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1. Eventos que propician las regulaciones éticas en la investigación Rosita Puig Diaz, Ed. D.
Educ. 901
2. Eventos In preparing America for nuclear attack during the Cold War years following World War II, thousands of US citizens became the innocent victims of over 4,000 secret and classified radiation experiments conducted by the Atomic Energy Commission (AEC) and other government agencies, such as the Department of Defense, the Department of Health, Education and Welfare, the Public Health Service (now the CDC), the National Institutes of Health, the Veterans Administration (VA), the CIA, and NASA.
Millions of people were exposed to radioactive fallout from the continental testing of more than 200 atmospheric and underground nuclear weapons, and from the hundreds of secret releases of radiation into the environment. Over 200,000 “atomic vets” who worked closely with nuclear detonations at the Nevada test site during the 1950s and 1960s were especially vulnerable to radiation fallout.
Also affected were the thousands of so-called “downwinders”, who lived in nearby small towns in Nevada, Utah, Colorado and New Mexico. These downwinders (along with the animal populations) suffered the worst cumulative radioactive effects of fallout, along with a contaminated environment teeming with radioactive food and farm products. The plight of these poor country people exposed to government-induced radiation sickness has been recorded in Carole Gallagher’s remarkable photo-essay American Ground Zero: The Secret Nuclear War (The Free Press, 1993).
In reviewing declassified AEC records (now the Department of Energy) from the 1950s, Gallagher was shocked to discover one document that described the people downwind of the Nevada Test Site as “a low use segment of the population.” Her shock at such callous bigotry caused her to eventually move West to research, investigate and document those who lived closest to the Test Site, as well as workers at the site, and soldiers repeatedly exposed to nuclear bombs during the military tests
In preparing America for nuclear attack during the Cold War years following World War II, thousands of US citizens became the innocent victims of over 4,000 secret and classified radiation experiments conducted by the Atomic Energy Commission (AEC) and other government agencies, such as the Department of Defense, the Department of Health, Education and Welfare, the Public Health Service (now the CDC), the National Institutes of Health, the Veterans Administration (VA), the CIA, and NASA.
Millions of people were exposed to radioactive fallout from the continental testing of more than 200 atmospheric and underground nuclear weapons, and from the hundreds of secret releases of radiation into the environment. Over 200,000 “atomic vets” who worked closely with nuclear detonations at the Nevada test site during the 1950s and 1960s were especially vulnerable to radiation fallout.
Also affected were the thousands of so-called “downwinders”, who lived in nearby small towns in Nevada, Utah, Colorado and New Mexico. These downwinders (along with the animal populations) suffered the worst cumulative radioactive effects of fallout, along with a contaminated environment teeming with radioactive food and farm products. The plight of these poor country people exposed to government-induced radiation sickness has been recorded in Carole Gallagher’s remarkable photo-essay American Ground Zero: The Secret Nuclear War (The Free Press, 1993).
In reviewing declassified AEC records (now the Department of Energy) from the 1950s, Gallagher was shocked to discover one document that described the people downwind of the Nevada Test Site as “a low use segment of the population.” Her shock at such callous bigotry caused her to eventually move West to research, investigate and document those who lived closest to the Test Site, as well as workers at the site, and soldiers repeatedly exposed to nuclear bombs during the military tests
3. Eventos The Nuremberg Trials were a series of military tribunals, held by the victorious Allied forces of World War II, most notable for the prosecution of prominent members of the political, military, and economic leadership of the defeated Nazi Germany. The trials were held in the city of Nuremberg, Bavaria, Germany, in 1945–46, at the Palace of Justice. The first and best known of these trials was the Trial of the Major War Criminals before the International Military Tribunal (IMT), which tried 24 of the most important captured leaders of Nazi Germany, though several key architects of the war (such as Adolf Hitler, Heinrich Himmler, and Joseph Goebbels) had committed suicide before the trials began.
The Nuremberg Code is a set of research ethics principles for human experimentation set as a result of the Subsequent Nuremberg Trials at the end of the Second World War. (1947)
The Nuremberg Trials were a series of military tribunals, held by the victorious Allied forces of World War II, most notable for the prosecution of prominent members of the political, military, and economic leadership of the defeated Nazi Germany. The trials were held in the city of Nuremberg, Bavaria, Germany, in 1945–46, at the Palace of Justice. The first and best known of these trials was the Trial of the Major War Criminals before the International Military Tribunal (IMT), which tried 24 of the most important captured leaders of Nazi Germany, though several key architects of the war (such as Adolf Hitler, Heinrich Himmler, and Joseph Goebbels) had committed suicide before the trials began.
The Nuremberg Code is a set of research ethics principles for human experimentation set as a result of the Subsequent Nuremberg Trials at the end of the Second World War. (1947)
4. Eventos Jewish Chronic Disease Hospital Study
Again, this one came up in August 2010's Paper 1
Jewish Chronic Disease Hospital Study (1963):
Studies were conducted at the Jewish Chronic Disease Hospital in New York City to develop information on the nature of the human transplant rejection process. Chronically ill patients who did not have cancer were injected with live human cancer cells. The physicians did not inform the patients as to what they were doing. The physicians' rationalization for their actions was as follows: (i) they did not want to scare the patients and (ii) they thought the cells would be rejected.
Jewish Chronic Disease Hospital Study
Again, this one came up in August 2010's Paper 1
Jewish Chronic Disease Hospital Study (1963):
Studies were conducted at the Jewish Chronic Disease Hospital in New York City to develop information on the nature of the human transplant rejection process. Chronically ill patients who did not have cancer were injected with live human cancer cells. The physicians did not inform the patients as to what they were doing. The physicians' rationalization for their actions was as follows: (i) they did not want to scare the patients and (ii) they thought the cells would be rejected.
5. Eventos WILLOWBROOK HEPATITIS STUDY
From 1963 through 1966, studies were carried out at the Willowbrook State School, a New York State institution for “mentally defective persons.”
These studies were designed to gain an understanding of the natural history of infectious hepatitis and subsequently to test the effects of gamma globulin in preventing or ameliorating the disease.
The subjects, all children, were deliberately infected with the hepatitis virus; early subjects were fed extracts of stools from infected individuals and later subjects received injections of more purified virus preparations.
Investigators defended the deliberate injection of these children by pointing out that the vast majority of them acquired the infection anyway while at Willowbrook, and perhaps it would be better for them to be infected under carefully controlled research conditions.
During the course of these studies, Willowbrook closed its doors to new inmates, claiming overcrowded conditions. However, the hepatitis program, because it occupied its own space at the institution, was able to continue to admit new patients. Thus, in some cases, parents found that they were unable to admit their child to Willowbrook unless they agreed to his or her participation in the studies.
This case caused a public outcry because of the perception that parents and their children were given little choice about whether or not to participate in research.
WILLOWBROOK HEPATITIS STUDY
From 1963 through 1966, studies were carried out at the Willowbrook State School, a New York State institution for “mentally defective persons.”
These studies were designed to gain an understanding of the natural history of infectious hepatitis and subsequently to test the effects of gamma globulin in preventing or ameliorating the disease.
The subjects, all children, were deliberately infected with the hepatitis virus; early subjects were fed extracts of stools from infected individuals and later subjects received injections of more purified virus preparations.
Investigators defended the deliberate injection of these children by pointing out that the vast majority of them acquired the infection anyway while at Willowbrook, and perhaps it would be better for them to be infected under carefully controlled research conditions.
During the course of these studies, Willowbrook closed its doors to new inmates, claiming overcrowded conditions. However, the hepatitis program, because it occupied its own space at the institution, was able to continue to admit new patients. Thus, in some cases, parents found that they were unable to admit their child to Willowbrook unless they agreed to his or her participation in the studies.
This case caused a public outcry because of the perception that parents and their children were given little choice about whether or not to participate in research.
6. Eventos 1974 Federal Protections for Human Subject
1979 The Belmont Report 1980 Publication of the FDA Regulations
1981 HHS & FDA Revise Regulations
1982 CIOMS Guidelines
The Declaration of Helsinki[1] is a set of ethical principles regarding human experimentation developed for the medical community by the World Medical Association (WMA). It is widely regarded as the cornerstone document of human research ethics. (WMA 2000, Bošnjak 2001, Tyebkhan 2003)
It is not a legally binding instrument in international law, but instead draws its authority from the degree to which it has been codified in, or influenced, national or regional legislation and regulations (Human and Fluss 2001). Its role was described by a Brazilian forum in 2000 in these words "Even though the Declaration of Helsinki is the responsibility of the World Medical Association, the document should be considered the property of all humanity" (Human and Fluss 2001).6th version 2008
The Declaration of Helsinki[1] is a set of ethical principles regarding human experimentation developed for the medical community by the World Medical Association (WMA). It is widely regarded as the cornerstone document of human research ethics. (WMA 2000, Bošnjak 2001, Tyebkhan 2003)
It is not a legally binding instrument in international law, but instead draws its authority from the degree to which it has been codified in, or influenced, national or regional legislation and regulations (Human and Fluss 2001). Its role was described by a Brazilian forum in 2000 in these words "Even though the Declaration of Helsinki is the responsibility of the World Medical Association, the document should be considered the property of all humanity" (Human and Fluss 2001).6th version 2008
7. Eventos Jesse Gelsinger (June 18, 1981 - September 17, 1999) was the first person publicly identified as having died in a clinical trial for gene therapy. He was 18 years old. Gelsinger suffered from ornithine transcarbamylase deficiency, an X-linked genetic disease of the liver, the symptoms of which include an inability to metabolize ammonia - a byproduct of protein breakdown. The disease is usually fatal at birth, but Gelsinger had not inherited the disease; in his case it was the result of a genetic mutation and as such was not as severe - some of his cells were normal which enabled him to survive on a restricted diet and special medications.
Gelsinger joined a clinical trial run by the University of Pennsylvania that aimed at developing a treatment for infants born with severe disease. On September 13, 1999, Gelsinger was injected with an adenoviral vector carrying a corrected gene to test the safety of the procedure. He died four days later, September 17, at 2:30 pm, apparently having suffered a massive immune response triggered by the use of the viral vector used to transport the gene into his cells, leading to multiple organ failure and brain death.
A Food and Drug Administration (FDA) investigation concluded that the scientists involved in the trial, including the co-investigator Dr. James M. Wilson (Director of the Institute for Human Gene Therapy), broke several rules of conduct:
Inclusion of Gelsinger as a substitute for another volunteer who dropped out, despite having high ammonia levels that should have led to his exclusion from the trial
Failure by the university to report that two patients had experienced serious side effects from the gene therapy
Failure to disclose, in the informed-consent documentation, the deaths of monkeys given a similar treatment.
The University of Pennsylvania later issued a rebuttal[1] but paid the parents an undisclosed amount in settlement. Both Wilson and the University are reported to have had financial stakes in the research.[2][3] The Gelsinger case was a severe setback for scientists working in the field.[citation needed
Jesse Gelsinger (June 18, 1981 - September 17, 1999) was the first person publicly identified as having died in a clinical trial for gene therapy. He was 18 years old. Gelsinger suffered from ornithine transcarbamylase deficiency, an X-linked genetic disease of the liver, the symptoms of which include an inability to metabolize ammonia - a byproduct of protein breakdown. The disease is usually fatal at birth, but Gelsinger had not inherited the disease; in his case it was the result of a genetic mutation and as such was not as severe - some of his cells were normal which enabled him to survive on a restricted diet and special medications.
Gelsinger joined a clinical trial run by the University of Pennsylvania that aimed at developing a treatment for infants born with severe disease. On September 13, 1999, Gelsinger was injected with an adenoviral vector carrying a corrected gene to test the safety of the procedure. He died four days later, September 17, at 2:30 pm, apparently having suffered a massive immune response triggered by the use of the viral vector used to transport the gene into his cells, leading to multiple organ failure and brain death.
A Food and Drug Administration (FDA) investigation concluded that the scientists involved in the trial, including the co-investigator Dr. James M. Wilson (Director of the Institute for Human Gene Therapy), broke several rules of conduct:
Inclusion of Gelsinger as a substitute for another volunteer who dropped out, despite having high ammonia levels that should have led to his exclusion from the trial
Failure by the university to report that two patients had experienced serious side effects from the gene therapy
Failure to disclose, in the informed-consent documentation, the deaths of monkeys given a similar treatment.
The University of Pennsylvania later issued a rebuttal[1] but paid the parents an undisclosed amount in settlement. Both Wilson and the University are reported to have had financial stakes in the research.[2][3] The Gelsinger case was a severe setback for scientists working in the field.[citation needed
8. Eventos
