Education

Audit recommends University of Iowa speed up its review of human-subjects research

'There is currently no prioritization of studies'

The University of Iowa Hospitals and Clinics Holden Comprehensive Cancer Center is the state's only National Cancer Inst
The University of Iowa Hospitals and Clinics Holden Comprehensive Cancer Center is the state’s only National Cancer Institute-designated comprehensive cancer center. A recent internal audit recommends speeding up the review of new drugs or treatments involving human test subjects. (The Gazette)

IOWA CITY — University of Iowa applications for human-subject research that warrant a full board review take a median 77 days to consider — compared to a national median of 45 — possibly hindering the campus’ ability to compete for funding and slowing its pursuit of potentially lifesaving or life-changing advancements.

A November internal audit of the UI Human Subjects Office, Institutional Review Board and other committees revealed unnecessary duplication, lack of resources and inefficiencies.

Those revelations earned the audit a “high” impact flag from auditors — meaning, among other things, the shortcomings could have serious effects, amount to “unacceptable weaknesses” or produce substantial savings if corrected.

“There is currently no prioritization of studies reviewed by the (Institutional Review Board), resulting in the increased risk that high-dollar, high-impact and high-risk research proposals are not being timely processed,” according to the audit, which the Board of Regents recently received.

The Institutional Review Board, said UI spokeswoman Jeneane Beck, is committed to protecting the rights and welfare of human research subjects and thus was glad the routine audit’s findings related to administrative processes “rather than the quality of work being done to protect human subjects.”

“The audit’s findings do not reflect on the quality of the work done to protect the health and welfare of human subjects involved in research on campus,” Beck said. “No one is at risk as a result of these activities.”

Beck said none of the findings suggest non-compliance with federal and state regulations or UI policies. Throughout the report, she said, UI management spelled out plans to address auditor concerns by bolstering committee supports, re-evaluating current processes and reviewing peer practices.

THE SAME QUEUE

The Human Subjects Office will survey Big Ten academic groups and the Council on Governmental Relations to identify “prioritization practices among peer institutions,” according to a management response to findings that its review board processes unfunded study applications alongside high-impact, high-dollar or high-risk applications.

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In 2018, according to the audit, 60 to 65 percent of new studies reviewed were unfunded — sharing the same queue as those involving “investigational drugs or protocols for patients with untreatable conditions, who may be occupying a hospital bed.”

Other high-impact studies sharing the queue with unfunded projects included clinical trials with competitive terms and timelines; high-dollar funded research; or academic-related proposals involving students with time restrictions.

“Studies are currently indiscriminately reviewed in the order that they are received to maintain the (review board’s) objectivity,” according to the audit. “If studies were to be prioritized, the decision/policy to do so should come from college administration … so that unbiased consideration from these groups is maintained.”

CANCER CENTER REVIEWS

Auditors looked specifically at trial proposals from the UI Holden Comprehensive Cancer Center, which are subject to additional scrutiny — via more reviews and committees. That, according to the audit, adds “a significant number of days” in the lead-up to a clinical trial.

“As a result of this additional review, (cancer center) trials currently take between four and six months to review,” according to the audit. “If (the cancer center) can decrease the amount of time it takes to review trials, it may be able to compete for more clinical trials, including early phase trials, which are often more complicated and more lucrative.”

Managers, according to the audit, committed to evaluate strategies to streamline reviews for relevant cancer center trials — with a target response date of July.

The UI, in its response to the auditor suggestion it consider a research proposal’s financial viability earlier in the review process, reported efforts are underway to “improve budgeting and budget negotiations for clinical research.”

WORKLOADS INCREASED

When assessing the workflow of Iowa’s Investigational Drug Services committee and Pharmacy and Therapeutic Resources committee, auditors found workloads have soared in recent years, “while the number of resources dedicated to this group has remained the same.”

The Investigational Drug Services and Pharmacy group primarily ensures drug sourcing, preparation and dispensing protocols are complete, according to the audit, which found submitted protocols and paperwork often are lacking and require follow-up.

The group also is responsible for preparing 20 to 40 research medications a day, meeting with sponsors and monitors, auditing research protocols and managing drug inventories.

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The Pharmacy and Therapeutic Resources committee — which, among other things, reviews proposals involving new and ancillary medicines to ensure research subjects are properly warned of side effects — has just one member.

That person works 12 hours a week, “while the annual number of expedited modifications requiring review has increased from 101 to 160 from 2014 to 2018.”

The jump has propelled a rise in the “median time to review for modifications from three days in 2014 to 25.5 days in 2018,” according to the audit.

“This suggests that P & T committee review is the greatest bottleneck in the expedited modification form review process.”

Auditors recommended increasing resources for the committees to match the workload.

GRANTS, RESEARCH FUNDING

The UI annually generates hundreds of millions in external funding for research — only some of which involves human subjects.

Grants and other funding supporting UI research and scholarship in the last full year from July 1, 2018, to June 30, 2019 reached an all-time high. Research funding alone during that period rose $32.4 million, or 7 percent, to $467 million.

The UI Holden Comprehensive Cancer Center is Iowa’s only National Cancer Institute-designated comprehensive cancer center — a recognition of the role the center, its investigators and other health care professionals play in advancing cancer research.

Areas of the cancer center’s research include genes and pathways, experimental therapeutics and cancer epidemiology and population science.

Comments: (319) 339-3158; vanessa.miller@thegazette.com

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