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IRB Historical Timeline

Events Year Actions
Tuskegee Syphilis Study 
Elixir Sulfanilamide Disaster 1937  
  1938 Federal Food, Drug & Cosmetic Act
Monster Study on stuttering 1939  
Nazi Experiments on Prisoners (1939-45) 1940s  
Stateville Penitentiary Malaria Study 1940s  
Radiation Experiments Begin (1944-74) 1944  
  1944 Penicillin used to treat syphilis
Guatemala STD Experiments 1946  
MIT Science Club Study (1946-53) 1946  
  1947 Nuremberg Code
  1948 UN adopts Universal Declaration of Human Rights
George Otto Gey extracts cells from Henrietta Lacks 1951  
Sloan-Kettering Cancer Study 1952  
Wichita Jury Study 1953  
Military LSD experiments
Willowbrook Hepatitis Study (1956-71) 1956  
Thalidomide Tragedy 1957  
Harvard Psilocybin Experiments (1960-63) 1960  
Milgram Obedience Study 1962 Kefauver-Harris Drug Amendment 
to Food, Drug & Cosmetic Act
Jewish Chronic Disease Hospital Cancer Study 1963  
  1964 Declaration of Helsinki
Beecher Article 1966 US Surgeon General’s Directives on Human Experimentation 
Institutional review required
Tearoom Trade Study published 1970  
Stanford Prison Experiment 1971  
Tuskegee Syphilis Study exposed. Study ends. 1972  
  1974 Tuskegee lawsuit settled out of court.
  1974 National Research Act passed by Congress
  1974 National Commission for the Protection of Human Subjects of Biomedical & Behavioral Researchestablished. DHEW funded research to be reviewed by IRBs
  1974 45 CFR 46: IRB procedures established
Subpart C: Special Protections for Pregnant Women and Fetuses
  1978 President Carter establishes the Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research (1978-83) leading to the creation of The Common Rule
  1978 Subpart C: Special Protections for Prisoners
  1979 Belmont Report
  1981 FDA regulations for IRBs at 21 CFR revised to correspond with DHHS regulations
  1982 CIOMS Guidelines
  1983 Subpart D: Special Protections for Children
Arizona State University’s Havasupai Research Study (1989-2004) 1989  
  1990 International Conference on Harmonization Guidelines (ICH Guidelines created)
  1991 Common Rule
MIT Science Club experiments exposed. 1993  
1930s & 40s Radiation Experiments Publicized 1993  
  1993/5 Advisory Committee on Human Radiation Experiments Report
  1995 President Clinton creates the 
National Bioethics Advisory Committee (1995-2001)
University of Rochester student participant Nicole Wan dies in minimal risk medical study 1996 HIPAA Privacy Rule
Death of Jesse Gelsinger in University of Pennsylvania medical study 1999  
  2000 OPRR is promoted to OHRP
  2001 President Bush replaces the NBAC with 
the President’s Council on Bioethics
  2001 University of Iowa apologies for Monster Study
Columbia Restaurant Study 2001 AAHRPP incorporated
Boston College's The Belfast Project begins (2001-2006) 2001  
Havasupai Tribe learn the extent of the ASU research study 2004 SACHRP established
  2007 University of Iowa settles Monster Study lawsuit
  2010 US apologizes for the Guatemala STD Experiments
  2010 ASU settles Havasupai lawsuit
  2011 ANPRM for Revision to the Common Rule
  2012 Boston College's Belfast Project interviews under legal review
  2012 UK Concordant to Support Research Integrity
  2013 University of Alabama's SUPPORT Study suspended by OHRP
Stanford & Dartmouth Voter Experiment 2014  
  2014 UNC IRB suspends whistle-blower's research study on literacy of atheletes
OKCupid Mismatched Matchmaking Experiment 2014  
Facebook Emotional Contagion Study 2014  
UCLA Study: Same Sex Marriage: Effect of the Canvasser 2015 NPRM for Revision to the Common Rule
  2017 Presidential Commission for the Study of Bioethical Issues concludes upon the inauguration of the new president and is not replaced.
  2017 The Final Revisions to the Common Rule is published on January 19, 2017 in the Federal Register.
  2018 The Final Rule was implemented by July 18, 2018. Now known as the "Revised Common Rule" or "The 2018 Requirements"