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Regents committee hears systemwide overview of research compliance, rising regulatory burdens

University of Minnesota Board of Regents Audit and Compliance Committee · May 9, 2025
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Summary

University of Minnesota audit committee heard presenters describe research‑integrity offices, IRB/IACUC/IBC roles, PI and unit responsibilities, growing federal requirements and how the university is preparing for AI and research‑security challenges.

The University of Minnesota Board of Regents’ Audit and Compliance Committee heard an overview of the system’s research compliance administration on May 2025 from the offices responsible for research integrity and compliance.

Joanne Billings, Associate Vice President for Research Integrity and Compliance, and Danielle Uuntala, Director of Research Integrity and Compliance, told the committee the system’s compliance work spans policy, training, auditing, monitoring and enforcement and involves multiple standing committees such as the Institutional Review Board (IRB), Institutional Animal Care and Use Committee (IACUC) and Institutional Biosafety Committee (IBC).

The presenters said those units handle protocol review, approvals, inspections and education; they highlighted partnerships with Health, Safety & Risk Management, General Counsel, Internal Audit and the health information privacy compliance office for HIPAA-related ancillary reviews. “We work with many partners to uphold the high standards of safety in our research environments,” Uuntala said.

Why this matters: committee members pressed presenters for a concrete example to understand how oversight works in practice. Billings described a typical clinical trial workflow: investigators develop a budget and nondisclosure agreements with industry sponsors, sponsor project administration handles contract and award terms, IRB review covers human‑subjects protections and HIPAA issues, and specialized units such as radiation safety or the IBC review protocol elements as needed. Those reviews must be completed—and often require continuing review—before participant recruitment begins.

Presenters emphasized that principal investigators are ultimately responsible for day‑to‑day compliance. “A lot of that responsibility then falls on the PI and the PI’s team to make sure that they’re complying with all of the requirements that were laid out by the IRB,” one presenter said, adding that deans and department chairs provide oversight at the unit level and grant administrators support award management.

Committee members and presenters also discussed the pace of federal change. Uuntala said the federal research‑policy landscape has expanded rapidly over recent years—“we have gone from one federal research requirement to roughly 270 in 2024,” she said—and that many new rules since 2014 have increased training burdens, data‑security obligations and conflict‑of‑interest scrutiny. Presenters said the office seeks to keep training meaningful while minimizing redundant administrative burden.

Regents asked how the university stays agile on evolving issues such as artificial intelligence and research security. The presenters said they coordinate with peer institutions (Big Ten partners), professional associations and campus groups; they cited a recent University of Minnesota conference on the ethics of AI and said draft policies on AI use and authorship for research are in progress. “We want to be kind of following each other,” Uuntala said of national peer collaboration.

The presentation closed with committee members thanking the presenters and noting that compliance functions, while resource intensive, also protect the institution from the larger costs of noncompliance.

What’s next: the committee received the briefing for information and did not take formal action. Presenters and regents indicated continuing engagement on AI policy development, institutional conflict‑of‑interest reviews and communication strategies to explain compliance processes to the public.