IRB Requirements and Guidance for COVID-19 Impacted Studies

Please refer to VPR Announcement for current University wide restrictions for ALL Human Subject Research regardless of reviewing IRB.

What will the UVA IRB require for my study?

The following information is ONLY applicable for studies regulated by a UVA IRB. If your study is regulated by a non-UVA IRB you should consult directly with that IRB for their requirements.

The federal research regulations require that the IRB review modifications to a study before they are implemented; there is one important exception, “where necessary to eliminate apparent immediate hazards to the human subjects.” 45 CFR 46.108(3)(iii) and 21 CFR 56.108(a)(4).

Should you determine that such changes in your procedures are required, you may implement them immediately, without prior notice to or approval from the IRB. Implementing protocol changes without prior IRB approval must be limited to changes directly related to eliminating an immediate hazard.

Changes that can be implemented without prior notice or approval:

  • Replacing in-person visits with telephone calls.
  • Replacing in-person visits that do not require HIPAA oversight with UVA Zoom Conferencing.  You are advised to turn off the Cloud Recording feature.
  • Replacing in-person visits that do require HIPAA oversight with a HIPAA compliant Zoom Conferencing if already available in your department.

Note: Programs such as Zoom and FaceTime are not HIPAA compliant and therefore not allowed for research involving health information. Account requests for HIPAA compliant Zoom Conferencing may be sent to Telemedicine@virginia.edu. Please be aware that at this time new accounts are only being prioritized for clinical patient care.

Notifying the IRB about changes identified above:

For All Studies:

  • No notification to the IRB or IRB approval for the above changes is needed at this time.
  • For Full Board studies ONLY: If the change in procedures will continue past May 15, 2020, the study team will be required to submit a modification to the IRB.

Researchers must submit a modification for approval prior to implementing any additional changes.

Other Notifications:

  • It is the responsibility of the PI to make appropriate notifications to sponsors and/or federal agencies.

Until further notice, the UVA IRBs will implement the following:

  • CITI training renewals will not be required at the time of continuation reviews.
  • Pausing any study due to COVID-19 will require the PI to document in study files which procedures were paused. If applicable, this information should also be shared with the IRB at the time at the next continuation review. Study teams are not required to notify the IRB at this time.

The UVA IRBs request the following until further notice:

  • For any urgent matters, please contact the appropriate IRB staff member by email.
  • For urgent email requests to the IRB-HSR include COVID-19 in the subject line and send to IRBHSR@virginia.edu.
  • For urgent email requests to the IRB-SBS include COVID-19 in the subject line and send to irbsbshelp@virginia.edu
  • Do not submit personnel changes to remove individuals from studies.
  • Consider only making and submitting personnel changes to add new individuals if needed for subject safety.