Does the Common Rule require that all federally funded research be reviewed by an IRB?

The assertion that not all federally funded research is required to be reviewed by an Institutional Review Board (IRB) is accurate due to specific conditions set within the Common Rule. While the Common Rule does establish a framework for the ethical conduct of research involving human subjects, it also specifies certain exemptions. For example, research that involves the analysis of publicly available data or studies where human subjects cannot be identified may not require IRB review. Furthermore, the requirement for IRB review primarily applies when human subjects are directly involved in the research, and even then, certain categories of exempt research or specific types of investigational projects may not necessitate a formal review.

Understanding this nuance is key, as it highlights the balance the Common Rule seeks to achieve between protecting human subjects and facilitating research progress by recognizing that not all research activities pose the same level of risk to participants.