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La recherche biomédicale en quête de principes

Author: Anne-Sophie Ginon; Isabelle Vacarie; Université Paris Nanterre.
Publisher: [S.l.] : [s.n.], 2002.
Dissertation: Thèse de doctorat : Droit : Paris 10 : 2002.
Edition/Format:   Thesis/dissertation : Thesis/dissertation : FrenchView all editions and formats
Summary:
Le droit de la recherche biomédicale est un excellent révélateur d'une nouvelle construction de l'ordre public entendu comme un corps de règles indisponibles ou indérogeables. En s'appliquant indifféremment à la personne juridique capable, à ses éléments et ses produits, et même à l'embryon humain in vitro, ce droit met à l'épreuve le concept de personne comme sujet de droit. Les articles 16 et
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Details

Genre/Form: Thèses et écrits académiques
Additional Physical Format: La recherche biomédicale en quête de principes / Anne-Sophie Ginon
Lille : ANRT, [2005]
1 microfiche. (@Lille-thèses)
(ABES)202578542
Material Type: Thesis/dissertation
Document Type: Book
All Authors / Contributors: Anne-Sophie Ginon; Isabelle Vacarie; Université Paris Nanterre.
OCLC Number: 493696841
Description: 1 vol. (447 f.) ; 30 cm.
Responsibility: Anne-Sophie Ginon ; [sous la direction de Isabelle Vacarie].

Abstract:

Le droit de la recherche biomédicale est un excellent révélateur d'une nouvelle construction de l'ordre public entendu comme un corps de règles indisponibles ou indérogeables. En s'appliquant indifféremment à la personne juridique capable, à ses éléments et ses produits, et même à l'embryon humain in vitro, ce droit met à l'épreuve le concept de personne comme sujet de droit. Les articles 16 et suivants du Code civil constituent autant de points fixes aux conventions de recherche qui limitent, et même, empêchent la réalisation sur les ressources humaines d'expériences déjà réalisées sur les autres espèces vivantes. La personne humaine témoigne d'une autre dimension de la personne entendue comme point de différenciation entre l'homme et le reste du vivant. Plus encore, les conditions de validité des recherches sont des standards législatifs dont le sens n'apparaît qu'à chacune de leur mise en oeuvre. La création d'instances administratives ad hoc chargées d'apprécier la validité juridique de chaque protocole de recherche consacre un nouveau mode de régulation qui distribue différemment les pouvoirs issus de la Constitution. Sa confrontation avec la jurisprudence constitutionnelle montre que ces instances administratives apportent une garantie essentielle au respect des conditions de validité du CSP et relèvent tant pour leur création que pour leur mode composition ou de fonctionnement de la loi. Mais le droit de la recherche biomédicale décrit également les conditions de la relation juridique qui se noue entre l'investigateur et le sujet de recherche. Gratuité, droit de retrait à tout moment et absence d'équivalence contractuelle sont les traits caractéristiques du contrat de bienfaisance dont les fondements ont dû être rénovés pour appréhender la relation de recherche. Outil pour rendre compte de la législation, le contrat de bienfaisance est également utile pour évaluer les propositions actuelles de réforme ainsi que pour repérer l'abandon des éléments et des produits du corps humain. Diverses obligations sont alors mises à la charge du promoteur. Elles expriment une justice contractuelle distincte du droit commun puisque distributive, à la mesure du service rendu. Rendant acceptable la dissymétrie inhérente à l'opération juridique gratuite, ces règles marquent la présence d'un ordre public indérogeable, sauf dispositions plus favorables, propre aux contrats gratuits.

The law relating to biomedical research is an excellent indicator of the development of a new ordre public (public policy) understood as being a body of inalienable rules. Applying equally to the legally capable person, to the body parts and products and even to the human in vitro embryo, this law brings into question the concept of person as a legal entity. In the Civil code, articles 16 and the articles that follow constitute concrete terms in research contracts that limit or even prevent the carrying out of experiments on human resources that have already been carried out on other living species. Human person implies a different dimension to that of person understood as differentiating between the individual human being and other living organisms. Moreover, the conditions necessary for legitimate research are legislative standards, the aim of which only becomes clear when they are actually applied. The creation of ad hoc administrative bodies charged with examining the legality of each research protocol, represents a new type of regulation that distributes constitutional powers differently. Confrontation with the constitutional case-law illustrates that these administrative bodies provide an essential guarantee of respect for the conditions laid down in the Public Health Code and that not only their creation, but also their composition and working, originate in statute. However, the law of biomedical research also expresses the conditions of the legal relationship that is formed between the investigator and the research subject. Prohibition of payment, the right to withdraw at any moment and lack of reciprocal duty are the characteristics of a beneficence contract, the basis of which has had to be reviewed to take into account the research relationship. As a tool to respond to the legislation, the beneficence contract is also useful in evaluating the current reform proposals as well as in covering the abandonment of human body parts and products. The promoter is therefore under certain duties. These duties represent a contractual justice that is not present in the general law because they are distributive in nature corresponding to the service provided. By rendering acceptable the inherent asymmetry of a unilateral contractual relationship, these rules indicate the presence of an inalienable ordre public particular to unilateral contracts (contrats gratuits) except where more favourable provisions may already exist.

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