• Karen J Schwenzer.
• Department of Anesthesiology, University of Virginia Health System, Box 800710, Charlottesville, VA 22908-0710, USA.
• Resp Care. 2008 Oct 1; 53 (10): 1354-61.

AbstractThe federal government regulates human research with a local institutional review board (IRB) at your institution. Your IRB's main responsibility is to protect the rights and welfare of human subjects recruited to participate in research. The IRB is responsible for reviewing and approving all research protocols that involve human subjects. The IRB evaluates your study design to ensure that it has the possibility of answering your research hypothesis. The IRB focuses on the risks and benefits of your research. The IRB wants to know that research subjects are recruited fairly and that the potential for benefit is distributed equitably. They also want to know how you plan to protect research subjects from the risks of research and how you will manage the data, especially protected health information. Though the Code of Federal Regulations is extensive, this article provides information to help you navigate your research protocol through the layers of regulations, including the Privacy Rule of the Health Insurance Portability and Accountability Act of 1996. Whether conducting a simple chart review or participating in a multi-site randomized placebo-controlled trial, if you follow tried-and-true scientific methods and good clinical practice, you will be able to work effectively with your IRB.

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