The Role of Institutional Review Boards in Facilitating Research, Marketing of Drugs and Devices, and Protecting Human Subjects

Abstract

Concern for outside review of medical research involving human subjects has been documented as far back as the early Nineteenth Century. It was not until 1966, however, when applicants for Public Health Service grant funding were subjected to such a requirement, that researchers were required to undergo review. Institutional Review Boards (IRB) are the bodies charged with performing the mandated screening functions by the Department of Health and Human Services (HHS) for federally funded projects and by the Food and Drug Administration (FDA) in the drug and device approval process.

This paper explores an IRB's responsibilities under the HHS and FDA regulations generally, and emphasizes several critical attendant issues including: the manufacturer's IRB; IRB members' individual liability; compensation for research injuries; civil rights protections afforded subjects; impact upon academic and health practitioner research; and effect upon drug and device approvals.