As part of the ongoing effort to ensure appropriate planning and accommodations for safely conducting clinical research activities involving direct contact with participants in the context of COVID-19, the SOM has established a Clinical Research Review Committee (CRRC). All SOM human subjects studies wishing to initiate or resume direct contact with study participants are asked to complete the electronic form to provide basic study information, confirm preparedness to meet the guidelines, and describe the considerations for safety of the participants and co-workers in the setting of COVID-19. Please note, completion of the form requires attestation and signature of the PI.

General workflow description:

Once the PI submits the form, it will undergo administrative review for completeness by the CRSO (within 1 business day). Following administrative approval, the form will be routed to the PI’s Department Chair (or designee) and Director of the Administering Unit (or designee) (if applicable). If a Chair or Director does not support the study to continue as described in the context of COVID-19, they will communicate directly with the PI. If the Chair and Director do support the PI’s recommendation to initiate direct contact with study participants, the form will then be reviewed by members of the SOM CRRC. Upon completion of CRRC review (within 2 business days), comments and notice of approval or disapproval will be emailed to the PI.

To check the status of a submission, click here to view the Dashboard (Onyen login required).

Important notes:

  • If you previously received approval to conduct essential study activities involving direct contact with participants from the Office of the Vice Chancellor for Research, you do not need to pause study activities. However, you are still required to complete the SOM form for additional review by the CRRC.
  • Please remember that modifying study methods or activities may require IRB review/approval. You may also need to update your study status on clinicaltrials.gov. You do not need to wait for IRB approval in order to complete the SOM request form.
  • All studies involving direct contact with participants are additionally required to provide an information sheet to subjects (unless enrollment is due to a COVID diagnoses and treatment), that outlines the risk of COVID-19 and the risk mitigation strategy that has been developed.

If you are ready to submit your study information, click here to access the form.

If you would like to review the elements of the form prior to starting the electronic form, click here to view a PDF (note, the electronic form includes branching logic, not available in this PDF version).

If you have questions about the guidelines or the process to initiate direct contact with study participants, please contact crso@med.unc.edu.