Campus Human Subjects Policy Gets Changes
With university and federal attention being focused more on Institutional Review Boards ‚ the panels that approve research involving humans ‚ Duke is in the process of making its IRB policy for the campus more streamlined and easier for faculty to follow.
The Academic Council on Sept. 28 approved new guidelines for human subjects policy for non-medical schools and departments. (Medical regulations governing use of human subjects are handled by policies specific to the medical center.)
Linda George, professor of sociology and chair of the campus IRB, said the changes are meant to remove a quirk in current campus human subjects policy: Duke's policy is both more and less stringent than current federal rules. That's because Duke has one set of policies for federally funded research and a second for research funded from other sources.
"These changes are intended to remove any differences so that there is only one set of rules governing all human subjects research," George said.
The new policy accepts federal standards for human subjects research for all research projects. It ensures all research will face the same review procedure regardless of funding source.The differences aren't dramatic, George said, because the Office of Research Support, the administrative arm of the campus IRB, has been for several years enforcing the federal standard on all research without any noticeable negative effect.
The changes show particular sensitivity to research in two areas, George said: research conducted on university employees by their supervisors, and research conducted by faculty members on their students. Projects of these sort will get significant review, George said, although most internal classroom data collection, such as traditional class evaluation forms, will be outside of the review. Even if the classroom data are used in a wider research project, in most cases the project will get an quick, expedited review.
"The bottom line is that with these changes, no review will be more complex or longer than it is currently, and many projects will be reviewed more quickly," George said.
The Duke campus IRB initiated the review of Duke policies and proposed removing unnecessary restrictions, said Lorna Hicks of the Office of Research Support.
Gray areas will occur, and at the council meeting, Clare Tufts of the department of Romance studies asked for clarification of a departmental study of student attitudes about language learning.
Her questions highlighted the fact that one thing being retained from the old policy is the belief that student participation in research must be voluntary. Faculty supervision of such projects raises issues of coercion, but George said there are simple ways of addressing the concern.
"There's no reason why we wouldn't approve projects such as these," George said. "But it does involve the potential for coercion, and it's our responsibility to look out in these situations. ... We don't make the rules, but we can not put the university at risk for losing government research funding because we don't follow them."
Duke is sensitive to this issue in part because the federal government shut down many research projects at the medical center for several days in 1999 over questions the government had about the IRB process. Officials say the campus has to be just as vigilant on the issue.
George said the IRB committee and ORS are working with campus faculty members to ensure they are aware of their responsibilities on human subjects research, even in fields where it's been less of a consideration in the past.
"The extent to which faculty members are aware of the conditions under which they must seek IRB approval or exemption varies widely across departments," George said. "Psychology and sociology are non-problematic in that regard - these issues have been a part of their 'professional culture' for a long time. Interestingly, Fuqua is also very sophisticated and compliant with these issues.
"I do think it is fair to say, however, that all departments are better informed than they were a year ago. Lorna and I have spent a great deal of time visiting departments and performing other educational activities to inform the campus of this issue."