When Is Institutional Review Board Approval Necessary for Quality Improvement Projects?

Abstract

Institutional review boards (IRBs) were developed to protect the safety, rights, and welfare of human research subjects. The role of IRBs is to perform critical oversight for research conducted on human subjects to ensure the research is scientific, ethical, and regulatory (McNett & Lawry, 2009; Sims, 2008). The IRB also functions as a resource to researchers providing educational mentoring and guidance to novice and expert researchers (Kotzer & Milton, 2007). Internationally, the World Health Organization’s Declaration of Helsinki is the most widely cited ethical standard for research recommending approval from an ethical review board (Wagner, 2003). The Belmont report, prepared by a U.S. national commission, provided ethical guidelines for conducting research with human subjects. This Belmont report provides guidelines supported by three ethical principles. These basic principles should be followed for any research activity. The first principle is respect for persons, which includes recognizing an individual’s autonomy and dignity. The second principle is beneficence, protecting the individual from harm by optimizing the benefits. This principle indicates that benefits must outweigh the potential harms. The third principle from the Belmont report is justice. This principle focuses on the fair distribution of the benefits and burdens of the research (Department of Health, Education and Welfare, 1979). These ethical standards guide IRBs in their purpose of protecting the rights, safety, and well-being of research participants. Important terms to consider in determining when the IRB is responsible for overseeing the rights, safety, and Editorial