Are protocol and consent form changes required by the IRB for all studies prior to restarting face-to-face interactions?
Last updated: 5.28.2020
No, changes are not required by the IRB for all studies prior to restarting. The risk of acquiring COVID-19 is not specifically a research risk, but rather a risk of everyday life, unfortunately. Therefore, at this time, it is not necessary for all studies involving in-person interactions to add risks related to COVID to their study materials or the consent document.
Study teams must provide subjects with information about what to expect during their face to face interaction, including screening, physical distancing, and measurements in place to minimize risks associated with the spread of COVID-19. These protection measures are required by the institution in order to safely conduct face-to-face visits. They are not considered research specific activities and as such, do not need to be submitted to the IRB for review. Several campus groups are working on templates and other resources and we will provide links to these when they’re available.