Last update: 5.28.2020
Study teams should consider replacing in-person study visits with “remote” options for questionnaires, surveys, screening, follow-up, and consenting. Please see Remote Study Activities Guidance to help plan for how recruitment, research interventions, and data collection can occur remotely. (Please see the guidance at the bottom of the HIPAA page regarding tools that can be used for remote study visits.) These changes must be approved in advance by the IRB as a change of protocol, unless they are necessary to eliminate apparent immediate hazards to participants.
- For exempt studies, a change does NOT need to be submitted to allow for remote study activities as a result of COVID-19.
- When submitting a COVID-19-related change, please note this in the submit activity form so we can prioritize these changes appropriately.
- Implementing Changes to Eliminate Immediate Hazards to Subjects Guidance can be done prior to receiving IRB approval.
- Other changes to study visits NOT intended to eliminate an apparent immediate hazard to subjects, must be by approved by the IRB before being implemented.