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.

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.

"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.

China sets new ethics rules for human studies.

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

[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.

The philosopher as partner: an introduction to the scholarship of Robert M. Veatch.

A diverse group of scholars reflect on the scholarship of Robert M. Veatch, the breadth of which is unmatched in modern day bioethics. Essays were written by both philosophers and clinician-philosophers, by contemporaries and mentees. They span the breadth of Bob's work and include analyses of his ideas about death, dying and organ transplantation, human experimentation and research ethics, disability, equality and justice, the doctor-patient relationship, the history of bioethics, as well as his pedagogical approach to teaching bioethics to clinicians across the health care spectrum. Recognition of Bob's influence in the modern field of bioethics and the challenges that persist are clearly identified.

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).

A Scientific Method to the Madness of Unit 731's Human Experimentation and Biological Warfare Program.

The Japanese Imperial Army Unit 731's Biological Warfare (BW) research program committed atrocious crimes against humanity in their pursuit of biological weapons development during the Second World War. Due to an American cover-up, the details behind Unit 731's human experimentation were slow to be revealed. The recent literature discloses the gruesome details of the experiments but characterizes the human trials as crude in nature. Further, there is a lack of clarity as to how human trial results were extrapolated for use in real world missions. Through an examination of testimony from the Soviet Union's Khabarovsk War Crime Trials, this paper argues that Unit 731's inoculation and airborne warfare experiments on prisoners of war were scientifically rigorous. The scientific method is used as the basis against which the scientific rigor of the experiments is tested. The paper reveals that the successes and failures of the human trials were extrapolated to BW missions during the Sino-Japanese war. American researchers' expectations of BW data were fulfilled, thus paving the way for an immunity deal. Ethical standards in medicine before WWII were not well established, but wartime medical practices and experimentation reveal the context in which the pursuit of scientific knowledge has no boundaries.