Indignity of Nazi data: reflections on the utilization of illicit research.

Human rights may feel self-apparent to us, but less than 80 years ago, one of the most advanced countries at the time acted based on an utterly contrary ideology. The view of social Darwinism that abandoned the idea of the intrinsic value of human lives instead argued that oppression of the inferior is not only inevitable but desirable. One of the many catastrophic outcomes is the medical data obtained from inhuman experiments at concentration camps. Ethical uncertainty over whether the resulting insights should be a part of the medical literature provides a chance to consider the seemingly irreplaceable social construct of human dignity. Would any medical benefit justify the utilization of this illicit data? Would utilization even qualify as an insult to the dignity of the exploited subjects, or is this a question about intersubjective meaning? This work discusses the wisdom in blind adherence to human dignity, the possibility of retrospective insults, moral complicity, contrary viewpoints, and possible resolutions.

"The Warmth of His Continuing Interest": Henry K. Beecher, the Bioethics Revolution, and Pharmaceutical Industry Funding of Academic Medical Science in Cold War America.

This paper examines anesthesiologist Henry K. Beecher's funding relationship with pharmaceutical manufacturer Edward Mallinckrodt, Jr. Beecher is a familiar figure to both medical ethicists and historians of medicine for his role in the bioethics revolution of the 1960s and 1970s. In particular, his 1966 article "Ethics and Clinical Research" is widely considered a turning point in the post-World War II debate about informed consent. We argue that Beecher's scientific interests should be understood in the context of his funding relationship with Mallinckrodt and that this relationship shaped the direction of his work in important ways. We also argue that Beecher's views on research ethics reflected his assumption that collaboration with industry was a normal part of how academic science is conducted. In the conclusion of the paper we suggest that Beecher's failure to consider his relationship with Mallinckrodt as worthy of ethical deliberation has important lessons for academic researchers who collaborate with industry today.

The Dangers of White Supremacy: Nazi Sterilization and Its Mixed-Race Adolescent Victims.

Mixed-race African German and Vietnamese German children were born around 1921, when troops drawn from the French colonial empire occupied the Rhineland. These children were forcibly sterilized in 1937. Racial anthropologists had denounced them as "Rhineland Bastards," collected details on them, and persuaded the Nazi public health authorities to sterilize 385 of them. One of the adolescents later gave public interviews about his experiences. Apart from Hans Hauck, very few are known by name, and little is known about how their sterilization affected their lives. None of the 385 received compensation from the German state, either as victims of coerced sterilization or as victims of Nazi medical research. The concerned human geneticists went unprosecuted. (Am J Public Health. 2022;112(2):248-254. https://doi.org/10.2105/AJPH.2021.306593).

Biomedical Research in Times of Emergency: Lessons From History.

Coronavirus disease 2019 (COVID-19) has sickened millions, killed hundreds of thousands, and utterly disrupted the daily lives of billions of people around the world. In an effort to ameliorate this devastation, the biomedical research complex has allocated billions of dollars and scientists have initiated hundreds of clinical trials in an expedited effort to understand, prevent, and treat this disease. National emergencies can stimulate significant investment of financial, physical, and intellectual resources that catalyze impressive scientific accomplishments, as evident with the Manhattan Project, penicillin, and the polio vaccines in the 20th century. However, pressurized research has also led to false promises, disastrous consequences, and breaches in ethics. Antiserum in the 1918 flu epidemic, contaminated yellow fever vaccines in World War II, and unethical human experimentation with mustard gas offer just a few cautionary exemplars. It is critical to continue biomedical research efforts to address this pandemic, and it is appropriate that they receive priority in both attention and funding. But history also demonstrates the importance of treating early results-such as those associated with hydroxychloroquine-with caution as we only begin to understand the biology, epidemiology, and potential target points of COVID-19.

Research on Tuberculosis in Nazi Germany and the Cruelest Medical Experiments on Jewish Children: An Observational Review.

BACKGROUND: Germany was a scientifically advanced country in the 19th and early 20th centuries, particularly in medicine, with a major interest in research and the treatment of tuberculosis. From 1933 until 1945, Nazi Germany perverted scientific research through criminal experimentations on captured prisoners of war and on "subhumans" by scientifically untrained, but politically driven, staff. This article exposes a series of failed experiments on tuberculosis in adults, experiments without scientific validity. Nonetheless, Dr. Kurt Heißmeyer repeated the experiment on Jewish children, who were murdered for the sake of personal academic ambition. It is now 75 years since liberation and the murdered children must be remembered. This observational review raises questions of medical and ethical values.

Belmont in Context.

Given its outsized influence as a core document in bioethics, it is worth reminding ourselves of the historical context in which the Belmont Report came to be. This article examines the societal forces that helped bring about the Belmont Report and that shaped its conception of ethical research. A product of a public investigation that included many nonscientists and espoused philosophical principles, the Report internalized a growing call in the late 1960s for oversight over the research enterprise, which had long been the private realm of physician-investigators. Belmont helped bring about a regulatory and oversight apparatus to the research enterprise, as well as a language and discipline of bioethics that added a multidisciplinary set of voices and decision-makers to discussions of what constitutes ethical research. Because it reflected the spirit of protectionism engendered by events of the 1960s and 1970s, Belmont also helped emphasize the importance of informed consent and the protection of vulnerable populations. But because the Report was a product of its time, contingent on historical developments and highly publicized events, it is not necessarily responsive to new factors that now condition the research enterprise.

Belmont in Europe: A Mostly Indirect Influence.

This paper traces the reception of the Belmont Report in Europe and its influence on the development of European research ethics thinking and European research ethics systems. It is very difficult to trace a clear, linear reception history because it is difficult to disentangle the influence of the Report from the influence of concurrent developments, such as the 1975 revision of the World Medical Association Declaration of Helsinki and the requirement for research ethics review in the Vancouver Group's 1978 "Uniform Requirements for Manuscript Submission." The Report's insistence that the focus of research ethics should be the rights and interests of the individual research subject, and the use of an ethical framework and not ethical theory as the basis of analysis and justification of recommendations, were nevertheless very important for the development of research ethics. The divergence between Europe and the US in the governance of non-biomedical research can at least partly be explained by the absence of strong drivers for the introduction of research ethics committees outside of biomedicine in Europe, and by the ability of non-biomedical researchers to mobilize effectively against the introduction of such committees.

The Belmont Report and Innovative Practice.

One of the Belmont Report's most important contributions was the clear and serviceable distinction it drew between standard medical practice and biomedical research. A less well-known achievement of the Report was its conceptualization of innovative practice, a type of medical practice that is often mistaken for research because it is new, untested, or experimental. Although the discussion of innovative practice in Belmont is brief and somewhat cryptic, this does not reflect the significant progress its authors made in understanding innovative practice and the distinctive ethical issues it raises. This article explores the history and broader context of Belmont's conception of innovative practice, its strengths and weaknesses, and its contemporary relevance for scholars working in bioethics and health policy. While this conception of innovative practice deserves our attention, it is inherently limited in some important ways.

The Origins and Drafting of the Belmont Report.

This article describes the origins and drafting of the Belmont Report by members of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.

"A Revolution in Favor of Reproduction"? Gynecology and Obstetrics in the "Third Reich".

During the "Third Reich," the majority of German gynecologists and obstetricians did not hesitate to put themselves at the service of those in power. In 1933, many gynecologists initially only focused on the fact that the biopolitical objectives of the National Socialists matched their own long-standing demands for population policy measures and the early detection and prevention of cancer. In addition, cooperating with the Nazis promised the political advancement of the profession, personal advantages, and the honorary title of Volksgesundheitsführer (national health leaders). As a result, gynecologists exchanged resources with the regime and thus contributed significantly to the implementation of the criminal racial policies of the Nazis. At the congresses of the Deutsche Gesellschaft für Gynäkologie (German Society of Gynecology) "non-Aryan" members, mostly of Jewish descent, were excluded, the law on forced sterilization of 1933 (Gesetz zur Verhütung erbkranken Nachwuchses/Law for the Prevention of Offspring with Hereditary Diseases) was scientifically legitimized, its implementation was propagated, and relevant surgical techniques were discussed with regard to their "certainty of success." In the course of these forced sterilizations, existing pregnancies were also terminated and the victims were misused for illegal scientific examinations or experiments. Drawing upon racial and utilitarian considerations, gynecologists did not even shy away from carrying out late abortions on forced laborers from the East during the Second World War, which were strictly prohibited even under the laws of the time. Some gynecologists carried out cruel experiments on humans in concentration camps, which primarily served their own careers and the biopolitical goals of those in power. The few times gynecologists did protest or resist was when the very interests of their profession seemed threatened, as in the dispute over home births and the rights of midwives. Social gynecological initiatives from the Weimar Republic, which were mainly supported and carried out by gynecologists persecuted for their Jewish descent since 1933, were either converted into National Socialist "education programs" or simply came to an end due to the exclusion of their initiators. German gynecologists had hoped for a large-scale promotion of the early detection of malignant diseases of the uterus and breasts, to which they had already made important contributions since the beginning of the 20th century. But even though the fight against cancer was allegedly one of the priorities of the Nazis, no comprehensive measures were taken. Still, a few locally limited initiatives to this end proved to be successful until well into the Second World War. In addition, German gynecologists established the modern concept of prenatal care and continued to advance endocrinological research and sterility therapy. After the end of the Nazi dictatorship, the historical guilt piled up during this period was suppressed and denied for decades. Its revision and processing only began in the 1990s.

The Eye Color Experiment: From Berlin to Auschwitz and Back.

BACKGROUND: In an effort to alter eye color during World War II, devout Nazi researcher Karin Magnussen had adrenaline eye drops administered to inmates at the concentration camp Auschwitz-Birkenau. A Sinti family, with a high prevalence of heterochromia iridis, was forced to participate in this study. Members of this family, as well as other victims, were later killed and had their eyes enucleated and sent to Magnussen for examination. Magnussen articulated the findings of these events in a manuscript that has never been published. The author is the first ophthalmologist to review this manuscript. The generation who experienced the atrocities of World War II will soon be gone and awareness of what happened during this tragic chapter of world history is fading. OBJECTIVES: To describe these events to raise awareness among future generations. METHODS: A literature review and archival search was conducted. RESULTS: Magnussen's research was based on an animal study published in 1937. For Magnussen's study, adrenaline drops were administered to inmates, including a 12-year-old girl from the Sinti family. As there was a reported case of deaf-mutism within the family, Waardenburg syndrome seems to be the most plausible explanation for this family's heritable heterochromia. CONCLUSIONS: The effort to change eye color was doomed to fail from the beginning because there was a probable diagnosis of Waardenburg syndrome. Extinction of humans for ophthalmological research is an insane act beyond imagination. For the sake of these victims, and for the generations who still feel their pain, it is imperative to tell their stories.

Electroconvulsive Therapy in the Shadow of the Gas Chambers: Medical Innovation and Human Experimentation in Auschwitz.

Six years after it was first introduced into psychiatry in 1938, electroconvulsive therapy (ECT) became the subject of criminal human experiments in Nazi Germany. In 1944, at the Auschwitz III / Monowitz camp hospital, the Polish Jewish prisoner psychiatrist Zenon Drohocki started experimental treatments on prisoners with an ECT device that he had constructed himself. According to eyewitnesses, Drohocki's intention to treat mentally unstable prisoners was soon turned into something much more nefarious by SS doctors (including Josef Mengele), who used the device for deadly experiments. This article provides an account of this important and little-known aspect of the early history of ECT, drawing on an extensive array of historical literature, testimonies, and newly accessible documents. The adoption of ECT in Auschwitz is a prime example of the "grey zone" in which prisoner doctors had to operate-they could only survive as long as the SS considered their work useful for their own destructive purposes.

Experimental infections in humans-historical and ethical reflections.

Vaccine efficacy and prophylactic treatment of infections are tested best when the vaccinated or treated individual is challenged through deliberate infection with the respective pathogen. However, this trial design calls for particular ethical caution. Awareness of the history of challenge trials is indispensable, including trials that were problematic or even connected to abuse. We briefly introduce historical aspects of experimental infections in humans and the ethical debate around them and give estimates of the numbers of volunteers participating in human experimental infection models. Challenge models can offer a great chance and benefit for the development of medical interventions to fight infectious diseases, but only when they are appropriately controlled and regulated.

L'efficacité des vaccins et le traitement prophylactique des infections sont mieux testés lorsque l'individu vacciné ou traité est exposé par le biais d'une infection délibérée par l'agent pathogène concerné. Cependant, cette conception d'essai appelle à une prudence éthique particulière. Il est indispensable de connaître l'histoire des essais cliniques, y compris des essais qui se sont avérés problématiques ou même liés à des abus. Nous présentons brièvement les aspects historiques des infections expérimentales chez l'homme et le débat éthique autour d'eux et donnons des estimations du nombre de volontaires participant à des modèles d'infection expérimentale humaine. Les modèles d'exposition peuvent offrir une grande chance et un avantage pour le développement d'interventions médicales pour lutter contre les maladies infectieuses, mais uniquement lorsqu'elles sont contrôlées et réglementées de manière appropriée.

Trends in health research ethics in the Philippines during the American Colonial Period (1898-1946).

Research involving human participants has been conducted in the Philippines since the beginning of the Spanish colonial period. Such studies are expected to adhere to internationally accepted ethical guidelines. This paper discusses trends in clinical research ethics in the Philippines during the American colonial period (1898-1946). Specifically, studies were assessed on: 1) their observance of ethical protocols, including review; 2) identification of inclusion and exclusion criteria in the selection of participants; 3) use of vulnerable subjects; and 4) practice of the informed consent process. Only the informed consent process had a significant logistic correlation with progression of years. Recruitment of vulnerable groups was common during this period; children and prisoners were the most common participants. Trends in medical ethics in the Philippines reflected those in the United States prior to the publication of the Nuremberg Code, which served as a milestone in the protection of human welfare in clinical research.

Research ethics aspects of experimentation with LSD on human subjects: a historical and ethical review.

In this paper our aim is to examine whether research conducted on human participants with LSD-25 (lysergic acid diethylamide) raises unique research ethical questions or demands particular concerns with regard to the design, conduct and follow-up of these studies, and should this be the case, explore and describe those issues. Our analysis is based on reviewing publications up to date which examine the clinical, research and other uses of LSD and those addressing ethical and methodological concerns of these applications, just as some historical examinations of this subject. The first chapters of the paper give an overview regarding the history of LSD-research with human participants, healthy volunteers and patients alike. The remaining chapters have a focus on questions regarding the potential ethical issues of such human trials in the contemporary research ethics framework. We also consider briefly political and regulatory issues regarding this substance that possibly affect its clinical and research applications.

From in vivo to in vitro: How the Guatemala STD Experiments Transformed Bodies Into Biospecimens.

Policy Points: While most scholarship regarding the US Public Health Service's STD experiments in Guatemala during the 1940s has focused on the intentional exposure experiments, secondary research was also conducted on biospecimens collected from these subjects. These biospecimen experiments continued after the Guatemala grant ended, and the specimens were used in conjunction with those from the Tuskegee syphilis experiments for ongoing research. We argue there should be a public accounting of whether there are still biospecimens from the Guatemala and Tuskegee experiments held in US government biorepositories today. If such specimens exist, they should be retired from US government research archives because they were collected unethically as understood at the time. CONTEXT: The US Public Health Service's Guatemala STD experiments (1946-1948) included intentional exposure to pathogens and testing of postexposure prophylaxis methods for syphilis, gonorrhea, and chancroid in over 1,300 soldiers, commercial sex workers, prison inmates, and psychiatric patients. Though the experiments had officially ended, the biospecimens collected from these subjects continued to be used for research at least into the 1950s. METHODS: We analyzed historical documents-including clinical and laboratory records, correspondence, final reports, and medical records-for information relevant to these biospecimen experiments from the US National Archives. In addition, we researched material from past governmental investigations into the Guatemala STD experiments, including those of the US Presidential Commission for the Study of Bioethical Issues and the Guatemalan Comisión Presidencial para el Esclarecimiento de los Experimentos Practicados con Humanos en Guatemala. FINDINGS: Identified spinal fluid, blood specimens, and tissue collected during the Guatemala diagnostic methodology and intentional exposure experiments were subsequently distributed to laboratories throughout the United States for use in ongoing research until at least 1957. Five psychiatric patient subjects involved in these biospecimen experiments died soon after experimental exposure to STDs. The same US government researchers working with the Guatemala biospecimens after the exposure experiments ended were also working with specimens taken from the Tuskegee syphilis study. CONCLUSIONS: There should be a complete public accounting of whether biospecimens from the Guatemala and Tuskegee experiments are held in US government biorepositories today. If they still exist, these specimens should be retired from such biorepositories and their future disposition determined by stakeholders, including representatives from the communities from which they were derived.

Human Experimentation in Public Schools: How Schools Served as Sites of Vaccine Trials in the 20th Century.

Schools have long been critical partners for public health authorities in achieving widespread vaccination. In the mid-20th century, however, public schools also served as sites of large-scale experiments on novel vaccines. Through examining the experimental diphtheria, polio, and measles vaccine trials, I explored the implications of using schools in this manner, as well as the continuities and discontinuities among the three cases. Common to all of them was that the use of schools brought decision-making into the public sphere, subjecting parents to social pressures and the influences of school officials and community members. However, the effects of using schools varied as well, as their social and institutional significance interacted differently with the narratives surrounding each disease, the public's changing perception of medicine and science, and society's changing values. These insights show not only the power of public institutions to influence opinions and perceptions, but also the subtle forces that one's authority figures, peers, and community members may bring to a seemingly private decision-making process. These considerations are relevant to health interventions today, such as the complex debate over community consent in global health research. (Am J Public Health. 2018;108:1015-1022. doi: 10.2105/AJPH.2018.304423).

American Doctors at the Nuremberg Medical Trial.

Three Hippocratic physicians played critical roles in the prosecution of 23 Nazi doctors charged with murder and torture for conducting lethal medical experiments on concentration camp prisoners. Two of the physicians, Leopold Alexander and Andrew C. Ivy, were Americans, and the other, Werner Leibbrandt, was German. At the 70th anniversary of the Doctors' Trial it is fitting to recall the three's influences and contributions to the formulation of strict research ethics rules, known as the Nuremberg Code. Their contributions help us better understand why they insisted on strict research rules and yet ultimately were unable to apply these rules to their own research. Exploring their contributions at Nuremberg may help us appreciate the continuing difficulty physician-researchers have with accepting public regulation of research.

Beyond Nazi War Crimes Experiments: The Voluntary Consent Requirement of the Nuremberg Code at 70.

The year 2017 marks both the 70th anniversary of the Nuremberg Code and the first major revisions of federal research regulations in almost 3 decades. I suggest that the informed consent provisions of the federal research regulations continue to follow the requirements of the Nuremberg Code. However, modifications are needed to the informed consent (and institutional review board) provisions to make the revised federal regulations more effective in promoting a genuine conversation between the researcher and the research subject. This conversation must take seriously both the therapeutic illusion and the desire of both the researcher and the research subject not to engage in sharing uncertainty.