A need for oversight with regard to human subjects research historically dates back to the 1930s, most notably, the Syphilis Study1,2 which began in 1932 and the Nazi Medical War Crimes3 during World War II. These and other cases led to the Nuremberg Code of 1947 which established an outline for voluntary consent and a need for the study (what would later become research towards generalizable knowledge). Shortly thereafter, the UN adopted a Universal Declaration of Human Rights in 1948 which firmly established such fundamental human rights on an international stage.
The first Federal Policy for Protection of Human Rights was established in 1953, and is generally considered to be the precursor to today's current IRB system. The evolution into today's IRB is grounded in the Belmont Rule of 1979 which focuses on three major principles required of ethical conduct of research with humans; (1) respect for persons, (2) beneficence, and (3) justice. By this standard, an IRB is reviewing research to ensure there is respect for the subjects, that the research should have the welfare of that subject included as a goal in the research, and that the research is conducted as fairly as possible.
Today's IRB follows the Federal Policy for the Protection of Human Subjects (a.k.a. the Common Rule) and is classified in the Department of Health and Human Services regulations 45 CFR part 46. To learn more, please review this video provided by the U.S. Department of Health and Human Services.
Human subjects research is classified into three categories: Exempt, Expedited, and Full Committee Review. Exempt research requires an IRB review, but does not require the convening of the full IRB. At FSW, this determination can be made solely by the IRB Chairperson. Low risk research such as anonymous surveys or anonymous non-invasive observation of public behavior would qualify as exempt. Expedited research also does not require the convening of the full IRB, and can also be made solely by the IRB Chairperson. If the IRB Chairperson cannot approve of the research under expedited review, it is set on the agenda for the upcoming IRB convening. Limited risk research such as surveys that are not anonymous or slightly invasive observations such as vocal or visual recordings of volunteers would qualify as expedited. Full committee review research requires the convening of the IRB. Some examples of research requiring full committee review include those in which subject identification or their results may cause risks in reputation, employability, financial status, or insurability.
1 Brandt, AM. 1978. Racism and Research: The Case of Tuskegee Syphilis Study. Hastings Center Report 8(6): 21-29. 2 Jones, JH. 1993. Bad Blood: Tuskegee Syphilis Experiment. Rev. ed. New York: Free Press. 3 Annas, GJ, and Grodin, MA. 1992. The Nazi Doctors and the Nuremburg Code, Human Rights in Human Experimentation. New York: Oxford University Press.
Below are some additional helpful links for background into the purpose and structure of IRBs.