Auditing the Editor: A Review of Key Translational Issues in Epigenetic Editing

Currently, most advances in site-specific epigenetic editing for human use are concentrated in basic research, yet, there is considerable interest to translate this technology beyond the bench. This review highlights recent developments with epigenetic editing technology in comparison with the canonical CRISPR-Cas genome editing, as well as the epistemic and ethical considerations with preemptive translation of epigenetic editing into clinical or commercial use in humans. Key considerations in safety, equity, and access to epigenetic editing are highlighted, with a spotlight on the ethical, legal, and social issues of this technology in the context of global health equity

Physicians' attitudes toward medical and ethical challenges for patients in the vegetative state: comparing Canadian and German perspectives in a vignette survey

Background: Physicians treating patients in the vegetative state (VS) must deal with uncertainty in diagnosis and prognosis, as well as ethical issues. We examined whether physicians' attitudes toward medical and ethical challenges vary across two national medical practice settings. Methods: A comparative survey was conducted among German and Canadian specialty physicians, based on a case vignette about the VS. Similarities and differences of participants' attitudes toward medical and ethical challenges between the two samples were analyzed with non-parametric tests (Mann-Whitney-U-Test). Results: The overall response rate was 13.4%. Eighty percent of all participants correctly applied the diagnostic category of VS with no significant differences between countries. Many of the participants who chose the correct diagnosis of VS attributed capabilities to the patient, particularly the ability to feel pain (70%), touch (51%) and to experience hunger and thirst (35%). A large majority of participants (94%) considered the limitation of life-sustaining treatment (LST) under certain circumstances, but more Canadian participants were in favor of always limiting LST (32% vs. 12%; Chi-square: p < 0.001). Finding long-term care placement was considered more challenging by Canadian participants whereas discontinuing LST was much more challenging for German participants. Conclusions: Differences were found between two national medical practice settings with respect to physicians' experiences and attitudes about treatment limitation about VS in spite of comparable diagnostic knowledge

Defusing the legal and ethical minefield of epigenetic applications in the military, defense, and security context

Epigenetic research has brought several important technological achievements, including identifying epigenetic clocks and signatures, and developing epigenetic editing. The potential military applications of such technologies we discuss are stratifying soldiers’ health, exposure to trauma using epigenetic testing, information about biological clocks, confirming child soldiers’ minor status using epigenetic clocks, and inducing epigenetic modifications in soldiers. These uses could become a reality. This article presents a comprehensive literature review, and analysis by interdisciplinary experts of the scientific, legal, ethical, and societal issues surrounding epigenetics and the military. Notwithstanding the potential benefit from these applications, our findings indicate that the current lack of scientific validation for epigenetic technologies suggests a careful scientific review and the establishment of a robust governance framework before consideration for use in the military. In this article, we highlight general concerns about the application of epigenetic technologies in the military context, especially discrimination and data privacy issues if soldiers are used as research subjects. We also highlight the potential of epigenetic clocks to support child soldiers’ rights and ethical questions about using epigenetic engineering for soldiers’ enhancement and conclude with considerations for an ethical framework for epigenetic applications in the military, defense, and security contexts.</p

Informed consent for MRI and fMRI research: Analysis of a sample of Canadian consent documents

<p>Abstract</p> <p>Background</p> <p>Research ethics and the measures deployed to ensure ethical oversight of research (e.g., informed consent forms, ethics review) are vested with extremely important ethical and practical goals. Accordingly, these measures need to function effectively in real-world research and to follow high level standards.</p> <p>Methods</p> <p>We examined approved consent forms for Magnetic Resonance Imaging (MRI) and functional Magnetic Resonance Imaging (fMRI) studies approved by Canadian research ethics boards (REBs).</p> <p>Results</p> <p>We found evidence of variability in consent forms in matters of physical and psychological risk reporting. Approaches used to tackle the emerging issue of incidental findings exposed extensive variability between and within research sites.</p> <p>Conclusion</p> <p>The causes of variability in approved consent forms and studies need to be better understood. However, mounting evidence of administrative and practical hurdles within current ethics governance systems combined with potential sub-optimal provision of information to and protection of research subjects support other calls for more scrutiny of research ethics practices and applicable revisions.</p

Forensic applications of molecular genetics: ethics and law to inform policy issues

Molecular analysis of DNA variation has usurped the place of all earlier technologies in forensic identification of victims and suspects alike. Although the field of ethics has made attempts to cope with the plethora of available genetic information, especially in clinical application, there has been little scrutiny of emerging ethical issues in the forensic domain. Legal scholarship highlights some aspects of the emerging issues, with particular relevance to the challenges faced in court and those regarding individual liberties. The overall objective of this thesis was to evaluate the scientific validity, ethical acceptability and legal accountability of the forensic applications of molecular genetics. In particular, contemporary science has allowed us to access information far beyond what was originally anticipated, such that trace DNA can be obtained trivially from any individual. As a consequence, the scope and composition of existing DNA banks far exceeds the legislative mandate. Chapter 1 reviews the current legal standards for evidence and assesses the level of exactitude necessary for forensic DNA testing to meet evidentiary standards. An evaluation of current practices in DNA banking revealed adequate informed consent practices; the need for a re-examination of access to public health samples with attention to local population interests and the necessity for developing standardized guidelines for banking practices and uniform quality assessment measures (Chapter 2). Comparing current forensic and genomic markers revealed similar concordance and discordance rates with a slight performance advantage towards the forensic markers. The results indicate that multiple runs are necessary to ensure reliability (Chapter 3). A significant ethical issue arises from the forensic practice of surreptitious DNA sampling. This lack of transparency violates autonomy, threatens the legitimacy of the State's intL'analyse moléculaire des variations de l'ADN a supplanté toutes les technologies médicolégales antérieures d'identification des victimes et des suspects. Bien que le champ de l'éthique ait tenté de gérer la pléthore d'information génétique disponible, particulièrement dans les applications cliniques, il y a eu peu d'examen des enjeux éthiques émergeants dans le domaine médicolégal. La recherche juridique met en évidence certains aspects des enjeux émergeant avec une pertinence particulière pour les défis auxquels les tribunaux sont confrontés ainsi que les défis à l'égard des libertés individuelles.L'objectif général de cette thèse était d'évaluer la validité scientifique, l'acceptabilité éthique et la responsabilité légale dans les applications médicolégales de la génétique moléculaire. En particulier, la science contemporaine nous a permis d'accéder à des informations qui vont au-delà de ce qui était anticipé à l'origine si bien que des traces d'ADN peuvent être obtenues trivialement de tout individu. En conséquence, l'étendue et la composition des banques existantes d'ADN excèdent de loin le mandat législatif. Le premier chapitre revoit les standards légaux d'évidence et évalue le niveau d'exactitude nécessaire afin que les tests d'ADN médico-légaux rencontrent les standards d'évidence. Une évaluation des pratiques actuelles dans la mise en banque d'ADN a révélé des pratiques de consentement éclairé adéquate, le besoin de réexaminer l'accès aux échantillons de santé publique en portant l'attention aux intérêts des populations locales et la nécessité de développer des lignes directrices standardisées pour les pratiques de mise en banque et de mesures uniformes de l'évaluation de la qualité (chapitre 2). La comparaison des marqueurs médicolégaux actuels aux marqueurs génomiques a révélé des taux de concordance et de discor

The Adoption of Cloud Computing in the Field of Genomics Research: The Influence of Ethical and Legal Issues.

This study aims to understand the influence of the ethical and legal issues on cloud computing adoption in the field of genomics research. To do so, we adapted Diffusion of Innovation (DoI) theory to enable understanding of how key stakeholders manage the various ethical and legal issues they encounter when adopting cloud computing. Twenty semi-structured interviews were conducted with genomics researchers, patient advocates and cloud service providers. Thematic analysis generated five major themes: 1) Getting comfortable with cloud computing; 2) Weighing the advantages and the risks of cloud computing; 3) Reconciling cloud computing with data privacy; 4) Maintaining trust and 5) Anticipating the cloud by creating the conditions for cloud adoption. Our analysis highlights the tendency among genomics researchers to gradually adopt cloud technology. Efforts made by cloud service providers to promote cloud computing adoption are confronted by researchers' perpetual cost and security concerns, along with a lack of familiarity with the technology. Further underlying those fears are researchers' legal responsibility with respect to the data that is stored on the cloud. Alternative consent mechanisms aimed at increasing patients' control over the use of their data also provide a means to circumvent various institutional and jurisdictional hurdles that restrict access by creating siloed databases. However, the risk of creating new, cloud-based silos may run counter to the goal in genomics research to increase data sharing on a global scale

Physicians' attitudes toward medical and ethical challenges for patients in the vegetative state: comparing Canadian and German perspectives in a vignette survey

Background: Physicians treating patients in the vegetative state (VS) must deal with uncertainty in diagnosis and prognosis, as well as ethical issues. We examined whether physicians' attitudes toward medical and ethical challenges vary across two national medical practice settings. Methods: A comparative survey was conducted among German and Canadian specialty physicians, based on a case vignette about the VS. Similarities and differences of participants' attitudes toward medical and ethical challenges between the two samples were analyzed with non-parametric tests (Mann-Whitney-U-Test). Results: The overall response rate was 13.4%. Eighty percent of all participants correctly applied the diagnostic category of VS with no significant differences between countries. Many of the participants who chose the correct diagnosis of VS attributed capabilities to the patient, particularly the ability to feel pain (70%), touch (51%) and to experience hunger and thirst (35%). A large majority of participants (94%) considered the limitation of life-sustaining treatment (LST) under certain circumstances, but more Canadian participants were in favor of always limiting LST (32% vs. 12%; Chi-square: p < 0.001). Finding long-term care placement was considered more challenging by Canadian participants whereas discontinuing LST was much more challenging for German participants. Conclusions: Differences were found between two national medical practice settings with respect to physicians' experiences and attitudes about treatment limitation about VS in spite of comparable diagnostic knowledge

Intersex Stigma and Discrimination: Effects on Patient-Centred Care and Medical Communication

Individuals with intersex variations fall outside the normative sex binary of male and female for various reasons. These individuals are highly stigmatized and discriminated against in the legal, medical and social spheres. In this paper, we analyze manifestations of such discrimination in the healthcare context and hypothesize that Patient Centred Care (PCC) and Shared Decision Making (SDM) approaches are improperly practiced with intersex individuals. Through a narrative review of current literature, we present evidence of improper practice of PCC and SDM and its effects on intersex individuals and, in the pediatric context, their parents. Misinformation by medical practitioners to parents of intersex individuals promotes the perpetuation of unnecessary surgical interventions. We propose strategies to improve intersex medical care, including better adherence to SDM and PCC guidelines as well as the sociocultural normalisation of intersex identity. Current perceptions of surgical interventions done on intersex infants and children need to better align with evidence-based physical and psychological health risks. All these strategies are part of preserving the autonomy and physical integrity of intersex individuals and ensuring that their well-being remains at the heart of their care in the medical context.Les personnes présentant des variations intersexuelles se situent en dehors du binaire sexuel normatif homme/femme pour diverses raisons. Ces personnes sont fortement stigmatisées et discriminées dans les sphères juridiques, médicale et sociale. Dans cet article, nous analysons les manifestations de cette discrimination dans le contexte des soins de santé et nous émettons l’hypothèse que les approches de soins centrés sur le patient (SCP) et de prise de décision partagée (PDP) sont mal pratiquées avec les personnes intersexuées. Un examen narratif de la littérature actuelle permet de présenter les preuves d’une pratique inadéquate des SCP et de la PDP, ainsi que leurs répercussions sur les personnes intersexuées et, dans le contexte pédiatrique, sur leurs parents. La désinformation des parents de personnes intersexuées par les praticiens médicaux favorise la perpétuation d’interventions chirurgicales inutiles. Nous proposons des stratégies pour améliorer les soins médicaux aux personnes intersexuées, notamment une meilleure adhésion aux directives de la SCP et du PDP ainsi que la normalisation socioculturelle de l’identité intersexuée. Les perceptions actuelles des interventions chirurgicales pratiquées sur les nourrissons et les enfants intersexués doivent mieux correspondre aux risques pour la santé physique et psychologique fondés sur des preuves. Toutes ces stratégies s’inscrivent dans le cadre de la préservation de l’autonomie et de l’intégrité physique des personnes intersexuées et de la garantie que leur bien-être reste au cœur de leur prise en charge dans le contexte médical

Distribution of interviews conducted according to group of participants.

<p>Distribution of interviews conducted according to group of participants.</p