Research with human embryonic stem cells: ethical considerations. By Geron Ethics Advisory Board.
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Inevitably a policy-oriented report on issues as complex and as rapidly changing as the medical and scientific uses of human tissue can achieve neither philosophical purity nor regulatory completeness. The council's strategy has been to begin with robust ethical principles, for which sound philosophical arguments can be given, which will (it is hoped) command widespread support. The council went on to argue for guidelines of sufficient, but not vapid, generality which could be of practical use to the various medical intermediaries, professional and regulatory bodies and research ethics committees which will carry out the tasks of detailed regulation and of making decisions that affect uses of human tissue. The council's hope is that the recommendations of the report can be absorbed into regulatory and professional practice, and where needed into government policy. If they can, the increasing diversity of uses of human tissues need lead neither to overt nor to covert 'commercialisation of the human body', but will also not put unnecessary restrictions on advances in research and medical practice.
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Recent media depictions of the dangers of biomedical research have fueled public and regulatory scrutiny of academic research institutions. The authors argue that if these institutions are to preserve the trust that the public has historically bestowed upon them, they must go beyond mere compliance with regulatory mandates. Several steps are suggested that institutions can take to strengthen and supplement ongoing compliance efforts, steps the authors believe will bolster the public's confidence in the integrity of academic research institutions. These steps grow out of the authors' analysis of three key components of institutional trustworthiness: (1) shared goals between research institutions and the communities they serve, (2) robust institutional oversight of research activities, and (3) training programs that build professional character. The authors' recommendations include the use of research advisory councils to assure the public that research goals reflect community interests, more collaborative relationships between institutional review boards and members of investigative teams, and educational programs that emphasize the importance of professional integrity in biomedical research. These efforts will help preserve public confidence that an institution's research priorities are appropriate and that the research it conducts is ethical. Preserving this public trust is central to the long-term success of biomedical research and the institutions in which such research takes place.
The European Group on Ethics is made up of 12 independent experts appointed by the European Commission. It is a multidisciplinary body that advises the Commission on ethical aspects of science and new technologies in connection with the preparation or implementation of EU legislation or policies. Its latest, 17th, opinion is reproduced below: since the current EU framework programme of medical research encourages partnerships with developing countries, it concerns the ethics of such research.
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There is a growing gap between the tidal wave of information emerging from the Human Genome Project and other molecular biology initiatives, and the clinical research needed to transform these discoveries into new diagnostics and therapeutics. While genomics-based technologies are being rapidly integrated into pharmaceutical R&D, many steps in the experimental process are still reliant on traditional surrogate model systems whose predictive power about human disease is incomplete or inaccurate. There is a growing trend underway in the research community to introduce actual human disease understanding as early as possible into discovery, thereby improving accuracy of results throughout the R&D continuum. Such an approach (known as clinical genomics: the large scale study of genes in the context of actual human disease) requires the availability of large quantities of ethically and legally sourced, high-quality human tissues with associated clinical information.Heretofore, no source could meet all of these requirements. Ardais Corporation was the first to address this need by pioneering a systematized, standardized network for the collection, processing, dissemination and research application of human tissue and associated clinical information, all of which rest on the highest ethical standards. Based on a novel model of collaboration between industry and the academic/medical community, Ardais has created procedures, structures, technologies, and information tools that collectively compromise a new paradigm in the application of human disease to biomedical research. Ardais now serves as a clinical genomics resource to dozens of academic researchers and biopharmaceutical companies, providing products and services to accelerate and improve drug discovery and development.
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