It’s about balance. As interim assistant vice president for research and graduate studies overseeing the Office of Regulatory Affairs, J. R. Haywood looks for ways to balance the regulatory burden on researchers with the need to assure the safety of human subjects of research. Early this year MSU took a major step toward addressing that challenge. After long consideration and consultations on campus and off, VP Gray, MSU’s institutional official for human subjects protection, agreed that MSU should “uncheck the box.”
The box is item 4(b) in MSU’s federal wide assurance, which is the mechanism by which the university assures that it complies with federal regulations governing human subjects research. Checking the box for item 4(b), however, is optional. Checking it says MSU agrees to apply those regulations to all research, regardless of funding source, and even if the research receives no internal or external funding. “Unchecking the box allows us some flexibility in the way we apply the policies and procedures,” Haywood says. “It does not in any way reduce the protection we give human subjects.”
The University of Michigan has also unchecked the box and is conducting two demonstration projects to study the results of the change. MSU has joined those projects, says Judy McMillan, director for MSU’s human subjects protection program (HRPP).
One demonstration project explores the effects of approving human subject protocols for two years. Projects supported with federal funds can be approved for only one year at a time, McMillan notes. “Many other projects have minimal risk to human subjects and are not funded or are funded by non-federal funds,” she adds. If they are determined to meet the criteria for the demonstration project, they would not be required to have annual reviews by the institutional review board (IRB).
The other demonstration project evaluates the addition of a new category that allows a project to qualify for exempt status. Called Exemption Category #7, it allows projects that are limited to analysis of identifiable data to be classified as exempt and thus not required to obtain annual IRB review of the protocol.
"Changing the requirement for re-approval to every two years instead of every year in these cases eases the regulatory burden,” Haywood says. “Since these are projects where human subjects incur minimal or no risk, the changes have no impact on the safety of the subjects.”
MSU’s HRPP staff are reviewing policies and procedures to incorporate these changes. They are also planning educational outreach activities for explaining the details of the changes to campus researchers. “Meanwhile, we hope investigators will contact us with their questions,” McMillan says.