Historical Overview

8. The Emergence of Formal Requirements for Ethics Evaluation

Some events in research ethics are historically significant because they prompted concrete actions. In the Tuskegee syphilis study [US, Advisory Committee on Human Radiation Experiments, Report Chapter 3], researchers observed the effects of untreated syphilis in black men. Started in 1932, it was not until 1972 that revelations about the conduct of the study exposed the need for clearer guidance. A flurry of regulatory activity followed and a US federal statute (National Research Act, 1974) was adopted. This is still in force today. It formally requires research institutions to establish independent, local, multidisciplinary institutional review boards (IRBs). The purpose is to protect human research participants. These institutional review boards in the US have the same role as research ethics committees (RECs), as they are called in the EU and many other countries.