From De Minimis to Gold Standard

Case Study: Lehigh Valley Health Network Accredited Since 2009

The Situation
Lehigh Valley Health Network routinely oversees approximately 400 research protocols. Most involve Phase 3 clinical trials designed to provide patients with treatment alternatives for chronic or life-threatening conditions. Back when Lehigh Valley Health Network began looking at accreditation, the organization had a single institutional review board (IRB) and was in compliance with federal regulations, but “was operating at a relatively de minimis level,” says Scott Lipkin, DPM, Chief, Network Office of Research and Innovation.

The Challenge
To meet AAHRPP’s accreditation standards, Lehigh Valley Health Network had to create a comprehensive, integrated human research protection program (HRPP). As part of that effort, the organization was required to develop policies and procedures, establish training programs, and professionalize and strengthen the IRB.

The Solution
Lehigh Valley Health Network reorganized and revamped its research protection efforts, including:

• Changing the reporting structure for the IRB to establish it as an independent committee.
• Adding a second IRB to ensure that research protocols receive the necessary, thorough review.
• Creating scientific review committees to ensure departmental review before research is submitted to the IRB.
• Developing an education program.
• Establishing a quality improvement/quality assurance program.
• Creating a community outreach program.
• Integrating the work of the IRB with other departments, including pharmacy, materials management, and legal services.
• Strengthening conflict-of-interest reporting requirements and integrating them with corporate compliance efforts. 
• Hiring additional staff.

In essence, Lehigh Valley Health Network built an HRPP that emphasized that the responsibility for research protections is borne not just by the IRB but by the entire organization. Change of that magnitude would not have been possible, Lipkin says, without “an unyielding financial and political commitment from the institutional official and the rest of the senior leadership team.”

The Results
Lehigh Valley Health Network’s efforts were officially recognized March 27, 2009, when the organization was awarded AAHRPP accreditation. That distinction boosted Lehigh Valley Health Network’s standing with researchers, with regulators, and among its peers. Accreditation also acknowledged that “we were doing a better job,” Lipkin says. “We didn’t just strengthen protections; we created a comprehensive, sustainable HRPP to ensure enhanced protections for the long term.”

A greater emphasis on education helped IRB chairs, members, and staff gain a better understanding of the federal regulations. That, in turn, bolstered confidence and increased the IRB’s willingness to take advantage of the flexibility in the regulations―to lessen the regulatory burden while providing equivalent protections.

The bottom line, according to Lipkin, is that Lehigh Valley Health Network transformed its research operation for the good of patients, researchers, and the organization as a whole. “We were a big success story,” he says. “In 2 ½ years, we went from functioning at a low level to achieving the gold standard of accreditation.”