ABSTRACT
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.
Subject(s)
Ethics Committees, Research , Humans , Ethics, Research , Human Experimentation/ethics , Human Experimentation/legislation & jurisprudence , Human Experimentation/standardsABSTRACT
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.
Subject(s)
Human Rights , National Socialism , Humans , Philosophy, Medical , Personhood , Human Experimentation/ethics , Human Experimentation/history , MoralsABSTRACT
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.
Subject(s)
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/ethicsABSTRACT
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.
Subject(s)
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, ResearchABSTRACT
Rules are needed for human research in commercial spaceflight.
Subject(s)
Human Experimentation , Research Subjects , Space Flight , Humans , Space Flight/ethics , Human Experimentation/ethics , Human Experimentation/legislation & jurisprudenceABSTRACT
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)
Subject(s)
Humans , Animal Experimentation/ethics , Human Experimentation/ethics , Ethics, Research , ChimeraABSTRACT
Doing research with human subjects is costly and cumbersome. Can AI chatbots replace them?
Subject(s)
Artificial Intelligence , Human Experimentation , Humans , Human Experimentation/ethics , Computer Simulation , Language , DehumanizationABSTRACT
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!
Subject(s)
Rare Diseases/therapy , Bioethics , Human Experimentation/ethics , Social ParticipationABSTRACT
Neste primeiro especial sobre Doenças Raras, vamos conversar sobre os vários e profundos desafios que as doenças raras e ultrarraras trazem para a vida, para a Ciência e para a Ética em Pesquisa. Como lidar com esses desafios? Descubra já, ouvindo agora este episódio.
Subject(s)
Rare Diseases/genetics , Genetic Diseases, Inborn , Mutation , Ethics, Research , Human ExperimentationABSTRACT
Neste sétimo especial sobre a Cartilha dos Direitos dos Participantes de Pesquisa, vamos falar sobre o direito dos Participantes de Pesquisa aos benefícios da pesquisa. Vem com a gente!
Subject(s)
Ethics, Research , Patient Rights , Human Experimentation/legislation & jurisprudenceABSTRACT
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!
Subject(s)
Patient Rights , Human Experimentation/ethics , Ethics, Research , ConfidentialityABSTRACT
Neste quinto especial sobre a Cartilha dos Direitos dos Participantes de Pesquisa, vamos falar sobre os direitos ao ressarcimento e ao método contraceptivo escolhido.
Subject(s)
Human Experimentation , Ethics, Research , Research Expenditures , Contraceptive Prevalence SurveysABSTRACT
Neste quarto especial sobre a Cartilha dos Direitos dos Participantes de Pesquisa, vamos falar sobre os direitos à assistência e à indenização.
Subject(s)
Human Experimentation/legislation & jurisprudence , Patient Rights , Bioethics , Ethics Committees, ResearchABSTRACT
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.
Subject(s)
Biological Specimen Banks/standards , Human Experimentation/ethics , Bioethics , Specimen Handling/standardsABSTRACT
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.
Subject(s)
Human Experimentation/ethics , Patient Freedom of Choice Laws , BioethicsABSTRACT
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.
Subject(s)
Human Experimentation/ethics , Bioethics , Ethics Committees, Research , Telemedicine , ConfidentialityABSTRACT
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.
Subject(s)
Bioethics , Patient Rights , Human Experimentation/ethics , Clinical Protocols/standards , Ethics Committees, ResearchABSTRACT
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."