Investigators are being surveyed to provide feedback about their perceptions of the regulatory process for research at the UI. The Institutional Review Board, the body that oversees all research involving human subjects conducted or sponsored by the UI, recently e-mailed 1,595 principal investigators and co-investigators asking them to participate.
On the Web: Illinois white paper “Improving the System for Protecting Human Subjects”
The survey of UI investigators not only will analyze and help improve research administration at Illinois, it also will be used to examine how IRBs in general function and to help other institutions improve their practices.
"There's almost no empirical information about IRBs out there," said C.K. (Tina) Gunsalus, special counsel in the Office of University Counsel and chair of the Center for Advanced Study Project Steering Committee that proposed conducting the survey in the Illinois white paper "Improving the System for Protecting Human Subjects: Counteracting IRB 'Mission Creep.' "
"We don't even know basic information such as how many IRBs exist, much less sophisticated information about how and whether they actually assist in their goal of assuring an ethical environment for research with human subjects and ethical protections for them," Gunsalus said. "We know that this system came into effect with very good intentions, and that it's been running for decades, but there are some problems with it."
Citing numerous recent studies, the committee wrote that the research self-regulation system nationwide is jeopardized by a massive workload that surpasses its regulatory capabilities, a situation that the committee called mission creep.
And much of that burdensome workload - which is overwhelming IRBs, delaying studies and alienating scholars - is bureaucratic overhead generated by exaggerated efforts to protect against program shutdowns and lawsuits, the committee wrote.
"As a consequence, mission creep is causing IRBs to lose the respect and 'buy-in' of the very people they are meant to regulate; they are misdirecting their energies, threatening both academic and First Amendment freedoms; and, most importantly, mission creep is taking needed resources from the most risky research, which truly does need IRB oversight," the committee wrote.
The committee proposed gathering "examples of good practices and examples of poor practices," to establish a clearinghouse, and sharing that information with other institutions that want to reduce bureaucratic overhead and improve procedures while maintaining their compliance with ethical and regulatory mandates.
The survey of UI investigators was based upon the Survey of Investigator Experiences in Human Research that was conducted at the University of Michigan in 2007 with 858 investigators.
The key findings of the Michigan survey indicated that while investigators supported the concept of ethical/regulatory oversight of research, they reported difficulty gaining prompt approval of applications, difficulty preparing consent documents and applications that met every IRB standard, and overly stringent interpretations of regulations and policies by the IRB that added little to the protection of human subjects.
"Vice Chancellor for Research Ravi Iyer requested that all units on campus conduct a customer satisfaction surey to determine how our units are doing in terms of day-to-day interactions and service to investigators," said Sue Keehn, director of the IRB. "At about the same time, the CAS requested that Iyer consider surveying investigators using the Michigan survey. We decided to modify the Michigan survey to meet both objectives rather than conduct two separate surveys."
The Illinois survey went live last week and will be available online through August, Keehn said, Invitations to participate were e-mailed to every investigator and the next two co-investigators on every application that the IRB received since 2007.
"It's important that we get a large response and that people provide comments where possible," Keehn said. "Any information that we can get from investigators that will help us streamline our process will be extremely valuable to us. If we can improve service, that's what we really want to do."
Results of the Illinois survey should be available sometime this fall.