A Timeline of Human Subjects Research Regulation,
borrowed from the PEERRS training program.
1932 - The Syphilis Study
1930s-40s -The Nazi Experiments and Nuremberg Doctors Trial
1947 - The Nuremberg Code
1950s - Thalidomide Tragedy: Thalidomide, a new sleeping pill, is found to have caused birth defects in thousands of babies born in Western Europe. News reports on the role of Dr. Frances Kelsey, FDA medical officer, in keeping the drug off the U.S. market, arouse public support for stronger drug regulation.
1962-Kefauver-Harris Amendments to the Food, Drug and Cosmetic Act: These amendments were intended to ensure drug efficacy and greater drug safety. For the first time, drug manufacturers are required to prove to FDA the effectiveness of their products before marketing them.
1963 - The Milgram Study: Yale psychologist Stanley Milgram conducted a study to test his theory of obedience that involved deception of participants, who were led to believe they were administering electric shocks to other individuals. See "Obedience to Authority: An Experimental View," (Harper/Collins, 1983) by Milgram for more on his work.
1964 – Declaration of Helsinki
1966 - The Beecher Article: Henry K. Beecher, a Harvard-educated surgeon, published an article in 1966, "Ethics and Clinical Research," which cited 22 specific examples of human research being conducted in the United States that did not follow the Nuremberg Code of 1947. The article caused a national stir and led to new policies for investigators by the NIH and FDA, including the establishment of the IRB system in use today.
1970s - The Syphilis Study Exposé: It wasn't until an article appeared in the New York Times in 1972 that the Tuskegee Syphilis study was examined, shut down and reparations begun to the study victims and their families.
1970s/80s - European Protests:The 1970s and 1980s were a time of strongly-voiced privacy concerns in Europe over national censuses. Large numbers of people - in England, Germany, the Netherlands, and Northern Ireland, in particular -- protested because they felt the census undermined information privacy.
1971-1981 - Holland's Census :In the 1970s, non-participation in a voluntary census test was close to 25% nationwide, and nearly 50% in major cities, following widespread public debate about privacy rights in relation to new computer technologies. Facing no new legislation on data protection, the government canceled the 1981 census altogether.
1974 - The National Research Act: The federal law that established the requirement of human subjects research review by Institutional Review Boards.
1978 - Belmont Report
1980-present - German Census : Motivated by privacy and confidentiality concerns, pressure groups in Germany mounted a public campaign that resulted in cancellation of Germany's 1983 national census, a redesign of national data collection, and creation of one of the strictest privacy protection laws relating to the census. Since that time, Germany has had no census inclusive of the entire population.
1981 - Consolidated HHS/FDA Regulations: After many years of independently issuing guidelines and regulations, HHS and the FDA attempted to consolidate their regulations regarding human subjects research.
1982 - CIOMS Guidelines
1991 - Common Rule
