Common Elements Of IRB Assessments

By Michele Russell-Einhorn, JD, Chief Compliance Officer and Institutional Official

Every institutional review board (IRB) is subject to inspections from time to time. The Food and Drug Administration (FDA) inspects IRBs to ensure human participants’ rights and welfare are properly protected. The Association for the Accreditation of Human Research Protection Programs (AAHRPP) regularly examines us as part of our accreditation maintenance. Additionally, many audit the IRB.

It’s critical for the IRB to follow appropriate regulations and guidance in its reviews, ensure reviews are conducted free of bias and conflict of interest (COI), and conduct due diligence to confirm quality is upheld for the studies they oversee. They continue to improve processes while ensuring participants are properly protected.

Most IRB inspections and audits focus on some common elements. This blog aims to provide an overview of such items to help you understand the standards to which Advarra’s IRB and others are measured against.