Internationalisation des services génétiques : Perspectives légales et éthiques

L’internationalisation des services génétiques s’explique à la fois par la rareté de certains troubles génétiques et par le nombre restreint de laboratoires effectuant des tests spécialisés. Par leur nature même, les tests génétiques comportent des risques et doivent faire l’objet d’un contrôle serré. L’absence de contrôle international des laboratoires génétiques soulève d’importantes questions juridiques et éthiques. Le présent mémoire démontre, dans un premier article, les normes d’encadrement des laboratoires génétiques canadiens. Un second article compare des normes d’encadrement des laboratoires génétiques dans quatre pays membres de l’OCDE : la France, les États-Unis, l’Australie et le Royaume-Uni. Dans troisième article, les principaux droits des patients des services génétiques au Canada, aux États-Unis, en Australie et au Royaume-Uni sont comparés. Finalement, un quatrième article analyse les implications éthiques de la coexistence de différentes normes d’encadrement des laboratoires et des droits des patients, dans le contexte actuel d’internationalisation des services génétiques. Cette analyse éthique est effectuée selon trois perspectives reconnues : le principisme, l’utilitarisme et le déontologisme. L’hétérogénéité des normes régissant les laboratoires génétiques soulève des questions éthiques et démontre la nécessité d’ouvrir un dialogue international afin d’uniformiser les normes d’encadrement des laboratoires génétiques.The internationalization of clinical genetic services can be explained both by the rarity of certain genetic disorders and by the limited number of laboratories performing specialized tests. By its very nature, genetic testing carries risk and must be strictly controlled. The absence of international control over genetic laboratories raises important legal and ethical issues. In the first article, this paper looks at the testing standards for Canadian genetic laboratories. A second article compares genetic laboratory testing standards in four OECD member countries, namely: France, the United States, Australia and United Kingdom. In the third article, the key rights of genetic patients in Canada, the United States, Australia and United Kingdom are compared. Finally, a fourth article studies the ethical implications of the heterogeneousness of genetic laboratory control standards and patient rights against the prevailing backdrop of the internationalization of genetic services. This ethical study is based on three recognized theories: principlism, utilitarianism and deontologism. The heterogeneous articulation of standards governing genetic laboratories raises ethical issues and demonstrates the need to harmonize international standards

La recherche internationale en génétique et l’utilisation secondaire des données : entre dissociation et harmonisation

L’étude des polymorphismes et des aspects multifactoriels des déterminants de la santé suscite un engouement majeur envers la recherche populationnelle en génétique et génomique. Cette méthode de recherche requiert cependant la collecte et l’analyse d’un nombre élevé d’échantillons biologiques et de données associées, ce qui stimule le développement des biobanques. Ces biobanques, composées des données personnelles et de santé de milliers de participants, constituent désormais une ressource essentielle permettant l’étude de l’étiologie des maladies complexes et multifactorielles, tout en augmentant la rapidité et la fiabilité des résultats de recherche. Afin d’optimiser l’utilisation de ces ressources, les chercheurs combinent maintenant les informations contenues dans différentes biobanques de manière à créer virtuellement des mégacohortes de sujets. Cependant, tout partage de données à des fins de recherche internationale est dépendant de la possibilité, à la fois légale et éthique, d’utiliser ces données aux fins pressenties. Le droit d’utiliser les données personnelles, médicales et génétiques de participants dans le cadre de recherches internationales est soumis à un ensemble complexe et exhaustif d’exigences légales et éthiques. Cette complexité est exacerbée lorsque les participants sont décédés. Fondée sur une révision de l’interprétation individualiste du concept de consentement éclairé, ainsi qu’une perspective constructiviste des concepts de confiance et d’autonomie, cette thèse se situe au carrefour de la recherche, du droit et de l’éthique, et a pour objectif de proposer un modèle promouvant l’harmonisation éthique et juridique des données aux fins de recherches internationales en génétique.The study of polymorphisms and multifactorial aspects of health determinants enthuses many researchers with regard to populationnal research in genetics and genomics. The research method accompanying this field of research, however, requires the collection and analysis of a large number of biological samples and associated data, which fosters the development of biobanks. Biobanks, which contain personal and health data of thousands of participants, are therefore an essential resource to study the complex etiology of multifactorial diseases, and increase the speed and reliability of results. To optimize the use of these resources, many researchers now combine information from different biobanks to create “virtual” mega-cohorts of research participants. Thus, any attempt to share the data for international research is dependent on the legal and ethical right to use such data. Irrespective, the right to use the personal, medical and genetic data of participants in the context of international research is subject to complex and comprehensive legal and ethical frameworks. This complexity is exacerbated when research participants are deceased. Based on a review of the individualistic interpretation of the notion of informed consent and a constructivist approach to trust and autonomy, this thesis situates itself at the crossroads of research, law and ethics. It aims to propose a model promoting the legal and ethical harmonization of data for international genetic research

Genomic cloud computing:Legal and ethical points to consider

The biggest challenge in twenty-first century data-intensive genomic science, is developing vast computer infrastructure and advanced software tools to perform comprehensive analyses of genomic data sets for biomedical research and clinical practice. Researchers are increasingly turning to cloud computing both as a solution to integrate data from genomics, systems biology and biomedical data mining and as an approach to analyze data to solve biomedical problems. Although cloud computing provides several benefits such as lower costs and greater efficiency, it also raises legal and ethical issues. In this article, we discuss three key 'points to consider' (data control; data security, confidentiality and transfer; and accountability) based on a preliminary review of several publicly available cloud service providers' Terms of Service. These 'points to consider' should be borne in mind by genomic research organizations when negotiating legal arrangements to store genomic data on a large commercial cloud service provider's servers. Diligent genomic cloud computing means leveraging security standards and evaluation processes as a means to protect data and entails many of the same good practices that researchers should always consider in securing their local infrastructure.</p

Towards a data sharing Code of Conduct for international genomic research

Data sharing is increasingly regarded as an ethical and scientific imperative that advances knowledge and thereby respects the contributions of the participants. Because of this and the ever-increasing amount of data access requests currently filed around the world, three groups have decided to develop data sharing principles specific to the context of collaborative international genomics research. These groups are: the international Public Population Project in Genomics (P3G), an international consortium of projects partaking in large-scale genetic epidemiological studies and biobanks; the European Network for Genetic and Genomic Epidemiology (ENGAGE), a research project aiming to translate data from large-scale epidemiological research initiatives into relevant clinical information; and the Centre for Health, Law and Emerging Technologies (HeLEX). We propose seven different principles and a preliminary international data sharing Code of Conduct for ongoing discussion

Comment opérationnaliser et évaluer la prise en compte du concept ‘FAIR' dans le partage des données: Vers une grille simplifiée d’évaluation du respect des critères FAIR.

National audienceIndexed identifier ? Identification Are each data/dataset identified by an indexed and independant identifier ? Persistent metadata / data link ? Metadata traceability Are the metadata linked to the dataset through a persistent identifier? Metadata & authority linked ? Metadata traceability Are the metadata of each dataset linked to a unique authority (responsible for the datasets at a given time)? Unique, global, persistent ID? Identification Are the data identifiers unique, global and persistent ? Are the data identifiers unique, global and persistent ? Datasets linked to authority ? Metadata traceability Are all datasets linked to an authority (legal entity) through a unique and persistent identifier over time (e.g. institution, association or established body)? In case of a legal reuse restriction (such as personal data, state and public security, national defense secret, confidentiality of external relations, information systems security, secrets in industrial and commercial matters) , is the restriction properly justified?SHARC (SHAring Reward & Credit) est un groupe d’intérêt scientifique interdisciplinaire créé dans le cadre de RDA (Research Data Alliance) dans le but de faciliter le partage des données de recherche (et des ressources) par la valorisation de l’ensemble des activités pré-requises à ce partage, tout au long du cycle de vie des données. Dans ce cadre, un sous-groupe de travail SHARC élabore des grilles d’évaluation des chercheurs afin de mesurer leur niveau de prise en compte des principes FAIR dans la gestion de leurs données.La grille d’évaluation présentée dans ce poster est destinée à être complétée par tout scientifique produisant et / ou utilisant des données. Il s'agit d'un résumé d'une grille d'évaluation plus étendue conçue pour un partage optimal des données (non encore mise en œuvre pour le moment par la plupart des scientifiques).L'évaluation est basée sur les critères de conformité FAIR. Pour remplir cet objectif, la grille affiche le minimum de critères qui doivent absolument être appliqués par les chercheurs pour attester de leur pratique FAIR. Ces critères sont organisés en 5 groupes: «Motivations de partage»; "Trouvable", "Accessible", "Interopérable" et "Réutilisable". Pour chaque critère, 4 degrés d’évaluation sont proposés ("Jamais / Non évaluable"; "Si obligatoire"; "Parfois"; "Toujours"). Au moins un degré mais un seul doit être sélectionné par critère. L'évaluation doit être effectuée pour chaque catégorie F / A / I / R; L'évaluation finale est la somme de chaque degré coché rapportée au nombre total de critères dans chaque catégorie F / A / I / R. Des règles d'interprétation prenant en compte les «motivations du partage» sont proposées

Bridging consent: from toll bridges to lift bridges?

<p>Abstract</p> <p>Background</p> <p>The ability to share human biological samples, associated data and results across disease-specific and population-based human research biobanks is becoming increasingly important for research into disease development and translation. Although informed consent often does not anticipate such cross-domain sharing, it is important to examine its plausibility. The purpose of this study was to explore the feasibility of bridging consent between disease-specific and population-based research. Comparative analyses of 1) current ethical and legal frameworks governing consent and 2) informed consent models found in disease-specific and population-based research were conducted.</p> <p>Discussion</p> <p>Ethical and legal frameworks governing consent dissuade cross-domain data sharing. Paradoxically, analysis of consent models for disease-specific and population-based research reveals such a high degree of similarity that bridging consent could be possible if additional information regarding bridging was incorporated into consent forms. We submit that bridging of consent could be supported if current trends endorsing a new interpretation of consent are adopted. To illustrate this we sketch potential bridging consent scenarios.</p> <p>Summary</p> <p>A bridging consent, respectful of the spirit of initial consent, is feasible and would require only small changes to the content of consents currently being used. Under a bridging consent approach, the initial data and samples collection can serve an identified research project as well as contribute to the creation of a resource for a range of other projects.</p

Analyse comparative du devoir de renseignement et d'étiquetage du fabricant de produits pharmaceutiques en droit québécois et suisse

Résumé: Peu d 'auteurs et de tribunaux ont étudié les modalités propres au devoir de renseignement des fabricants de produits pharmaceutiques disponibles en vente libre. Afin d' apporter un nouvel éclairage en la matière, il est tout d' abord nécessaire d'identifier les dispositions législatives et arrêts de jurisprudence traitant de la question. Après avoir déterminé le contenu et l'étendue du devoir d' information des fabricants de médicaments, notamment grâce à l'éclairage de la doctrine et des décisions relatives au devoir d'information du médecin, il devient alors possible de conclure que les règles canadiennes d'étiquetage des médicaments ne permettent pas aux fabricants de se décharger complètement de leur devoir d'information. À défaut d'être accompagnée de solutions concrètes, une telle conclusion est tout à fait inutile. C'est pourquoi l' étude de la législation helvète est pertinente. En effet, l'industrie pharmaceutique suisse doit satisfaire des normes d'étiquetage beaucoup plus exigeantes, qui convergent vers les modalités du devoir d ' information. Reste à savoir si la solution suisse peut être appliquée en droit canadien. Malgré les différences existantes entre ces deux pays, rien n'indique une impossibilité à cet égard.||Abstract: Few authors or courts have scrutinized the duty to inform of over-the-counter pharmaceuticals manufacturers . To shed new light on this matter, relevant legal provisions and jurisprudence must first be identified . After determining the content and extent of the duty to inform of drug manufacturers, namely by examining the doctrine and decisions regarding the duty to inform of physicians, one may justly conclude that Canadian rules governing drug labeling do not allow manufacturers to eschew their duty to inform. Unless accompanied by concrete solutions, however, such a conclusion holds no value. For this reason, studying Swiss legislation becomes pertinent, as the Swiss pharmaceutical industry must meet far more rigorous standards , which emphasize the duty to inform. It remains to be seen whether the Swiss solution can be applied in Canadian law. Despite existing differences between these two countries, there is no indication that this solution cannot be adopted

P3G — 10 years of toolbuilding: From the population biobank to the clinic

Over the past ten years, the Public Population Project in Genomics and Society (“P3G”) has grown as a consortium. It has expanded its range of services and resources to adapt to the ever-evolving needs of the research community. From its outset – when P3G first tackled the building of biobanks as resources as well as data cataloguing and harmonization for data integration – to its new mission and vision, it has continually developed the tools for the conceptualization and design of population biobanks from their inception to their use to their closure. In so doing, P3G has become key in fostering research infrastructures to facilitate transition to the clinic. The consortium has become a crucial stakeholder in the international scientific, ethical, legal, and social research communities

Evaluating FAIRness practise: need for an integrated ecosystem of assessment linked to crediting and rewarding mechanisms.

Short introduction describing the scope of the group and if any previous activities Data sharing statements and promotion face a challenging reality, as many obstacles remain on several fronts. Among them is the lack of relevant and recognized rewarding mechanisms for the very specific efforts required to share organized datasets and physical resources (Cambon-Thomsen et al., 2011; Mabile et al., 2016). The RDA-SHARC interest group is an interdisciplinary group set up to unpack and improve crediting and rewarding mechanisms in the data/resource sharing process. The main objective is to encourage the adoption of data sharing activities-related criteria in the research evaluation process at the institutional, national and European/international levels. As a step forward, FAIR sharing assessment grids are being built by RDA-SHARC IG members. To be generic and trans-disciplinary, assessment grids should be understandable by all scientist including those who are not experts in data science. The two grids displayed as a tree-graph structure are based on previous works on FAIR data management (Reymonet et al., 2018; Wilkinson et al., 2016; Wilkinson et al., 2018; and E.U.Guidelines about FAIRness DMPs): 1/ the self-assessment grid is conceived as a checklist for scientists to identify whether their own activities are compliant to FAIR principles and to pinpoint the hurdles that hinder efficient sharing and reuse of data. 2/ the two-level grid (simplified / extensive) is conceived as a chart for the evaluator to assess the quality of the researcher/scientist sharing practices, over a given period of time, taking into account the means & supports available over that period. Assessment criteria are classified according to their level of stringency regarding FAIRness (essential / recommended / desirable). The scope of this session is to build the stepwise processes required to enhance adoption of the proposed FAIR assessment grids-prototypes by the various stakeholders. The questions to be discussed are: What are the pros and cons of the proposed assessment prototypes/grids? What are the steps required by the various actors in the evaluation ecosystem for grids adoptions? How to use this ecosystem for credit and rewarding? Which levels of implementation should be considered? The next step would be to design a pilot use of the modified grids in order to gather empirical data. Meeting agenda (for this presentation) ● Goals of the group’s project; current standing; objectives of the meeting: Introduction to the group? A. Cambon-Thomsen (FR) 10 min ● Grids in SHARC recommendations, L. Mabile (FR) 5 min ● Grids construction and structure, R.David (FR) 10 mi