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February 13, 2017   Columns Articles | Inside UGA | Human Subjects Office paves way for clinical research
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Human Subjects Office staff, from left, Brooke Harwell, Angela Bain, Kim Fowler and Mysti Scheuer assist researchers working on improving human health. Photo by Dorothy Kozlowski

Human Subjects Office paves way for clinical research

James Hataway

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By James Hataway | February 13, 2017
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As UGA continues to invest in research focused on improving human health, the Human Subjects Office is working to become more effective at protecting subjects while also boosting efficiency.

Housed in the university's Office of Research, the HSO performs professional and administrative functions in support of the Institutional Review Board, the faculty-led research oversight committee charged with ensuring that research involving human subjects is conducted in compliance with federal, state and institutional policies and procedures.

"UGA's research portfolio is poised to expand rapidly in the area of clinical and translational research," said Christopher King, associate vice president for research and director of the Office of Research Compliance. "Our researchers have excelled at basic biomedical research, but there is a real need, both locally and nationally, to translate these basic discoveries into improved health for people.

"The collaborative relationships we are developing with the Augusta University/UGA Medical Partnership, and Piedmont Athens Regional and Saint Mary's hospitals, as well as local medical practices, will increase UGA's capacity to conduct research that addresses pressing health issues," King said.

With these new partnerships in mind, the HSO recently began a quality improvement review to strengthen the university's Human Research Protection Program.

"We want to do everything we can to ensure that our human subjects are protected while also avoiding bottlenecks in the administrative process," said Kimberly Fowler, interim director of the HSO.

Process improvements and investigator education and training are major thrusts of quality improvement, she explained.

In years past, it was customary for all research proposals involving human subjects to receive the same review even when not required by regulation. Now, following the implementation of new risk-based policies and procedures, the HSO will evaluate each proposal on a case-by-case basis, only involving the IRB when required by regulation.

"For example, there were 843 submissions to the Human Subjects Office between Jan. 1 and Oct. 31 of 2016. All of these were reviewed by the Human Subjects Office, but only 184 proposals required IRB review," Fowler said.

Not only does this new review process help speed the approval of new proposals, but it also allows the IRB to focus resources on the growing number of clinical research projects. In the last three years, the number of clinical studies increased nearly 160 percent, from 27 studies in 2014 to 70 studies in 2016.

The IRB also has grown from 15 members to 51, with several new board members specializing in clinical research. This increase in the number of board members also has allowed the IRB to review applications more frequently, holding two meetings per month rather than just one.

Those meetings are split between two major working groups, a social and behavioral board and a clinical board.

Fowler and other HSO staff also hold workshops with faculty, staff and students to help them better understand the human subjects policies and procedures, and they encourage members of the university to reach out if they would like HSO staff to visit a lab or classroom.

These improvements to HSO procedures are part of an effort to achieve accreditation from the Association for the Accreditation of Human Research Protection Programs, an independent nonprofit organization that evaluates research organizations to ensure that their HRPPs meet standards for quality and protection.

"The protection of human subjects is paramount, and we are working toward this accreditation to ensure that we put in place a review process that is as efficient as it is rigorous," Fowler said.

For more information about the HSO or to speak with someone in the office, visit research.uga.edu/hso.

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