Amendments to IRB-approved protocols do not need prior approval if they:

Amendments to IRB-approved protocols that must be immediately implemented for subject health do not require prior approval because the urgency of the situation necessitates prompt action to protect the health or safety of the participants. In such cases, the IRB recognizes that delays caused by the requirement for prior review could potentially compromise participant welfare. Therefore, these amendments can be enacted swiftly, and the IRB is typically informed of the changes at a later date, such as during the next scheduled meeting. This approach balances the need for participant safety with the ethical oversight provided by the IRB.

When considering the other options, changes that only alter the consent form generally require approval to ensure that all participants are adequately informed of any new risks or changes in the study. Expedited review procedures are meant for certain types of minimal-risk research changes but do not negate the requirement for prior approval in every scenario. Recording amendments and including them in a final report is good practice for compliance but does not exempt changes from the requirement for initial IRB approval.