Human experimentation

Human experimentation (medical experiments performed on human beings) is an important part of medical research, and many people volunteer for clinical trials of medical treatments. Some people also volunteer to be subjects for experiments in basic medical science and biology.

Some experiments can involve the testing of cosmetic products or ingredients on humans instead of animals. In some notable cases, doctors have performed experiments on themselves, when they have been unwilling to risk the lives of others: this is known as self-experimentation.

History of human experimentation
Human experimentation and research ethics evolved over time.

Ancient history
Aulus Cornelius Celsus, a 1st century Roman physicist, experimented on prisoners.

Early modern science
Among the first documented human subject research experiments  were vaccination trials in the 1700's. In these early trials, physicians used themselves or their family members 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 (1749-1823) experiments, in which he first tested smallpox vaccines on his son and neighbourhood children. In an instance of self-experimentation, Johann Jorg (1779-1856) swallowed 17 drugs in various doses to record their properties. Conversely, the famous scientist Louis Pasteur (1822-1895) "agonized over treating humans," though he was confident of previous results obtained through animal trials. He consented to treat a human only when he was convinced that the death of his first test subject, a child, "appeared inevitable." [Rothman 1993]

Early 20th century
In the 1900s,  the progress of medicine began to accelerate, and the treatment of research subjects also changed. The concept of human rights emerged, and with it came discussions of various codes of ethics of scientific disciplines.

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]

Medical experimentation has also been performed on humans without informed consent, both covertly and under coercion. The pretext of medical experimentation has been used as a justification for some of the most shameful atrocities in recorded human history. In Great Britain, human experimentation on 80,000 political prisoners occurred in the Andaman Islands  From 1932 until the 1970s, in the United States, citizens were experimented upon in the Tuskegee Syphilis Study.

World War II
During the second World War, Nazi human experimentation occurred in Germany. At the war's conclusion, 23 Nazi doctors and scientists were tried for the murder of concentration camp inmates who were used as research subjects. Of the 23 professionals tried at Nuremberg, 15 were convicted, 7 were condemned to death by hanging, 8 received prison sentences from 10 years to life, and 8 were acquitted. [Mitscherlich 1992]

In summary, the Nuremberg Code includes the following guidlines for researchers:
 * Informed consent is essential.
 * Research should be based on prior animal work.
 * The risks should be justified by the anticipated benefits.
 * Research must be conducted by qualified scientists.
 * Physical and mental suffering must be avoided.
 * Research in which death or disabling injury is expected should not be conducted.

In Japan, Unit 731 experimented with prisoner vivisection and dismemberment.

In the United States (1940), four hundred prisoners in Chicago were infected with Malaria to study the effects of new and experimental drugs for the disease. Beginning in 1942, mustard gas experiments were conducted on 4,000 United States service men in order to study the effects on the human nervous system. These tests concluded in 1945.

Declaration of Helsinki
In 1964 the World Medical Association developed a code of research ethics that came to be known as the Declaration of Helsinki. It was a reinterpretation of the Nuremberg Code, with an eye to medical research with therapeutic intent. Subsequently, journal editors required that research be performed in accordance with the Declaration. This document set the stage for the implementation of the Institutional Review Board (IRB) process. [Shamoo & Irving 1993]

Beecher Article
In 1966, anaesthesiologist Dr. Henry K. Beecher wrote an article, "Ethics and Clinical Research", describing 22 examples of research studies with controversial ethics that had been conducted by reputable researchers and published in major journals. Beecher wrote, "Medicine is sound, and most progress is soundly attained...". He believed, however, that if unethical research were not prohibited it would "do great harm to medicine". Beecher provided estimates of the number of unethical studies and concluded "unethical or questionably ethical procedures are not uncommon". [Beecher 1996]

Belmont Principles
The Public Health Service Syphilis Study was among the most influential in shaping public perceptions of research involving human subjects. When the press "blew the whistle" on the study, US Congress appointed a panel that determined that the PHS Syphilis Study should be stopped immediately and that oversight of human research was inadequate. The Panel recommended that Federal regulations be designed and implemented to protect human research subjects in the future. Subsequently, federal regulations were enacted, including the National Research Act, 45 Code of Federal Regulations 46, and 21 Code of Federal Regulations 50.

In 1974, the United States Congress authorized the formation of the National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research, known to most people in research ethics as the National Commission. Congress charged the National Commission to identify the basic ethical principles that underlie the conduct of human research. To accomplish this task, the National Commission looked at writings and discussions that had taken place to date and asked, "What are the basic ethical principles that are used to judge the ethics of human subject research?" Congress also asked the National Commission to develop guidelines to assure that human research is conducted in accordance with those principles.

In 1979, the National Commission met and published the Belmont Report. The Belmont Report is "required reading" for everyone involved in human subject research. The Belmont Report identifies three basic ethical principles that underlie all human subject research. These principles are commonly called the Belmont Principles. The Belmont Principles include respect for persons, beneficence, and justice.

After World War II, but not ongoing issues

 * United States: MKULTRA, the Tuskegee syphilis experiment (The Public Health Service Syphilis Study), hepatitis experiments on children at Willowbrook State School, Jewish Chronic Disease Study (1963), San Antonio Contraception Study (1971), Tea Room Trade Study, Obedience to Authority Study (Milgram Study), dermatological experiments on prisoners at Holmesburg Prison in Philadelphia (see Hornblum 1998), and human radiation experiments.
 * United Kingdom: (voluntary) human experimentation at Porton Down in the 1950s, leading to the death of Ronald Maddison
 * Pharmaceutical giant Pfizer came under fire in 2001 for allegedly testing meningitis drugs on African children.

Human vivisection
Vivisection has long been practised on human beings. Herophilos, the "father of anatomy" and founder of the first medical school in Alexandria, was described by the church leader Tertullian as having vivisected at least 600 live prisoners. In recent times, the wartime programs of Nazi Dr. Josef Mengele and the Japanese military (Unit 731 and Dr. Fukujiro Ishiyama at Kyushu Imperial University Hospital) conducted human vivisections on concentration camp prisoners in their respective countries during WWII. In response to these atrocities, the medical profession internationally adopted the Nuremberg Code as a code of ethics. This code of ethics does not prohibit vivisection on humans.

Human volunteers can consent to be subjects for invasive experiments which may involve, for example, the taking of tissue samples (biopsies), or other procedures which require surgery on the volunteer. These procedures must be approved by ethical review, and carried out in an approved manner that minimizes pain and long term health risks to the subject. Despite this, the term is generally recognized as pejorative: one would never refer to life-saving surgery, for example, as "vivisection." The use of the term vivisection when referring to procedures performed on humans almost always implies a lack of consent.

Ongoing issues

 * North Korea: Alleged North Korean human experimentation

In the last several years, reports of unethical studies including gene transfer, cancer, and psychiatric research have heightened public awareness of issues related to human experimentation.

Questionable psychological experiments
Several experiments have been conducted on consenting volunteers whose ethical nature is now considered questionable. Following exposure of these experiments, rules regarding informed consent have been tightened.
 * Milgram experiment
 * Stanford prison experiment

Further Readings

 * Goliszek, Andrew. In the Name of Science: A History of Secret Programs, Medical Research, and Human Experimentation, St. Martin's Press 2003, ISBN 0312303564
 * Hornblum, Allen. Acres of Skin: Human Experiments at Holmesburg Prison: A True Story of Abuse and Exploitation in the Name of Medical Science.  Routledge, 1998.
 * Kevorkian, Jack: A brief history of experimentation on condemned and executed humans. JAMA 77 (1985) pp.215-226
 * Lederer, Susan: Subjected to science. Human experimentation in America before the Second World War Baltimore, Maryland: Johns Hopkins University Press 1995