U to scrutinize human research subjects review boards

Dan Haugen

Following complaints from some faculty members, the University will review how it administers a federally mandated program to protect human research subjects.

Members of the Faculty Consultative Committee raised concerns about the University’s Institutional Review Board process in a January 2002 meeting.

Sociology professor Candace Kruttschnitt told the committee the review boards – which must approve all research projects involving human subjects – appeared to be taking an excessively long time to complete reviews.

She also claimed turnover in board membership made expectations for research proposals moving targets.

“When I brought it up, there were enough people saying ‘yeah’ that it became an issue,” Kruttschnitt said. “We need to make the process quick, reasonable and more transparent.”

This month, the Office of the Vice President for Research and the Faculty Senate will be surveying University researchers on their experiences with those panels.

The goal is to measure the type and frequency of faculty members’ concerns, said David Hamilton, interim vice president for research.

“If the survey comes out saying that there are a lot of problems, then we clearly are going to have to focus on those problems,” Hamilton said.

Some of the complaints raised last year have been addressed, Hamilton said. For example, the University, which previously had four panels for medical research and one for the social sciences, in March added a new panel in dealing exclusively with social science student research.

The panel is expected to speed the process for student researchers attempting to complete projects by the end of the semester.

“The people in the (Institutional Review Board) office are extraordinarily competent people,” Hamilton said. “Once (the problems) were clearly articulated, they understood.”

Institutional review boards are mandated by the federal government’s National Research Act of 1974. Prior to that, a growing base of subject-abuse stories raised public awareness of the need for oversight.

The law requires that a panel of at least five members approve any research involving human subjects. It applies to research funded by the U.S. Department of Health and Human Services or carried out on products regulated by the Food and Drug Administration.

Individual institutions must establish the panels, which have to include at least one member with primarily scientific interests and one with primarily nonscientific interests.

Some review board issues are not unique to the University.

A 1998 report by the U.S. Department of Health and Human Services inspector general found that “Across the country (institutional review boards) are inundated with research plans and are under enormous pressure to review them quickly. At the same time, many are finding it difficult to recruit and maintain members.”

University panel members are unpaid volunteers who work nearly 10 hours per month preparing for and attending meetings. Assistant Vice President for Regulatory Affairs Dick Bianco said recruiting volunteers is a never-ending task.

“It’s a huge time commitment. It’s a lot of work, and you don’t really get any academic credit for it at this stage,” he said. “It’s really hard for me to ask an assistant professor to do this because they need to concentrate on their career and getting tenure.”

Hamilton said he does not have the answer – nor do any of his colleagues he has spoken with at other universities.

“We’re in the early stages of trying to figure it out,” Hamilton said. “There’s such diversity among the panelists in terms of where they come from that to put in place an incentive that is recognized as an incentive by everyone is just about impossible.”

The University received a $250,000 National Institutes of Health grant in the fall to improve its review-board infrastructure. More of the approval process will be done electronically.

“We are working very hard to enhance our service to the research community,” said Moira Keane, director of the University’s Research Subjects’ Protection Programs, which facilitate the review boards.

Jeff Ratliff-Crain, a social sciences professor at the University’s Morris campus, also raised concerns at the January 2002 meeting. Now, he said, there has been a significant improvement in the review process.

“It’s been an astounding change,” Ratliff-Crain said.

He said response times have gone from approximately two weeks to approximately two days.

“Turnaround times have improved,” Keane said. “It has been a longstanding goal to be as responsive as we can.”

Keane said the review board support staff grew last year as a result of decisions made before the concerns were raised in the faculty meeting.

Ratliff-Crain serves on the new social science student research panel. After one meeting, he said he is optimistic about the panel’s potential, but that it is too soon to say for sure how it will fare in the long term.

Kruttschnitt said she is happy with the effort some administrators are making and is reserving some judgment until she sees the survey results.

“I think Hamilton is doing a spectacular job by sending out a survey and really quantifying the whole question,” she said. “That’s really important.”

A survey expert is currently reviewing the survey to see that the questions are phrased correctly. After that, Hamilton said, the survey would likely be e-mailed to faculty within a couple of weeks.

Dan Haugen covers research and technology
and welcomes comments at [email protected]