A key initiative of the School of Medicine Research Roadmap is to improve the university’s research infrastructure and reduce barriers to research.
During the Roadmap’s development, Task Forces #2 (Strategic Initiative #2: Advance the School of Medicine capacity in translational research) and #3 (Strategic Initiative #3: Promote research excellence through effective organizational systems and infrastructure) identified slow study start-up as a barrier to advancing research at OHSU.
The Roadmap provided funding for an initial evaluation, the first part of an overall IRB (Institutional Review Board*) improvement project.
The three goals of the IRB project are:
- Improve turnaround time from submission to approval
- Ensure consistent, high-quality reviews that meet regulatory requirements
- Reduce administrative burden for research community
Several initiatives in four main areas were undertaken:
- Implementing comprehensive, standardized policies and procedures
- Improving IRB office and board workflow and efficiency
- Redesigning approach for collecting study information from investigators
- Reducing investigator requirements
The IRB adopted a toolkit developed by a national IRB expert, Jeff Cooper, MD, to help standardize the policies, procedures and review tools used by the IRB. The toolkit features a systematic approach to IRB review using checklists and worksheets to achieve consistency across reviews based on the criteria required for review and approval.
The new review process was implemented for expedited reviews on Nov. 1. Full board reviews using the new review process will be implemented by early next year.
In addition, the IRB implemented a number of changes that will make IRB submissions easier for investigators:
- Extended the continuing review requirement for exempt studies from one year to three years
- Eliminated IRB review of several documents
- Replaced the Lay Language Summary with a shorter Brief Project Description and provided a better template for simple studies
- Will also be eliminating about half of the IRQ questions that are redundant or non-essential
In the first quarter of FY14, the IRB improved its new study approval time by 21 percent despite increases in the number of study reviews from last year.
“This has been a great project to work on, and I definitely view it as an ongoing initiative,” said Kathryn Schuff, M.D., MCR, IRB chair and professor of medicine. “The Research Roadmap provided the resources for a major jumpstart to what we plan as a continuous approach of evaluation and improvement of IRB processes and our service to the research community. We’ve taken the first step towards improving IRB approval time, set that as an ongoing goal, and I am committed to also making the IRB submission process easier for researchers at the same time.”
There will also be a new electronic IRB system that will be created specifically to support the use of the toolkit. The development and design process for IRB 7 will begin early next year.
*What does the IRB do? An institutional review board (IRB), also known as an independent ethics committee (IEC), is a committee that approves, monitors and reviews biomedical and behavioral research that involves humans. The IRB is charged with protecting the rights and welfare of the research subjects. The IRB may approve, require modifications in (to secure approval) or disapprove research.
Pictured: (top) Kathryn Schuff, M.D., MCR, IRB chair; (bottom) Dr. Schuff describes the IRB improvement process at the December IRB Chair’s Forum.