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Cultural variation in informed consent for clinical research participation
Published in Paul M.W. Hackett, Christopher M. Hayre, Handbook of Ethnography in Healthcare Research, 2020
Although the Nuremberg Code, adopted in 1947, emphasized the ethical necessity of informed consent for research participation, many investigators continued to study human subjects without obtaining their consent. For example, participants in the Tuskegee Syphilis Study (1932–1972), which was sponsored by the U.S. Department of Health, Education, and Welfare, were not told that they were in a research study. They were told only that they were receiving treatment for “bad blood.” Likewise, subjects in the U.S. Department of Energy’s secret human radiation experiments, which took place from the 1930s to the 1960s, were not told that they were participating in research or that they were receiving radiation. Human subjects in the Jewish Chronic Disease Hospital Experiments, which took place in 1963, were not told that they had been injected with liver cancer cells as part of a study of the immune system’s response to cancer (Resnik 2018).
Informed consent
Published in Yann Joly, Bartha Maria Knoppers, Routledge Handbook of Medical Law and Ethics, 2014
The move towards stricter research ethics review of informed consent forms and more detailed rules does not mean that no further serious violations occurred in the decades following these developments. In fact, several reports have emerged of serious violations of informed consent standards following the adoption of informed consent requirements. New Zealand, for example, was confronted with a Tuskegee-like research scandal involving ‘observational studies’ of women suffering from cervical cancer, which led to a public inquiry (Committee of Inquiry 1988). In the US, President Clinton set up in 1994 an Advisory Committee to investigate postwar research involving radiation that took place in the context of the Cold War, and which revealed numerous instances of research with no or questionable informed consent from research subjects (Advisory Committee on Human Radiation Experiments 1995). More recently, Canadian historian Ian Mosby unearthed nutritional research undertaken in the post-WWII period on aboriginal communities and aboriginal children residing in residential schools, which raises troubling questions about failures of, or serious problems with, informed consent and exposure of research subjects to harm (Mosby 2013).
From Tracers to Treatment
Published in Alan Perkins, Life and Death Rays, 2021
There is no question that the science of the Manhattan project was brilliant. It had built on earlier knowledge in physics and biology and established methods for the medical use of radioactive materials in the human body. The radiotracer studies performed at Los Alamos, although initially motivated by radiation safety concerns, made a huge contribution to the understanding of human biology and medicine. The safety limits established at Los Alamos for the amounts of radionuclides within the human body enabled doctors to safely administer radioisotopes to humans for research, diagnosis and therapy. Although there was no excuse for the way the human radiation experiments of the time were undertaken, it is notable that the scientists and medics working with these new radioactive materials undertook many of the first experiments on themselves. One notable individual was Wright Langham, an analytical chemist who worked with the medical team at Los Alamos. His contribution to the science of radiobiology is often overlooked because he was so closely involved with the human plutonium studies. He pioneered the Los Alamos work for the assay of plutonium in urine samples and used whole body radiation counting equipment to determine retained activity in the body. He also developed methods for estimating human radiation doses using test objects filled with radioactivity to mimic the body and its internal organs. He was often seen with the plastic men he used in his experiments (Figures 8.3 and 8.4). These test objects are now known as ‘phantoms’ and are widely used by medical physicists and medical equipment engineers for the calibration of X-ray machines, gamma cameras, PET scanners and radiotherapy units. Tragically Wright Langham died along with eight other passengers in a plane crash in 1972 when an aircraft shuttle to Los Alamos, chartered by the Los Alamos Scientific Laboratories, lost power and nose-dived into a field shortly after taking off from Albuquerque International Airport.
Radiation protection biology then and now
Published in International Journal of Radiation Biology, 2019
Andrzej Wojcik, Mats Harms-Ringdahl
The ICRP did not meet between 1937 and 1950 (Clarke and Valentin 2009), so no recommendations on internal exposure limits were given until 5 years after World War II. In its 1950 recommendations, the ICRP states that the commission ‘is not in a position to make firm recommendations regarding the maximum permissible amounts of radioactive isotopes that may be taken into, or retained in the body’ (ICRP 1951). Nevertheless, based on maximum permissible exposures to radioactive isotopes for occupational workers used in U.S.A., Canada and U.K., exposure limits were given for radium, plutonium, strontium, polonium, tritium, carbon 14, sodium 15, phosphor 32, cobalt 60, and iodine 131 (ICRP 1951). Although the ICRP does not specify the source of data for the limits, it can be assumed that they, at least partly, came from the extensive animal experiments (Haley et al. 2011). However, it must be mentioned that some of the knowledge must also have come from human radiation experiments which were commonly carried out between the years 1944 and 1974 in U.S.A. and other nuclear program states (Advisory Committee on Human Radiation Experiments, 1995). Medical patients, prisoners, soldiers and children were intentionally exposed to radiation and isotopes, often without their knowledge or consent. Human experiments were not unique to the radiation field but were in line with the ethical standards (or the lack of such) at the time. Also, the process of acquiring scientific results from the Life Span Study of Hiroshima and Nagasaki survivors during the first 20 years of the program carried out by the Atomic Bomb Casualty Commission (ABCC) was criticized for low ethical standards in that survivors were treated as Guinea pigs (Beatty 1993).