USA — Country Report United States of America

To understand the law as it protects biomedical research subjects and patients in the United States, it is first necessary to have a basic understanding of the United States legal system. The United States is a federation of states. Legislative and regulatory competency exists, therefore, both at the federal and state level. The legislative competency of the federal government is limited to those areas where the states have ceded jurisdiction to the federal government. In most areas of law, federal and state legislative jurisdiction are concurrent, and both federal and state law must be complied with, though in a few areas, such as patent law, federal regulation is exclusive. Where, however, the federal government has legislative competency, and federal and state laws conflict, federal law takes precedence. In the context of biomedical research and medical care, federal jurisdiction is based primarily on the power of the federal government to regulate commerce among the states and to oversee the spending of federal money. The commerce power is broad, but is also not unlimited. Some matters, in particular areas that the states have traditionally governed through criminal law and that do not involve commercial relationships, are beyond the reach of the Commerce Power. The spending power is the jurisdictional basis of the federal “Common Rule” governing research involving human subjects, the main source of authority on most of the topics addressed by this Report.