Assessing the quality and performance of institutional review boards

Institutional review boards (IRBs) play a pivotal role in protecting human subjects participating in research. While IRBs were established for the primary purpose of protecting human subjects, nearly five decades later there has been no empirical evidence demonstrating that IRBs in fact protect human research subjects. This is because IRB oversight alone is insufficient in protecting human subjects. In addition to IRBs, investigators, institutions, research participants, research sponsors, and the Federal government all share responsibilities for protecting human subjects. In the United States, IRBs carry out their mission of protecting human research subjects through implementation of the Federal Policy for the Protection of Human Subjects, also known as the Common Rule. Here I propose that the quality of IRBs be defined as how well they implement the Common Rule and present examples of measuring IRB quality and performance so defined that lead to quality improvements. Based on this definition, the quality of IRB reviews and IRB decisions can also be defined that are quantifiable and measurable, allowing future assessment and improvement of these important IRB qualities.