Updated Guidance and Letter to Investigators Regarding IRB Reporting Requirements for Protocol Deviations During the COVID-19 Public Health Emergency

The Human Research Protection Program (HRPP) has updated the May 8, 2020 memo detailing IRB reporting requirements for protocol deviations made in response to COVID-19 and for adherence to the Office of Research Guidance for Onsite Clinical Research Activities. This new letter, dated February 12, 2021, explains that study changes that may increase risk to participants must now receive IRB approval prior to implementation. We are making these changes at this time in recognition of progress made in understanding the principal mode of transmission of SARS-CoV-2, and UCSF’s implementation of significant preventive policies and procedures that mitigate the risk of transmission of the virus.

The letter may be shared with research sponsors to describe the types of protocol deviations made in response to the ongoing COVID-19 pandemic that do and do not require prior UCSF Institutional Review Board (IRB) approval. It is attached here, and is also available on the IRB COVID-19 FAQ’s & Resources page. Please refer to FAQ Q1 on that same page for more details on reporting requirements.