Factors for the Development of Research Ethics

Write 500 words on each of the following. Each of these subjects we dealt with in class briefly. I would like you to explain in more detail what they are about, and how they contributed to the development of research ethics as we know it today.

1. The Nuremberg Code

In Nazi concentration camps in World War II, atrocious experiments were performed on unwilling prisoners of war. These horrors of human experimentation included “high-altitude” tests in which inmates were put into high-altitude chambers without oxygen for the purpose of advancements in aviation medicine. Other inmates had sections of bones, muscles and nerves removed without anaesthesia in order to study bone, muscle and nerve regeneration [5]. Healthy prisoners were given injections from festering tissues of others with wound infections to investigate antibiotic therapy. Pieces of wood and glass were placed in open wounds to mimic war injuries [4]. These are just some of the experiments performed in order to gain information that might prove useful to the treatment of German soldiers.

The Nuremberg trials were held with the purpose of bringing Nazi war criminals to justice. There were 13 trials held between 1945-1949. Nazi party officials, high-ranking military officers, German industrialists, lawyers and doctors were among the defendants charged with crimes against peace and crimes against humanity. The best-known of the trials was “The Trial of Major War Criminals”, however “The Doctors Trial” is perhaps most interesting in the context of research ethics [1]. Of the 23 defendants, 16 were found guilty. The verdict also developed the Nuremberg Code. This written document established 10 ethical principles for protecting human subjects. This document aimed to protect humans from enduring the kind of cruelty and exploitation that the prisoners suffered at the concentration camps [2]. It states that, above all, participation in research must be voluntary. The main points include that the results of the research must be useful and unobtainable by other means, no study should be conducted if it is believed to cause death or disability, the study must avoid unnecessary suffering, the risks should never exceed the benefits, and experiments should be conducted only by qualified scientists. Other notable points are that subjects are entitled to end their participation at any time and the investigators must be prepared to stop the study when injury, disability or death is likely to occur [6].

The Code proved quite significant in the aftermath of the trials. It established well overdue limits on research involving humans. While these legal justifications were controversial at the time, they were a milestone toward the establishment of a permanent international court and developed important precedent for dealing with later cases of crimes against humanity. The findings at Nuremberg contributed directly to the United Nations Genocide Convention (1948) and Universal Declaration of Human Rights (1948) [1]. The Code is also one of several key documents that impacted the principles of Good Clinical Practice (GCP) [2]. The Declaration of Helsinki (1964) expanded upon the principles outlined in the Nuremberg Code. While the Code focuses on the human rights of research subjects, the Declaration of Helsinki focuses on the obligations of physician-investigators to research subjects. An important creation of the second revision of the Declaration was the creation of Research Ethics Committees. The Nuremberg Code has forever altered the way both physicians and the public view the proper conduct of medical research on human subjects [3].

References:

1. History. (2019). Nuremberg Trials. [online] Available at: https://www.history.com/topics/world-war-ii/nuremberg-trials [Accessed 6 Aug. 2019].
2. Jarmusik, N. (2019). The Nuremberg Code And Its Impact On Clinical Research. [online] Imarcresearch.com. Available at: https://www.imarcresearch.com/blog/bid/359393/nuremberg-code-1947 [Accessed 6 Aug. 2019].
3. New England Journal of Medicine. (2019). Fifty Years Later: The Significance of the Nuremberg Code | NEJM. [online] Available at: https://www.nejm.org/doi/full/10.1056/NEJM199711133372006 [Accessed 6 Aug. 2019].
4. Roelcke, V. (2004). Nazi medicine and research on human beings. The Lancet, 364, pp.6-7.
5. Spitz, V. (2005). Doctors from hell. Boulder, Colo.: Sentient Publ.
6. The Nuremberg Code (1947). (1996). BMJ, 313(7070), pp.1448-1448.

2. The Tuskegee Study

The U.S. Public Health Service conducted an infamous and unethical clinical study between 1932 and 1972 known as “The Tuskegee Study of Untreated Syphilis in the African American”. The study began at a time when these was no known treatment for syphilis. The study originally enrolled 600 black men, many of which were poor. Of the men, 399 had syphilis and a control group of 201 men did not have the disease. They were recruited by the promise of free medical care, free meals and free burial insurance. The aim of the study was to observe the natural history of untreated syphilis. However, the men in the study were not made aware of this and so the study was conducted without the benefit of the patients’ informed consent. The study was only meant to last 6 months, but it had a duration of 40 years. Doctors falsely informed the participants that they were being treated for “bad blood”. This was a local term used to describe several ailments. The men were only given placebos such as aspirin, even though penicillin became the recommended treatment for syphilis in 1947. Researchers from the U.S. Public Health Service convinced local physicians to continue the study without treating any participants. They withheld penicillin and information about it from the patients. The researchers provided no care as the men died, went blind or insane or experienced other sever health problems due to their untreated syphilis in order to tracks the disease’s full progression. A leak to the press resulted in the study’s termination in November 1972. By this time, 28 participants had died from syphilis, 100 more had died from related complications, at least 40 spouses had been diagnosed with it and the disease had been passed to 19 children at birth [3].

The Tuskegee Syphilis study is known as “arguably the most infamous biomedical research study in U.S. history” [2]. The first major ethical issue is informed consent. The participants of the study were not told about all aspects of the research. This lack of information could have influenced their decision to participate. The second major ethical issue is the withholding of treatment for research purposes. Patient welfare was neglected. Several other issues surrounded the study all based around race and science. The study forced people to rethink and redefine practices involving human experimentation. The study was deemed unethical for reasons related to ethical standards. The study has caused major alterations in U.S. law and regulations for the protection of human subjects in clinical studies. Revelations from the study led to the Belmont Report (1979) and to the development of the Office for Human Research Protection. The National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research and the National Research Act were established. Engaging with an Institutional Review Board is a necessity when undertaking a study. Now studies require informed consent, communication of diagnosis and accurate reporting of test results. Each of these principles were grossly violated in the Tuskegee Study [1].

References:

1. Heintzelman, C. (2003). The Tuskegee Syphilis Study and Its Implications for the 21st Century. [online] SocialWorker.com. Available at: https://www.socialworker.com/feature-articles/ethicsarticles/The_Tuskegee_Syphilis_Study_and_Its_Implications_for_the_21st_Century/  [Accessed 6 Aug. 2019].
2. Katz, R., Kegeles, S., Kressin, N., Green, B., Wang, M., James, S., Russell, S. and Claudio, C. (2006). The Tuskegee Legacy Project: Willingness of Minorities to Participate in Biomedical Research. Journal of Health Care for the Poor and Underserved, 17(4), pp.698-715.
3. Nix, E. (2017). Tuskegee Experiment: The Infamous Syphilis Study. [online] HISTORY. Available at: https://www.history.com/news/the-infamous-40-year-tuskegee-study [Accessed 6 Aug. 2019].

3. The Belmont Report

Due to the publicity of the Nuremberg Trials and the Tuskegee Syphilis Study, the National Research Act of 1974 was established. The National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research was subsequently developed to identify the basic ethical principles that would be the foundation of conducting biomedical and behavioural research involving human subjects. The Belmont Report is a report established by this commission.

The full title of the report is the “Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research” and it was published in 1978. This document was informed by intensive discussions that lasted almost 4 years. The Belmont Report identifies basic ethical principles and guidelines that address ethical issues resulting from the conduct of research with human participants [2]. In the process of creating this report, the commission acknowledged the existence of other codes governing human research and wanted to look at the topic more generally to allow recognition of fundamental principles. Researchers/investigators could then address these principles to resolve dilemmas for which other codes have no answer. The commission concluded that the core principles underlying ethical research with human participants are (A) respect for persons, (B) beneficence, and (C) justice. Informed consent, risk/benefit analysis and appropriate selection of patients are the tools applied to recognize these principles [1].

The report itself provides detailed accounts for each of these core principles. The first principle “respect for persons” incorporates two ethical convictions. Individuals should be treated as autonomous bodies, and secondly, that those with diminished autonomy are have the right to protection. In the report, an autonomous person is defined as an individual capable of deliberation about personal goals and of acting under the direction of such deliberation. “Respect for persons” insists that subjects take part in the research voluntarily and with adequate information [3].

In relation to the second principle “beneficence”, the report states that persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making sure to secure their well-being. There exists an obligation to do no harm and maximize possible benefits and minimize possible harms. These obligations affect both individual investigators and society at large, as they extend both to specific research projects and to the whole enterprise of research [3].

Lastly, the third principle “justice” enjoins that no grouping be selected for research by virtue of ease of access to the researchers, or by reason of vulnerability. This principle demands that those involved in research address the question of “who ought to receive the benefits of research and bear its burdens?”. An injustice is said to occur when some benefit to which a person is entitled is denied without good reason, or when some burden is appointed unduly. In other words, equals ought to be treated equally [3].

The Belmont Report serves as a historical document and supplies the moral framework for understanding regulations in the U.S. on the use of human subjects in research experiments.

References:

1. Fischer, B. (2005). A Summary of Important Documents in the Field of Research Ethics. Schizophrenia Bulletin, 32(1), pp.69-80.
2. HHS.gov. (2019). The Belmont Report. [online] Available at: https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html [Accessed 6 Aug. 2019].
3. United States. (1978). The Belmont report: ethical principles and guidelines for the protection of human subjects of research. [Bethesda, Md.], The Commission.