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.