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Syphilis Study at Tuskegee
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Nazi Medical War Crimes
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Cold War Human Radiation Experiments
The U.S. Government conducted more than 400 experiments to determine the effects of exposure to ionizing radiation on human health or to calibrate instruments designed to detect radiation.
Click Human Radiation Experiments for more information. -
Nuremberg Doctors' Trial
The individuals who conducted Nazi experiments during WWII were tried separately from other war criminals because of their professional status as physicians and the horrendous and unique
nature of their crimes. They were found guilty of “crimes against humanity.”
See Here for more information. -
Nuremberg Code and APA
Nuremberg Code
The Nuremberg Code became the first international standard for the conduct of research and introduced the modern era of protection for human research subjects. American Psychological Association
The American Psychological Association began to develop a code of Ethical Standards that included issues in human subjects research.
See APA Standards for more information. -
UN adopted Universal Declaration of Human Rights
The United Nations adopted The Universal Declaration of Human Rights, which was inspired by atrocities committed during World War II and states the conviction that human rights needed to be preserved at the international level.
See Here for more information. -
First US Federal Policy for Protection of Human Subjects
The first U.S. Federal policy for the protection of human subjects was put into place for research conducted at the Clinical Center, NIH. This policy provided a mechanism for prospective review of proposed research by individuals having no direct involvement or
intellectual investment in the research. This system is the model for the current IRB system. -
Jewish Chronic Disease Hospital Study
Studies were undertaken at the Jewish Chronic Disease Hospital in New York to develop information about the human immune system's response to cancer. Live cancer cells were injected into chronically ill and debilitated patients who were told they were receiving a skin test. The investigators were eventually prosecuted and found guilty of fraud, deceit, and unprofessional conduct. -
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Willowbrook Study
Studies were carried out at the Willowbrook State School for "mentally defective persons," to gain an understanding of the transmission of infectious hepatitis and, subsequently, to test the
effects of gamma globulin in preventing or ameliorating the disease.
Residents of Willowbrook, all of whom were children, were
deliberately infected with hepatitis, by ingesting the stools of infected persons or receiving injections of more-purified virus preparations. -
Declaration of Helsinki
The World Medical Association drafted the first international agreement recommending ethical standards for clinical research. Current Version Here -
Henry Beecher's Publication
Henry Beecher published an article in the New England Journal of Medicine describing 22 cases of human subjects research that involved ethical violations. Beecher argued against increasing
regulations and in favor of responsible investigators. His perspective has been cited as influencing Federal policy to outline general requirements for informed consent and to delegate specific standards to local review processes. -
National Research Act of 1974
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The Belmont Report
The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research issued Ethical Principles and Guidelines for the Protection of Human Subjects of Research. This is the cornerstone document of ethical principles and HHS regulations for the protection of research subjects based on respect for persons, beneficence, and justice. See HERE for more information. -
Publication of FDA Regulations
The FDA regulates research involving products regulated by the FDA, including research and marketing permits for drugs, biological products, and medical devices for human use, etc.,
whether or not HHS funds are used. If HHS funds are used in FDA-regulated research, the research must be compliant with both HHS and FDA regulations. More information about the FDA regulations and FDA-specific requirements can be found at http://www.fda.gov/. -
Publication of the Common Rule
The Federal Policy for the Protection of Human Subjects or the "Common Rule" was published in 1991and codified in separate regulations by 15 Federal departments and agencies
See HERE for more information. -
Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule
The Privacy Rule was enacted in response to public concerns over potential abuses of the privacy of health information. Implementation and oversight of the Privacy Rule are the responsibility of the HHS Office for Civil Rights.
Additional information about how the Privacy Rule impacts research can be found HERE
