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Greenville Hospital System, Spartanburg Regional are the first to go live with HSSC's statewide internet clinical research tool

COLUMBIA, S.C., July 10, 2008 – Before any research study involving human subjects can begin, an Institutional Review Board (IRB), an oversight committee composed of physicians, scientists and community members, must carefully review it for ethical standards and regulatory compliance. Traditionally done with paper documents, the review process is cumbersome, time consuming and resource-intensive—attributes that don’t support the light-speed pace required of medical research today.

South Carolina’s clinical research enterprise recently took a giant leap forward thanks to Health Sciences South Carolina (HSSC). The research collaborative made up of the state’s public research universities and four largest health systems is leading an initiative to unify and automate members’ IRB processes with a powerful, Internet-based solution. Known as eIRB, it enables the electronic submission and review of human subject research studies. Not only does it streamline studies conducted by individual institutions, eIRB supports collaborative, multi-site studies among HSSC members, a major advantage. In February, Greenville Hospital System University Medical Center (GHS) and Spartanburg Regional Healthcare System became the first HSSC members to go live with eIRB to support their active clinical research enterprises. At any one time, GHS has 600 clinical trials, while Spartanburg Regional has as many as 400.

The statewide rollout of eIRB continues when HSSC members Palmetto Health and the University of South Carolina become fully operational in August. The Medical University of South Carolina will follow.

HSSC President and CEO Jay Moskowitz says the implementation of eIRB is a critical element of a statewide information technology (IT) infrastructure that will enable South Carolina to become a world leader in biomedical research, and in the process, transform the state’s economy, improve public health and enhance the safety and quality of clinical trials. “Biomedical research is a highly competitive field, both for funding and brainpower. With eIRB, HSSC and its members are now on par with an elite group of research institutions, a group that includes Johns Hopkins University, Duke University and the University of Pittsburgh.”

Moskowitz continued, “eIRB is a powerful enabler that will help accelerate the review process, eliminate inefficiency and protect the safety of participants. It also will make South Carolina more competitive as we pursue research funding from sources like the National Institutes of Health and National Science Foundation as well as from pharmaceutical and medical device companies.”

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Randy Shelley, director of Research Technology at the University of South Carolina, has led a statewide team of IT specialists from HSSC member organizations to develop a uniform IRB process to facilitate greater research collaboration in South Carolina. “In the past, the universities and medical systems each had their own IRB process. While researchers and review boards from different institutions could work together, the lack of uniformity slowed everything down. With all HSSC members using the same process with some additional institution-specific features, no question is asked two different ways. We’re on the same page and can work far more efficiently,” he says.

HSSC’s eIRB process relies on software from Click Commerce, a leading provider of automated research administration and compliance systems. It allows HSSC members to capture the entire regulatory process, monitor and support the flow of information between researchers and the Institutional Review Boards, prevent loss of documents, provide 24/7 access to protocol information, and deliver a complete electronic document.

Spartanburg Regional is currently using eIRB for new clinical research trials applications to its Institutional Review Board. Leesa Judd, RN, is the clinical systems analyst for IRB and Clinical Research at Spartanburg Regional. She says the move to electronic applications is making life easier for everyone. “The old way involved making up large packets of information for everyone, which used a tremendous amount of paper and time. The new electronic format is easier to review and cuts time and paper use,” Judd says.

By mid July, all three Greenville Hospital System IRBs will be live on the eIRB system for new study submissions, says Jean Winter, CIP, institutional review board coordinator, Greenville Hospital System. “The logistics of the review process have been redesigned. In the past, we relied on snail mail, interoffice mail, couriers, and fax to get the applications to our Institutional Review Board. With eIRB, that’s a thing of the past. The applications are online and ready to review at any time,” she says.

Don’t underestimate the “green effect” of HSSC’s new eIRB process. According to data from Wake Forest University Health Sciences, which has instituted eIRB, the process saves substantial amounts of time, money and resources. Using eIRB in their healthcare system alone has resulted in significant annual savings in printing costs, 5.7 tons of paper, and 15 work weeks spent copying and distributing the required paperwork.

About Health Sciences South Carolina
Established in April 2004, Health Sciences South Carolina (HSSC) is a statewide public-private collaborative of universities and health systems possessing the shared vision of using health sciences research to improve the health and economic wellbeing of South Carolina. HSSC includes Clemson University, the Medical University of South Carolina, the University of South Carolina, Greenville Hospital System University Medical Center, Palmetto Health, and Spartanburg Regional Healthcare System. For more information, visit www.healthsciencessc.org.

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