This tutorial provides information on the rules and regulations governing research involving human subjects at UW-Stout under the federal Common Rule (45 CFR 46) and U.S. Food and Drug Administration (FDA) regulations (21 CFR 50, 56, 312, 600, and 812).
The tutorial consists of four main modules, with examples, and a certification page. The examples illustrate the concepts introduced in the module.
Module 1: Introduction will help you decide whether your research project will be subject to the rules and regulations governing the involvement of human subjects in research.
Module 2: Ethical, Historical, and Legal Background, will explain why UW-Stout has an extensive process for approving all research that involves human subjects.
Module 3: Basic Principles, will describe the fundamental ethical principles that guide all decisions concerning the conduct of research with human subjects at UW-Stout. It will also review issues relating to privacy and information security.
Module 4: Approval Process, will describe the research approval process at UW-Stout and the roles of UW-Stout's Institutional Review Board (IRB).
UW-Stout keeps records of those who have completed human subjects training. The certification pages at the end of this tutorial are the mechanism for keeping these records. BE SURE to fill out the certification when you complete the tutorial! A copy of this certificate must accompany each research proposal submitted.
The tutorial should take approximately one hour to complete. You are responsible for the entire content of the training.
The Association for Practical and Professional Ethics, Harvard University, the National Institutes of Health, and the University of Minnesota have all generously allowed the University of Wisconsin-Madison to adopt and modify examples and other material presented in this tutorial.
UW-Stout would like to thank UW-Madison for granting permission to adapt this IRB Human Subject Tutorial. Lastly, University of Wisconsin-Stout would like acknowledge the IRB work of the University of Michigan, Case Western Reserve University, University of Las Vegas, University of Georgia and the Pennsylvania State University. UW-Stout recognizes the work of David DeLambo, UW-Stout IRB member and Faculty Research Associate, for his significant contribution to this tutorial.