La protection de l'humain au-delà du réglementaire dans la recherche bio-médicale (notice n° 430463)
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| fixed length control field | 03539cam a2200217 4500500 |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20250120231325.0 |
| 041 ## - LANGUAGE CODE | |
| Language code of text/sound track or separate title | fre |
| 042 ## - AUTHENTICATION CODE | |
| Authentication code | dc |
| 100 10 - MAIN ENTRY--PERSONAL NAME | |
| Personal name | Donnadieu, Stéphane |
| Relator term | author |
| 245 00 - TITLE STATEMENT | |
| Title | La protection de l'humain au-delà du réglementaire dans la recherche bio-médicale |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. | |
| Date of publication, distribution, etc. | 2010.<br/> |
| 500 ## - GENERAL NOTE | |
| General note | 86 |
| 520 ## - SUMMARY, ETC. | |
| Summary, etc. | La recherche biomédicale est réglementairement très encadrée par plusieurs lois ayant pour socle commun le plein consentement du participant. Plusieurs textes se sont ajoutés les uns aux autres pour garantir une meilleure sécurité des participants. Mais au-delà de ce contexte réglementaire manquant parfois de visibilité et de souplesse pour répondre à l’étendue de la recherche chez l’homme, agissent des personnes à tous les niveaux que ce soit le promoteur dont les intérêts peuvent être scientifiques, mais parfois associés à des buts financiers, l’investigateur chargé d’inclure, d’informer loyalement le participant et de le suivre tout au long de l’essai, le comité de protection des personne dont les tâches s’élargissent au fil des années, demandant davantage à ses membres issus de la communauté scientifique, mais aussi de la société civile, tous bénévoles pour rendre des avis engageant leur responsabilité. Enfin des participants, volontaires ou malades, dont la motivation peut parfois être la recherche du bénéfice d’une thérapeutique innovante, parfois le maigre gain d’une indemnisation limitée par le législateur, le plus souvent être le témoignage d’un engagement citoyen. |
| 520 ## - SUMMARY, ETC. | |
| Summary, etc. | Protecting Human Beings Over and Beyond the Regulations Governing Bio-Medical Research. Biomedical research is governed by an extremely strict set of regulations laid down by a number of laws, each of which underline the necessity for full and clear consent on the part of the participating individual involved. Successive texts have been voted by Parliament to ensure the safety of these individuals. Yet over and above the legal context surrounding biomedical research, sometimes cruelly lacking in clarity and flexibility in the light of the advancing scope of research in the field of human medicine, a number of other stakeholders also play key roles. These range from project leaders, whose goal may be purely scientific but not necessarily devoid of financial interest, to investigators responsible for enrolling and informing participants and following their progress throughout the trial period, to the Committee for the Protection of Individuals, whose task has become increasingly heavy over recent years, putting greater pressure on its members from both the scientific community and interest groups, all of whom are volunteers and who make decisions which engage their personal liability. We will also look at the participants themselves, whether they be volunteers or sufferers of a given condition or disease, people often motivated by a personal quest for treatment or cure through medical innovation, or meagre financial profit as provided for and restricted by the law, or by their desire as citizens to contribute to the general good. |
| 690 ## - LOCAL SUBJECT ADDED ENTRY--TOPICAL TERM (OCLC, RLIN) | |
| Topical term or geographic name as entry element | Recherche biomédicale |
| 690 ## - LOCAL SUBJECT ADDED ENTRY--TOPICAL TERM (OCLC, RLIN) | |
| Topical term or geographic name as entry element | Comité de protection des<br/>personnes |
| 690 ## - LOCAL SUBJECT ADDED ENTRY--TOPICAL TERM (OCLC, RLIN) | |
| Topical term or geographic name as entry element | Committee for the Protection of Individuals |
| 690 ## - LOCAL SUBJECT ADDED ENTRY--TOPICAL TERM (OCLC, RLIN) | |
| Topical term or geographic name as entry element | Biomedical Research |
| 786 0# - DATA SOURCE ENTRY | |
| Note | Champ psychosomatique | 55 | 3 | 2010-04-12 | p. 75-81 | 1266-5371 |
| 856 41 - ELECTRONIC LOCATION AND ACCESS | |
| Uniform Resource Identifier | <a href="https://shs.cairn.info/revue-champ-psychosomatique-2009-3-page-75?lang=fr&redirect-ssocas=7080">https://shs.cairn.info/revue-champ-psychosomatique-2009-3-page-75?lang=fr&redirect-ssocas=7080</a> |
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