UI researchers take precautions with study subjects amid COVID-19 concerns

The University of Iowa Human Subjects Office and Institutional Review Boards have recommended guidelines to researchers to ensure their safety and the safety of their subjects.

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Brooklyn Draisey, Managing Editor

While the University of Iowa has not yet restricted research activities, the UI Human Subjects Office and Institutional Review Board put out guidelines to ensure researchers and vulnerable participants remain healthy amid growing numbers of coronavirus cases in Iowa.

There are currently 14 COVID-19 cases in Johnson County, one of which is being treated at UI Hospitals and Clinics. The UI has suspended in-person classes starting after spring break until at least April 3.

According to an email from the office, principal investigators should make the health and safety of project personnel, collaborators, and human subjects a priority, and take special precautions when working with vulnerable populations such as people over age 70 or those with underlying health conditions.

“… Any research team that has not yet begun research activities should ensure that doing so will not jeopardize members of the research team or participants,” the email said. “In addition, should the COVID-19 landscape change significantly, there may come a point when research activities — including research with human subjects — will be restricted and application reviews might be paused in the interest of individual and public health.”

It was recommended in the email that researchers should establish contingency plans for if researchers have to do their work remotely, such as identifying research priorities, managing data, arranging for remote access to files, and communicating with team members and participants who need close monitoring. Investigators should also prepare for a situation where their data collection has to halt.

For Biomedical and Social Behavioral Studies research, investigators should ensure staff is healthy and no one at study sites has tested positive for the virus and consider asking participants about their travel history and whether they are dealing with flu-like systems. They should also avoid bringing large groups of people together for things such as data gathering.

UI research often includes subjects at UIHC, which is requiring that anyone who has recently traveled internationally or has respiratory symptoms must be screened, and are discouraged from entering the building. The email recommended that researchers try to decrease in-person visits by using telecommunication or visiting subjects at home. Subjects could receive blood tests at remote locations and have investigation materials mailed to them.

If participants have shortness of breath or fever, they should not visit, the email stated, and instead set up a video visit.

Investigators will be able to amend protocols if necessary, but must submit an amendment to the Human Subjects Office and the IRB.

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