Human Research Protections ― Working With the Irb

The process of human research is an increasingly complex endeavor with a multitude of occasions to potentially cause harm to subjects, violate federal regulations intended to protect human subjects, abuse Protected Health Information, and corrupt data. Human research in the United States is highly regulated and an Institutional Review Board for Human Research (IRB) is the local enforcer. Out of necessity, IRBs have multiple requirements, policies, and forms designed to ensure compliance with federal regulations and state laws governing human research. These mandates represent an ethical process used to protect human subjects, investigators, and organizations. This book is a comprehensive, practical guide to assist investigators, their study teams, and healthcare graduate students to effectively and efficiently interact with IRBs. Also, both experienced and novice IRB members will find this book provides a clear foundation for their decision making. The author has condensed the available human research protections conceptual and legalistic information into a basic, concise, functional guide that those involved in human research readily can apply to their own research questions, settings, and populations. The researcher will be able to quickly find help to complete one task such as writing an informed consent document or constructing all the required elements of a human subject protection plan. Practicing clinical and basic healthcare scientists, human research support staff, members of IRBs, healthcare graduate students required to conduct human research to earn their degrees, and faculty in academic healthcare settings will find this book useful. Among the topics included are levels of IRB review, preparing an approval application for the IRB, the informed consent process and document, and special issues such as vulnerable populations, use of biospecimens, and de-identifiication of Protected Health Information.