November 28, 2018
Using a systems approach and bettering communications between entities in the regulatory environment could improve Institutional Review Board (IRB) performance, according to a recent study by ACTRI researchers. This environment includes the IRB, ancillary reviews, research billing coverage analysis and clinical trial contracting offices. Published in the Journal of Clinical and Translational Science, the article by John Fontanesi, Anthony Magit, Jennifer J. Ford, Han Nguyen, and Gary S. Firestein* is highlighted as one of the top three by the journal’s new Editor-in-Chief, Dr. George A. Mashour.
“Fontanesi and colleagues investigated ways to optimize human IRB performance. Any clinical and translational researcher can attest to the importance of this process, especially with respect to efficiency,” said Dr. Mashour in an introductory Q&A as the new editor.
The ACTRI article, “Systems approach to assessing and improving local human research Institutional Review Board performance,” was published online in JCTS on August 8, 2018.
Research is the lifeblood of the UC San Diego School of Medicine, and much of this research is conducted on volunteers who must consent. The IRB was created to protect the safety and rights of the individuals volunteering. What is seldom recognized, Fontanesi noted, is that the IRB is part of a larger regulatory environment.
“At UC San Diego there are 18 potential regulatory entities ranging from environmental safety, conflict of interest and contracting, to embryonic cell use and scientific validity,” Fontanesi said. “These entities have influence on study approval and length of time it takes for approval.” While the IRB’s sole responsibility is to ensure the rights of research volunteers, it cannot release the consent form required to begin a study until all the other entities have reviewed and approved that study.
The objective of the Fontanesi et al study was to quantify how the entities within the regulatory environment governing human subject research are dependent upon one another, including IRBs, coverage analysis and contract negotiations. “Under the guidance of ACTRI director Dr. Firestein, we studied a systems engineering approach to understand and improve this ‘ecosystem,’” Fontanesi said. Systems engineering evaluates all the components of an overall process.
The ACTRI research team analyzed more than 8,000 IRB, coverage analysis and contract applications between 2013 and 2016 to improve the time needed to launch human research studies. Several factors influence timelines, including staffing ratios, funding sources and ancillary reviews, and data-driven improvements should be explored, they concluded. “Understanding and improving the interdependencies between IRB, coverage analysis and contract negotiation offices require a systems approach and might benefit from predictive analytics,” the authors said.
Fontanesi likened the regulatory environment to gardens to further explain the complexity of the approval process. “Plants in a garden grow at different rates and have different requirements; some need more water or light or careful tending to flourish. Studies are similar in that they have various approval timelines affected by the number of arms, the source of funding and the number and type of ancillary reviews--all of which change from one year to the next," he said.
[Fontanesi is a Professor Emeritus and former director of the Center for Management Science in Health; Dr. Magit is director of the UC San Diego Human Research Protections Program; Ford is the former director of the Office of Clinical Trials Administration (OCTA) and current director of the Conflict of Interest Office, Research Compliance; Nguyen is the director of the Office of Coverage Analysis Administration (OCAA); and Dr. Firestein is the director of ACTRI.]
Read the JCTS publication