La responsabilité civile des conseillers en génétique au Québec et les conséquences juridiques de la non-reconnaissance : vers un encadrement juridique?

Depuis maintenant quelques décennies, les conseillers en génétique jouent un rôle de plus en plus important dans le domaine de la génétique médicale. Leur apport ainsi que l’importance de leur rôle sont aujourd’hui incontestables. Leur statut juridique, cependant, demeure incertain et requiert une analyse approfondie. En effet, n’étant pas reconnue par le Code des professions du Québec, la pratique du conseil génétique se trouve conséquemment privée de la protection octroyée par ce Code aux autres professionnels, notamment celle ayant trait au titre et à l’exclusivité des actes. Devant ce statu quo et dans l’optique de la protection du public, l’étude de la responsabilité civile du conseiller en génétique s’avère nécessaire. Trois obligations principales ressortent de cette analyse, soit les obligations de compétence, de renseignement et de confidentialité. En ce qui a trait aux conséquences juridiques de la non-reconnaissance, elles ne sont pas négligeables. En vérité, l’inertie du législateur québécois floue la relation qu’a le conseiller en génétique avec les autres membres de son équipe multidisciplinaire, et ce, surtout en ce qui a trait à la délimitation des actes qu’il peut prodiguer. En effet, ce dernier risque d’empiéter sur certains aspects de la pratique médicale et infirmière, engendrant ainsi sa responsabilité pénale. Finalement, il s’est avéré important de chercher des pistes de solutions étrangères pouvant se transposer au Québec. Le cas de la France se trouve à être un exemple pertinent, puisque le législateur français a reconnu législativement le conseiller en génétique en tant que professionnel et a protégé tant le titre que l’exclusivité des actes de ce dernier.In recent decades, genetic counselors have played an increasingly important role in the field of medical genetics. Today, their contribution and the importance of their role are indisputable. Their legal status, however, remains uncertain and requires further analysis. Indeed, not being recognized by the Professional Code of Quebec, the practice of genetic counselors is consequently deprived of the protection granted by this Code to other professionals, notably the exclusivity of their titles and acts. Given this status quo and with the aim of protecting the public, a study of the civil liability of genetic counselors becomes necessary. Three main duties of genetic counselors emerge from this analysis: the duty to proficiency, the duty to inform, and the duty of confidentiality. Moreover, there are several legal consequences for non-recognition of this emerging profession. Indeed, the inaction of the Quebec legislator has resulted in a confusing relationship between the genetic counselor and the other members of the multidisciplinary team, especially with regard to the delimitation of services which the counselor can provide. Indeed, the latter may infringe on certain aspects of the medical practice and nursing, thereby engendering his penal liability. This situation leads us to foreign jurisdictions in an effort to find possible solutions which can be transposed in Quebec. The situation in France comes as a relevant example, since the French legislature has legally recognized the genetic counselor as a professional and has protected his title as well as the exclusivity of his practice

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

Parental Access to Children's Raw Genomic Data in Canada: Legal Rights and Professional Responsibility

Children with rare and common diseases now undergo whole genome sequencing (WGS) in clinical and research contexts. Parents sometimes request access to their child's raw genomic data, to pursue their own analyses or for onward sharing with health professionals and researchers. These requests raise legal, ethical, and practical issues for professionals and parents alike. The advent of widespread WGS in pediatrics occurs in a context where privacy and data protection law remains focused on giving individuals control-oriented rights with respect to their personal information. Acting in their child's stead and in their best interests, parents are generally the ones who will be exercising these informational rights on behalf of the child. In this paper, we map the contours of parental authority to access their child's raw genomic data. We consider three use cases: hospital-based researchers, healthcare professionals acting in a clinical-diagnostic capacity, and “pure” academic researchers at a public institution. Our research seeks to answer two principal questions: Do parents have a right of access to their child's raw WGS data? If so, what are the limits of this right? Primarily focused on the laws of Ontario, Canada's most populous province, with a secondary focus on Canada's three other most populous provinces (Quebec, British Columbia, and Alberta) and the European Union, our principal findings include (1) parents have a general right of access to information about their children, but that the access right is more capacious in the clinical context than in the research context; (2) the right of access extends to personal data in raw form; (3) a consideration of the best interests of the child may materially limit the legal rights of parents to access data about their child; (4) the ability to exercise rights of access are transferred from parents to children when they gain decision-making capacity in both the clinical and research contexts, but with more nuance in the former. With these findings in mind, we argue that professional guidelines, which are concerned with obligations to interpret and return results, may assist in furthering a child's best interests in the context of legal access rights. We conclude by crafting recommendations for healthcare professionals in the clinical and research contexts when faced with a parental request for a child's raw genomic data

The genetic discrimination observatory : confronting novel issues in genetic discrimination

Genetic discrimination (GD) is the differential or unfair profiling of an individual on the basis of genetic data. This article summarizes the actions of the Genetic Discrimination Observatory (GDO) in addressing GD and recent developments in GD since late 2020. It shows how GD can take many forms in today’s rapidly evolving society.http://www.journals.elsevier.com/trends-in-geneticshj2022Immunolog

Of research participants and population biobanks: Reciprocity as a conceptual basis to relational autonomy

The principle of autonomy has been the cornerstone of the physician's duty to inform since paternalistic medical practices receded in the second half of the 20th century. One prevalent conception of autonomy claims that the extent of the duty to inform (and, by extension, the duty to disclose) is inversely proportional to an intervention's expected therapeutic benefit. Indeed, Canadian Courts have found that research participants are not in a therapeutic relationship. As a consequence, they do not stand to benefit as patients in a clinical setting would. This distinction, according to judicial interpretation, demands a more exacting standard of information disclosure, one in which researchers are required to provide participants a full and frank disclosure of all facts, opinions and probabilities, no matter how remote, as well as any other material information about the research. As research becomes increasingly longitudinal (analyzed and accessed over time), international (crossing boundaries and legal jurisdictions), and less directly focused on individuals, the feasibility of applying this standard is being called into question. Additionally, research has come to rely less on direct interventions and ever more on bioinformatics technologies that generate massive amounts of data. This is especially true in the case of population biobanks, which aim to study data and samples collected over an extended period and on the scale of entire populations. This thesis will demonstrate that the dominant jurisprudential interpretation of the standard of disclosure applicable in the research context has a conception of individualistic autonomy at its core. It will then outline the multiple limitations individualistic autonomy faces in the context of population biobanks. This is so for two reasons: first, it fails to recognize the complexities of benefit considerations in the research setting. Second, given its unidirectional aims (any interaction centres around the participant), individualistic autonomy fails to acknowledge the multilateral relationships necessarily implicated in population biobanking research, including those that implicate the broader research community and the general public. In carrying out this analysis, this thesis will pay special attention to alternative approaches and focus specifically on relational autonomy. It will demonstrate that for relational autonomy to be applied in the population biobanking context, it will need to be situated in a conceptual framework that practically describes, acknowledges and sustains the multilateral relationships found in this species of research, without also compromising the rights of participants. Using theoretical discussions, this thesis will argue that, despite certain limitations, the concept of reciprocity as a basis for relational autonomy will succeed to do just that. It will, moreover, form the basis of a reconceived duty to inform for researchers and a new standard of disclosure that is more meaningful to research participants.À partir de la deuxième moitié du 20e siècle, avec le recul des pratiques médicales paternalistes, le principe de l'autonomie s'est imposé comme la pierre angulaire du devoir d'information du médecin. Une conception courante de l'autonomie pose que l'étendue du devoir d'information (et, par extension, de l'obligation de divulgation) est inversement proportionnelle au bénéfice thérapeutique potentiel d'une intervention. En effet, les tribunaux canadiens ont établi que les participants à un projet de recherche ne se trouvent pas en situation de relation thérapeutique. En conséquence, de tels participants ne bénéficieront pas de leur participation à la recherche de la même manière que des patients pourraient bénéficier d'une intervention dans un contexte clinique. Cette distinction, selon l'interprétation qu'en ont fait les tribunaux, impose un devoir plus exigeant d'information aux chercheurs, qui sont tenus de divulguer aux participants l'ensemble des faits, opinions et probabilités, sans exception et aussi lointains soient-ils, ainsi que de leur fournir toute autre information importante liée à la recherche. Alors que la recherche devient de plus en plus longitudinale (analysée et consultée au fil du temps), internationale (traversant les frontières et les juridictions), et moins centrée sur les individus, la faisabilité de l'application de cette norme exigeante est remise en question. De plus, la recherche se base désormais de moins en moins sur des interventions directes, et se base plutôt sur des technologies bio-informatiques qui génèrent de grandes quantités d'information. Cela est particulièrement vrai dans le cas des biobanques populationnelles, qui visent à étudier des données et des échantillons récoltés sur de longues périodes de temps et à l'échelle de populations entières. Cette thèse démontrera que le courant dominant concernant l'interprétation jurisprudentielle du standard de divulgation applicable à la recherche est fondé sur une conception individualiste de l'autonomie. Les multiples limites de cette conception de l'autonomie dans le contexte des biobanques populationnelles seront ensuite présentées. Ces limites existent pour deux raisons : premièrement, la conception individualiste de l'autonomie ne reconnait pas la complexité des considérations relatives au bénéfice potentiel de la recherche. Deuxièmement, de par son but unidirectionnel (toute interaction est centrée sur le participant), l'autonomie individualiste ne permet pas de reconnaitre les relations multilatérales nécessairement impliquées dans la recherche effectuée à l'aide de biobanques populationnelles, incluant les relations qui impliquent la communauté scientifique et le grand public. En réalisant cette analyse, cette thèse portera une attention particulière aux approches alternatives et se concentrera sur l'autonomie relationnelle. Cette thèse démontrera également qu'afin que l'autonomie relationnelle puisse être appliquée dans le contexte des biobanques populationnelles, elle devra se situer dans un cadre conceptuel qui décrit, reconnait et soutient les relations multilatérales que l'on retrouve dans ce type de recherche, sans pour autant compromettre les droits des participants. En faisant appel à des discussions théoriques, cette thèse argumentera que, malgré certaines limitations, le concept de réciprocité en tant que base pour l'autonomie relationnelle parviendra à faire exactement cela. Ce concept formera également la base d'un devoir d'information reconçu et d'un nouveau standard de divulgation plus significatif pour les participants à la recherche

Online Portals for Sharing Health Research: Comparative Guidance amid Regulatory Uncertainty

Online resources offer a uniquely efficient way of sharing health research with scientists and the public. Using web portals to make results and study information available to diverse audiences could work to accelerate research translation and empower patients to play a more active role in their care. But using online tools to broadly share health information raises several challenging ethical and regulatory questions. Issues such as equity, privacy, and patient empowerment may create challenges for regulators, portal developers, as well as researchers. It is additionally unclear whether web portals designed to facilitate access to research results and general health information will be regulated as medical devices under emerging regimes that control software with medical purposes. This paper aims to comparatively address whether online therapeutic portals for sharing health research are likely to be regulated in Canada, the United States, the United Kingdom, and France. We find that though these jurisdictions have each taken recent steps to regulate software as medical devices, the applicable regimes will generally not capture online portals for sharing health research. Though online portals for sharing health research are probably unregulated in many (if not most) jurisdictions, agencies have nevertheless signalled their concerns regarding several important ethical considerations (such as equity, transparency, and safety), to which portal developers and researchers should be attentive and respond. We describe here one set of issues highlighted by regulators – that is, efficiency, equity, transparency, confidentiality, communication, empowerment, training, and safety & efficacy – and consider how to best guide the design of online portals in a context of regulatory uncertainty

The author who wasn't there? Fairness and attribution in publications following access to population biobanks

We conducted a document analysis that explored publication ethics and authorship in the context of population biobanks from both a theoretical (e.g. normative documents) and practical (e.g. biobank-specific documentation) perspective. The aim was to provide an overview of the state of authorship attribution in population biobanks and attempt to fill the gap in discussions around the issue. Our findings demonstrate that the most common approach adopted in both the normative and biobank-specific documentation is acknowledgment. A co-authorship approach was second and highlighted concerns surrounding the fairness of imposing authorship of the scientific leadership as a condition to access data and biosamples, as well as the alignment with the International Committee of Medical Journal Editors' criteria such as what is deemed a significant contribution and how to ensure accountability. Based on these findings, we propose a three-prong approach, that may be cumulative, to address the issue of authorship attribution in the context of population biobanks, namely 1) the biobank should be appropriately acknowledged; 2) an invitation for co-authorship should be made based on the spirit of collaboration and provided a substantial contribution has been made; and 3) a citation/referencing option should be available.status: publishe