• An Introduction to Ethics for Paramedics

    by Alan Batt. Last modified: 26/02/14

    ethics1

    What are ethics?

    Ethics are rules of behavior based on ideas about what is morally good and bad. Bioethics is the study of ethics brought about by advances in biology and medicine. The scope of bioethics is wide-ranging, dealing with a vast array of issues such as those arising from issues like abortion, euthanasia, clinical trial design, surrogacy, organ donation, termination of life support, stem cell research, genetic testing, cloning and more.

    Ethical Principles

    Four fundamental principles of ethics should apply when we talk about medical ethics:

    1. Non-maleficence – Primum non nocere – “first, do no harm”.
    2. Respect for autonomyVoluntas aegroti suprema lex – the patient has the right to refuse or choose their treatment.
    3. BeneficenceSalus aegroti suprema lex – a practitioner should act in the best interest of the patient.
    4. Justice – concerns the distribution of scarce health resources, and the decision of who gets what treatment.

    Two additional ethical values are also often discussed in light of certain events like those listed below

    1. Respect for persons – the patient and care provider have the right to be treated with dignity.
    2. Honesty – the concept of informed consent.

    Related readings

     

    What is informed consent?

    Informed consent is a process by which a subject voluntarily and freely confirms his/her willingness to participate in a trial/study, after having been informed of all involved aspects – risks, benefits, possible side-effects and outcomes.

    informed

    •  
      Hutton JL1, Eccles MP, Grimshaw JM. Ethical issues in implementation research: a discussion of the problems in achieving informed consent. Implement Sci. 2008 Dec 17;3:52. PMID: 19091100.
    •  
      Weindling P. The origins of informed consent: the International Scientific Commission on Medical War Crimes, and the Nuremburg code. Bull Hist Med. 2001 Spring;75(1):37-71. PMID: 11420451.
    •  
      Sacchini D1, Pennacchini M. Informed consent. Clin Ter. 2010;161(4):397-9. PMID: 20931166.

    Why do we need ethics in research?

    Prior to 1949, no informed consent was needed from participants in research studies. In fact, some participants didn’t even know they were they subjects of a research study! Without an ethical approach to experimentations we end up with the likes of…

    Nazi experiments in concentration camps – 1940s

    AuschwitzNazi doctors subjected prisoners to a barrage of “medical experiments” through the SS concentration camp network, including camps such as Dachau and Auschwitz. Inmates were forced to stand for hours in freezing water or naked in the bitterly cold air. Sections of bones, muscles, and nerves were removed from subjects without use of anesthesia, and other inmates were deliberately exposed to mustard gas and other vesicants which caused severe chemical burns.

    Inmates were injected with trial immunisations for the prevention and treatment of contagious diseases, including malaria, typhus, tuberculosis, typhoid fever and yellow fever in order to study the effects. Medical experiments on twins such as injection of different dyes into the eyes of twins to see whether it would change their colour to literally sewing twins together in attempts to create conjoined twins were carried out in Aushcwitz under the direction of Dr. Josef Mengele.

    Other experiments were also carried out on prisoners such as sea-water ingestion, sterilisation through radiation, surgery and injections, gangrene, poisonings, low-pressurisation, and head-injuries. Prisoners were forced into participating; refusal meant execution; they did not willingly volunteer and there was never informed consent. Typically, the experiments resulted in death, disfigurement or permanent disability, and as such are considered examples of medical torture.

    • Lagnado, Lucette (1992). Children of the Flames; Dr. Josef Mengele and the Untold Story of the Twins of Auschwitz. Penguin
    • Spitz, Vivien (2005). Doctors from Hell: The Horrific Account of Nazi Experiments on Humans. Sentient Publications
    • Nyiszli, Miklos (2011) Auschwitz: A Doctor’s Eyewitness Account. Arcade
    •  
      López-Muñoz F1, García-García P, Alamo C. The pharmaceutical industry and the German National Socialist Regime: I.G. Farben and pharmacological research. J Clin Pharm Ther. 2009 Feb;34(1):67-77. PMID: 19125905.
    •  
      Bogod D. The Nazi hypothermia experiments: forbidden data? Anaesthesia. 2004 Dec;59(12):1155-6. PMID: 15549970.
    •  
      López-Muñoz F1, Alamo C, García-García P, Molina JD, Rubio G. The role of psychopharmacology in the medical abuses of the Third Reich: from euthanasia programmes to human experimentation. Brain Res Bull. 2008 Dec 16;77(6):388-403. PMID: 18848972.
    •  
      Chelouche T. Medicine and the Holocaust--lessons for present and future physicians. Med Law. 2008 Dec;27(4):787-804. PMID: 19202857.

    Willowbrook State School Hepatitis Study – 1960s

    willowFunded in part by the US Surgeon General’s Office, during the 1960s residents in the Willowbrook State School for the Disabled (children who were mentally disabled) were deliberately infected with hepatitis. Early subjects were fed extracts of stools from infected individuals in milkshakes and later subjects received injections of more purified virus preparations. 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.

    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. Parents of these children were coerced into giving consent for their child to partake in the study by the lack of available space in the school – they were unable to admit their child to Willowbrook unless they agreed to his or her participation in the studies.

    Tuskegee & Guatemala Syphilis Studies – 1940s – 1970s

    tuskFrom 1946 – 1948, American Doctors infected soldiers, prostitutes, prisoners and mental patients in Guatemala with syphilis and other sexually transmitted diseases, without the informed consent of the subjects. They treated most subjects with antibiotics, but the study resulted in at least 83 deaths.

    The experiments were led by Dr. John Charles Cutler from the United States Public Health Service, who later took part in the later stages of the Tuskegee syphilis experiment.

    The Tuskegee study enrolled 600 impoverished sharecroppers from Macon County, Alabama who had syphilis – they were never told they had syphilis, nor were they ever treated for it. The study was controversial for reasons related to ethical standards, primarily because researchers knowingly witheld information of treatment and treatment itself from the study participants. Penicillin had been vaildated as an effective cure for syphilis in 1947.

    Unit 731 – Japanese biological weapons study – 1940s

    u731Unit 731 was a covert biological and chemical warfare research and development unit of the Japanese Army that undertook lethal human experimentation during the Second Sino-Japanese War and World War II. It was responsible for some of the most notorious war crimes carried out by Japanese personnel. Between 3,000 and 12,000 men, women, and children died as a result of human experimentation carried out in Unit 731.

    Prisoners of war, those who fought against the Japanese forces, criminals and those arrested for “suspicious activities” were infected with diseases then cut up without anaesthetic to see how the diseases developed. Limbs were cut off in the same way to study blood loss or allowed to develop gangrene to observe decomposition. Organs were removed without anaesthesia,

    Chemical and biological weapons were tested on live human subjects, people were buried alive or injected with sea water (to determine if it could be a substitute for saline), starved to death and frozen, placed into centrifuges and spun until death; injected with animal blood and exposed to lethal doses of x-rays as part of the experiments carried out by Unit 731.

    Nuremberg Code 1949

    Following the revelations during the Nuremberg Trials of the atrocities carried out under the name of medical research in the Nazi concentration and extermination camps, the Nuremberg Code was drafted.

    It contains 10 Key Points:

    1. Informed voluntary consent essential
    2. Experiment should be aimed to yield fruitful results for the good of society
    3. The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease
    4. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.
    5. No experiment should be conducted where there is a prior reason to believe that death or disabling injury will occur
    6. The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.
    7. Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death
    8. The experiment should be conducted only by scientifically qualified persons
    9. During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible.
    10. During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.

    Download from: http://history.nih.gov/research/downloads/nuremberg.pdf

    Declaration of Helsinki 1964

    The Declaration of Helsinki is a set of ethical principles regarding human experimentation developed in 1964 for the medical community by the World Medical Association originally, which has been revised on several occassions, most recently in 2013 (7th revision).

    The Declaration is morally binding on physicians, and that obligation overrides any national or local laws or regulations, if the Declaration provides for a higher standard of protection of humans than the latter.

    It promotes many of the same principles of the Nuremberg Code, with an emphasis on informed consent, the right to self-determination, research subject’s welfare, the increased vulnerability of certain individuals and groups, promotion of the scientific process and gives advice on the ethical implementation of clinical trials.

    More Reading

    Free chapter on Ethics & Law for the Paramedic

    Download from: http://mcgraw-hill.co.uk/html/0335243878.html

     
    Weisse AB. Saving lives, not sacrificing them: the inevitable clash between medical research and the protection of medical subjects. Proc (Bayl Univ Med Cent). 2013 Jul;26(3):306-10. PMID: 23814400.
     
    Bhatt A. Evolution of clinical research: a history before and beyond james lind. Perspect Clin Res. 2010 Jan;1(1):6-10. PMID: 21829774.

    Cite this article as: Alan Batt.(26/02/14) "An Introduction to Ethics for Paramedics" in Prehospital Research Support Site, available at http://prehospitalresearch.eu/?p=1495. Accessed 17/11/19.

    References

     
    1.

    Sacchini D1, Pennacchini M. Informed consent. Clin Ter. 2010;161(4):397-9. PMID: 20931166.

     
    2.

    Weisse AB. Saving lives, not sacrificing them: the inevitable clash between medical research and the protection of medical subjects. Proc (Bayl Univ Med Cent). 2013 Jul;26(3):306-10. PMID: 23814400.

     
    3.

    Bhatt A. Evolution of clinical research: a history before and beyond james lind. Perspect Clin Res. 2010 Jan;1(1):6-10. PMID: 21829774.

     
    4.

    Chelouche T. Medicine and the Holocaust–lessons for present and future physicians. Med Law. 2008 Dec;27(4):787-804. PMID: 19202857.

     
    5.

    López-Muñoz F1, García-García P, Alamo C. The pharmaceutical industry and the German National Socialist Regime: I.G. Farben and pharmacological research. J Clin Pharm Ther. 2009 Feb;34(1):67-77. PMID: 19125905.

     
    6.

    Hutton JL1, Eccles MP, Grimshaw JM. Ethical issues in implementation research: a discussion of the problems in achieving informed consent. Implement Sci. 2008 Dec 17;3:52. PMID: 19091100.

     
    7.

    López-Muñoz F1, Alamo C, García-García P, Molina JD, Rubio G. The role of psychopharmacology in the medical abuses of the Third Reich: from euthanasia programmes to human experimentation. Brain Res Bull. 2008 Dec 16;77(6):388-403. PMID: 18848972.

     
    8.

    Markman JR1, Markman M. Running an ethical trial 60 years after the Nuremberg Code. Lancet Oncol. 2007 Dec;8(12):1139-46. PMID: 18054883.

     
    9.

    Weindling P. The origins of informed consent: the International Scientific Commission on Medical War Crimes, and the Nuremburg code. Bull Hist Med. 2001 Spring;75(1):37-71. PMID: 11420451.

     
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    Shuster E. Fifty years later: the significance of the Nuremberg Code. N Engl J Med. 1997 Nov 13;337(20):1436-40. PMID: 9358142.

     
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    Woods D. Lessons still need to be learned from Nuremberg. BMJ. 1996 Dec 7;313(7070):1422. PMID: 11644869.

     
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    Grodin MA, Annas GJ. Legacies of Nuremberg. Medical ethics and human rights. JAMA. 1996 Nov 27;276(20):1682-3. PMID: 8922458.

     
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    Bogod D. The Nazi hypothermia experiments: forbidden data? Anaesthesia. 2004 Dec;59(12):1155-6. PMID: 15549970.

     
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    Nie JB. The United States cover-up of Japanese wartime medical atrocities: complicity committed in the national interest and two proposals for contemporary action. Am J Bioeth. 2006 May-Jun;6(3):W21-33. PMID: 16754432.

     
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    Watts J. Victims of Japan’s notorious Unit 731 sue. Lancet. 2002 Aug 24;360(9333):628. PMID: 12241948.

     
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    Girdwood RH. Experimentation on prisoners by the Japanese during World War II. Br Med J (Clin Res Ed). 1985 Aug 24;291(6494):530-1. PMID: 11652444.

     
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    Lantos JD. Does pediatrics need its own bioethics? Perspect Biol Med. 2010 Autumn;53(4):613-24. PMID: 21037414.

     
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    Mays VM. The Legacy of the U. S. Public Health Services Study of Untreated Syphilis in African American Men at Tuskegee on the Affordable Care Act and Health Care Reform Fifteen Years After President Clinton’s Apology. Ethics Behav. 2012 Nov 1;22(6):411-418. PMID: 23630410.

     
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    Levine RS1, Williams JC, Kilbourne BA, Juarez PD. Tuskegee redux: evolution of legal mandates for human experimentation. J Health Care Poor Underserved. 2012 Nov;23(4 Suppl):104-25. PMID: 23124504.

     
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    Mays VM. Research Challenges and Bioethics Responsibilities in the Aftermath of the Presidential Apology to the Survivors of the U. S. Public Health Services Syphilis Study at Tuskegee. Ethics Behav. 2012;22(6):419-430. PMID: 23878499.

     
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    Rothman DJ. Research ethics at Tuskegee and Willowbrook. Am J Med. 1984 Dec;77(6):A49. PMID: 6507454.

     
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    Alan Batt

    Alan Batt

    Paramedic, educator, researcher
    Alan is a critical care paramedic, paramedic educator and prehospital researcher, currently working around the world as an educator and researcher. He has previously worked and studied across Europe, North America and the Middle East. He holds a Graduate Certificate in Intensive Care Paramedic Studies, and an MSc in Critical Care. His main interests are in care of the elderly, end-of-life care, patient safety, professionalism (including role and identity), and paramedic education.

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