Human Experimentation and Human Subject Protections

Human Experimentation and Human Subject Protections

The Bush administration’s legal framework to protect CIA interrogators from violating US statutory and treaty obligations prohibiting torture47 effectively contravened well-established legal and ethical codes that, had they been enforced, should have protected prisoners against human experimentation, and should have prevented the EIP itself from being initiated in the first place. This strategy therefore may have effectively employed one criminal act to protect against liability for another, as illegal and non-consensual

human experimentation can constitute a war crime  and a crime against humanity, when its perpetration is systematic and widespread.

The Nuremberg Code

International and US prohibitions restricting human experimentation were developed in response to some of the most serious human rights violations of the 20th century. Following the trials of German health professionals at Nuremberg after World War II, international attention was focused on the practice of human experimentation inflicted upon vulnerable human subjects. The fundamental right of individuals to choose not to be subjected to human experimentation  was first codified in the form of the Nuremberg

Code—a direct response to atrocities that took place during the war. Among other protections, the Nuremberg Code states that the voluntary informed consent of the human subject in any experiment is absolutely essential, and that volunteer subjects should always be at liberty to end their participation

in the experiment. In addition, the Nuremberg Code states that any experiment should be conducted so as to avoid all unnecessary physical and mental suffering and injury. Implementation of the Nuremberg Code was neither immediate nor consistent. Despite the experiences of World War II, human experimentation on vulnerable populations without the participants’ consent continued in the United

States into the second half of the 20th century. One of the most egregious examples was the Tuskegee syphilis experiment, in which poor African-American men in the South were denied treatment for syphilis so that researchers could study the natural progression of the untreated disease.

The National Commission

In the wake of public outrage surrounding these nonconsensual experiments, the US Congress created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (National Commission), a group of leading experts in medicine, law, and ethics, charged with developing guidelines on human subject research based on ethical principles. The National Commission made its recommendations in the Belmont Report, establishing “respect, beneficence and justice” as

principles guiding the ethical conduct of research, including the right of informed consent.51 The Belmont Report established the concept that the ethical conduct of research required that volunteer subjects be informed about the risks and benefits, if any, that might accrue to them before they gave their consent. Additional protections were established for vulnerable populations, such as prisoners, whose ability

to give truly informed consent may be problematic. As further protection for human subjects, the National

Commission called for establishment of institutional review boards within medical and scientific organizations. These bodies comprise combinations of researchers, ethics experts, and laypeople that oversee study design based upon ethical principles.

The Common Rule

These human subject protections became codified in federal regulations,52 as well as in codes of professional conduct. Collectively, these regulations are known as the Common Rule. The Common Rule applies to all federally funded human subject experimentation, including all research conducted

by the CIA and the DoD. By the end of the 20th century, therefore, all people who were subject to US experimentation were protected by three interconnected bodies of law: customary international law,

US federal statute, and federal regulations — specifically, the Common Rule. Although the Nuremberg Code is a code of conduct and not, by its terms, a treaty binding explicitly named parties, in the decades following the 1947 articulation of Nuremberg, prohibitions against human experimentation without the informed consent of the volunteer subjects have been deemed by international legal scholars to be

part of “customary international law.” This makes human experimentation without the informed consent of volunteer subjects one of a small number of acts (including genocide and torture) that are so heinous that they are universally considered to be crimes against humanity.


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Posted on July 3, 2010, in Human Experimentation, Uncategorized and tagged , , . Bookmark the permalink. Leave a comment.

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