Amendments Involving Changes To IRB Approved Protocols Do Not Need Prior IRB Approval If…

Changes or amendments to a research study can take a variety of forms. In most cases involving IRB approved protocols, amendments involving any changes to the protocol may not need prior IRB approval if certain conditions are met.

The criteria and conditions for whether or not prior IRB approval is needed can vary depending on the type of study and the changes proposed. Generally, if the changes are considered minor or do not significantly alter the study design, review, or consent process, prior IRB approval is not necessary.

For example, if the changes involve the addition of a new study site, the addition of new personnel to the research team, or the addition of new instruments or data collection procedures, prior IRB approval may not be needed. Similarly, changes to the consent process such as adding new informed consent language, or changes to the procedures for recruiting and enrolling participants may not need prior approval.

In any case, the IRB may require the investigator to provide detailed information regarding the proposed change and the rationale for making the change. Depending on the nature and scope of the change, the IRB may also require a modification to the protocol and additional reporting requirements.

It is important for investigators to understand the criteria and conditions for whether or not prior IRB approval is needed when making changes to IRB approved protocols. While the IRB may evaluate the changes on a case-by-case basis, it is the responsibility of the investigator to ensure that the proposed changes do not significantly alter the study design, review, or consent process.