Dear UCI Human Subject Researchers:
Please remember that you do not need prospective IRB approval to eliminate apparent immediate hazards to human research subjects due to SARS-CoV-2/COVID-19. Make the change and keep a change log. At the next IRB modification request, refer to your change log and update the protocol accordingly. [1]
Address the following in your IRB Modification Request:
1.Current & Past Participants: Do the changes constitute information that may change a current subject’s willingness to continue participation (necessitating re-consent)? Should the changes be provided to past participants? If so, include proposed notification documents with your modification request. A suggested template Participant Notification Letter is available on the Office of Research – Research Continuity Webpage.
2.Future Participants: If enrollment is ongoing, be sure that the current Consent Form or Study Information Sheet reflects changes as applicable.
3.Study Procedures: Regardless of enrollment status, please update the Protocol Narrative to reflect current study procedures describing the SARS-CoV-2/COVID-19 related changes.
A Note on Social Distancing: Specify whether procedure changes are temporary due to SARS-CoV-2/COVID-19 social distancing, or whether they are permanent.