An Ethic of Connectedness: Book Review of The Connected Self: The Ethics and Governance of the Genetic Individual

Compte-rendu / ReviewThe Connected Self: The Ethics and Governance of the Genetic Individual met les lecteurs au défi de réfléchir à la fois à la complexité des enjeux sociaux et scientifiques liés à la recherche sur le génome humain et à leur influence sur les conceptions du soi. L’auteure, Heather Widdows, propose que les principes courants de la bioéthique (gouvernant la recherche biomédicale) ne reflètent pas suffisamment l’interaction des individus avec leurs communautés et les réseaux sociaux. Selon elle, la reconnaissance de telles interactions dans la compréhension de la génétique et de la santé est nécessaire afin que les politiques protègent réellement les participants des dommages qui pourraient en résulter.The Connected Self: The Ethics and Governance of the Genetic Individual challenges readers to engage in both the social and scientific complexities of researching the human genome, and how they influence evolving conceptions of the self. Heather Widdows proposes that the existing principles of bioethics, which govern biomedical research, insufficiently reflect the interactions of individuals to their communities and social networks, and argues that recognition of such interactions in understanding genetics and health is necessary for policies to effectively safeguard research participants from harms that may result

A missed opportunity for shared responsibility in adolescent contraception

The American Academy of Pediatrics Committee on Adolescence recently endorsed IUDs as the clinical contraceptive method of choice among sexually active adolescents. This commentary highlights the ways in which these recommendations reinforce a gender normative notion that contraceptive responsibilities continue to lie squarely with young women, and now adolescent girls. It critiques the absence of guidance from the Committee regarding how to approach both sexual partners equally in discussions of contraception. The reflection also identifies paucity in how to address sexual health among trans/intersexed adolescents and those with complex sexual orientations. Such exclusion has adverse implications, inviting marginalization of young people during particularly vulnerable years of sexual development. Moreover, sexual healthcare among adolescents ushers a poignant transition in the broader healthcare continuum for many young people. This circumstance underscores the immediacy of critical dialogue regarding contraception/sexual health between an adolescent’s new healthcare provider (the primary care physician) and familiar healthcare provider (their pediatrician). Absent strategies that promote equal responsibility for contraception among sexually active adolescents, the Committee’s recommendations have far-reaching consequences for the future of adolescent sexual health(care), and the family physicians who will eventually care for them

On Teaching the Sum While Paying Attention to the Parts: Whole Person Care through Ethnography in Medical Education

Objective—This article provides a reflection on medical teaching opportunities for whole person care based on our experiences mentoring 2nd-year medical students through an Ethnography Practicum at a Canadian university.                                                                  Background—The Ethnography Practicum is a new addition to the Family Medicine Transition to Clinical Practice (TCP) curriculum introduced in the second year of medical school at McGill University. It involves 30 hours of instruction (6 hours in lectures with an instructor, and 24 hours in small-group tutorials with the authors), and 9 hours of fieldwork observations in various community health settings across Montreal, QC. The primary aims of the Practicum converge with those of the TCP generally in two important ways: to inculcate in students the concepts of patient centered care, and to promote family medicine as both an academic discipline and career option.                    Results and Discussion— Our experiences illustrate two tensions that shape students’ expectations and experiences throughout their involvement in the Practicum and, in turn, highlight the implications for teaching whole-person care. First, ethnography as a combination of different methods has itself been the locus of tensions between positivist and critical traditions in the three last decades. Second, the Practicum is situated precisely at the crossroads of key moments on the professional identity formation continuum for our students. Such a crossroads is disruptive to the status quo of medical traineeship characteristic of the first two years in medical school, and thus reorients professional identity formation. The above tensions reveal how ethnography is not only a revered research tradition in the humanities, but can also be a conduit to whole person care-inspired clinical practice.Conclusion—As instructors and mentors involved in this Ethnography Practicum, we are continually forging a new relevance for organizational ethnography in medical training, where medical students can reflect and act on competencies beyond clinical ones. The Practicum provides a space for students to wrestle with alternative epistemologies to understanding the social world in which medicine is embedded. We lastly provide pragmatic ways to better address these tensions in an effort to support students as they proceed through the (multifaceted) development of their professional identities as future physicians

Leveraging algorithms to improve decision-making workflows for genomic data access and management

Studies on the ethics of automating clinical or research decision making using artificial intelligence and other algorithmic tools abound. Less attention has been paid, however, to the scope for, and ethics of, automating decision making within regulatory apparatuses governing the access, use, and exchange of data involving humans for research. In this article, we map how the binary logic flows and real-time capabilities of automated decision support (ADS) systems may be leveraged to accelerate one rate-limiting step in scientific discovery: data access management. We contend that improved auditability, consistency, and efficiency of the data access request process using ADS systems have the potential to yield fairer outcomes in requests for data largely sourced from biospecimens and biobanked samples. This procedural justice rationale reinforces a broader set of participant and data subject rights that data access committees (DACs) indirectly protect. DACs protect the rights of citizens to benefit from science by bringing researchers closer to the data they need to advance that science. DACs also protect the informational dignities of individuals and communities by ensuring the data being accessed are used in ways consistent with participant values. We discuss the development of the Global Alliance for Genomics and Health Data Use Ontology standard as a test case of ADS for genomic data access management specifically, and we synthesize relevant ethical, legal, and social challenges to its implementation in practice. We conclude with an agenda of future research needed to thoughtfully advance strategies for computational governance that endeavor to instill public trust in, and maximize the scientific value of, health-related human data across data types, environments, and user communities

The Raison d'Être of Mutual Recognition: An Analysis of the 2015 Reform to Research Ethics Review Policies, Processes and Problems in Québec

Ethics review is a pre-requisite to conducting research involving humans in Canada, and indeed in most international jurisdictions. The Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans (TCPS2) serves as the national policy framework for research ethics review in Canada, and outlines three potential oversight models: independent, delegated and reciprocal. While the independent model preserves institutional oversight of research, it contributes to a duplicative system that can unduly delay research and impose barriers to research collaboration. This analysis centres on a 2015 reform to the policy model of research ethics review for collaborative, multi-site studies in the province of Québec. Informal interviews with key informants supplemented a document analysis of provincial research ethics policies using the comparative framework proposed by Lavis and colleagues. Consolidating bureaucratic structures and preserving locally-relevant review studies that span multiple sites remain among the most pressing challenges to transitioning from an independent model, and could provide reference for other provinces that have, or are currently in the process of such a transition

Primary Care and the Ethics of Integrating Genomic Medicine

Objectives: To explore the practical barriers to, and implications of, incorporating genomic technologies in the primary care setting. In evaluating the primary care mission and anticipated role of genomic medicine in conversation with one another, I discuss the ways in which the primary care philosophy problematizes innovations afforded to clinical medicine through whole genome sequencing. I discuss these themes in relation to the evaluation frameworks that must precede full integration, specifically the Analytic validity, Clinical validity, Clinical Utility and Ethical, legal social considerations (ACCE) model. Finally, my analysis will consider the added ethical nuances for integrating genomic medicine in the wake of new standards for healthcare delivery in the U.S.Methods: I review the literature concerning 1) models for evaluating the applicability of emerging genomic technologies in the primary care setting, namely the ACCE model proposed by the Center for Disease Control, and 2) anticipated changes to primary care delivery through proposed healthcare legislation.Results: Three main facets of primary care delivery problematize full integration of genomic medicine in clinical practice. They include: primary care providers' propensity to maintain therapeutic relationships with patients over the lifecourse, acuity to community health patterns, and gaps in genetic/genomic-specific knowledge among practicing clinicians. Implementation of genomic medicine requires that technologies be adaptable to the heterogeneity of the primary care clinic, in both the diverse populations it serves and broad spectrum of resource availability.Conclusions: The rapid pace at which genomic technology has fundamentally altered the direction of medical research scene is extraordinary to say the least. The potential benefits for incorporating these innovations depict a clinical landscape that predicts and prevents disease before it manifests, and cares for patients using treatments that are tailored to their own genetic person. The primary care arena presents unique challenges to the evaluation, diffusion and translation of genomic technologies. Yet the same aspects that present limitations also reinforce the reasons why the primary care setting is a critical forum in which to operationalize genomic medicine in practice. With so much dialogue generated around ushering in a new era of medicine, it is unclear whether this is celebrating the novelty of the genomic revolution, or the reinvigoration of a longstanding clinical tradition in patient-centered primary care

Evaluating the gap between research ethics review and data sharing in the pediatric infrastructure sciences: a case of big data and little ethics?

BACKGROUND: Clinical progress in genomics-enabled learning health systems relies on the production, use and exchange of data, including from children. The policies and practices guiding proportionate governance of such production, access and exchange are, however, markedly limited in the pediatric genomics space. The need for policy-practice coherence in genomic data sharing can be accentuated when involving children, from whom data may require special protections. Absent understanding the ethical-legal bases upon which responsible pediatric data sharing rests, present and future children may not reap the benefits of a healthcare system that continuously ‘learns’ from the production, use and exchange of their data. The purpose of this thesis is twofold: to identify the ethical, legal, social and scientific factors that enable ‘responsible’ genomic and associated clinical data sharing involving children; and to develop a policy framework guiding responsible sharing for the pediatric genomics community in Canada. METHODS: A systematic review of reasons was combined with policy Delphi methods to develop the Key Implications of Data Sharing (KIDS) framework for pediatric genomics. Thematic content, and descriptive statistical analyses were used to understand how 12 Canadian pediatricians, genomic researchers, ethicists and bioethics scholars prioritize the ethical-legal, social and scientific policy positions outlined in the KIDS framework. RESULTS: The panel reached consensus on 9 of 12 original policy positions identified in the systematic review and refined during a key informant committee meeting of international data sharing experts. Discrepant views related to informational risks, data access and oversight of anonymized versus coded genomic data were primary sources of dissention. CONCLUSION: This thesis makes two contributions to the theory and practice of responsible data sharing involving children in Canada. First, it suggests that skepticism of data anonymization drives support for more stringent access controls and oversight when data involve children. Second, greater emphasis on data accountability—coupled with data security—could serve as a more effective policy lever to preserve patient trust in data sharing given rapid progress in computation, ensuring children remain at the forefront of genomic innovation.CONTEXTE: Les progrès cliniques dans les systèmes de santé apprenants favorisés par la génomique reposent sur la production, l'utilisation et l'échange de données, y compris celles provenant d'enfants. Les politiques et pratiques guidant la « gouvernance proportionnée » de cette production, de cet accès et de ces échanges font toutefois nettement défaut dans l'espace de la génomique pédiatrique. La nécessité d'une cohérence entre les politiques et les pratiques en matière de partage de données génomiques peut être accentuée lorsque des enfants sont impliqués, ceux-ci pouvant nécessiter des protections spéciales. En l’absence d’une compréhension des bases éthiques et légales sur lesquelles repose un partage responsable des données pédiatriques, les enfants actuels et futurs ne peuvent pas profiter des avantages d’un système de santé qui « apprend » continuellement de la production, de l’utilisation et de l’échange de leurs données. L’objet de cette thèse est donc double: identifier les facteurs éthiques, juridiques, sociaux et scientifiques permettant un partage « responsable » de données génomiques et cliniques associées impliquant des enfants; et élaborer un cadre guidant le partage responsable des données pour la communauté de la génomique pédiatrique au Canada. MÉTHODES: Une revue systématique des arguments a été combinée avec la méthode « Delphi de politiques publiques » (Policy Delphi) pour développer le cadre de KIDS (Key Implications of Data Sharing) pour la génomique pédiatrique. L’analyse thématique de contenu et des analyses statistiques descriptives ont été utilisées pour comprendre comment 12 pédiatres, chercheurs en génomique, éthiciens et chercheurs en bioéthique du Canada accordent la priorité à différentes positions politiques définies, dans le cadre KIDS, en termes éthiques, juridiques, sociaux et scientifiques. RÉSULTATS: Le panel a atteint un consensus sur 9 des 12 positions de politiques. Les points de vue divergents liés aux risques informationnels, à l'accès aux données et à la surveillance des données génomiques anonymisées par rapport aux données codées ont été les principales sources de dissension. CONCLUSION: Cette thèse apporte deux contributions à la théorie et à la pratique du partage responsable de données impliquant des enfants au Canada. La première suggère que le scepticisme concernant l'anonymisation des données entraine l’appui à des mesures de contrôles d'accès et de surveillance plus strictes lorsque les données impliquent des enfants. Deuxièmement, une plus grande importance accordée à la responsabilisation à l’égard des données – associée à la sécurité des données – pourrait constituer un levier politique plus efficace pour préserver la confiance des patients dans le partage des données face aux progrès rapides des capacités de calcul, garantissant ainsi que les enfants restent au premier plan de l'innovation génomique

On the ethics of engagement: health-related quality of life in terminally ill children and adolescents

Background— Pediatric cancer remains the leading cause of disease-related death in children and adolescents. Promoting excellence in the care of terminally ill children is socially dependent on recognizing the complex dimensions of death, dying and living that emerge from situating the child as an active social and moral agent in their healthcare. The continued underrepresentation of children’s voices at the end of life, however, fails to ground modalities of care in the unique and evolving realities they face as palliative patients. Qualitative health research with terminally ill children has been proposed as a meaningful vehicle for engagement, to investigate the various dimensions of health-related quality of life and to augment their participatory agency in end of life care.Objective—To explore the ethics of qualitative engagement in assessing health-related quality of life (HRQoL) among children and adolescents with cancer, and to identify areas where there is paucity of effective qualitative methods for such engagement in pediatric palliative care research.Methods—This analysis was conducted as a critical assessment—combining policy and literature mapping from developmental child psychology, childhood sociology, jurisdictional codes of ethics for pediatric research and pediatric palliative care research—based on the framework for scoping review by Arksey and O’Malley (2005). Conclusion—Qualitative HRQoL research with terminally ill children demands innovative methods that afford greater legitimacy to children’s moral and social agency in palliative care settings. Because ensuring an optimal health-related quality of life (HRQoL) is the panacea of pediatric palliative care, it is an ethical imperative that care practices become the province of childhood expertise and social epistemologies of terminal illness. What emerges from the critical assessment is that such methods are poised to respect children’s participatory rights pursuant to the new sociology of the child and prevailing ethical norms governing pediatric research. Qualitative engagement in pediatric palliative care is both ethically defensible and a necessary element to delivering comprehensive patient care.Contexte –Le cancer pédiatrique est la principale cause de mortalité par maladie chez les enfants et les adolescents. Afin de favoriser l’excellence dans les soins de fin de vie chez les enfants en phase terminale, il est nécessaire de comprendre la perception sociale des dimensions complexes de la mort, des mourants et de la vie ainsi que de reconnaître les enfants comme des acteurs moraux et sociaux dans leurs soins de santé. Alors que la voix des enfants en fin de vie est sous-représentée, ces patients recevant des soins palliatifs font pourtant face à une réalité unique et en constante évolution. Une recherche qualitative auprès d’enfants en fin de vie a été proposée comme puissant véhicule pour engager cette population, pour étudier les diverses dimensions de la qualité de vie liée à la santé, ainsi que pour favoriser l’approche participative dans les soins de fin de vie. Objectif—L’objectif est d’explorer l'éthique de l'engagement dans l'évaluation de la qualité de vie liée à la santé (QVLS) chez les enfants et les adolescents atteints de cancer, ainsi que d'identifier les domaines où il y a une pénurie de méthodes qualitatives efficaces pour un tel engagement dans la recherche en soins palliatifs pédiatriques.Méthodologie—Cette analyse est basée sur une évaluation critique, fondée sur une revue systématique telle que proposée par Arkey et O’Malley (2005). L’évaluation critique représente une cartographie des politiques et de la littérature portant sur la psychologie associée au développement de l’enfant, la sociologie de l’enfance et les codes de conduite en éthique de la recherche pédiatrique et en soins palliatifs pédiatriques. Conclusion—La recherche qualitative pour l’évaluation de la QVLS chez les enfants et adolescents en soins palliatifs requière l’adoption de méthodes innovatrices, accordant une plus grande légitimité aux acteurs moraux et sociaux que représentent les enfants en soins palliatifs. Assurer une qualité de vie liée à la santé (QVLS) est la panacée pour les soins palliatifs pédiatriques. Pour y parvenir, il est impératif que l’éthique se soucie des pratiques et reconnaisse l’expertise des enfants et de l’épistémologie sociale de la maladie en phase terminale. À la lumière de l'évaluation critique qui a été réalisée, il ressort que ces méthodes sont disposées à respecter les droits de participation des enfants en vertu de la nouvelle sociologie de l'enfant et des normes régissant l’éthique de la recherche pédiatrique. L’engagement qualitatif dans les soins palliatifs pédiatriques est à la fois éthiquement défendable et un élément crucial à la prestation de soins complets aux patients