Topic: Human Subjects Research

The COVID-19 Protocol Deviation Note to File (DOC) is intended to be participant-specific, outlining the deviations that occurred for an individual participant due to COVID-19. A separate Protocol Deviation Note to File should be kept for each affected participant.

The COVID-19 Note to File (DOC) is intended to be a global Note to File, kept in a study’s regulatory binder, explaining COVID-19’s impact on the study overall.

The Documentation of Informed Consent with COVID-19 Participants – Impartial Witness form is required when an informed consent document cannot be collected by the study team due to COVID-19 isolation.

Guidance for Consenting Hospitalized Patients by Phone or Video Conference (PDF) Please note this process should only be used for studies requiring written consent for hospitalized patients by phone or video conference for clinical trials while on isolation for confirmed or suspected COVID-19. This modified consent process must be reviewed and approved by the IRB prior to […]

For studies requiring written consent, the COVID-19 Documentation of Written Informed Consent (DOC) includes processes for when direct communications with participants is not feasible or safe due to COVID-19.

The Documentation of Verbal Consent with LAR-PG (DOC) is for use only in studies with an IRB-approved waiver of documentation of consent (no written signature required) but consent by a parent/legal guardian or Legally Authorized Representative is needed.

The Documentation of Verbal Consent (DOC) is for use only in studies with an IRB-approved waiver of documentation of consent (no written signature required).