Last updated: 7.1.2020
Department chairs, center directors, and deans are responsible for making decisions about which studies in their department, center, and/or school can restart face-to-face visits. Because COVID-19 is not considered a risk of participating in research, but rather a risk of everyday life, the IRB does not require re-review of the risks of previously approved studies. In addition, 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 are 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 department chairs, center directors, and deans to address questions about whether changes are needed to specific research studies prior to restarting face-to-face visits. The IRB can advise on what study changes could be made to address department chairs, center directors, and dean’s concerns about subject population, study design, study location changes, or other related issues. For questions for the Health Sciences IRBs, please contact IRBDirector@hsirbs.wisc.edu.