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The Research Data Alliance (ambassador poster) With over 9000 members from 137 countries, RDA provides neutral space where its members can come together to work towards Research Data Sharing without barriers. The Research Data Alliance (RDA) was launched as a community-driven initiative in 2013 by the European Commission, the United States Government's National Science Foundation and National Institute of Standards and Technology, and the Australian Government's Department of Innovation with the goal of building the social and technical infrastructure to enable open sharing and re-use of data. RDA has a grass-roots, inclusive approach covering all data lifecycle stages in all science domains, engaging data producers, users and stewards, addressing data exchange, processing, and storage. It has succeeded in creating the neutral social platform where international research data experts meet to exchange views and to agree on topics including social hurdles on data sharing, education and training challenges, data management plans and certification of data repositories, disciplinary and interdisciplinary interoperability, as well as technological aspects. ; Text mainly from RDA website. www.rd-alliance.org/about-rda

Under the auspices of a multi-national European scientific project involving whole genome sequencing, GEUVADIS, we set out to investigate the attitudes of the participating scientists of having their own genome sequenced. The views of such researchers on this subject have not been fully explored before and we utilized questionnaires and discussion groups to elicit their opinions. Many said that it was the first time that they had an opportunity to discuss ethical and social issues about sequencing. The many ongoing multi-national science projects present a good opportunity for social science research involving scientists and would benefit from rigorous research methodology, taking into account any language barriers.

Biobanks include biological samples and attached databases. Human biobanks occur in research, technological development and medical activities. Population genomics is highly dependent on the availability of large biobanks. Ethical issues must be considered: protecting the rights of those people whose samples or data are in biobanks (information, autonomy, confidentiality, protection of private life), assuring the non-commercial use of human body elements and the optimal use of samples and data. They balance other issues, such as protecting the rights of researchers and companies, allowing long-term use of biobanks while detailed information on future uses is not available. At the level of populations, the traditional form of informed consent is challenged. Other dimensions relate to the rights of a group as such, in addition to individual rights. Conditions of return of results and/or benefit to a population need to be defined. With 'large-scale biobanking' a marked trend in genomics, new societal dimensions appear, regarding communication, debate, regulation, societal control and valorization of such large biobanks. Exploring how genomics can help health sector biobanks to become more rationally constituted and exploited is an interesting perspective. For example, evaluating how genomic approaches can help in optimizing haematopoietic stem cell donor registries using new markers and high-throughput techniques to increase immunogenetic variability in such registries is a challenge currently being addressed. Ethical issues in such contexts are important, as not only individual decisions or projects are concerned, but also national policies in the international arena and organization of democratic debate about science, medicine and society.

Biobanks include biological samples and attached databases. Human biobanks occur in research, technological development and medical activities. Population genomics is highly dependent on the availability of large biobanks. Ethical issues must be considered: protecting the rights of those people whose samples or data are in biobanks (information, autonomy, confidentiality, protection of private life), assuring the non-commercial use of human body elements and the optimal use of samples and data. They balance other issues, such as protecting the rights of researchers and companies, allowing long-term use of biobanks while detailed information on future uses is not available. At the level of populations, the traditional form of informed consent is challenged. Other dimensions relate to the rights of a group as such, in addition to individual rights. Conditions of return of results and/or benefit to a population need to be defined. With 'large-scale biobanking' a marked trend in genomics, new societal dimensions appear, regarding communication, debate, regulation, societal control and valorization of such large biobanks. Exploring how genomics can help health sector biobanks to become more rationally constituted and exploited is an interesting perspective. For example, evaluating how genomic approaches can help in optimizing haematopoietic stem cell donor registries using new markers and high-throughput techniques to increase immunogenetic variability in such registries is a challenge currently being addressed. Ethical issues in such contexts are important, as not only individual decisions or projects are concerned, but also national policies in the international arena and organization of democratic debate about science, medicine and society.

International audience ; This article highlights the regulatory challenges of the assessment process of Gene Therapy Medicinal Products. It also addresses the puzzling institutional maze that influences the regulatory path for the marketing of these products as shown through various examples in the European Union and in China.

International audience ; This article highlights the regulatory challenges of the assessment process of Gene Therapy Medicinal Products. It also addresses the puzzling institutional maze that influences the regulatory path for the marketing of these products as shown through various examples in the European Union and in China.

International audience ; This article highlights the regulatory challenges of the assessment process of Gene Therapy Medicinal Products. It also addresses the puzzling institutional maze that influences the regulatory path for the marketing of these products as shown through various examples in the European Union and in China.

International audience ; This article highlights the regulatory challenges of the assessment process of Gene Therapy Medicinal Products. It also addresses the puzzling institutional maze that influences the regulatory path for the marketing of these products as shown through various examples in the European Union and in China.

International audience ; This article highlights the regulatory challenges of the assessment process of Gene Therapy Medicinal Products. It also addresses the puzzling institutional maze that influences the regulatory path for the marketing of these products as shown through various examples in the European Union and in China.

This article is based on the findings of an EU-funded qualitative research project, entitled 'From GMP to GBP: Fostering good bioethics practices [GBP] among the European biotechnology industry', which seeks to improve the understanding of bioethical issues through the observation of the daily practices in European biotechnology companies and proposes a methodology approaching ethical issues. The comparative study was carried out in biotech companies in France, Italy, Sweden, Hungary and Belgium which develop a wide range of new technologies, all of them involving human materials or where human subjects participate (in clinical trials). Based on our findings in these local settings, we suggest that the notion of bioethics and the way its production is theorised need to be re-conceptualised. We argue that material practices and moral statements are intermingled in inextricable ways that render the formation of bioethical concerns fully dependent on the organisational landscape in which it is embedded. More precisely, the here presented co-production model of moral statements and organisational practices presents a set of common factors that influence how bioethical discourses are shaped, despite the heterogeneity of their epistemic cultures. For example, the procedural design of cell-based-products, the modes of collecting and storing biological specimen, the relationship between patients and companies and technological transfers to emerging countries are defining components that contribute to the shaping process of bioethical concerns. Thus, the path dependency of bioethical concerns relies on an already existing, specific infrastructure and existing relationships within and outside a company rather than on external judgement subsequently applied to its objects, or a collection of processes of reasoning coming from external institutions.

Large-scale population biobanks, which aim to collect biological tissues, personal health information, and genomic data, are being introduced worldwide with the promise of increasing knowledge on chronic diseases such as diabetes and heart disease. Experts recognize the need for public participation to address the many social, legal and ethical complexities raised by the introduction of biobanks for public health research. However many researchers and decision makers struggle with how to promote public participation. This paper presents six issues that public participation must address. These issues are then applied to three large scale genetic biobank projects: CARTaGENE, Generation Scotland, and the United Kingdom Biobank. Finally, the efforts of these biobanks will be compared to the British Columbia Biobank deliberation project, which implemented a deliberative public participation experiment on biobanking.

The European Medicines Agency (EMA) is a European Agency as it is a decentralized body governed by European public law; it has its own legal personality and is also distinct from the European Union institutions (Council, Parliament, Commission, etc.). The EMA presents itself, and is commonly recognised, as a public health agency. This is notably supported by its recent transition from the Regional Direction of Research to the Regional Direction of Public Health. Four recognized principles of public health can be identified as such: assessment, transparency, precaution and independence. These principles appear to be closely linked to those forming the basis of good European governance regarding agencies: efficacy, coherence, openness, participation and responsibility. Thus, it is interesting to study how these principles are applied by the EMA in order to assess the reality of its qualification as a Public Health European Agency. The principles of assessment and transparency seem to be largely applied whereas the principles of precaution and independence are more problematic.