In consultation with Dr. Kevin Black, interim dean of the College of Medicine, we are updating the scope of the Revised Standards for in-person human subjects research. Effective October 1, the Revised Standards are applicable to ALL studies with an in-person research component.
Previously, human subjects research considered potentially therapeutic (drug or device studies) were exempt from the Revised Standards. Moving forward, all study personnel with in-person contact with research participants must be fully vaccinated OR the study must be reviewed by the COVID Safety Committee. In addition, studies previously approved through InfoReady will also need to resubmit if study team members with in-person interaction are not fully vaccinated.
Studies that previously did not require review have until October 15 to submit to the COVID Safety Committee. Studies will be reviewed by their college, followed by the University COVID Safety Committee. Studies that did not originally require review or were previously approved may continue while they are under review. It is important to note that this review is separate from the IRB review and focuses solely on conducting research as safely as possible during the pandemic.
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