Suchergebnisse

Simple SummaryThe use of research animals is regulated within the EU through Directive 2010/63/EU on the protection of animals used for scientific purposes, as well as through national legislations and guidelines. However, the ethical review process, which all animal research must undergo, has been heavily criticized. This pilot study has analyzed the ethical review process in Sweden, focusing on how well legislative demands are fulfilled by researchers and animal ethics committees. After developing a score sheet, 18 documents (including both applications and decisions) were thoroughly reviewed, and the requests in the application form were compared to legal demands. The results revealed a number of issues concerning how HBA (harm-benefit analysis) was conducted by the committees, application, and review of the 3Rs (Replace, Reduce, Refine), as well as how humane end-points, severity assessment, and the "upper limit" of suffering were implemented and assessed. The study further indicates disconcerting discrepancies between the Swedish application forms for project evaluation, national legislation, and the directive as well as a lack of transparency throughout the review process. These findings risk compliance with the directive, animal welfare, research validity, and public trust. Therefore, a number of suggestions for improvements are provided, and the need for further research is emphasized.The use of animals in research entails a range of societal and ethical issues, and there is widespread consensus that animals are to be kept safe from unnecessary suffering. Therefore, harm done to animals in the name of research has to be carefully regulated and undergo ethical review for approval. Since 2013, this has been enforced within the European Union through Directive 2010/63/EU on the protection of animals used for scientific purposes. However, critics argue that the directive and its implementation by member states do not properly consider all aspects of animal welfare, which risks causing unnecessary animal suffering and decreased public trust in the system. In this pilot study, the ethical review process in Sweden was investigated to determine whether or not the system is in fact flawed, and if so, what may be the underlying cause of this. Through in-depth analysis of 18 applications and decisions of ethical reviews, we found that there are recurring problems within the ethical review process in Sweden. Discrepancies between demands set by legislation and the structure of the application form lead to submitted information being incomplete by design. In turn, this prevents the Animal Ethics Committees from being able to fulfill their task of performing a harm-benefit analysis and ensuring Replacement, Reduction, and Refinement (the 3Rs). Results further showed that a significant number of applications failed to meet legal requirements regarding content. Similarly, no Animal Ethics Committee decision contained any account of evaluation of the 3Rs and a majority failed to include harm-benefit analysis as required by law. Hence, the welfare may be at risk, as well as the fulfilling of the legal requirement of only approving "necessary suffering". We argue that the results show an unacceptably low level of compliance in the investigated applications with the legal requirement of performing both a harm-benefit analysis and applying the 3Rs within the decision-making process, and that by implication, public insight through transparency is not achieved in these cases.In order to improve the ethical review, the process needs to be restructured, and the legal demands put on both the applicants and the Animal Ethics Committees as such need to be made clear. We further propose a number of improvements, including a revision of the application form. We also encourage future research to further investigate and address issues unearthed by this pilot study.

Ethical decision-making about trauma-related studies requires a flexible approach that counters assumptions and biases about victims, assures a favorable ethical cost-benefit ratio, and promotes advancement of knowledge that can benefit survivors of traumatic stress. This paper reviews several ethical issues in the field of traumatic stress: Benefit and risks in trauma-related research, whether trauma-related research poses unique risks and if so what those might be, informed consent and mandatory reporting, and supervision of trauma-related research. For each topic, we review potential ethical issues, summarize the research conducted thus far to inform ethical practice, and recommend future practice, research questions and policies to advance the field so that research on trauma can continue to be a win-win situation for all stakeholders in the research enterprise.

THE AUTHOR EXPLAINS HOW THE COMMITTEE SYSTEM OPERATES IN THE INDIAN PARLIAMENT.

Tuberculosis (TB) remains a major global public health problem as also defined by the World Health Organization (WHO). On the other hand, the incidence of TB worldwide decreases at a lower rate than the intended targets, and it is seen that the targets set for 2015 will not be achieved at the global level. According to the WHO, failure to achieve the targets in TB control results from "resource constraints", "conflict and instability" and "generalized human immunodeficiency virus epidemics". This article is aimed to maintain an ethical debate in TB control and to investigate the WHO's TB control policy and question the reasons for failure of this policy. Within the scope of this article; the TB of TB control was problematized at macro political level within the context of philosophy, while the approach of health care staff to TB patients was analysed at micro level within the context of professional ethics.

AbstractBioethics in Singapore: The Ethical Microcosm provides a rich and detailed account of how Singapore has addressed the challenge of informing and creating policy to guide the burgeoning field of biomedical research. Chapters in this edited volume each contribute to a meaningful understanding of the Singaporean perspective on bioethics in the context of various alternative international frameworks.

SIMPLE SUMMARY: The use of research animals is regulated within the EU through Directive 2010/63/EU on the protection of animals used for scientific purposes, as well as through national legislations and guidelines. However, the ethical review process, which all animal research must undergo, has been heavily criticized. This pilot study has analyzed the ethical review process in Sweden, focusing on how well legislative demands are fulfilled by researchers and animal ethics committees. After developing a score sheet, 18 documents (including both applications and decisions) were thoroughly reviewed, and the requests in the application form were compared to legal demands. The results revealed a number of issues concerning how HBA (harm–benefit analysis) was conducted by the committees, application, and review of the 3Rs (Replace, Reduce, Refine), as well as how humane end-points, severity assessment, and the "upper limit" of suffering were implemented and assessed. The study further indicates disconcerting discrepancies between the Swedish application forms for project evaluation, national legislation, and the directive as well as a lack of transparency throughout the review process. These findings risk compliance with the directive, animal welfare, research validity, and public trust. Therefore, a number of suggestions for improvements are provided, and the need for further research is emphasized. ABSTRACT: The use of animals in research entails a range of societal and ethical issues, and there is widespread consensus that animals are to be kept safe from unnecessary suffering. Therefore, harm done to animals in the name of research has to be carefully regulated and undergo ethical review for approval. Since 2013, this has been enforced within the European Union through Directive 2010/63/EU on the protection of animals used for scientific purposes. However, critics argue that the directive and its implementation by member states do not properly consider all aspects of animal welfare, which risks causing ...

Annotation, The concept of RRI has emerged as a new framework to be used by the European Commission for research projects. It now lies at the core of the Horizon 2020 programme and is designed to replace current assessment practices focused on ethical review. The book analyses the shift from ethical review to RRI: what remains of the former, what has been gained? It then makes a critical presentation of existing ethical reviews from the perspectives of moral philosophy and the philosophy of technology and discusses conceptions of ethical assessment on different levels