Human Subjects Research and COVID-19

Effective February 27, 2023, the special policy for Human Subjects Research During the COVID-19 Pandemic is suspended indefinitely.

Should the now endemic COVID-19 conditions worsen or should another infectious pandemic emerge, this policy, or one much like it, will again go into effect.

What suspension of this policy means for investigators:

1. The CGU IRB will resume applying normal exemptions for all human subjects research (HSR) whether it is conducted in-person or remotely.
2. For new studies: It will no longer be necessary to complete an additional outline to describe the procedures you will follow to mitigate risk related to COVID-19 infection. Bear in mind however, that if you are conducting research involving in-person interaction with a population that is particularly susceptible to viral infections or is otherwise health compromised, this would constitute a risk that should be addressed in your Research Outline.
3. For ongoing studies:
   1. Those approved with protocols that included COVID-19 risk mitigation procedures (RMPs):
      1. If you will continue to follow the COVID-19 RMPs, you don’t need to do anything.
      2. If you plan to discontinue use of the RMPs, submit an amendment informing us you will no longer be employing RMPs.
   2. Those approved for remote-only research
      1. If you will continue to conduct research activities remotely, you don’t need to do anything.
      2. If you plan to transition at least some activities to in-person, submit an amendment informing us what research activities will now be conducted in-person.
   3. For 3a.ii and 3b.ii,
      1. If you are not conducting research with populations who are at higher risk for infection or complications from infections (e.g., residents at senior centers, immunocompromised individuals), you may implement your study changes as soon as you have submitted your amendment. You are not required to wait for IRB approval.
      2. If you are conducting research with populations who are at higher risk for infection or complications from infections, we advise that you keep RMPs in place. You are required to wait for IRB approval before implementing any study changes.

Suspending this policy does not mean that investigators should no longer be concerned about the risks of spreading COVID-19 (or other contagious diseases) through research activity. The CGU IRB simply acknowledges that the risks and dangers to human subjects have diminished and, for the most part, the remaining risks have become part of what ordinary persons experience on a typical day. We encourage you to continue to be cautious and to conduct research safely and ethically. At a minimum, with respect to COVID-19, this would include keeping abreast of, and heeding, the recommendations of the CDC, WHO or the local health authority where you are conducting the research.