Welcome!

This tutorial provides information on the rules and regulations governing research involving human subjects at UW-Milwaukee 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).

This tutorial does not DOES NOT provide training on the federal Health Insurance Portability and Accountability Act (HIPAA) and its applications to human subjects research. Such training is required for medical researchers but is provided separately.

The tutorial consists of four main modules, three sets of examples, and a certification page. The optional examples illustrate the concepts introduced in the preceding module.

Module 1, Introduction, will help you decide whether your research projects will be subject to the rules and regulations governing the involvement of human subjects in research. It will also explain who must take human subjects training by completing this tutorial.

Module 2, Ethical, Historical, and Legal Background, will explain why the UW-Milwaukee 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-Milwaukee. It will also review issues relating to privacy and information security.

Module 4, Approval Process, will describe the research approval process and the role of UW-Milwaukee's Institutional Review Board (IRB).

As part of the effort to guarantee that all research on campus provides protection to human subjects, UW-Milwaukee keeps records of all personnel who have completed human subjects training. The certification pages at the end of this tutorial are the mechanism for keeping these records. In addition, you may need to demonstrate to a funding agency or an IRB that you have completed this training.

BE SURE to fill out the certification when you complete the tutorial!

The tutorial should take approximately an hour to complete.

Acknowledgements

The Association for Practical and Professional Ethics, Harvard University, the National Institutes of Health, University of Minnesota, and the University of Wisconsin-Madison have all generously allowed the University of Wisconsin to adopt and modify examples and other material presented in this tutorial.

UW-Milwaukee has provided many of the photographs for this tutorial.