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.

Single IRB Review and Local Context Considerations: A Scoping Review.

A leading concern about single IRB (sIRB) review for multisite studies, as is now required by federal policies, is whether and how sIRBs consider local context in their review. While several types of local context considerations have been proposed, there is no shared agreement among those charged with the ethics oversight of human subjects research as to the goals and content of local context review, nor the types of research studies for which sIRB review might be inappropriate. Through a scoping review of published scholarship, public comments, and federal guidance documents, we identified five assumed goals for local context review: protecting the rights and welfare of local participants; ensuring compliance with applicable laws and policies; assessing feasibility; promoting the quality of research; and promoting procedural justice. While a variety of content was proposed to be relevant, it was largely grouped into four domains: population/participant-level characteristics; investigator and research team characteristics; institution-level characteristics; and state and local laws. Proposed characteristics for exclusion from sIRB requirements reflected both protection- and efficiency-based concerns. These findings can inform ongoing efforts to assess the implications of policies mandating sIRB review, and when exceptions to those policies might be appropriate.

Nippon Medical School's Ethical Review Processes for Studies Involving Human Subjects.

All life science and medical research involving human subjects must be conducted in compliance with the Declaration of Helsinki and the relevant laws and guidelines. Additionally, its scientific and ethical suitability must be reviewed by a committee well versed in the nature and content of the research. Failure to comply with these requirements when conducting research involving human subjects is a serious violation of Japanese laws, guidelines, and local regulations, so several ethics committees and institutional review boards have been established within the Nippon Medical School (NMS) Foundation and its affiliated institutions. It is essential for investigators to keep up to date with the latest developments in the ethical review process and to ensure that any projects they propose to embark on are subjected to an appropriate ethical review before the research is initiated. To help researchers and other staff affiliated with the NMS Foundation keep abreast of these developments, this report outlines NMS's current ethical review processes for research involving human subjects.

A comparative ethical analysis of the Egyptian clinical research law.

BACKGROUND: In this study, we examined the ethical implications of Egypt's new clinical trial law, employing the ethical framework proposed by Emanuel et al. and comparing it to various national and supranational laws. This analysis is crucial as Egypt, considered a high-growth pharmaceutical market, has become an attractive location for clinical trials, offering insights into the ethical implementation of bioethical regulations in a large population country with a robust healthcare infrastructure and predominantly treatment-naïve patients. METHODS: We conducted a comparative analysis of Egyptian law with regulations from Sweden and France, including the EU Clinical Trials Regulation, considering ethical human subject research criteria, and used a directed approach to qualitative content analysis to examine the laws and regulations. This study involved extensive peer scrutiny, frequent debriefing sessions, and collaboration with legal experts with relevant international legal expertise to ensure rigorous analysis and interpretation of the laws. RESULTS: On the rating of the seven different principles (social and scientific values, scientific validity, fair selection of participants, risk-benefit ratio, independent review, informed consent and respect for participants) Egypt, France, and EU regulations had comparable scores. Specific principles (Social Value, Scientific Value, and Fair selection of participants) were challenging to directly identify due to certain regulations embodying 'implicit' principles more than explicitly stated ones. CONCLUSION: The analysis underscores Egypt's alignment with internationally recognized ethical principles, as outlined by Emanuel et al., through its comparison with French, Swedish, and EU regulations, emphasizing the critical need for Egypt to continuously refine its ethical regulations to safeguard participant protection and research integrity. Key issues identified include the necessity to clarify and standardize the concept of social value in research, alongside concerns regarding the expertise and impartiality of ethical review boards, pointing towards a broader agenda for enhancing research ethics in Egypt and beyond.

Tecnologías de inteligencia artificial en investigación en salud con seres humanos: un reto a la responsabilidad en la toma de decisiones / Artificial intelligence technologies in health research with human beings: a challenge to responsibility in decision making

Existe una responsabilidad ética en el desarrollo del conocimiento científico. La investigación biomédica representa un beneficio para la humanidad resultando ser el pilar sobre el que se asientan los avances diagnósticos y terapéuticos. Además del respeto a los estándares exigidos, existe la trascendente responsabilidad de formarse. Se considera a la educación y al control adecuado como los garantes de una investigación respetuosa de las buenas prácticas. Planteamos la enseñanza de la integridad científica desde una etapa temprana en las carreras de grado para incorporar la importancia de la credibilidad, siendo este el acervo más valioso que tiene el investigador y la institución en la cual estos desarrollan su labor. Una educación sólida en bioética es la mejor manera de adoptar una conducta íntegra, y por ende responsable, al realizar proyectos de investigación. La formación ética debe ser una construcción constante resultando necesario plantear estrategias multidimensionales para evitar prácticas inadecuadas.

Ethically cleared to launch?

Rules are needed for human research in commercial spaceflight.

Guinea pigbots.

Doing research with human subjects is costly and cumbersome. Can AI chatbots replace them?

Ethicizing history. Bioethical representations of Nazi medicine.

The article presents and analyzes different approaches of U.S. bioethicists in comprehending the Nazi medical crimes after 1945. The account is divided into two sections: one dealing with discussions on research ethics and the Nuremberg Code up until the 1970s and the other ranging from the 1970s to the present and highlighting bioethics' engagement with Nazi analogies. The portrayal of different bioethical scholars, institutions, and documents-most notably Henry K. Beecher, Jay Katz, the Belmont Report, the Hastings Center, Arthur L. Caplan, and Robert M. Veatch-provides a nuanced interpretation of the motives that bioethicists held and the strategies that they applied to establish an understanding of the Nazi medical crimes and their relation to contemporary bioethical issues. In this, the different approaches shared a common goal: To integrate the Nazi medical crimes into an ethical framework by means of selective acknowledgments and representation of their history.

China sets new ethics rules for human studies.

Revised regulations follow controversy over work that created genetically edited babies.

"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 genesis of informed consent in the context of medical research ethics 1900-1931]. / Die Genese des Informed Consent im Kontext der medizinischen Forschungsethik 1900­1931.

At the turn of the 20th century, the problem of human experimentation and the need to obtain consent became more important among medical practitioners and the general public. The case of the venereologist Albert Neisser, among others, is used to trace the development of research ethics standards in Germany between the end of the 19th century and 1931. The concept of informed consent, which originated in research ethics, is also of central importance in clinical ethics today.

[Current status and challenges of long-term safety evaluation of using tests of cosmetics on human body].

The use of cosmetics in the crowd has the long-term characteristics. The adverse reactions of cosmetics reported in other country in the world suggest that human patch tests and short-term human using test may not be sufficient to evaluate the safety of high-risk new cosmetic raw ingredients, and long-term human using test should be conducted for evaluation. Therefore, this article reviews the key factors that affect long-term human trial trials, such as site of use, single-use amount, frequency of use, duration of use, and subject conditions, providing supportive evidence for standardized safety evaluation standards for long-term human using test of cosmetics.

Medical experimentation on prisoners (part 3): the main milestones of the evolving ethical' texts and codes.

Ethical foundations related to the use of human beings in medical research, already existed in the oldest texts. The historical evolution of regulations (in terms of texts and codes) had always drawn its legitimacy and its logic from the historical context. The main aim of these regulations was to satisfy a need to restore moral or physical prejudices, by hoping by means of the law, that these abuses would not be repeated. Although they were the main victims of medical experimentation, prisoners were rarely specifically identified in these legislations. This history note, the third in a series on medical experimentation on prisoners, aims to describe the major founding texts of ethics in medical experimentation, drawing attention to the historical context as well as the issues that shaped these documents.