Basic Institutional Review Board (IRB)
Regulations and Review Process

Content Authors
Ada Sue Selwitz, M.A.
The University of Kentucky

Norma Epley, M.S.
East Carolina University

Janelle Erickson, MPH
Institute for Systems Biology
Introduction

The purpose of this module is to provide a basic understanding of the human subject protection regulations that govern the participation of human volunteers in research in the United States.

Learning Objectives

By end of the module you should be able to:

Describe the role, authority, and composition of the IRB.
List the IRB requirements for conducting research involving human subjects.
Describe the types of IRB review.
Describe the process of working with the IRB.
Identify other regulations and regulatory groups that require compliance based on the type of research being conducted.
IRB Role, Authority, and Composition

The Role of the IRB

An Institutional Review Board (IRB) is a review committee established to help protect the rights and welfare of human research subjects. Regulations require IRB review and approval for research involving human subjects if it is funded or regulated by the federal government. Most research institutions, professional organizations, and scholarly journals apply the same requirements to all human research. Although federal regulations refer to IRBs, an institution may have chosen a different name for this committee.
To clarify when IRB review is required, let's define some terms:

Research: Federal regulations define research as: "a systematic investigation... designed to develop or contribute to generalizable knowledge." [45 CFR 46.102(d)] If an investigator is unclear about whether a planned activity is research, the investigator should contact his/her IRB office.

Human Subjects: The Department of Health and Human Services (DHHS) regulations define a