Evaluating the Science and Ethics of Research on Humans: A Guide for IRB Members

Issues in Law & Medicine, Spring, 2008

Mazur, Dennis J. Evaluating the Science and Ethics of Research on Humans: A Guide for IRB Members. Baltimore, M.D.: The John Hopkins University Press, 2007; www.press.jhu.edu.

This is a reference guide for new and veteran members of IRBs that explains the basic concepts behind the work of institutional review boards and will help them better understand the issues involved and the tasks they will be required to perform. The most important purpose of an institutional review board is to protect the human participants in research. For three major research areas--drugs, medical devices, and genetic information--the author shares the methods he has found useful in protecting human participants: the systematic review of scientific protocols and informed consent forms and thorough adherence to applicable federal regulations. The author explains how proposed research projects are to be reviewed from both scientific and ethical dimensions, how and when to ask key questions of principal investigators, how to work with principal investigators and research teams to ensure the best protection of human participants, and why to schedule regularly spaced reviews of a project that may have adverse outcomes. The book contains helpful summaries and checklists throughout based on the author's thirty years of research experience.

Dennis J. Mazur, M.D., Ph.D., is a professor of medicine and senior scholar at the Center for Ethics in Health Care, Oregon Health and Science University. He has chaired the institutional review board in the Department of Veterans Affairs Medical Center, Portland, Oregon, for more than fifteen years.