Clinical trials must address a number of laws, regulations, and other sources of requirements when communicating privacy and confidentiality protections to potential participants. This article outlines relevant requirements from Common Rule regulations, Food and Drug Administration regulations, Health Insurance Portability and Accountability Act…

The United States is a world leader in biomedical clinical research. America's existing human subject research regulations structure affords sizable protections for the ethical treatment of research volunteers. Early initiatives such as the Belmont Report were specific to federally funded research. Over the past several decades guidelines such as…