The IRB at Mayo began in 1971 as the "Committee on Investigations involving Human Subjects". From 1972 to 1983 it was known as the "Human Studies Committee". It was not until 1984 that the term Institutional Review Board was first used at Mayo. Since that time, the IRB has grown from a single committee to six Full Boards (the sixth approved to begin in January 2006). The volume of research protocols has also been steadily increasing.

Institutional Review Boards (IRBs) are committees charged by the United States government with protecting the rights and welfare of human subjects involved in research. The use of IRBs began in the National Institutes of Health (NIH) when a memorandum issued in 1966 required that investigators receiving funding from public health grants obtain a review of research by a "committee of his institutional associates".

In 2002, Mayo’s IRB reported submission of more than 2,500 new studies (full board and expedited). The average among all other institutions surveyed by the New England Journal of Medicine was about 400, and 600 was the average for high volume institutions.

In 2004, 22,762, items were submitted to the IRB. This represents a 14% increase over the submissions in 2003. To date, submissions in 2005 are on pace to equal or exceed those of 2004.

There are nearly 6,500 active studies currently being managed by the IRB office. Approximately 2,000 of these are greater than minimal risk (Full Board) studies.