How to submit a modification because of the COVID-19 impact.
For studies that were reviewed by the Convened IRB or received an Expedited review and wish to move to no face-to-face interactions with participants:
Submit a modification to the IRB. Instructions on how to submit a modification may be found here - ESTR Support - Submit a Modification
Send a comment with the text “COVID-19 modification" to the IRB Administrator that will be assigned to your submission. Instructions on how to leave a comment may be found here - ESTR Support - Communicating With Staff Be sure to select “IRB Coordinator” before you send!
Studies which offer direct therapeutic benefit to participants or those studies where stopping procedures would cause harm to the study subject:
For health and safety, these changes can be instituted immediately; please submit a Report of New Information (RNI) to the IRB to report the temporary modifications within five business days.
For studies that received a not human subjects or exempt determination:
These studies may implement changes to prevent face-to-face contact immediately and do not need to submit a modification to the IRB if the change would not change the not human subjects or exempt determination. For example, if you change your study from face-to-face to phone or electronic data collection, a modification is not required. However, if you are changing your study population from adults to children, this would require a modification to the IRB.
If you must submit a modification, also send a comment with the text “COVID-19 modification" to the IRB Administrator that will be assigned to your submission. Instructions on how to leave a comment may be found here - ESTR Support - Communicating with Staff Be sure to select “IRB Coordinator” before you send!