A review of current issues in the regulation of human subject research in the United States

The United States has developed an extensive, nationally mandated struc-

ture to regulate research with human subjects at the local institutional level. While emphasis on local institutional control has been and remains the

source of some unique strengths, nonetheless it has some problematic

implications. Institutional Review Boards (IRBs) established by individual

hospitals, universities, and research institutions review research protocols

and determine compliance with federal regulations. But the role of IRBs is

changing in the face of recent developments in the federal regulatory

environment, the expansion of tort-based private litigation, and the regret-

tably declining role of academic medical centers in human research.