How to report changes to the ethics committee?
Most guidelines encourage sponsors and investigators to engage with their local IRB/IEC as early as possible as emergent changes are anticipated in protocols due to COVID-19.(1,2,4) Some sponsors may choose to redesign their studies to require less labor, at the same time in a way that salvages the study. The changes made to minimize the hazard or protect the life and well being of participants and investigators may be implemented without IRB approval before filing an amendment, but are required to be reported later. The amendment needs to include the specific protocol deviation and the reason for the deviation. For example, specific visits conducted by virtual contact rather than as specified in the protocol due to the current situation, generally would be acceptable. For efficacy assessments, protocol modifications are required for the collection of endpoints done via methods alternate to the ones specified in the protocol such as virtual assessments, delays and alternate collection of specimens.(4)