Does Accreditation Improve the Protection of Human Research Subjects and the Quality of Institutional Review Board Reviews?

Twenty-five years ago, the Institute of Medicine recommended voluntary, external accreditation of human research protection programs to enhance the protection of human subjects participating in research and to preserve public trust in our system of protecting human research subjects. Today, accreditation of human research protection programs as well as independent institutional review boards has been well established. It is carried out by a sole accrediting organization, the Association for the Accreditation of Human Research Protection Programs, Incorporated. However, there has been no evaluation of whether accreditation improves human research subject protections or the quality of institutional review board reviews, and whether accreditation is cost-effective. Thus, it is imperative that we find out whether accreditation has achieved its primary objective of enhancing human research subject protections and the quality of institutional review board reviews.