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COVID-19 IRB Guidance - Updated

March 20, 2020

UC Merced Institutional Review Board (IRB) will continue to process, review and approve protocol submissions.  Should the COVID-19 landscape change significantly, there may come a point when research activities including human research subjects will be restricted and submission reviews might be paused in the interest of individual and public health.

In response to the COVID-19 pandemic, CA Governor Gavin Newsom issued a statewide stay at home order for all residents.  As a result of this order, all human subjects research requiring face-to-face, in person interaction shall cease immediately.  To continue previously planned research involving in person interactions, researchers should consider remote alternatives  like phone, online data collection and Zoom. 

Should researchers decide to modify protocols to reduce potential COVID-19 exposure of subjects or staff, please do so without waiting for IRB approval. The IRB will process all modifications as quickly as possible, but researchers should feel free to make risk-reduction changes as quickly as is feasible. Researchers should file a modifications submission and, if you change your protocol prior to review and approval, submit a deviation report to the IRB as soon as you can. Any infection-reducing deviations will be viewed as minor. Exempt studies do not require modifications for this purpose. If modifying your study please identify “COVID” in the submission. This will allow the IRB to flag the modification to review and approve it quickly. Modifications are not necessary if researchers choose to pause protocols or components of protocols. If a study is federally funded, researchers should contact their program officer if research progress will be delayed. 

Researchers should consider whether they will need other flexibility in order to continue implementing the research. For example, many low risk procedures qualify for a waiver of written documentation (signed) consent. If the application describes written consent, researchers may wish to modify it to remove that requirement to allow for easier remote implementation.

Graduate student researchers who are lead investigators on IRB protocols should consult with their faculty advisors when considering any changes such as above or pausing their research studies.

We ask for patience as this is a quickly changing environment, but we will try to get researchers the most update information as soon as we can.

For additional up-to-date information, recommendations and resources regarding COVID-19 please see the following UC Merced sites: