Human Subject FAQs

• If there is a future outbreak of COVID-19, what should I do about my research?

  Researchers must maintain plans and be prepared to return to remote activities on short notice if this becomes necessary.

• When do I need to report protocol deviations to the Institutional Review Board (IRB)?

  Protocol deviations do not need to be reported to the IRB unless they impose an increase risk of harm to participants or adversely affect the integrity of the data. As a reminder, a protocol deviation is something that applies to one individual.
  
  ·        Example: A subject is not able to travel for an in-person visit because of self-quarantine. This is a minor deviation and does not need to be reported to the IRB unless it impacts the risk to the participant.
  
  ·        Example: A subject has self-reported or documented symptoms compatible with COVID-19 infection 24 hours prior to dosing or at the time of dosing. The Principal Investigator will determine whether or not the subject will not receive the study drug. This situation is considered a protocol deviation as it could impact subject risk. This deviation needs to be reported to the IRB.