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Significant Events in Human Subjects Research

4th Century B.C.: Hippocratic Oath: physicians must help patients and do no harm

1789: Edward Jenner performs smallpox experiments (swinepox, cowpox)

19th Century: "Gentlemen physicians" conduct experiments in their spare time

1824: London's Royal Society for the Prevention of Cruelty to Animals founded

1833: Dr. William Beaumont studies digestion by carrying out experiments through a hole in patient Alexis St. Martin's stomach, Mackinac Island, MI

1865: Claude Bernard, French physiologist and Professor of Medicine: treatise on methods and ethics of experimentation-An Introduction to the Study of Experimental Medicine-in which he claims that experiments that may do good are morally obligatory

1874: American Humane Society established

1886: Dr. Charles Francis Withington advocates a Bill of Rights to "secure patients against any injustice from the votaries of science" in Harvard dissertation

1900: Walter Reed gets first written consent forms in his yellow fever experiments in Cuba

1904: Ads in American newspapers seeking subjects for experiments

1913: George Bernard Shaw coins expression "human guinea pig": "The ... folly which sees in the child nothing more than the vivisector sees in a guinea pig: something to experiment on with a view to rearranging the world."

1914: Schloendoerf vs. New York Hospital: legal opinion by Justice Benjamin Cardozo that was the foundation for the right to self-determination. "Every human being of adult years and sound mind has a right to determine what shall be done with his own body?"

1926: R.A. Fisher's "The Arrangement of Field Experiments" describes the method of "randomization" that is used in clinical trials

1931: J.B. Amberson's "A Clinical Trial of Sanocrysin in Pulmonary Tuberculosis" is the first clinical trial that used the process of randomization.

1932: Syphilis experiments begin in Tuskegee, Alabama; not widely acknowledged until 40 years later

1935: R.A. Fisher, The Design of Experiments, 1st edition.

1938: H.S. Diehl's "Cold Vaccines: An Evaluation Based on a Controlled Study" was the first clinical trial in which the saline solution was called a "placebo"

1938: U.S. Federal Food, Drug and Cosmetic Act enacted

1944: U.S. begins secret radiation experiments on humans; experiments continue through 1974 but are not widely publicized until the late 1980s

1946: Bikini Atoll used as the target of U.S. bomb tests.

1946: Nuremberg trial of Nazi doctors who tortured prisoners under the guise of experimentation

1947: Nuremberg Code lists ten principles for researchers for the conduct of clinical studies-written by lawyers with a legalistic slant

1948: British Medical Research Council reports on a large clinical trial that had used randomization to assign individuals to experimental and control groups

1948: Andrew Ivy publishes "The History and Ethics of the Use of Human Subjects in Medical Experiments"

1948: First Universal Declaration of Human Rights

1949: Slippery slope concept formulated in Leo Alexander's article in New England Journal of Medicine addressing medical science under dictatorships

1949: World Medical Association's "International Code of Medical Ethics"

1956: Willowbrook hepatitis experiments initiated

1959: Henry Beecher publishes article "Experimentation in Man"

1961: Civil Rights Movement grows in U.S.

1962: Kefauver-Harris amendments to the Federal Food, Drug and Costmetic Act. They include the requirement that subjects in drug trials conducted in the U.S. give full and free consent

1963: Terminally ill patients given live cancer cells without their consent at Jewish Chronic Disease Hospital

1963: Milgram "obedience to authority" studies show that people are willing to inflict pain on others

1963: American Psychological Association publishes ethical standards

1964: Declaration of Helsinki written by physicians at the World Medical Association offering recommendations for ethical conduct of experiments with humans

1965: Congressional bill providing for humane treatment of animals in the U.S.

1966: Henry Beecher publishes article "Ethics and Clinical Research" in The New England Journal of Medicine

1967: John Fletcher publishes "Human Experimentation: Ethics in the Consent Situation"

1968: Senator Walter Mondale hearings

1968: M.H. Pappworth publishes Human Guinea Pigs: Experimentation on Man

1969: Hastings Center founded

1970: Paul Ramsey: The Patient as Person

1970s: Joint Commission on Accreditation of Healthcare Organizations begins defining patients' rights and standards for organizational ethics at hospitals

1970: Kennedy Institute of Ethics founded at Georgetown University

1971: Zimbardo Mock Prison Experiment at Stanford University-psychological research

1972: Patients Bill of Rights

1972: Unethical syphilis study in Tuskegee exposed in Washington Star

1973: Kennedy hearings

1974: National Commission for the Protection of Human Subjects established in the U.S.

1977: World Psychiatric Association adopts the Declaration of Hawaii, the first code of ethics designed specifically for psychiatrists

1977: World Psychiatric Association establishes a Review Committee to investigate cases of the abuse of psychiatry wherever they might occur

1978: Belmont Report outlines ethical principles for the protection of human subjects in research.

1981: Title 45, Code of Federal Regulations, Part 46: Protection of Human Subjects regulations for all DHHS supported research in the United States

1990: First human somatic cell gene therapy trial-gene therapy for Severe Combined Immune Deficiency

1993: Guidelines for inclusion of women and minorities as subjects in clinical research in the U.S.

1993: President's Advisory Committee on Human Radiation Experiments appointed

1995: U.S. National Bioethics Advisory Commission established (

1996: Publication of the Final Report of the President's Advisory Committee on Human Radiation Experiments

1997: President Clinton apologizes for Tuskegee experiments.


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