Systemic racism, systemic sexism, and the embryological enterprise.

The core of systemic racism and sexism is not merely an emphasis about human differences and thinking that another group of people is inferior to one's own. Rather, the institutional nature of racism or sexism establishes a permanent group hierarchy that is believed to reflect the laws of nature or the decrees of God. It thus becomes the norm of a culture to think and behave according to these rules. Notions of hierarchy became solidified into the Great Chain of Being during the Middle Ages, as did views concerning hereditary racial and gender superiority. During the Enlightenment, such classifications became established by philosophy and science. Starting in the 1800s, embryology and anthropology were used to provide evidence for the unilinear progression of species and races. The first evolutionary schemes were not "branching trees." In these schemes, women and non-white races were seen as embryonic or juvenile forms of the adult white male, and they were often depicted as intermediaries between the fully human and the animals. Such linear schemes of evolution remain part of popular culture and even some science, promoting the racism and sexism associated with them.

When is enough enough? Accurate measurement and the integrity of scientific research.

At a meeting of the Physical Society of London in 1925 participants expressed their concerns regarding a recent suggestion by the Australian physicist T. H. Laby for replicating the established value of the mechanical equivalent of heat. This rather controversial discussion about the value of redetermining this numerical fact brings to light different understandings of the moral economy of accuracy in scientific work; it signals a distinctive new stage in the historical understanding of accuracy and precision and the moral integrity in conducting research.

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.

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.

Evolution of research ethics in a low resource setting: A case for Uganda.

BACKGROUND: The globalization of clinical research in the last two decades has led to a significant increase in the volume of clinical research in developing countries. As of 2016, Uganda was the third largest destination for clinical trials in Africa. This requires adequate capacity and systems to facilitate ethical practice. METHODS: This was a retrospective study involving review of laws, guidelines, policies and records from 1896 to date. RESULTS: Modern medicine evolved from 1896 and by the time of Uganda's independence in 1962, a 1500 bed national referral hospital was in place and a fully-fledged medical school was established at the Makerere University. As the practice of medicine evolved in the country, so did medical research that addressed priority health issues. The growth in modern medicine was not matched with development of research infrastructure and regulatory systems. The first documented regulation of research activities was in 1970 while the first research ethics committee established in 1986 was to facilitate review of research related to the HIV/AIDs pandemic. In 1990 an Act of Parliament was passed to facilitate development and implementation of policies, hence the development of the national guidelines in 1997, training, establishment and accreditation of research ethics committees, conferences and research site monitoring. CONCLUSION: Over the past 120 years, the implementation and structural aspects of research ethics in Uganda have evolved through 70 years of no regulation, followed by 30 years of rudimentary regulation while the last 20 years have shown significant growth in the regulatory system associated with supportive laws, institutionalization of regulatory and training processes.

[Training PhD students in ethics and research integrity in France in 2018]. / Formation à l'éthique et à l'intégrité scientifique au sein des écoles doctorales françaises - Un premier état des lieux en 2018.

Since 2016, the national framework for doctoral studies in France states that doctoral schools from the French universities should ensure that every doctoral student receives a training in research ethics and integrity. The doctoral schools can organize the training at their convenience. We have conducted a study among all French doctoral schools about the modalities of this training in 2018. Our inquiry shows that the doctoral schools are well engaged in this effort of training on the whole territory, and are on the verge of reinforcing it. Overall, our inquiry shows a general awareness by the doctoral schools of the importance of these topics for tomorrow research.

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.

U.S. Public Health Service STD Experiments in Guatemala (1946-1948) and Their Aftermath.

The U.S. Public Health Service's sexually transmitted disease (STD) experiments in Guatemala are an important case study not only in human subjects research transgressions but also in the response to serious lapses in research ethics. This case study describes how individuals in the STD experiments were tested, exposed to STDs, and exploited as the source of biological specimens-all without informed consent and often with active deceit. It also explores and evaluates governmental and professional responses that followed the public revelation of these experiments, including by academic institutions, professional organizations, and the U.S. federal government, pushing us to reconsider both how we prevent such lapses in the future and how we respond when they are first revealed.

Reviving Human Research in Costa Rica.

Costa Rica is a small developing nation in Central America with a well-regarded universal health care system and a strong human rights tradition. In the latter part of the twentieth century, it became a popular site for clinical trials funded by multinational pharmaceutical companies. In light of concerns about ineffective oversight and alleged research abuses, the Constitutional Chamber of the Supreme Court passed a moratorium on all biomedical studies involving humans. This moratorium was in place between 2010 and 2014, when the Legislative Assembly passed a new national law to protect participants' rights and welfare. This case study reviews the history of human research protections in Costa Rica and provides recommendations for how Costa Rica can move forward responsibly as a leader in human research for the region.

Past responsibility: History and the ethics of research on ethnic groups.

The article argues for the possibility of researchers' historical responsibility vis-à-vis ethnic groups. Such responsibility for a discipline's past transgressions is often attributed to anthropology, human genetics, parts of archaeology, and medicine, but without a clear conception of the nature of a responsibility supposedly going beyond the individual's own actions. Two concretizations are presented in order to show the fruitfulness and challenges of what I shall call a continuity approach: first, the case of the reburial of Sami human remains in Neiden, Norway; second, the use of the race concept in ethical and scientific contexts following the so-called New Synthesis in biology, which according to many marks a break with a racist past. Since no theory of researchers' historical responsibility towards ethnic groups exists, two partly relevant theories are brought in to provide a basis: Jenna Thompson's theory of nation states' responsibilities for past transgressions against peoples and a stance in political theory arguing that the beneficiary should pay even in cases where the beneficiary was not to blame for the original transgression. On this basis I sketch a continuity theory of historical responsibility, without which a notion of historical responsibility would be inapplicable in most actual cases.

Historical Development of Health Research Ethics in Nepal.

Health research in Nepal initiated with a survey in malaria in 1952. The first regulatory body for health research was Nepal Medical Research Committee formed under Ministry of Health. Ethical Review Body is the first ethical review structure. Nepal Health Research Council is now an independent body to regulate health research in Nepal. Development of research ethics in Nepal is clearly evident with the development of ethical guidelines; functioning of Ethical Review Board; expansion of institutional review committees and initiation of online submission system. However, monitoring compliance with research ethics could be a challenge for the Nepal Health Research Council.

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.

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.