Institutional Review Board (IRB) Efficiency Project showing early success with increased investigator satisfaction in the IRB experience

By Natasha Kassulke, natasha.kassulke@wisc.edu

The Institutional Review Boards Office’s (IRB) Efficiency Project is largely completed, and the IRB has already realized success from its efforts. These successes include reporting that the median time from application submission to review by IRB staff has been cut in half (from 22 days to 10 days) and median time to IRB approval has decreased from 80 days to 45 days.

The IRB reviews all human subject research protocols in accordance with applicable federal regulations, state laws, and local and university policies.

The IRB Efficiency Project (IEP) was launched by the Office of the Vice Chancellor for Research and Graduate Education in partnership with Huron Consulting Services to reduce administrative burden for PIs by improving efficiency of the IRB review process, while simultaneously supporting the IRBs primary role of ensuring compliance with federal regulations, explains Lisa Wilson, interim IRB director.

“Nearly every aspect of the Human Research Protection Program has undergone changes, including adopting new review materials and processes, to align with project aims,” Wilson says.

“The goals of the IEP are aligned with UW’s 2020-2025 Strategic Framework, particularly with the Strategic Priorities of Excellence in Research and Scholarship and Living the Wisconsin Idea, in that they will contribute to improving and modernizing the UW human subjects research infrastructure,” explains Steve Ackerman, vice chancellor for research and graduate education. “These aims are also consistent with UW’s strong commitment to the protection of human subjects through regulatory compliance and the application of best practices for the review of human subjects research.”

“I’m grateful to our IRB leadership and staff for its work on this important project,” Ackerman adds. “We also have had great input and involvement from faculty and staff from across campus throughout the project. We started our efforts in this area nearly five years ago and have been building from important feedback we received early on from faculty about ways to improve their IRB experience.”

The IEP was a response to faculty-based surveys, reports and an assessment by Huron Consulting that indicated dissatisfaction, perceived burden, long review timelines (compared with peer institutions) and inefficient workflows in the IRB process and committee structure on campus.  Importantly, the assessments identified specific opportunities for efficiency improvements.

Key changes addressed in the IEP included elimination of IRB fees as soon as possible to significantly reduce burden and unifying the two campus IRB offices – Educational & Social/Behavioral Science IRB and Health Sciences IRBs – into a single IRB office. The unification created one administrative structure for HRPP-related business processes and accountability under the direction of the IRB Director, supported by Assistant Directors, Casey Pellien (Minimal Risk Research team) and Catherine Rogers (Health Science team).

“Central to the project’s success was creation of seven working groups tasked with implementation of unique components of the project, leveraging the experience of our staff and other campus stakeholders. We recognized that some practices were vital to our future success and engaging the members of the working group as well as those on the faculty advisory working group, allowed us to implement the required changes, while retaining the excellent parts of our service model,” explains Lynn Haynes, director of Office of Research Compliance. “Our entire leadership team, including the UW project manager Carol Pech, and IRB leadership Gretchen Anding, along with Casey and Catherine were especially instrumental in the IEP, supporting the faculty advisory working group and leading many of the smaller working groups.”

“I’m proud of the IRB staff,” says Catherine Rogers, IRB assistant director. “The IEP occurred during a period of massive transition across the board – changes in the administrative home for the office to the Office of the Vice Chancellor for Research and Graduate Education, staffing and leadership changes, and we were in the middle of a pandemic. But everyone rose to the occasion to review materials, add to the discussions and serve on committees in addition to onboarding new IRB members and completing our daily work assignments. We also have developed real camaraderie on the smaller panels that were created and could not have been as successful without the IRB member participation and passion for the project.”

Another key component of the IEP, according to Haynes, was customizing and adopting Huron’s HRPP Toolkit, a set of standard operating procedures for the IRB, to meet or exceed currently recognized IRB, HRPP, and Association for Accreditation of Human Research Protection Programs, Inc. (AAHRPP) standards, along with changes to the Application Review for Research Oversight at Wisconsin (ARROW) application to support the execution of these changes to business processes. ARROW is the online system for submission and review of IRB applications used by all IRBs at UW–Madison.

Development of a new protocol-based application option (for studies with a stand-alone protocol) in ARROW significantly shortened the application and eliminated duplication so researchers no longer need to provide the same information in the application that is found in their stand-alone protocols.

Haynes credits Travis Doran, associate director of the HRPP, with helping the office also unify about 36 policies into three primary policies and managing the online toolkit as well as a completely overhauled submission for AAHRPP re-accreditation that occurred in 2022.

“Adopting the HRPP Toolkit allowed us to remove duplicative regulatory content from our campus policies and focus our policy language on the minimal institutional requirements that exist apart from the regulations,” Doran says. “This reduction in policy content alongside the public-facing nature of the Toolkit materials contribute to the increased transparency of IRB and HRPP processes which was an important goal of the IEP.”

An important component of the project was to create a new website to house information for all UW–Madison IRBs. The website, designed by Monica Esquibel,, the Minimal Risk Research team manager, in collaboration with OVCRGE IT, is now complete and is home to the toolkit and Investigator Manual, designed to guide researchers through policies and procedures related to the conduct of Human Research that are specific to this institution. The manual is comprehensive and covers everything from who can serve as PI and the IRB review process, to investigator responsibilities post-approval. Other new sections to the manual address data and safety monitoring plans, and a section related to tribal research.

The Reliance and Navigation Team (RELIANT), also was created to support investigators engaged in multi-site and collaborative human research and assisting research navigating institutional requirements for human research that lie outside the IRB approval process.

“The IEP was a team effort,” says Casey Pellien, IRB assistant director.  “Years after launching the project, we are seeing its success and new improvements continue to come from the project. I’m proud of everyone involved in the project and look forward to what we will do together to continue to support progress in human subjects research areas and further build investigator and public trust in and support for our research enterprise at UW–Madison.”