For a better experience, click the Compatibility Mode icon above to turn off Compatibility Mode, which is only for viewing older websites.

Moving Beyond the Federal Funding Hook: Management-based Regulation in Biomedical Research


After World War II, the federal government established specific sets of regulations to oversee the conduct of biomedical research. These regulations tended to take the form of management-based regulations, and were generally imposed as conditions of federal funding. This Article identifies and describes the development of four areas of regulatory oversight: (1) human subjects research, (2) animal research, (3) scientific integrity and misconduct, and (4) financial conflicts of interest. Each is an example of management-based regulation: regulated entities have flexibility in designing policies and programs that meet generalized regulatory requirements.