IRB Review Of Changes To Previously Approved Research

By Jason Rush, Senior Director, Regulatory, and Emily Eldh, Senior Director, Compliance Programs

Throughout the course of conducting research involving human participants, it is common for planned modifications or revisions to be necessary. These may involve amendments to institutional review board (IRB)-approved protocols, among other study modifications.

It is the investigator's responsibility to ensure that any changes undergo IRB review before implementation. The IRB, in turn, is tasked with reviewing these changes to ensure ongoing compliance with regulatory criteria.

Amendments involving alterations to IRB-approved protocols and other study modifications are subject to various IRB review requirements. Researchers must also consider IRB considerations as they assess and propose study changes, ensuring adherence to ethical and regulatory standards.