IRB Historical Timeline

Events	Year	Actions
Tuskegee Syphilis Study (1932-72)	1932
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
MK-ULTRA: Military LSD experiments	1953
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"

The Institutional Review Board

IRB Historical Timeline

IRB Historical Timeline