Retrospective chart review research, which analyzes existing patient data, is an important way to get early-stage research off the ground, but the application process can be daunting for investigators.
“Chart review studies provide an essential way for residents and junior investigators, who generally have limited time and budgets for research, to get their foot in the door doing research,” said Amy Gelfand, MD, an assistant professor at UCSF and a pediatric neurologist at the UCSF Benioff Children’s Hospital. “However, junior researchers may avoid conducting chart-review research because of a challenging application process.”
Although chart-review studies qualify for expedited Committee on Human Research (CHR) review, Gelfand notes that the process of completing a 20-page form and waiting a median time of 32 days for approval can be burdensome. The CHR is UCSF's Institutional Review Board (IRB), a committee that reviews research involving human subjects to ensure ethical and equitable treatment of those subjects.
With the goal of streamlining this process, and supported by a pilot award from UCSF’s Clinical and Translational Science Institute (CTSI), Gelfand convened a multidisciplinary team to conduct a rigorous evaluation of the CHR application and approval pathway.
Amy Gelfand, MD
Aided by collaborators that included John Heldens, director of UCSF’s Human Research Protection Program (HRPP), the research team has significantly improved and shortened the application process, saving applicants valuable time.
“A revised application form helped to reduce time to approval from nearly a month to about six days, a major difference that could significantly change how much a resident could accomplish in a one month research elective,” said Gelfand.
The team also halved the number of back-and-forth rounds necessary between the researcher and the CHR staff before approval could be granted. “Not only does this reduce frustration for researchers, but it frees up the CHR staff so that they can focus on, and potentially expedite, other types of study applications at UCSF,” she said.
Streamlining the Application
The piloted CHR application form uses branching technology to determine which questions the investigator needs to answer, replacing the “free form” response format and guiding users to submit relevant data and responses.
“The new form also has a ‘Retrospective Record Review/Biospecimen Analysis’ pathway, allowing investigators conducting those kinds of studies to answer fewer questions than previously required,” said Melanie Mace, MA, a member of the CHR clinical staff and the research team.
“It was a great team, with a great approach – we solicited detailed feedback on the form with representatives from various UCSF schools and departments such as the School of Medicine, and departments of Pediatrics, Pharmacy, Surgery – to make it clear and as foolproof as possible before testing,” said Gelfand.
Gelfand’s original proposal for the CTSI pilot award, “Expedited CHR submission and approval for Chart Review Research (Category 5)” and resulting new form was pilot tested through a “shadow” online system by 20 users who needed to apply for CHR approval. Nineteen of the 20 participants completed the study.
The same number of users was tested through the traditional iMedRIS system during the same time period. The results demonstrated that the new CHR form saved pilot users a significant amount of time at various phases compared to the comparison group.
The form is now ready to be integrated into UCSF’s iMedRIS system for general use and the research team believes other institutions can follow the example of this pilot study and shorten their approval times.
UCSF's CTSI is a member of the Clinical and Translational Science Awards network funded through the National Center for Advancing Translational Sciences (grant Number UL1 TR000004) at the National Institutes of Health. Under the banner of "Accelerating Research to Improve Health," CTSI provides a wide range of resources and services for researchers, and promotes online collaboration and networking tools such as UCSF Profiles.