HRP consolidates offices to improve efficiency
Centralization also supports business areas
The process to bolster the human research protections program at Lehigh Valley Health Network began in 2006 when researcher and IRB chair Scott Lipkin began taking stock of the program and considering how to make it more efficient.
Lehigh Valley Health Network (LVHN) is a large academic community hospital with about 350 open protocols — a "typical large organization with a small research program," says Lipkin, DPM, CIP, chief of the LVHN Network Office of Research and Innovation. The clinical research program was not operating as a centralized, cohesive unit — there were 13 asynchronous research offices whose only common link was use of the IRB. "From the perspective of hiring, firing, opening and closing protocols, that was all done with a varying degree of accountability," Lipkin says. "As part of our evaluation, due to the size of our overall research program, what made sense for us was to centralize the program into one office."
With 13 separate research offices with their own processes, Lipkin and colleagues looked to create an infrastructure to improve efficiency, increase compliance, lessen administrative burden, and decrease turnaround times.
"Via centralization, we can not only support study design, but conduct the research and analyze the data. We can also create and deliver educational curricula with varying levels of complexity," Lipkin says.
After shoring up the program with accreditation from the Association for the Accreditation of Human Research Protection Programs (AAHRPP) in 2009, Lipkin and LVHN colleagues began to plan the centralization of the research office in earnest. After taking a year to create the policies and procedures, the Network Office of Research Innovation (NORI) came to life in 2011. NORI now consists of these offices:
• Office of Research Administration, which handles the business aspects of research, including research grants, negotiating contracts, and analyzing insurance and Medicare coverage for trials. To increase compliance with federal regulations, the office has also developed its own processes for billing and coding, and for ensuring time and effort reporting. The office also conducts coverage analysis for clinical trials and knows which studies are being done for standard of care, clinical analysis, etc.
• Office of Research Clinical Operations, which centralizes all research nurses and coordinators.
• Office of Research Education, Integrity, and Monitoring, which houses research design and medical editors, and produces core education curricula.
• Research Participant Protections Office, which oversees the human research protection program and provides administrative support to the IRB committees.
"From a political perspective, centralization was wildly unpopular," Lipkin says. "Two years later, the research community has learned to appreciate the virtues of the services and resources provided by the NORI office. Some of the ways that helped with acceptance of centralization were open channels of communication, transparency, and continuous quality improvement."
The NORI office developed processes to increase compliance with federal regulations, including creating standardized processes for billing and coding. The office has also established processes to ensure accuracy of time and effort reporting.
With the restructuring, "we’ve been able to increase the quality of research, and been very successful in lessening research compliance risk and enhancing the quality of human subject protections," Lipkin says. "Part of that was learning to do more with less. We’ve been able to provide significantly more research services to our Health Network utilizing a smaller number of full-time employees."
NORI takes on some of the administrative burden previously left to the IRB. Protocols go through departmental scientific review for resource attestation. Conflicts of interest related to research are reviewed and managed prior to IRB submission, the management plan is forwarded to the IRB as part of the research submission, and the IRB has final say with regard to the applicability of the plan. Once it passes departmental review, protocols are sent to the NORI directors for a feasibility assessment. This step looks at the significance of the research protocol, resource requirements, physical needs, enrollment potential, financial implications, vetting of principal investigators, and other issues. For example, when the IRB receives the protocol, it will know whether an investigator has the patient population to support the study, whether there are any competing studies, and if there is enough available funding to complete a study.
"With the centralization of research, we’ve been able to enhance the effectiveness of the IRB by allowing them to focus on research within the context of the regulatory criteria for research approval," Lipkin says. "Centralization of research services at LVHN has allowed us to support the IRB in their capacity as the ethics review committee while the research office is responsible for oversight of various institutional issues that once fell within the purview of the IRB. As a result, the quality of review and subsequent determinations by the IRB has improved significantly. From the IRB perspective, this has all been validated through successful FDA audit this year."
The office provides oversight for the newly created research compliance committee. The committee is responsible for review and management of all research related compliance issues. For example, the committee reviews allegations of noncompliance and sends its findings and management plans to the IRB. "The committee is empowered to make determinations and provide management plans to the IRB for their final blessing. This way, the IRB doesn’t get caught up with the politics of noncompliance," Lipkin says.
Taking much of the administrative legwork off of the IRB allows the members to focus more on protocols and less on other issues. "IRB members really focus on meeting regulatory requirements, and we’ve taken mission creep out of the IRB to allow them to function as an ethics committee. It makes their life so much easier — there’s much less guesswork." Lipkin says turnaround time for new protocols is usually three days from submission to feasibility review, and the IRB meets every other week.