SARS-CoV-2/COVID-19 Related IRB Modifications – Points to Consider

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.

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