کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
2579370 | 1130045 | 2009 | 9 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Collections of Human Biological Samples for Scientific Purposes. Why do Current Regulation Need to be Clarified and How?
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کلمات کلیدی
موضوعات مرتبط
علوم پزشکی و سلامت
داروسازی، سم شناسی و علوم دارویی
فارماکولوژی، سم شناسی و اقلام دارویی (عمومی)
پیش نمایش صفحه اول مقاله
چکیده انگلیسی
The collection of human biological samples is of major importance for future research in France and Europe. In recent years, new regulatory procedures have been designed to monitor these activities; but they are somewhat complex and some clarifications are needed. The law needs also to be amended. The definition of biobanking activities should be clarified, and regulatory procedures, including consultation of the Ethics Committee, declarations to the Ministry of Research and the protection of personal data, should be simplified. It is also of great importance to correctly define the modalities in which Biobanks are granted their authorisations. The role of Ethics Committees regarding the evaluation of information and the consent procedures should also be clarified, particularly when samples from children are used, or when the samples are used for genetic analyses. As well as scientific and public health aspects, the storage of human biological samples may also have important economic consequences. It is hence crucial to adapt the procedure for submitting patents, particularly when several public or private partners are working together. The possible changes to both French and European laws planned in the next months would be an ideal time to introduce these changes.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Thérapie - Volume 64, Issue 4, JulyâAugust 2009, Pages 259-267
Journal: Thérapie - Volume 64, Issue 4, JulyâAugust 2009, Pages 259-267
نویسندگان
Dominique Deplanque, Guillaume Birraux, Pierre-Henri Bertoye, Ãric Postaire,