For experiments on non-human subjects, see Animal testing.

Human subject research includes experiments (formally known as interventional studies) and observational studies. Human subjects are commonly participants in research on basic biology, clinical medicine, psychology, and all other social sciences. Humans have been participants in research since the earliest studies. As research has become formalized the academic community has developed formal definitions of "human subject research", largely in response to abuses of human subjects.

[edit] Definition of a human subject

In biostatistics or psychological statistics, a research subject is any object or phenomenon that is observed for purposes of research. In survey research and opinion polling, the subject is often called a respondent. In the United States Federal Guidelines a human subject is a living individual about whom an investigator conducting research obtains 1) Data through intervention or interaction with the individual, or 2) Identifiable private information (32 CFR 219.102.f). (Lim,1990)

[edit] History

[edit] Middle Ages

The influential Persian Muslim physician, Avicenna (Ibn Sina) introduced the use of biomedical research,^[1] clinical trials,^[2] randomized controlled trials,^[3][4] drug tests^[1] and efficacy tests^[5][6] on human subjects.

Human dissections were carried out by Ibn Zuhr (Avenzoar),^[7] who introduced the use of experimentation in surgery during the 12th century,^[8][9] as well as Ibn Tufail^[10] and Saladin's physician Ibn Jumay in the 12th century, Abd-el-latif in 1200,^[11] and Ibn al-Nafis in the 13th century.^[12]

[edit] Early Modern Times

HSR experiments were recorded during vaccination trials in the 1700s. In these early trials, physicians used themselves or their slaves as test subjects. Experiments on others were often conducted without informing the subjects of dangers associated with such experiments.

A famous example of such research were the Edward Jenner experiments, in which he first tested smallpox vaccines on his son and neighbourhood children. In an instance of self-experimentation, Johann Jorg swallowed 17 drugs in various doses to record their properties. Conversely, the famous scientist Louis Pasteur "agonized over treating humans," though he was confident of previous results obtained through extensive animal trials. He consented to treat a human only when he was convinced that the death of his first test subject, the child Joseph Meister, "appeared inevitable." (Rothman 1993)

[edit] Early 20th Century

In the 1900s, as the progress of medicine began to accelerate, the concept of the various codes of ethics of scientific disciplines changed dramatically, and the treatment of research subjects along with it.

Walter Reed's well-known experiments to develop an inoculation for yellow fever led these advances. Reed's vaccine experiments were carefully scrutinized, however, unlike earlier trials. (Brady 1982)

[edit] Modern Era

The infamous cases of human subjects abuse in the 20th century was Nazi experimentation, an example of research involving prisoners which came to light in the Nuremberg Doctors' trial and led to the Nuremberg Code of ethical human subjects research conduct. Research in the second half of the 20th century has been characterized by increasing attempts to protect human subjects through national agencies, institutional ethical review boards, and informed consent.

[edit] History of human subjects abuses

Strict policies now exist when a human being is the subject of an experiment. These evolved over time after particularly horrid abuses (and even atrocities) on human subjects: such as research involving prisoners, research on slaves and servants, and research on family members. In some notable cases, doctors have performed experiments on themselves when they have been unwilling to risk the well-being of others. This is known as self-experimentation.

[edit] 20th Century

Unit 731, a department of the Imperial Japanese Army located near Harbin (Manchukuo), experimented with prisoner vivisection, dismemberment, bacteria inoculation and induced epidemics on a very large scale from 1932 onward through the Second Sino-Japanese war. With the expansion of the empire during World War II, many other units were implemented in conquered cities such as Nanking (Unit 1644), Beijing (Unit 1855), Guangzhou (Unit 8604) and Singapore (Unit 9420). After the war, Supreme commander of occupation Douglas MacArthur gave immunity in the name of the United States to Shiro Ishii and all members of the units in exchange for all of the results.^[13] The United States blocked Soviet access to this information. However, some unit members were judged by the Soviets during the Khabarovsk War Crime Trials.

De-classified documents of the National Archives revealed that during the 1930s and 1940s, the British Army allegedly used hundreds of British and native British Indian Army soldiers as “guinea pigs” in their experiments to determine if mustard gas inflicted greater damage on Indian skin compared to British skin. It is unclear whether the trial subjects, some of whom were hospitalised by their injuries, were all volunteers.^{[14][15][16][17]}

Fort Detrick in Maryland was the headquarters of US biological warfare experiments. Operation Whitecoat involved the injection of infectious agents to observe their effects in human subjects.^[18]

[edit] After World War II

In Sweden, the Vipeholm experiments were conducted, where retarded test subjects were exposed to large amounts of sugar to induce dental caries. In the United Kingdom (voluntary) human experimentation at Porton Down in the 1950s, led to the death of Ronald Maddison. Pharmaceutical giant Pfizer came under fire in 2001 for allegedly testing meningitis drugs on Nigerian children.^[19] In Israel, a former worker of Negev Nuclear Research Center filed lawsuit, claiming that employees of the Center were given drinks with uranium without medical supervision and without obtaining written consent.^[20]

 [edit] United States

Main article: Human experimentation in the United States

There have been numerous human experiments performed in the United States, which have been considered unethical, and were often performed illegally, without the knowledge, consent, or informed consent of the test subjects.

Many types of experiments were performed including the deliberately infecting people with deadly or debilitating diseases, exposing people to biological and chemical weapons, human radiation experiments, injecting people with toxic and radioactive chemicals, surgical experiments, interrogation/torture experiments, tests involving mind-altering substances, and a wide variety of others. Many of these tests were performed on children and mentally disabled individuals. In many of the studies, a large number of the subjects were poor racial minorities or prisoners.

Many of these experiments were funded by the United States government, especially the Central Intelligence Agency and the United States military. The human research programs were usually highly secretive, and in many cases information about them was not released until many years after the studies had been performed.

Often, subjects were sick or disabled people, whose doctors told them that they were receiving "medical treatment", but instead were used as the subjects of harmful and deadly experiments, without their knowledge or consent. The ethical, professional, and legal implications of this in the United States medical and scientific community were quite significant, and led to many institutions and policies which attempted to ensure that future human subject research in the United States would be ethical and legal.

Public outcry over the discovery of government experiments on human subjects led to numerous congressional investigations and hearings, including the Church Committee, Rockefeller Commission, and Advisory Committee on Human Radiation Experiments, amongst others. However, as of 2010, not a single U.S. government researcher has been prosecuted for human experimentation, and many of the victims of U.S. government experiments have not received retribution, or in many cases, even acknowledgement of what was done to them.