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What is required from an IRB standpoint before restarting face-to-face research activities?

Last updated: 7.1.2020

As part of the departmental chair, center director, or dean approval process, researchers may be asked to provide their study protocol or other IRB-related materials for their review. The purpose of this is so that the individuals reviewing the restart request can ensure that the research study complies with campus requirements for reopening. This will also allow them to make any necessary determinations about prioritizing studies for restart.

Screening and testing activities meant to prevent the spread of COVID-19 are public safety activities and must be followed. As such, these are not considered study specific research activities and DO NOT need to be reviewed by the IRB.

However, in some circumstances, changes to IRB application materials may ultimately be required prior to restarting face-to-face research activities. Changes may be needed to address scientific or subject population concerns related to COVID-19. For example, a study was previously approved by the IRB to enroll subjects age 65 and older for a set of exercise tests. Because older adults are at higher risk for severe illness from COVID-19, the study team plans to change the frequency and types of exercise tests being conducted in the research study in order to limit subjects’ exposure to viral droplets.

In this case, the study team would need to submit a change of protocol to the IRB in order to change the study-specific activities.

The IRB is available as a resource for researchers to help address questions about whether changes are needed to specific research studies prior to restarting face-to-face visits. The IRB can advise on what changes could be made to address concerns about subject population, study design, or other related issues. Please contact the Health Sciences IRBs Office with questions.

Keywords:COVID, coronavirus   Doc ID:102571
Owner:Monica E.Group:Health Sciences IRBs
Created:2020-05-28 06:27 CDTUpdated:2020-07-01 12:09 CDT
Sites:Health Sciences IRBs
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