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.
Ethics Committees, Research , Schools, Medical , Humans , Biomedical Research/ethics , Ethical Review , Ethics, Research , Helsinki Declaration , Human Experimentation/ethics , Human Experimentation/legislation & jurisprudence , Japan , Schools, Medical/ethics
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.
Biomedical Research , Ethical Analysis , Egypt , Humans , Sweden , Biomedical Research/ethics , Biomedical Research/legislation & jurisprudence , Ethics, Research , France , Informed Consent/ethics , Informed Consent/legislation & jurisprudence , Clinical Trials as Topic/ethics , Clinical Trials as Topic/legislation & jurisprudence , Social Values , Research Subjects/legislation & jurisprudence , Human Experimentation/ethics , Human Experimentation/legislation & jurisprudence , European Union , Ethics Committees, Research
Rules are needed for human research in commercial spaceflight.
Human Experimentation , Research Subjects , Space Flight , Humans , Space Flight/ethics , Human Experimentation/ethics , Human Experimentation/legislation & jurisprudence
Las investigaciones con quimeras humano-animales han evolucionado gradualmente hasta día de hoy, en que se plantean grandes proyectos relacionados con el intento de solucionar patologías que nos ayu den a los seres humanos a paliar enfermedades. Sin embargo, se debe de tener en cuenta, que muchos de estos avances científicos llevan implícito un dilema ético importante en muchos casos, y más si se involucra a personas en dichos experimentos. En la presente revisión sistemática se buscó identificar estos problemas éticos relacionados con las quimeras, así como posibles soluciones a los mismos propuestas en la literatura, incluyendo medios técnicos para la realización de quimeras menos humanizadas. Se realizó una búsqueda bibliográfica sistemática en las bases de datos Pubmed, Embase y Medes con fecha 4 de enero de 2022. Se seleccionan los artículos que cumplían estrictamente con los objetivos seleccionados para la realización del trabajo. Un total de 21 artículos componen nuestra muestra, de los cuales se extraen problemas éticos relacionados con las quimeras, posibles soluciones y medios técnicos para evitar la obtención de quimeras demasiado humanizadas. Las cuestiones identificadas en los artículos seleccionados son problemas relacio nados con el bienestar animal, adquisición de rasgos humanos de las quimeras, preocupaciones médicas derivadas de la experimentación como pueden ser las zoonosis, el origen de las células pluripontenciales para la realización de quimeras, la creación de gametos humanos por parte de dichas quimeras, el qui merismo neurológico y el estatus moral de las quimeras. En el trabajo se aportan soluciones para estos problemas, tales como la utilización de genes suicidas en las células humanas que se activarían si estas se diferencian en células neuronales o el uso de la edición genética mediante el mecanismo CRISPR/Cas9 para incapacitar a estas células para que no se diferencien en células neuronales (AU)
Human-animal chimera research has gradually evolved to the present day, in which large projects re lated to the attempt to solve pathologies that help us human beings to alleviate diseases. However, it must be considered that many of these advances in science imply an important ethical dilemma in many cases, and even more so if we involve people in said experiments. In the present systematic review we sought to identify these ethical problems related to chimeras, as well as possible solutions to them proposed in the literature, including technical means for the realization of less humanized chimeras. A bibliographic search was carried out in the Pubmed, Embase and Medes databases on January 4th, 2022. The articles that strictly comply with the objectives selected for the completion of the work will be selected. A total of 21 articles makes up our sample, from which ethical problems related to chimeras, possible solutions and technical means to avoid obtaining too humanized chimeras will be extracted. The issues identified in the articles are problems related to animal welfare, acquisition of human traits from chimeras, medical concerns derived from experimentation such as zoonoses, the origin of pluripotential cells for chimera production, the cre ation of human gametes by said chimeras, neurological chimerism and the moral status of chimeras. This paper provides solutions for these problems, such as the use of suicide genes in human cells that would be activated if they differentiate into neuronal cells or the use of gene editing through the CRISPR/Cas9 mech anism to incapacitate these cells so that they do not differentiate into neuronal cells. The only question that remains elusive to the proposal of solutions is the one related to the potential moral status of chime ras (AU)
Humans , Animal Experimentation/ethics , Human Experimentation/ethics , Ethics, Research , Chimera
Doing research with human subjects is costly and cumbersome. Can AI chatbots replace them?
Artificial Intelligence , Human Experimentation , Humans , Human Experimentation/ethics , Computer Simulation , Language , Dehumanization
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!
Rare Diseases/therapy , Bioethics , Human Experimentation/ethics , Social Participation
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!
Patient Rights , Human Experimentation/ethics , Ethics, Research , Confidentiality
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.
Biological Specimen Banks/standards , Human Experimentation/ethics , Bioethics , Specimen Handling/standards
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.
Human Experimentation/ethics , Patient Freedom of Choice Laws , Bioethics
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.
Human Experimentation/ethics , Bioethics , Ethics Committees, Research , Telemedicine , Confidentiality
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.
Bioethics , Patient Rights , Human Experimentation/ethics , Clinical Protocols/standards , Ethics Committees, Research
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."
Ethics Committees, Research , Human Experimentation/ethics , Clinical Protocols/standards , Sociology, Medical
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.
Human Experimentation/ethics , Bioethics , COVID-19/prevention & control , Ethics Committees, Research
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!
Ethics Committees, Research , Patient Rights , Bioethics , Human Experimentation/ethics
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!
Social Vulnerability , Social Participation , Human Experimentation/ethics , Bioethics , Advisory Committees , Ethics Committees, Research
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.
Sexual Harassment , Sexism , Gender Role , Prejudice , Human Experimentation/ethics , Brazil , Science/history
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.
Human Experimentation/ethics , Bioethics , Bioethics , Informed Consent , Informed Consent
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.
Human Experimentation/ethics , Bioethics , Brazil , Racism , Human Rights , Black People
Com a nova pandemia do novo coronavírus, as pessoas voltaram a falar em "cobaias humanas". Descubra tudo que há por trás desse termo e porque ele foi substituído pela expressão "participante de pesquisa".
COVID-19/prevention & control , Human Experimentation/ethics , Bioethics , Ethics Committees, Research
Revised regulations follow controversy over work that created genetically edited babies.
Gene Editing , Human Experimentation , Humans , China , Human Experimentation/ethics , Gene Editing/ethics , Infant, Newborn
