The ethical review process.
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Nearly all establishments in the UK regulated under the Animals (Scientific Procedures) Act 1986 had introduced an ethical review process (ERP) within 9 months of its formal requirement, although quite a high proportion of more junior staff were not familiar with it. A significant proportion of those questioned believed that the ERP has improved the quality (particularly the ethical quality) of project licences. A smaller proportion of respondents believed that the ERP has had a beneficial impact on animal work and training. Nearly all the respondents viewed animal care and accommodation as good or excellent.
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Section IV takes a close practical look at Animal Care and Use Committees, their history, mandates, and the impediments they still experience in trying to promote animal welfare and an ethical scientific use of animals.
In the expanding repertoire of practices designed to increase the supply of organs for transplantation, non-heart-beating cadaver organ donation has generated an ongoing debate in the literature. The continuing stream of articles is disquieting in part because it documents a troubling "trial-and-error ethics" approach to the formulation of organ procurement policy, and because it raises serious questions about the reasons that the development of this policy is being mediated by published communication. In the light of concerns about the implicit support and credibility that professional publications give to organ procurement policies, restraint in publishing articles about non-heart-beating organ donation as well as in devising such policies is strongly advocated.
The National Bioethics Advisory Commission has proposed that regulatory oversight for research with human subjects be extended beyond the protection of individual research participants to include the protection of social groups. To accomplish this, the commission recommends that investigators and ethics review boards a) work directly with community representatives to develop study methods that minimize potential group harms, b) discuss group implications as part of the informed consent process, and c) consider group harms in reporting research results. We examine the utility of these recommendations in the context of research with American Indian and Alaska Native communities. Because much attention has been given to the question of how best to consult with members of these communities in the design and conduct of research, we believe it behooves investigators to consider the lessons to be learned from research involving American Indians and Alaska Natives. After describing several difficulties surrounding the application of the commission's approach to these research contexts, we propose a research agenda to develop best practices for working with local communities in the ethical assessment of epidemiologic and environmental health research.
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There is growing concern about the reuse and exploitation of biological materials (human tissues) for use in research worldwide. Most discussions about samples have taken place in developed countries, where genetic manipulation techniques have greatly advanced in recent years. There is very little discussion in developing countries, although collaborative research with institutions from developed countries is on the increase. The study sought to identify and describe ethical issues arising in the storage, reuse and exportation of samples in a developing country. Research protocols presented to two Ethics Review Committees in Kenya during a period of two years were reviewed. A record was made of the protocol title, sample collected, request for storage, reuse or exportation and whether or not subject consent was sought. The findings indicated that about 25% out of the 388 protocols sought permission for reuse and only half of those actually informed subjects of the contemplated re-use. Less than 20% requested storage and again, about half of them sought consent from subjects. There is an indication that investigators do not see the need to seek consent for storage, reuse and exportation of samples. It is proposed that these issues should be addressed through policy interventions at both the national and global levels.