The University is making major strides to tighten its regulation of research involving human subjects and animals.
Both professors and student researchers will be held to strict guidelines and must complete a mandatory training program offered by the National Institute of Health’s Web site, according to Institutional Review Board (IRB) Chair Susan Vines.
The Provost’s Office has also created the Office of Research Compliance (ORC) to help oversee such efforts. In addition to creating a comprehensive Web site that lists current federal guidelines for research, the ORC is working on a handbook that outlines exactly which type of research requires IRB approval.
The major changes were prompted by a controversial incident last year in which a psychology professor’s research on familial alcoholism was suspended after a student complained. It was later found that the professor hadn’t had proper approval to conduct such research and the IRB was unaware it had been going on.
“Considering the events that happened last year .I think the word has gotten around we’re going to take this seriously,” said Vines. “I think the University community is pretty cognizant about how important it is to comply to the guidelines.”
New federal regulations require the University to get a federal wide assurance, or a stamp of approval, on all its research. Without such approval, federal authorities may restrict external funds used by the University.
The University currently receives approximately $30 million in external funding, according to Christina Booth, the new coordinator of research compliance for the ORC. Of the $30 million, around $20 million goes to the Muskie School of Public Service.
Officials hope to keep that money safe.
“Federal regulations say if the University doesn’t have a federal wide assurance, the time will come when they can cut external funding,” said Margo Wood, associate provost for Graduate Studies and Research.
Establishing an ORC is a necessary part of getting a federal wide assurance, according to Wood.
“We’re doing what we’re doing because it’s required and because it’s the right thing to do,” said Provost Joe Wood.
Margo Wood couldn’t say how much the University has spent to form the ORC and the staff required to run it. She said staff salaries and related costs haven’t been set yet.
“We were just trying to get things done as quickly as possible,” she said. “The whole thing is being done as economically as possible, but it has to be done regardless.”
Vines said she’s expecting the ORC to be very busy this semester, estimating that around 40 new projects will need approval.
Booth said she hopes the new guidelines won’t impose a major burden to faculty and other researchers.
“Hopefully it won’t cause major changes because we have to assume that most of the projects were already in compliance,” she said. “There’s going to be some more intensive and substantial review. It’ll take more time, but hopefully it won’t be too arduous for anybody.”
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