Ingrid Callies

La personne de confiance, nouvel outil de la relation médecin patient

THE NOTION OF A PERSON OF TRUST: Introduced by the law dated March 4th 2002, the person of trust is there to accompany the patient in all his/her measures of care; this person is also conceived as an helper in medical decisions or when the patient participates in biomedical research protocols. DESIGNATION MODALITIES: Any adult, unprotected patient can designate a person of trust, whose intervention is not only limited to hospitalisation (the nursing staff are obliged to propose such a person), but can also intervene during care at home or at the doctors. The designation is made in writing and can be revoked at any time. The person of trust can be a relative, a friend or even the treating physician. A SPECIFIC ROLE: The person of trust can be of help in medical measures in routine medicine when the patients needs to be accompanied, and in the case of diagnosis or serious prognosis, and when the patient is incapable of expressing him/herself.

La personne de confiance : émergence, évolution et enjeux éthiques

La loi francaise du 4 mars 2002 a instaure la possibilite pour toute personne majeure de designer une personne de confiance. Celle-ci peut accompagner le patient dans ses demarches de soins et devenir en cas de besoin, un intermediaire privilegie pour representer l’avis du patient et a ce titre, elle peut etre consultee sans toutefois aller jusqu’a se substituer au consentement du patient.

Enjeux éthiques des collections d’échantillons humains dans le cadre de la recherche

Resume Le projet de loi relatif a la bioethique propose une modification en profondeur de la creation et de l’utilisation des collections d’echantillons biologiques humains a visee de recherche. La definition proposee etendrait l’actuelle definition, limitee au cadre genetique, a toutes les fins scientifiques en general. Par ailleurs, cette question renvoie a celle de l’atteinte au corps humain qui doit etre justifiee afin de permettre le recueil des echantillons qui suit differents regimes. Une fois les prelevements realises, se pose la question de l’utilisation des elements et produits obtenus dans le cadre de la constitution d’une collection. La protection des personnes a l’origine des echantillons doit etre au cœur de ce processus, ce qui a amene le legislateur a proposer l’elargissement des missions des comites consultatifs de protection des personnes dans la recherche biomedicale. Les differentes procedures qui seraient applicables sont parfois complexes et il est possible que les praticiens eprouvent parfois des difficultes a identifier celle applicable au cas de figure les concernant. Nous avons etabli des tableaux leur permettant de s’orienter avec plus de facilite.

French Jardé’s law and European regulation on drug trials: Harmonization and implementation of new rules

Jardés law, concerning research studies in humans, was enacted in March 2012 but did not come into force until November 2016. This delay is largely explained by the adoption of a European regulation on clinical trials on medicinal products that will probably not be applicable until October 2018. In addition to covering the respective areas of the French and European legislation, the round table provided an opportunity to discuss the principal measures that will apply to future research, particularly those concerning the operational procedures of the ethics committees and the national committee for research in humans, as well as measures relating to the management of serious adverse effects, more specifically in phase I studies in subjects not presenting with any disorder. This round table also enabled the formulation of recommendations to better anticipate the practical difficulties that the regulatory changes might engender. Finally, we highlight the numerous challenges in terms of training that these important regulatory changes impose and the absolute necessity to best adapt the restrictions to those that are planned in numerous other European countries so that France remains competitive in terms of clinical research and so that French patients may continue to benefit rapidly from the most innovative treatments.