Droits du patient
Menée par des professionnels de santé, la recherche clinique vise à améliorer les connaissances de la structure, de la biologie et du fonctionnement du corps humain et la compréhension du développement des maladies. Elle permet aussi de développer des techniques de diagnostic plus fiables ou plus précoces et des techniques de soins plus efficaces ou moins invasives.
Le but de la recherche clinique est donc de faire progresser les connaissances actuelles sur l’être humain.
Droit à une information claire, loyale, exhaustive
Durant toute la durée de la recherche clinique, le participant doit recevoir une information claire, loyale et appropriée. Cette information doit tenir compte du degré de compréhension du participant.
Droit à la confidentialité
Les données recueillies dans le cadre du projet de recherche sont protégées par le secret médical. De fait, seules les personnes habilitées ont accès à ces données.
Droit à l'anonymat
L’identité des participants doit rester confidentielle et ne doit donc pas être révélée.
Droit de retrait
Le participant à une étude clinique peut interrompre sa participation à tout moment sans avoir à se justifier.
Droit de refuser de participer
La personne sollicitée pour participer à un projet de recherche n’est pas obligée d’accepter et n’a pas de justification à donner. Sa prise en charge doit rester intacte en cas de refus. Elle signe alors un document attestant que la qualité de sa prise en charge médicale et de ses relations avec l'équipe soignante ne sera pas affectée par la décision de ne pas participer à l'essai.
Le “consentement éclairé” est obligatoire pour toute participation à un essai clinique.
Droit à l'accès, à la modification et à la suppression des données
Toutes les données collectées sont soumises aux dispositions de la CNIL (loi Informatique et Libertés).
Droit à la communication des résultats globaux de l'essai
S’ils en font la demande, les participants doivent recevoir les résultats globaux de l’essai clinique.
Assurance
Le promoteur d’une étude clinique a l'obligation de prendre une assurance permettant d'indemniser les préjudices éventuels liés à la participation au projet de recherche.
La non opposition voire le consentement sont recherchés préalablement à l'inclusion d'un patient dans une étude soutenant la recherche.
Par conséquent, en tant que patient, vous pouvez à tout moment, vous rapprocher du médecin qui vous suit ou de l'Unité de recherche clinique (URC) et de la Direction pour signaler votre souhait de ne pas être inclus.
Contactez-nous :
Certaines études, dites non-interventionnelles, ne nécessitent pas la signature du consentement écrit mais uniquement le recueil de l’accord oral du patient ou d’un proche ou encore le fait de pas manifester son refus.
Cette procédure est souvent appliquée dans les études rétrospectives visant à recueillir des données présentes dans les dossiers médicaux des patients. La non-opposition du patient à participer à l’étude sera spécifiée dans son dossier médical.
Pour un essai clinique, seuls les patients qui donnent leur consentement (ou ne s’y oppose pas en fonction du type d’essai) peuvent participer à un essai clinique : Il est donc impossible d'être inclus sans le savoir.
Ce consentement peut être retiré à tout moment sans justification et sans compromettre la qualité de votre prise en charge par l’équipe médicale.
Votre participation à un projet de recherche qui nécessite votre consentement ne sera effective qu’après lecture de la notice d’information expliquant les objectifs et le déroulement de l’étude et la signature d’un consentement de participation à l’essai clinique.
Une fois le consentement signé, vous êtes « inclus » dans l’essai clinique. Cette inclusion n’est pas définitive, vous pouvez décider d’arrêter l’étude à tout moment.
Avant de donner votre consentement pour participer à un projet de recherche clinique, vous devez avoir compris les explications données par l’investigateur.
N’hésitez pas à poser des questions.
Si vous ne comprenez pas certaines phrases, demandez des explications à l’investigateur ou à son équipe.
Une bonne compréhension de la note d’information est essentielle avant de décider de participer à l’essai.
La note d’information qui vous est remise doit reprendre toutes les informations données par l’investigateur, elle doit décrire les modalités du traitement, les bénéfices attendus, les risques encourus, le déroulement de l’essai afin que vous sachiez comment il va se dérouler. Vous pouvez vous y référer à n’importe quel moment, dès que vous avez une interrogation.
Pour toute question concernant la protection de vos données personnelles, vous pouvez vous adresser au Délégué à la Protection des Données (DPO) : dpo@ghtpdfr.fr
Je découvre les dernières études
DOI | PMID | Auteur(s) | Titre | Revue | ISSN | Année | Catég. | Type |
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