the U.S. District Court for the District of Rhode Island, “plaintiff would be deprived of the fruits of years of research, and the education community would be deprived of the fruits of the same.”

Li is seeking $200,000 in losses due to the quashing of her four-year-old research project.

The suit raises questions about the role of IRBs in regulating privately funded research, the fairness of their process and the tensions that arise when such boards govern the work of social scientists. IRBs initially were meant to protect human subjects from being exploited when they submitted to biomedical research. But the authority of these boards in universities has widened to monitor research in the social and behavioral sciences as well as the humanities. Critics say the spread of IRBs to other disciplines, coupled with a lack of accountability and safeguards for due process, have led them to become unduly empowered, overly cautious and poor facsimiles of the peer-review process -- all of which has stifled research.

The suit is also not the first time that faculty members at Brown have found fault with the way IRBs are run there. Past disputes have centered on whether social sciences were adequately treated by the IRB, and whether such panels should oversee research done by undergraduates.

According to Li’s complaint, she raised more than $830,000 from two private foundations -- $670,186 from the Spencer Foundation and $163,570 from the Foundation for Child Development -- for her research project, “European American and Chinese Immigrant Children's Learning Beliefs and Related Socialization at Home.”

Over the course of three years, Li interviewed the parents of Chinese-American children and made use of educational testing. It’s not clear from the complaint whether she tested the children herself or drew upon existing assessments (one of Li’s lawyers, Kathleen M. Hagerty, said that no one from the plaintiff’s side would comment publicly on the case as long as it’s active; Brown has also declined to comment). Her longitudinal analysis was meant to document the learning beliefs and socialization of a total of 300 white and Chinese American children of low, middle and upper-middle class backgrounds -- and to explore how these factors influence their learning and achievement.

Brown’s IRB approved payments of $600 to each family participating in the research, the complaint says. But, during the course of the investigation, Li says that she found that the lower-income families were spending far more time completing surveys and interviews than the middle or upper-middle income families. She decided that it would be fairer to pay the lower-income families $600 for three years and the upper- and middle-income ones $300 because this differential more accurately reflected the time they put into the investigation. All families signed consent forms reflecting the amount they would be paid, she says in the complaint.

Li later submitted to Brown a budget for her project, which reflected the different payment levels. It was approved, she says in the suit, though it’s not clear from the complaint whether it was the IRB or some other body within the institution that did so..

In February, she presented a request to the IRB to approve her efforts to modify parts of her investigation, including the pay differential. “The IRB denied that request and advised plaintiff that she may not use any of the data collected from the families that were paid $300 unless arrangements were made to make additional payments to those families to bring their total to $600,” Li alleges in her complaint. There was not enough money for her to do so, she says. “Plaintiff made numerous efforts to resolve this matter within the IRB, but to no avail.”

Li charges that the IRB overstepped its bounds by making her submit to its rule even though the money for her project came from private sources, not the federal government. She also notes in her complaint that her research involves educational testing, surveys and interviews and “poses no threat to any human subject.” While one clause of the federal guidelines that govern research involving human subjects says that IRBs must rule on any such research that is conducted or supported by a federal department or agency, it also seems to extend the reach of IRBs to any private research or funding entity, as long as it is doing research that is “designed to develop or contribute to generalizable knowledge.” Brown’s standards explain that all research conducted on human subjects must be cleared through its IRB, regardless of funding source.

Li also alleges that Brown’s IRB has no minority members and therefore fails to meet diversity guidelines set out under federal regulations. Those regulations call for an IRB that has members who are sufficiently qualified in experience and expertise, and to include consideration of race, gender, cultural backgrounds and sensitivity to community attitudes. Brown has one IRB composed of 11 regular voting members who have expertise in life, social and medical sciences. It can also bring in people who are equipped to consult on the cultural context of research. It wasn't immediately clear which racial and ethnic groups the members of Brown's IRB represent.

But it is Li's claim that she lacked an avenue through which she could appeal the IRB's decision that is most troubling -- and indicative of wider problems with IRBs, said Zachary M. Schrag, an associate professor of history at George Mason University, who has written a book, blogged (where he helped bring Li's case to light) and spoken out on the problems, as he sees them, with IRBs.

“If you want people to think the process is fair you have to give them a chance to appeal a decision,” said Schrag.

Even though an IRB does have a role to play in determining whether human subjects are paid appropriately, Schrag said, it's not clear that the punishment -- scuttling Li's research -- suited the alleged breach. “In this particular case, was the violation so great that it justifies what I take to be a pretty draconian action by the IRB?” he asked. “One can imagine sending a warning letter.”

 

 

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