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.

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?

Com Ciência e Com Respeito: episódio 27

Neste segundo especial sobre Doenças Raras, vamos conversar mais sobre os desafios que as doenças raras e ultrarraras trazem para o fazer Ciência e para a Ética em Pesquisa. Vem com a gente!

Com Ciência e Com Respeito: episódio 22

Neste sexto especial sobre a Cartilha dos Direitos dos Participantes de Pesquisa, vamos falar sobre os direitos ao anonimato, à confidencialidade e à privacidade. Confira!

Com Ciência e Com Respeito: episódio 15

O que são Biobancos? Para que servem? Como são formados? E principalmente: como garantir os direitos dos participantes de pesquisa que têm seus materiais biológicos guardados nesses lugares? Descubra aqui, ouvindo este episódio.

Com Ciência e Com Respeito: episódio 14

Neste terceiro especial sobre a Cartilha dos Direitos dos Participantes de Pesquisa, vamos falar sobre o direito de decidir com tal liberdade, ou seja: com calma, sem constrangimentos e até mesmo sobre questões após a pesquisa.

Com Ciência e Com Respeito: episódio 13

A tecnologia de hoje já permite que pesquisas com seres humanos sejam feitas sem que pesquisadores e participantes de pesquisa precisem se encontrar pessoalmente. Mas como fica a Ética em Pesquisa nesses casos? Descubra neste 13º episódio.

Com Ciência e Com Respeito: episódio 12

Neste segundo especial sobre a Cartilha dos Direitos dos Participantes de Pesquisa, vamos falar sobre o direito de entender a pesquisa, antes, durante e depois da mesma.

Com Ciência e Com Respeito: episódio 11

Por que projetos de pesquisa com metodologias das Ciências Humanas e Sociais precisam de análise ética? Quais os critérios dessas análises? Descubra essa e outras respostas no nosso 11º episódio."

Com Ciência e Com Respeito: episódio 09

A pandemia do novo Coronavírus trouxe muitos e enormes desafios para o Sistema CEP/Conep. Conheça agora alguns desses desafios e quais soluções foram encontradas para os mesmos.

Com Ciência e Com Respeito: episódio 08

Você sabe como surgiu a Cartilha dos Direitos dos Participantes de Pesquisa? Por que ela foi criada? Como tem sido usada? Confira neste oitavo episódio do nosso podcast!

Com Ciência e Com Respeito: episódio 07

Por que é tão importante que existam Representantes de Participantes de Pesquisa nos Comitês de Ética e na CONEP? Descubra isso e muito mais neste episódio!

Com Ciência e Com Respeito: episódio 06

Como os papéis que a sociedade imagina para homens e mulheres influenciam a vivência de meninas e mulheres na ciência, seja como pesquisadoras, seja como participantes de pesquisa? Venha pensar conosco sobre como otimizar essas relações.

Com Ciência e Com Respeito: episódio 05

Ser ou não ser participante de pesquisa: por que o momento dessa decisão é tão importante? Confira neste episódio as principais questões que influenciam nesse momento.

Com Ciência e Com Respeito: episódio 02

Como surgiram os direitos dos participantes de pesquisa? Acompanhe a jornada que levou o Brasil e outros países a protegerem esses direitos de maneira especial.