What is the IRB review process for COVID-19 research?
Effective March 23, 2020, a centralized process for assessing and reviewing some COVID-19 research has been implemented. This process applies both to new studies AND changes to already approved studies that involve collecting and or analyzing biospecimens. This process does NOT apply to other studies that qualify for exemption (including chart reviews) nor adding questionnaires to existing studies about subjects’ experience with COVID-19.
Researchers proposing such non-exempt COVID-19 projects should proceed as follows:
- Complete and submit the form found here.
- You will need to provide a study synopsis or draft study protocol.
- Projects will be assessed for feasibility within the current clinical context of the pandemic.
- If this is a new project (rather than a change to an existing study), that is approved to move forward with IRB review, we highly recommend these studies be submitted by the Office of Clinical Trials. This will help ensure a streamlined and quicker IRB review process. Please contact Jen Parnell, Director Office of Clinical Trials for assistance (firstname.lastname@example.org).
- At this time, we expect that all non-exempt multi-site COVID-19 research studies will go to the sIRB designated by the sponsor or coordinating center. Teams with investigator-initiated studies should consult with RELIANT (email@example.com ) about the best IRB review option (e.g., UW or an independent IRB).
- Researchers with questions about this process should contact Betsy Nugent, Chief Clinical Research Officer, directly.