IRB Performance & Metrics
The Quality Assurance (QA) program supports continuous quality improvement through evaluation, assessment, and action.
QA program quality improvement activities associated with the Institutional Review Board (IRB) performance are conducted in accordance with key program initiatives and Association for the Accreditation of Human Research Protection Programs (AAHRPP) standard I-5.
Standard I-5: The organization measures and improves, when necessary, compliance with organizational policies and procedures and applicable laws, regulations, codes, and guidance. The organization also measures and improves, when necessary, the quality, effectiveness, and efficiency of the Human Research Protection Program.
The University of Minnesota Human Research Protection Program (HRPP) publishes metrics related to IRB activities. These metrics are an important element of tracking and monitoring IRB performance and implementing quality improvement initiatives.
Many program improvements have been made since 2015, including implementation of the HRPP Toolkit and the Ethical Oversight Submission System (ETHOS), an electronic IRB submission system. The metrics provided below are used to measure and report progress toward our goals of enhancing the HRPP program and improving the IRB experience for researchers.
- Active Studies
- Monthly Submissions
- IRB Review
- Turnaround Time
- IRB Renew Project & Transition to ETHOS
- Median IRB Duration
- Research Community Feedback
- IRB Reliance
As of July 30, 2020, the IRB had 4,121 active [non-exempt] studies in its records, with 37-percent supported by sponsored project funding. In the 12-month period from July 1, 2019 to June 30, 2020, the IRB made 776 exempt determinations.
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 (NEW STUDY)
- Modifications to an existing study (MOD)
- Continuing review (CR)
- Minor modifications - add/change personnel (MINOR MOD)
- Reportable new information (RNI)
- Continuing Review with Modification (MOD CR)
- IRB Site for External IRB Studies (IRB SITE)
Note that average monthly submission volumes include only the original submission of an item to the IRB. These figures do not include investigator responses to modifications required, responses to deferral, or responses to pre-review clarifications requested. The IRB typically receives an additional 200–300 of these investigator responses each month.
Most submissions to the IRB are reviewed via “Committee Review” or “Non-Committee Review” procedures. A smaller percentage of submissions are reviewed via an external IRB or are determined to be “not human research”. A brief description of each review category is provided 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.
- An IRB external to the University of Minnesota conducts the regulatory review and oversight of a study.
Not Human Research Determinations
- The IRB determines activities do not meet the regulatory definition of “Human Research” under any of the following:
- U.S. Department of Health and Human Services (HHS) Regulations
- U.S. Food & Drug Administration (FDA) Regulations
HRPP adopted a number of new and enhanced approaches to the review of human research as part of the “IRB Renew Project” beginning in 2016 and lasting through 2018. Full migration to the online submission system, ETHOS, was completed in late 2018. Key milestones and activities of the IRB Renew Project are illustrated in the graphic below. The IRB continues to inform the community about key projects and initiatives. For detailed information about the HRPP’s current initiatives, read the Research Community Newsletter.
Using data available from ETHOS, the UMN HRPP has elected to publish two turnaround time (TAT) metrics, as described below:
- TAT Measure 1: Enables comparison of the UMN’s IRB performance with other institutions by reporting TATs according to national definitions established by the Association for the Accreditation of Human Research Protection Programs (“AAHRPP”) and National Center for Advancing Translational Sciences (“NCATs”).
- TAT Measure 2: Aligns with the way in which researchers experience all elements of the University of Minnesota’s local IRB review process. This includes time with other University ancillary review organizations and IRB pre-review.
TAT Measure 1 (AAHRPP/NCATs Definitions)
TAT Measure 2 (Full Process)
TAT Metrics for Exempt Determinations
The National Center for Advancing Translational Sciences (NCATS) initiated the Common Metrics Initiative as part of its 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. The ‘Median IRB Duration’ metric was established in 2016 and was ended by NCATs in early 2020.
During the four years when the ‘Median IRB Duration’ metric was active, HRPP collaborated with the University of Minnesota Clinical and Translational Science Institute (CTSI) on data collection and strategic management around the University of Minnesota’s median IRB duration. The chart below shows the University’s median IRB duration, as defined by the Common Metrics Initiative, for the time period from 2013 through 2019.
Key assumptions for the NCATS median IRB duration metric:
- Includes only studies reviewed by the convened IRB (“full committee review”); excludes studies reviewed via non-committee review procedures (expedited review or exempt);
- Includes only initial study submissions; excludes modification (MOD) and renewal (CR) submissions;
- Includes biomedical and social behavioral protocols;
- Includes only studies that received IRB final approval during the calendar year noted;
- Median IRB duration (as defined in the CTSA Program Common Metrics Operational Guideline for IRB Duration) is calculated as the median number of calendar days between the following time points:
- Receipt date (START): The receipt date is the actual date that the IRB office initially received an application for IRB review in their office or in an electronic inbox for review. For submissions to IRBs that perform triage or pre-review, the receipt date is the date the protocol is received back at the IRB office subsequent to such triage or pre-review;
- Final Approval Date (END): The final approval date is the date that the IRB determined that the protocol was approved with no IRB-related contingencies or stipulations remaining, so that, from the perspective of human subjects, the research can commence.
The Human Research Protection Program (HRPP) is committed to understanding and responding to the research community’s IRB experiences. As an accredited HRPP through the Association of Accredited Human Research Protection Programs (AAHRPP), it is the HRPP’s responsibility to continuously assess the program and identify opportunities for improvement. The following surveys collect the research community’s feedback and recommend an action plan.
Semi-Annual Research Community Survey
The semi-annual experience survey is sent to the research community every six months (in June and December) to gather more detailed feedback about the research community’s IRB experience. The survey questions focus on the quality, efficiency, and effectiveness of the IRB. IRB leaders will be able to better understand the research community’s experience and identify broad strengths and opportunities for improvement. Access the reports and IRB action plans:
- Survey Results - June 2019
- IRB Action Plan and Progress Report - June 2019
- Survey Results - December 2019
- IRB Action Plan and Progress Report - December 2019
HRPP Satisfaction Survey
This interaction-based survey asks researchers to provide feedback about their experience with the HRPP. The survey provides HRPP staff with valuable information about ways in which we can improve our performance and better serve the University research community. The information below summarizes recent feedback we have received from researchers via the survey.
Single IRB (sIRB) and external IRB are terms used to describe two forms of IRB reliance relationships. These relationships involve formal agreements between institutions, or between an institution and an independent IRB, allowing IRB regulatory review and oversight of a study by one IRB on behalf of another.
More information about IRB reliance is available: Single IRB (sIRB) and External IRB: Reliance Arrangements.
University of Minnesota Serving as sIRB
Most federally funded multi-site or cooperative research requires the designation of a single IRB (sIRB) to serve as the reviewing IRB for all participating sites. As of January 21, 2020, the UMN IRB may serve as the sIRB for federally funded cooperative or multi-site research (see “Checklist: Criteria for UMN Serving as sIRB (HRP-840).”
In Quarter 3, 2020 (July 2020 - September 2020) the IRB received 13 requests to serve as sIRB. Of those requests, 6 were accepted, 2 were declined, 4 were designated to an external IRB and 1 was withdrawn.
University of Minnesota Relying on an External IRB
Reliance on an external IRB refers to the use of an institutional review board (IRB) outside of the University of Minnesota (external IRB) to conduct the regulatory review and oversight of a study. The University has reliance arrangements in place with several IRBs and is part of a network of over 600 participating institutions that have joined SMART IRB and may use the SMART IRB Agreement to facilitate IRB reliance.
The figures below provide an overview of the current scope of University of Minnesota research relying on an external IRB and recent requests for reliance on an external IRB.