The History of Human Subjects Research and Rationale for Institutional Review Board Oversight.

The history of human subjects research and the abuses that led to the creation of the United States' (US) regulatory schema for research, which includes institutional review boards (IRBs), is long and complex. However, when one understands the history, one can see direct links between those abuses and the regulations, as well as the ethical principles, contained in the Belmont Report. To that end, we provide a brief analysis of the history of human subjects research and its abuses, including a lesser known case (the atrocities committed by Nazi scientists and physicians during World War II) and infamous cases in the US (including the Tuskegee Syphilis Study and Willowbrook). With that history in hand, we will then seek to understand the regulations that govern human subjects research and the IRB by grounding them both in the ethical principles in the Belmont Report.