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IRB Monitors Human Research

January 2, 2003

Heather Heilman

hheilman@tulane.edu

Ina Friedman didn't know what she was getting into when she accepted the invitation to chair the health sciences center Institutional Review Board in 1999. The IRB has the important responsibility of protecting human subjects of research at the university. That involves reviewing 300 new protocols and 800 ongoing ones every year.

Yet when Friedman took over the job, it was a part-time, unpaid position she also was working as a research coordinator at the General Clinical Research Center and seeing patients as a nurse practitioner at the time. But she soon realized that to do the job right would mean doing it full time.

Last year, Tulane President Scott Cowen created the Tulane Office of Human Research Protection and placed Friedman at its head, so that she now oversees the dissemination of policy and the tracking of protocol on both campuses. The office has a staff of five, including Richard Mirabelli, who has the newly created position of compliance educator.

His job is to make sure the research community understands the requirements of the IRB system. He's also helping to develop a new computer system, funded by a National Institutes of Health grant, which will allow board members to access the full protocol of any study under review.

"Our first and foremost responsibility is the protection of human research subjects," said Friedman. "We're also responsible to the faculty. There's a lot of competition for research money, and if we don't get things reviewed in a timely fashion we put our people at a disadvantage. So there's a fair amount of pressure here."

The health sciences center IRB meets twice a month. Some research activities that pose only minimal risklike the collection of blood from healthy subjects, for examplecan be expedited and reviewed by only one person. But anything beyond that entails detailed discussion and the approval of the full board.

"In order to review the breadth of studies we do, we have to have representatives from various fields," Friedman said.

Besides professors, the board includes nurses, study coordinators and community members without a science background. Except for Friedman and her staff, they all volunteer their time. All universities have IRBs, which are overseen by the Office of Human Research Protection within the U.S. Department of Health and Human Services. (A smaller Tulane uptown campus board, chaired by Janet Ruscher, associate professor of psychology, meets monthly and reviews social science, psychology, anthropology and social work protocols.)

According to Friedman, the board members' job is to protect the rights of each subject. In the clinical research setting, that means each subject must voluntarily consent to participate after being fully informed about the risks, benefits and purpose of the study. Extra safeguards must be in place to protect those whose autonomy is circumscribed, such as children, prisoners and the mentally ill. In addition, the privacy of all subjects must be protected.

Beyond that, the benefits of the study must be fairly distributed, so that researchers can't use a specific population for research without later making the benefits available to them. Subjects must be informed of adverse events such as unexpected symptoms or anticipated symptoms that seem unusually severe. The board reviews such events to determine whether they were related to the study and if the research should continue. Since they have to consider other sites of multi-center studies, they review more than 1,800 events a year.

"I feel very strongly that I don't want anyone to be compromised for the sake of research," Friedman said. "On the other hand, as a provider I would not want to have to take care of people with the medication we were limited to 10 years ago, or even five years ago."

The IRB rarely disapproves a project entirely. Instead, if board members have concerns about a protocol they will work with the researcher to make the necessary changes. But only the IRB can approve a study. While health sciences senior vice president Paul Whelton can disallow any study, said Friedman, he can't overrule the committee's disapproval.

Heather Heilman can be reached at hheilman@tulane.edu.

Citation information:

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