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The first international code of ethics for research on human subjects
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Saul Krugman, Joan Giles, and other researchers intentionally infected mentally disabled children with hepatitis to observe its natural progression. It was approved by the New York Department of Health.
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1963: US Public Health Service publishes its Guide for the Humane Care and Use of Laboratory Animals, requiring research institutions to form Institutional Animal Care and Use Committees (IACUCs) to review and oversee animal experiments.
1966: Animal Welfare Act, which protects animals used in research, excluding rodents and birds. Various states adopt or revise animal cruelty laws, which also protect animals used in research.
1975: Peter Singer publishes Animal Liberation. -
The World Medical Association published Ethical Principles for Research Involving Human Subjects. It has been revised numerous times, most recently in 2013.
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It was published in the New England Journal of Medicine alerting scientists and doctors to 22 unethical studies, including the Tuskegee syphilis study and the Willowbrook hepatitis study.
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The Act authorizes federal agencies (e.g. the NIH and FDA) to develop human research regulations. The regulations require institutions to form Institutional Review Boards (IRBs) to review and oversee research with human subjects.
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Influential Conference on Recombinant DNA and the regulation of biotechnology held at the Asilomar Conference Grounds
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The National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research publishes a report providing the conceptual foundation for a major revision of the U.S. research regulations
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The U.S. launches a $20 billion project to map and sequence the human genome. 3% of the project budget was initially devoted to ELSI
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It was announced one year later, in 1979.
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Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine
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Jessie Gelsinger dies in a human gene therapy experiment at the University of Pennsylvania. The event triggers heightened scrutiny of conflicts of interest in human subjects research, including institutional conflicts of interest. Penn settles a lawsuit brought by the Gelsinger family for an undisclosed amount of money.
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In October, He Jiankui, a scientist of the Southern University of Science and Technology in Shenzhen, China, announces the birth of the world’s first gene-edited babies, both girls. He claims that he used CRISPR-Cas 9 technology to modify the CCR5 gene to give the girls immunity to HIV. The announcement generates outrage around the world and many scientists and policymakers call for a ban on human germline, genome editing.
