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Human subject research

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Human experimentation involves medical experiments performed on human beings. It is an important part of medical research, and many people volunteer for clinical trials of medical treatments. 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. Much of the time, the subjects of human experimentation are prisoners, slaves, family members, or the experimenter him/herself.

Ancient history

Herophilus of Chalcedon was reputed by Celcus, amongst others, to have vivisected prisoners received from the Ptolemaic kings.

Early modern science

Among the first documented human subject research experiments were vaccination trials in the 1700s. 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 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 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)

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 changed 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)

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 atrocities. From 1932 until the 1970s, in the United States, citizens were experimented upon in the Tuskegee Syphilis Study.

In Japan, Unit 731 experimented with prisoner vivisection, dismemberment and induced epidemics on a very large scale from the late 1920s onward through World War II. After the war, immunity was exchanged with the United States for a tiny part of the results, so that in post-war Japan, Shiro Ishii and others continued to hold honoured positions. The United States blocked Soviet access to this information. The effects were lasting and China is still working to counteract the effects of buried pathogen caches.[citation needed]

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. Seven of them were condemned to death by hanging and eight received prison sentences from 10 years to life. Eight professionals were acquitted. (Mitscherlich 1992)

The result of these proceedings was the Nuremberg Code. It includes the following guidelines, among others, 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 1940 in the United States, 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 servicemen in order to study the effects on the human nervous system. These tests concluded in 1945.

Fort Detrick in Maryland was the headquarters of US biological warfare experiments. Operation Pettycoat involved the injection of infectious agents to observe their effects in human subjects [1].

Declaration of Helsinki

Main article: 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 exposed 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

In the United States

The CIA ran an extensive toxicology and chemical/biological warfare program in cooperation with the US military. The Edgewood Arsenal and US Army Medical Research Institute for Infectious Diseases at Fort Detrick in Maryland were the main headquarters for such studies. The CIA developed many of the exotic toxins, incapacitants, mind-altering substances and carcinogens. The CIA attempted to use toxins to assassinate on Fidel Castro and other world leaders such as General Abdul Karim Quassim of Iraq and Patrick Lumumba of the Congo who nationalized Congo's mineral mines. Mind-control substances were studied to facilitate interrogation and toxins were used as weapons in assassination. One of the toxins that the CIA studied extensively was derived from red algae called dinoflagellate which produced the red tide. The MK-ULTRA project was a CIA run human experiment program where prisoners and unwitting subjects were administered hallucigenic drugs in attempt to develop incapacitating substances and chemical mind control agents. The operation was run by Sidney Gottlieb. CIA researchers at the Bien Hua prison conducted human experiments on Vietnamese Communist subjects as a form of torture. The CIA was accused of murdering one of the unwitting subjects of the CIA LSD tests named Frank Olson [3]. The CIA claimed that the man committed suicide as an after-effect of the LSD but the family exhumed the body and a forensic pathologist found evidence of blunt trauma to the head suggesting that he was knocked out before being thrown out of the window of a hotel. This supported the Olsen family's claims that CIA killed had him because he wanted to expose the MK-Ultra program [4]. The Church Investigation revealed some information on this project.

A Manhattan District Attorney opened up an investigation but did not have enough evidence to prosecute. It is interesting to note that soon after this happened, the former CIA director William Colby drowned and he would have been a key witness. Dr. Sidney Gottlieb requested that William Colby destroy most of the documents on the MK-Ultra program. Some suspect that the trial would produce information that would devastate the reputation of the William Colby and other officials involved in MK Ultra[5].

The CIA also recruited the University of Pennsylvania dermatology professor named Dr. Albert Klingman to run the studies of the Holmsburg Prison. Kligman also conducted human studies on the effects of blistering agents on human skin [6].

The US government also conducted numerous human radiation experiments [7].

In Pinochet's Chile

Human experimentation was carried on in Colonia Dignidad, headed by ex-Nazi Paul Schäfer and used as a concentration camp by the DINA, Augusto Pinochet's secret police, according to March 2005 declarations by former CIA and DINA agent Michael Townley. These experimentations would have been carried out on detainees, with the cooperation of the DINA, the Bacterioogical War Army Laboratory located in Colonia Dignidad, and German occupants of the Colonia Dignidad.[1]

Human vivisection

Main article: Vivisection and experimentation debate

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 [8]. 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

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. [citation needed]

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.

Endnotes

  1. ^ Michael Townley fue interrogado por muerte de Frei Montalva, Radio Cooperativa, March 30, 2005 Template:Es icon

References

  • Beecher, Henry K. "Ethics And Clinical Research." The New England Journal of Medicine. Vol 274 No. 24, June 16, 1966, 1354 - 1360
  • Brady, Joseph V. and Jonsen, Albert R. "The Evolution of Regulatory Influences on Research with Human Subjects." Human Subjects Research - A Handbook for Institutional Review Boards. Ed. Greenwald, Robert A. et al. New York: Plenum Press, 1982. 3 - 18
  • Mitscherlich, Alexander and Mielke, Fred. "Epilogue: Seven Were Hanged." Ed. Annas, George J and Grodin, Michael A. The Nazi Doctors And The Nuremberg Code - Human Rights in Human Experimentation. New York: Oxford University Press, 1992. 105 - 107
  • Rothman, David J. "Ethics and Human Experimentation: Henry Beecher Revisited." The New England Journal of Medicine. Vol. 317, No. 19, Nov.5, 1987 - Public Responsibility in Medicine and Research, Boston, April 1 - 2, 1993
  • Shamoo, Adil E. and Irving, Dianne N. "Accountability in Research." 1993 in press - Public Responsibility in M

Further reading

  • Goliszek, Andrew. In the Name of Science: A History of Secret Programs, Medical Research, and Human Experimentation, St. Martin's Press 2003, ISBN 0-312-30356-4
  • 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
  • Moreno, Jonathan D. Undue Risk: Secret State Experiments on Humans. W H Freeman 1999, Routledge 2001.
  • Welsome, Eileen. The Plutonium Files: America's Secret Medical Experiments in the Cold War. Dell Publishing (Random House), 1999.

See also

External links

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