UI auditors find Human Subjects Office application review process lacks efficiency

The Office of Internal Audit at the University of Iowa has determined ways for the Human Subjects Office and its review committees to make research application review processes more efficient.


Roman Slabach

The Old Capital from the roof of UIHC in Iowa City, Iowa on March 25, 2019.

Kelsey Harrell, News Reporter

CEDAR FALLS — The Office of Internal Audit at the University of Iowa reported to the state Board of Regents at their meeting in Cedar Falls on Wednesday that the Institution’s Human Subjects Office, Institutional Review Board, and other Review Committees processes could be conducted more efficiently.

The Human Subjects Office, the review board, and committees reflect on research applications to consider safety, informed consent, resource utilization, alignment with institutional strategy, and risk management. This process takes a median of 77 days to complete at the UI, and the national median is 45 days.

Reducing the amount of time it takes for a research proposal to be approved would allow for better efficiency and for UI Health Care to better compete for clinical trials and industrial research with other institutions, according to regent documents.

The audit report recommends that the UI create working groups to decide what initiatives will be pursued, implement restructuring where it is needed, eliminate the current need to submit applications through multiple systems, and add prioritization for certain applications.

Patrice Sayre, regent chief audit executive, said management at the UI said it plans to complete the action plan for reconstructing the committees by December 2020.

Currently, research applications at the UI go through multiple boards and committees before they are approved because it often involves human subjects, said Sayre.

“This audit essentially is about efficiencies and not about non-compliance,” Sayre said.

When the Human Subjects Office finishes its review of the application, it then recommends what level of review the Institutional Review Board should complete, she added.

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The different levels of review include exempt, expedited, or full board. An exempt or expedited review requires an individual member of the Institutional Review Board to look it over, according to the regents’ documents.

The expedited applications take six business days to review while full board review can take up to 77 business days to complete, the documents read.

The audit committee found that there are opportunities to make the review process more efficient by creating multi-disciplinary working groups, Sayre said.

The applications should be streamlined through the Hawk Institutional Review Board, to cut down on the number of incomplete forms being processed through the system, and improving the review process, she said.

The auditors also found that there was no prioritization of reviewed studies that considered those that are high cost, high risk, and high impact proposals, Sayre said. The office will look at processes in peer institutes and discuss process with stakeholders, she added.