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)