May 23, 2008

Research subject protections build trust, speed studies

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Vanderbilt's Institutional Review Board includes (front row, from left) Jan Zolkower, Dena Johnson, Jeff Roe and (back row, from left) Erick Kapamas, Becca DuBose, Denise Roe and Chris Boeing. (photo by Dana Johnson)

Research subject protections build trust, speed studies

Vanderbilt University's Human Research Protection Program has received full, three-year re-accreditation with high marks.

“Something Vanderbilt should be proud of is the investment that it makes in human research protection,” said Denise Roe, director of the university's Institutional Review Board (IRB), which monitors the 3,400 studies involving human subjects under way across campus.

“It's one of the main things that build trust with the public,” added associate IRB director Julie Ozier.

Three years ago, Vanderbilt became the 13th research institution in the country to attain voluntary accreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP).

The association was established in 2001 to implement rigorous standards for studies involving human subjects, and to help ensure consistency and uniformity among institutions conducting biomedical, behavioral and social sciences research.

At about the same time, the Vanderbilt IRB, under the leadership of its medical director, Gordon Bernard, M.D., was undergoing a major overhaul and implementing other innovations to improve efficiency and communication.

During the past eight years, for example, the IRB staff has grown from three to more than 30, most of whom are research professionals.

The board has more than doubled the number of research protocols it monitors, while slashing by 80 percent the time it takes to review and approve a study.

“It was not unusual to take a year to get through the IRB,” said Bernard, who also is assistant vice chancellor for Research. “Now the turnaround time is about two months to get committee action, sometimes less than that.

“The four (IRB) committees meet every week to review the protocols so we can keep those studies approved and running,” he said. “Every study has to be reapproved at least every year, if not more frequently than that, so you have thousands and thousands of studies going through these committees. It's a massive administrative undertaking.”

Since 2006, the human research protection program at Vanderbilt also has:

• Appointed Jan Zolkower as research subject advocate to help communicate the importance of participating in research, and help resolve questions and concerns expressed by research participants;

• Posted a research subjects' “Bill of Rights” on the IRB Web site (; and

• Launched DISCOVR-E, an electronic study submission system designed by Jeff Roe, health systems information project manager, and by IRB programmers Erick Kapamas and Chris Boeing.

In addition, the IRB participated in development of an automated intelligence tool to assure accurate charging and billing of patient services in clinical trials. The tool, called “Subject Tracker,” was developed by the Department of Finance and the Informatics Center in conjunction with the Office of Grants and Contracts Management and Research Support Services in the Office of Research.

Re-accreditation “is a real tribute to this group … as the volume of research they are managing is remarkably expanded relative to the scene just a few years ago,” said Jeff Balser, M.D., Ph.D., associate vice chancellor for Research and interim dean of the School of Medicine.

“Our program remains a top 'go to' place for how to get it right.”