IU's research under review

IU is in the midst of a large scale review of research involving human subjects. The review, formerly limited to the IU-South Bend campus, has now expanded to campuses in Gary, Kokomo, Richmond and New Albany, and it could reach the IU-Bloomington campus once records are checked.\nThe review was launched as a result of an improperly planned experiment at the IUSB campus. \nThe study in question was conducted by an adjunct professor. The professor, without proper approval from the campus's Institutional Review Board, was drawing blood samples from volunteers. The professor indicated he wasn't aware he needed approval to conduct the research, which led to a University investigation.\nAnn Gellis, associate dean of research compliance at IU-Bloomington, said the review is being conducted internally, although the University has made the Federal Office of Human Research Protection aware of the situation.\n"We became aware that a researcher was taking blood samples from volunteers without proper approval," Gellis said. "We looked into it further, and he indicated that he had been told he didn't need approval. That led us to look closer at the Institutional Review Board at South Bend. We looked at their minutes and protocols, and we found many violations of the federal regulations on how to institute a study."\nThe investigation will look at Institutional Review Board minutes and procedures at the South Bend campus, IU-Northwest in Gary, IU-East in Richmond and IU-Southeast in New Albany. It is possible that IUB and IU-Purdue University at Indianapolis will come under investigation. If a campus is found not to be in compliance, the University and federal government can suspend all research involving human subjects. \nJerald Wilde, chair of IUE's Committee for Research and Grants, said that while his campus is under review, he doubts there will be any problems.\n"We're approaching this with extreme caution and with many controls throughout the IUE campus," Wilde said. "Dr. Walter Wagor and Karen Clark, co-chairs of the IUE IRB, are meticulous in the way they approach human subjects. There won't be problems at IUE. With our IRB, it would be impossible."\nMichael McRobbie, IU's vice president for research, told The Chronicle of Higher Education he expects the review to be completed by Dec. 1.\nIU spokesperson Bill Stephan said the incident in South Bend serves as an opportunity for the University to make sure it's in compliance with federal regulations.\n"There will be, over the course of the next month, a process by which IUB, IRB and others will look at how policies are being handled at regional campuses," Stephan said. "We're trying to be proactive in this matter. It's a way of making sure all campuses are in compliance with federal restrictions (regarding human subjects)."\n-- Contact staff writer Kehla West at krwest@indiana.edu.