Associate Professor of Education Jin Li filed a complaint in federal court late last month against the University in response to a Brown Institutional Review Board decision that blocked her from publishing three years worth of data from her study on the education and socialization of Chinese immigrant children.
Li declined to comment on the pending suit and the terms of the study on the advice of her lawyers, she said. The lawyers, Kathleen Hagerty and Thomas Dickinson, did not respond to requests for comment.
Vice President and General Counsel Beverly Ledbetter also declined to comment because the University has not officially been served with the lawsuit.
The complaint, filed Feb. 25 in the federal court for the district of Rhode Island, specifically points to the 45 Code of Federal Regulations section 46, "protection of human subjects," to justify Li's belief that her study should never have been subjected to IRB review because it involves no federal employees or funds and "poses no threat to any human subject."
The University's IRB office states on its website, "All ‘research' involving human participants must be reviewed and approved by the Institutional Review Board … to protect the rights and welfare of the human participants."
When implementing the code referenced in the lawsuit, the University also "explicitly requires research involving minors to have full Board Review," Regina White, associate vice president for research, wrote in an email to The Herald.
The IRB office was unable to comment on details relating specifically to the case, according to Mark Nickel, director of University communications.
According to Li's website, her longitudinal study followed three groups, each consisting of 100 children and their mothers. Study participants were divided into middle-class European Americans, middle-class Chinese immigrants and lower-class Chinese immigrants.
The project was funded by $833,756 in external grants from the Foundation for Child Development and the Spencer Foundation.
According to the complaint, the IRB approved Li's initial plans — which included a series of educational tests, surveys and interviews — to compensate each family $600 for three years of participation in the study. After beginning the investigation, Li discovered that "lower income families were consuming considerably more time" than middle- or upper-class participants.
Li altered the system of compensation to award the families in the lower-class group $600 while other subjects received a lowered sum of $300. As cited in the complaint, all participants were made aware of and agreed to this change through a consent form.
Jamison Kinnane '12, who was involved in the European-American portion of the study, said Li never discussed the financial details of the project with her. By the time she joined the project in fall 2009, the financial modifications had already been implemented.
The study began Nov. 1, 2007, and was slated for completion by Oct. 31, 2011. In February 2010, Li presented the IRB with the requested modifications to the study.
The IRB refused to grant the changes and informed Li she could not include data from the families who were paid $300 "unless arrangements were made to make additional payments to those families to bring their total to $600," according to the complaint.
Once a human research protocol has been approved, "the principal investigator is responsible for complying with the protocol exactly as approved by the IRB," White wrote.
Any changes to the study must be "specifically approved" by the IRB before they are implemented, she wrote. Detailed instructions for modifications to protocols are available on the IRB website.
This decision rendered Li "unable to use substantial portions of the data" because her current funding situation prevents retroactive payments to other subjects, according to the complaint.
Li estimates the damages of lost time and data to be worth upwards of $200,000 and "demands judgment in an amount sufficient to compensate her for her economic loss," according to the complaint.
Li's complaint alleges that she was denied "any opportunity" for an internal review of the IRB decision.
Currently, there is no formal internal review process, but investigators are able to appeal a decision to the vice president for research, White wrote.
"While in accordance with federal regulation, no University official may overturn a decision of the IRB," she wrote. The vice president for research "may facilitate a discussion between the board and the investigator with a goal of reaching a satisfactory resolution."
The complaint asserts that Li made multiple unsuccessful attempts to resolve the matter with the IRB.
