In early 1994, the FDA and other regulatory authorities made a number of visits to institutions in the Atlanta area. During these visits, a skill deficiency was defined. A group of IRB leaders and data collectors formed a study committee to increase the skill level of local IRB leaders. The study group meetings developed into holding a state convention to correct the identified deficiencies. In early fall, the idea developed into hosting a national convention. This association was born out of that need for training.

Association bylaws were developed in the fall of 1994. Collaboration was initiated with the Georgia Department of Education, IRB, legal counsel, FDA, and NCI for information and data collection. During this same time, a certification examination was drafted and approved.

The first national convention was held in 1995 with 26 delegates. Since that time, the association grew to more than 200 delegates.

The National Association of IRB Leaders, Inc. (NAIL) is an independent human research management education organization based in Atlanta, Georgia. The association is not formally affiliated with any agency, government body, or school.