The ethical uses of human tissue.
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SEARCH · PubMed Health
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The National Institutes of Health is the largest biomedical research institution in the world. It has become one of the world's most highly respected research centers in part because of its efforts over the years to provide the research community with leadership in both the ethical and scientific parameters of research involving humans. As its 113th birthday approaches at the turn of the century, its great legacy is providing an environment to stimulate and nourish the diversity and creativity of ideas, and thereby enable science to progress. This research must continue to be guided and tempered by consistent and critical federally-supported ethical analyses.
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Institutions in France are not yet well prepared to respond to allegations of scientific misconduct. Following a serious allegation in late 1997, INSERM, the primary organization for medical and health-related research in France, began to reflect on this subject, aided by scientists and jurists. The conclusions have resulted in establishing a procedure to be followed in cases of alleged misconduct, and also in reinforcing the application of good laboratory practices within each laboratory. Guidelines for authorship practices and scientific assessment must also be considered. Even though each institution must remain responsible for responding to allegations of scientific misconduct within its doors, INSERM would like to see national, European, and international co-ordination about the methods of such response.
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For a variety of historical and social reasons, research has become increasingly formalized and regulated. This change has potential benefits (reduction in fraud and misconduct, protection of vulnerable groups, financial probity) but also disadvantages (increased paperwork, time delays, constraints on research freedom). The terms 'research' and 'governance' mean different things in different contexts. Even with explicit guidance, ambiguities must be resolved by human judgement. Variation in the nature and outcome of approval decisions is therefore a fact of life. The type of approval needed for a research study depends on the official remit of the approval body, the question to be addressed; the methods to be used; the context in which the work will take place; the level of analysis and interpretation; and the plans for how the findings will be presented and used.
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