Many program improvements are in progress including implementation of the HRPP Toolkit and the Ethical Oversight Submission System (ETHOS), an electronic IRB submission system. The metrics provided below will be used to measure and report progress toward our goals of enhancing the HRPP program and improving the IRB experience for researchers.
As of January 2017, the IRB has 9,171 active studies in its records. The number of active studies by type are provided below:
While the number of active studies in IRB records is a helpful measure, it does not account for the multiple submissions often associated with a single active IRB study. Total IRB submission volumes is another useful metric, as it accounts for all categories of submissions associated with a study and enables HRPP staff to evaluate and track the IRB’s total workload on a continual basis. IRB submissions can be divided into the following categories:
- New Studies
- Modifications to an Existing Study
- Continuing Review
- Minor Modifications (Add/Change Personnel)
- Reportable New Information
Note: Average monthly submission volume figures include only the original submission of an item to the IRB. These figures do not include investigator responses to stipulations, responses to deferral, or responses to pre-review clarifications requested. The IRB typically receives an additional 200-300 of these investigator responses each month.
Submissions to the IRB are reviewed via “Committee Review” or “Non-Committee Review”. These IRB review methods are further described below:
- Full Committee Review: Greater than minimal risk study. Review is conducted by the full board at a convened IRB meeting.
- Exempt Review: Meets categories of exemption from IRB review. Review is conducted by experienced HRPP staff.
- Expedited Review: Not greater than minimal risk study. Review is conducted by at least one IRB committee member.
HRPP is adopting a number of new and enhanced approaches to the review of human research. Key milestones and activities of the “IRB Renew Project” are illustrated in the graphic below. For more detailed information about the HRPP’s initiatives, read the Research Community Newsletter.
Full migration to the new online submission system, ETHOS, will be completed in fall 2018. While we anticipate steady improvement in IRB turnaround times, we do not expect to realize the full benefit of these changes until after full migration to ETHOS. Please note that it is not unusual for institutions to experience slightly increased turnaround times at the start of implementation when all users are adapting to the new system and processes. HRPP staff will monitor turnaround times and feedback from the research community to identify and address potential sources of delay as quickly as possible.
Using currently available data, typical IRB turnaround times under the existing system can be provided for the following:
- Median number of calendar days from submission to exempt determination
- Median number of calendar days from submission to IRB final determination for full committee and expedited (non-committee) review
Additional turnaround time information will become available over the next several months as these new initiatives go into effect.
Median IRB duration - NCATS Common Metrics Initiative
The National Center for Advancing Translational Sciences (NCATS) initiated the Common Metrics Initiative as part of their effort to accelerate and improve clinical and translational research. The NCATS Common Metrics Initiative uses a specified set of metrics as the basis for collaborative strategic management around key topic areas. One of the topic areas is median IRB duration.
HRPP has been collaborating with the University of Minnesota Clinical and Translational Science Institute (CTSI) on data collection and strategic management around median IRB duration. The chart below shows the University of Minnesota’s median IRB duration, as reported to NCATS for the Common Metrics Initiative.
Key assumptions for the NCATS median IRB duration metric are listed below:
- Includes only studies reviewed by the convened IRB (“full committee review”). Studies reviewed via non-committee review procedures (expedited review or exempt) are not included.
- Includes only new study submissions. Amendments and renewal submissions are not included.
- Includes biomedical and social behavioral protocols. Student social protocols are not included.
- Includes only studies that received IRB final approval during the calendar year noted.
- Median IRB duration is calculated as the median number of calendar days from the date a complete application is received in the IRB office to the date IRB final approval is granted. For studies that were placed on a review hold due to missing or incomplete information, the hold lift date is considered the date a complete application is received in the IRB office.
IRB reliance agreements refer to the use of an IRB external to the University of Minnesota to conduct the regulatory review and oversight of a study. HRPP is responsible for negotiating and coordinating the execution of IRB reliance agreements. The figures below provide an overview of recent reliance agreement activity and the current scope of University research ceded to an external IRB.