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Our article aims to provide a comprehensive portrayal of how seven Asian jurisdictions have sought to address the challenge of genetic discrimination (GD) by presenting an analysis of the relevant legislation, policies, and practices. Based on our findings, policy discussion and action on preventing or mitigating GD have been narrowly framed in terms of employment, insurance, disability, marriage, and family planning. Except for South Korea, none of the jurisdictions we examined has adopted specific legislation to prevent GD. However, for Asia to truly benefit from its recent scientific and technological progress in genomics, we highlight the need for these jurisdictions to engage more proactively with the challenges of GD through a coordinated regulatory and governance mechanism.

The operationalization of One Health (OH) through digitalization is a means to deploy digital technologies (including Artificial Intelligence (AI), big data and related digital technologies) to better capacitate us to deal with growing climate exigency and related threats to human, animal and plant health. With reference to the concept of One Digital Health (ODH), this paper considers how digital capabilities can help to overcome ‘operational brakes’ in OH through new and deeper insights, better predictions, and more targeted or precise preventive strategies and public health countermeasures. However, the data landscape is fragmented and access to certain types of data is increasingly restrictive as individuals, communities and countries seek to assert greater control over data taken from them. This paper proposes for a dedicated global ODH framework—centered on fairness and equity—to be established to promote data-sharing across all the key knowledge domains of OH and to devise data-driven solutions to challenges in the human-animal-ecosystems interface. It first considers the data landscape in relation to: (1) Human and population health; (2) Pathogens; (3) Animal and plant health; and (4) Ecosystems and biodiversity. The complexification from the application of advance genetic sequencing technology is then considered, with focus on current debates over whether certain types of data like digital (genetic) sequencing information (DSI) should remain openly and freely accessible. The proposed ODH framework must augment the existing access and benefit sharing (ABS) framework currently prescribed under the Nagoya Protocol to the Convention on Biological Diversity (CBD) in at least three different ways. First, the ODH framework should apply to all genetic resources and data, including DSI, whether from humans or non-humans. Second, the FAIRER principles should be implemented, with focus on fair and equitable benefit-sharing. Third, the ODH framework should adopt multilateral approaches to data sharing (such as through federated data systems) and to ABS. By operationalizing OH as ODH, we are more likely to be able to protect and restore natural habitats, secure the health and well-being of all living things, and thereby realize the goals set out in the post-2020 Global Biodiversity Framework under the CBD.

The basis of medico-legal claims against a doctor may occur in contract law, tort law or criminal law. This chapter focuses on the ethical and legal requirement of informed consent, which in tort law relates to two legal actions, namely trespass to persons (or battery) and negligence, as they give effect to a patient’s right to autonomous decision-making on matters relating to her or his medical treatment and care. These legal actions have been central in defining legal expectations of the doctor’s responsibility to the patient which, apart from the provision of medical advice, includes medical diagnosis and treatment. Where medical advice is concerned, an important change in the legal standard of care, from one that was profession-centric to a more patient-centric formulation, is also considered. This development has been codified into statutory law, and is instructive in a number of ways. From a jurisprudential angle, it shows the law to be normatively open, as the change occurred interactively with the norms of medical ethics, and the practical realities of professional medicine. Developments since this change suggest that the courts may be more open to look beyond the doctor-patient relationship in addressing institutional and systemic deficiencies. If medical jurisprudence should advance in this direction, it may be fair to say that medical liability is likely to acquire a more prominent role in sustaining quality of medical care.

Research, innovation, and progress in the life sciences are increasingly contingent on access to large quantities of data. This is one of the key premises behind the “open science” movement and the global calls for fostering the sharing of personal data, datasets, and research results. This paper reports on the outcomes of discussions by the panel “Open science, data sharing and solidarity: who benefits?” held at the 2021 Biennial conference of the International Society for the History, Philosophy, and Social Studies of Biology (ISHPSSB), and hosted by Cold Spring Harbor Laboratory (CSHL).

The considerations and recommendations set out by Bhatia-Lin and colleagues (2019) for the appropriate use of social media platforms to locate and track research participants are timely and importa...

Summary: Digitalization in nephrology has progressed in a manner that is disparate and siloed, even though learning (under a broader Learning Health System initiative) has been manifested in all the main areas of clinical application. Most applications based on artificial intelligence/machine learning (AI/ML) are still in the initial developmental stages and are yet to be adequately validated and shown to contribute to positive patient outcomes. There is also no consistent or comprehensive digitalization plan, and insufficient data are a limiting factor across all of these areas. In this article, we first consider how digitalization along nephrology care pathways relates to the Learning Health System initiative. We then consider the current state of AI/ML-based software and devices in nephrology and the ethical and regulatory challenges in scaling them up toward broader clinical application. We conclude with our proposal to establish a dedicated ethics and governance framework that is centered around health care providers in nephrology and the AI/ML-based software to which their work relates. This framework should help to integrate ethical and regulatory values and considerations, involve a wide range of stakeholders, and apply across normative domains that are conventionally demarcated as clinical, research, and public health.

Genetic discrimination can be defined as the differential, negative, treatment or unfair profiling of an individual based on presumed or actual genetic characteristics or on omics data. In the face of rapidly developing omics and data-driven technologies, coordinated actions need to be undertaken by stakeholders to document and address adverse consequences of technical advances and the genetic revolution. This article aims to inform the community about an international organization developed to address genetic discrimination, the Genetic Discrimination Observatory (GDO), and developments that have occurred since its international launch in late 2020. These developments indicate that genetic discrimination can take many forms and happen in multiple contexts in today’s rapidly evolving scientific and social environment. The need for an international organisation such as the GDO to inform the community and respond to these developments becomes crucial in this context.

Summary box As a growing number of vaccines for COVID-19 gain emergency use designation, including emergency use authorisation and conditional marketing authorisation under different jurisdictions, the WHO Strategic Advisory Group of Experts on Immunization (SAGE)1 has issued a number of …

Background: The development of biobanks is associated with the emergence of new ethical challenges. In Egypt, several biobanks have been established, but there are no specific local ethical guidelines to guide their work. The aim of this study is to develop recommendations for the Egyptian human biobanking ethical guidelines, which take into consideration the specific cultural and legal framework in Egypt. Methods: We searched the literature for available biobanking ethical guidelines. Six themes were the concern of search, namely; informed consent, data protection, return of results, sharing of samples and data, community engagement, and stakeholder engagement. If a document refers to another guideline, the new source is identified and the previous step is repeated. Results: Ten documents were identified, which were analyzed for the themes mentioned above. Guidelines and best practices were identified, and then compared with the published documents about ethical, legal and social issues (ELSI) related to biomedical research in Egypt to reach best recommendations. Conclusions: We have proposed, by way of recommendations, key characteristics that a national ethics framework in Egypt could have. On informed consent, the practice of broad consent may be harmonized among biobanks in Egypt. Clear policies on return of research results, training requirements and availability of genetic counseling could also be instituted through the national framework. Additionally, such a framework should facilitate community and stakeholders engagement, which is important to secure trust and build consensus on contentious issues arising from sample and data sharing across borders and commercialization, among other concerns.

This chapter studies Hong Kong’s response to the Covid-19 pandemic. Hong Kong’s experience with the Severe Acute Respiratory Syndrome (SARS) epidemic in 2003 helped to prepare the health system for a pandemic, allowing it to avoid a complete lockdown of the city. Social-distancing measures, aggressive testing, and contact tracing have also been critical in controlling the local transmission of the disease. However, when historians and health policy researchers look back at the early days of the outbreak, they are likely to cite the impact of the five-day strike of healthcare professionals in February 2020 as a critical turning point in Hong Kong’s initially hesitant response. The chapter then focuses on this strike and the role of the healthcare profession in shaping public health policy. It argues that the striking healthcare professionals used their standing in Hong Kong to revive the city’s collective memory of the SARS outbreak, mobilizing public action, and possibly triggering a stronger public health intervention by the government. © the several contributors 2021.

The Global Alliance for Genomics and Health (GA4GH) aims to accelerate biomedical advances by enabling the responsible sharing of clinical and genomic data through both harmonized data aggregation and federated approaches. The decreasing cost of genomic sequencing (along with other genome-wide molecular assays) and increasing evidence of its clinical utility will soon drive the generation of sequence data from tens of millions of humans, with increasing levels of diversity. In this perspective, we present the GA4GH strategies for addressing the major challenges of this data revolution. We describe the GA4GH organization, which is fueled by the development efforts of eight Work Streams and informed by the needs of 24 Driver Projects and other key stakeholders. We present the GA4GH suite of secure, interoperable technical standards and policy frameworks and review the current status of standards, their relevance to key domains of research and clinical care, and future plans of GA4GH. Broad international participation in building, adopting, and deploying GA4GH standards and frameworks will catalyze an unprecedented effort in data sharing that will be critical to advancing genomic medicine and ensuring that all populations can access its benefits., B.P.C. acknowledges funding from Abigail Wexner Research Institute at Nationwide Children’s Hospital; T.H. Nyrönen acknowledges funding from Academy of Finland grant #31996; A.M.-J., K.N., T.F.B., O.M.H., and Z.S. acknowledge funding from Australian Medical Research Future Fund; M.S. acknowledges funding from Biobank Japan; D. Bujold and S.J.M.J. acknowledge funding from Canada Foundation for Innovation; L.J.D. acknowledges funding from Canada Foundation for Innovation Cyber Infrastructure grant #34860; D. Bujold and G.B. acknowledge funding from CANARIE; L.J.D. acknowledges funding from CANARIE Research Data Management contract #RDM-090 (CHORD) and #RDM2-053 (ClinDIG); K.K.-L. acknowledges funding from CanSHARE; T.L.T. acknowledges funding from Chan Zuckerberg Initiative; T. Burdett acknowledges funding from Chan Zuckerberg Initiative grant #2017-171671; D. Bujold, G.B., and L.D.S. acknowledge funding from CIHR; L.J.D. acknowledges funding from CIHR grant #404896; M.J.S.B. acknowledges funding from CIHR grant #SBD-163124; M. Courtot and M. Linden acknowledge funding from CINECA project EU Horizon 2020 grant #825775; D. Bujold and G.B. acknowledge funding from Compute Canada; F.M.-G. acknowledges funding from the Deutsche Forschungsgemeinschaft (DFG, German Research Foundation) – NFDI 1/1 “GHGA – German Human Genome-Phenome Archive; R.M.H.-S. acknowledges funding from Duke-Margolis Center for Health Policy; S.B. and A.J.B. acknowledge funding from EJP-RD EU Horizon 2020 grant #825575; A. Niewielska, A.K., D.S., G.I.S., J.A.T., J.R., M.A.K., M. Baudis, M. Linden, S.B., S.S., T.H. Nyrönen, and T.M.K. acknowledge funding from ELIXIR; A. Niewielska acknowledges funding from EOSC-Life EU Horizon 2020 grant #824087; J.-P.H. acknowledges funding from ETH Domain Strategic Focal Area “Personalized Health and Related Technologies (PHRT)” grant #2017-201; F.M.-G. acknowledges funding from EUCANCan EU Horizon 2020 grant #825835; B.M.K., D. Bujold, G.B., L.D.S., M.J.S.B., N.S., S.E.W., and Y.J. acknowledge funding from Genome Canada; B.M.K., M.J.S.B., S.E.W., and Y.J. acknowledge funding from Genome Quebec; F.M.-G. acknowledges funding from German Human Genome-Phenome Archive; C. Voisin acknowledges funding from Google; A.J.B. acknowledges funding from Health Data Research UK Substantive Site Award; D.H. acknowledges funding from Howard Hughes Medical Institute; S.B. acknowledges funding from Instituto de Salud Carlos III; S.-S.K. and K.T. acknowledge funding from Japan Agency for Medical Research and Development (AMED); S. Ogishima acknowledges funding from Japan Agency for Medical Research and Development (AMED) grant #20kk0205014h0005; C.Y. and K. Kosaki acknowledge funding from Japan Agency for Medical Research and Development (AMED) grant #JP18kk0205012; GEM Japan acknowledges funding from Japan Agency for Medical Research and Development (AMED) grants #19kk0205014h0004, #20kk0205014h0005, #20kk0205013h0005, #20kk0205012h0005, #20km0405401h0003, and #19km0405001h0104; J.R. acknowledges funding from La Caixa Foundation under project #LCF/PR/GN13/50260009; R.R.F. acknowledges funding from Mayo Clinic Center for Individualized Medicine; Y.J. and S.E.W. acknowledge funding from Ministère de l’Économie et de l’Innovation du Québec for the Can-SHARE Connect Project; S.E.W. and S.O.M.D. acknowledge funding from Ministère de l’Économie et de l’Innovation du Québec for the Can-SHARE grant #141210; M.A.H., M.C.M.-T., J.O.J., H.E.P., and P.N.R. acknowledge funding from Monarch Initiative grant #R24OD011883 and Phenomics First NHGRI grant #1RM1HG010860; A.L.M. and E.B. acknowledge funding from MRC grant #MC_PC_19024; P.T. acknowledges funding from National University of Singapore and Agency for Science, Technology and Research; J.M.C. acknowledges funding from NHGRI; A.H.W. acknowledges funding from NHGRI awards K99HG010157, R00HG010157, and R35HG011949; A.M.-J., K.N., D.P.H., O.M.H., T.F.B., and Z.S. acknowledge funding from NHMRC grants #GNT1113531 and #GNT2000001; D.L.C. acknowledges funding from NHMRC Ideas grant #1188098; A.B.S. acknowledges funding from NHMRC Investigator Fellowship grant #APP177524; J.M.C. and L.D.S. acknowledge funding from NIH; A.A.P. acknowledges funding from NIH Anvil; A.V.S. acknowledges funding from NIH contract #HHSN268201800002I (TOPMed Informatics Research Center); S.U. acknowledges funding from NIH ENCODE grant #UM1HG009443; M.C.M.-T. and M.A.H. acknowledge funding from NIH grant #1U13CA221044; R.J.C. acknowledges funding from NIH grants #1U24HG010262 and #1U2COD023196; M.G. acknowledges funding from NIH grant #R00HG007940; J.B.A., S.L., P.G., E.B., H.L.R., and L.S. acknowledge funding from NIH grant #U24HG011025; K.P.E. acknowledges funding from NIH grant #U2C-RM-160010; J.A.E. acknowledges funding from NIH NCATS grant #U24TR002306; M.M. acknowledges funding from NIH NCI contract #HHSN261201400008c and ID/IQ Agreement #17X146 under contract #HHSN2612015000031 and #75N91019D00024; R.M.C.-D. acknowledges funding from NIH NCI grant #R01CA237118; M. Cline acknowledges funding from NIH NCI grant #U01CA242954; K.P.E. acknowledges funding from NIH NCI ITCR grant #1U24CA231877-01; O.L.G. acknowledges funding from NIH NCI ITCR grant #U24CA237719; R.L.G. acknowledges funding from NIH NCI task order #17X147F10 under contract #HHSN261200800001E; A.F.R. acknowledges funding from NIH NHGRI grant #RM1HG010461; N.M. and L.J.Z. acknowledge funding from NIH NHGRI grant #U24HG006941; R.R.F., T.H. Nelson, L.J.B., and H.L.R. acknowledge funding from NIH NHGRI grant #U41HG006834; B.J.W. acknowledges funding from NIH NHGRI grant #UM1HG009443A; M. Cline acknowledges funding from NIH NHLBI BioData Catalyst Fellowship grant #5118777; M.M. acknowledges funding from NIH NHLBI BioData Catalyst Program grant #1OT3HL142478-01; N.C.S. acknowledges funding from NIH NIGMS grant #R35-GM128636; M.C.M.-T., M.A.H., P.N.R., and R.R.F. acknowledge funding from NIH NLM contract #75N97019P00280; E.B. and A.L.M. acknowledge funding from NIHR; R.G. acknowledges funding from Project Ris3CAT VEIS; S.B. acknowledges funding from RD-Connect, Seventh Framework Program grant #305444; J.K. acknowledges funding from Robertson Foundation; S.B. and A.J.B. acknowledge funding from Solve-RD, EU Horizon 2020 grant #779257; T.S. and S. Oesterle acknowledge funding from Swiss Institute of Bioinformatics (SIB) and Swiss Personalized Health Network (SPHN), supported by the Swiss State Secretariat for Education, Research and Innovation SERI; S.J.M.J. acknowledges funding from Terry Fox Research Institute; A.E.H., M.P.B., M. Cupak, M.F., and J.F. acknowledge funding from the Digital Technology Supercluster; D.F.V. acknowledges funding from the Australian Medical Research Future Fund, as part of the Genomics Health Futures Mission grant #76749; M. Baudis acknowledges funding from the BioMedIT Network project of Swiss Institute of Bioinformatics (SIB) and Swiss Personalized Health Network (SPHN); B.M.K. acknowledges funding from the Canada Research Chair in Law and Medicine and CIHR grant #SBD-163124; D.S., G.I.S., M.A.K., S.B., S.S., and T.H. Nyrönen acknowledge funding from the EU Horizon 2020 Beyond 1 Million Genomes (B1MG) Project grant #951724; P.F., A.D.Y., F.C., H.S., I.U.L., D. Gupta, M. Courtot, S.E.H., T. Burdett, T.M.K., and S.F. acknowledge funding from the European Molecular Biology Laboratory; Y.J. and S.E.W. acknowledge funding from the Government of Canada; P.G. acknowledges funding from the Government of Canada through Genome Canada and the Ontario Genomics Institute (OGI-206); J.Z. acknowledges funding from the Government of Ontario; C.K.Y. acknowledges funding from the Government of Ontario, Canada Foundation for Innovation; C. Viner and M.M.H. acknowledge funding from the Natural Sciences and Engineering Research Council of Canada (grant #RGPIN-2015-03948 to M.M.H. and Alexander Graham Bell Canada Graduate Scholarship to C.V.); K.K.-L. acknowledges funding from the Program for Integrated Database of Clinical and Genomic Information; J.K. acknowledges funding from the Robertson Foundation; D.F.V. acknowledges funding from the Victorian State Government through the Operational Infrastructure Support (OIS) Program; A.M.L., R.N., and H.V.F. acknowledge funding from Wellcome (collaborative award); F.C., H.S., P.F., and S.E.H. acknowledge funding from Wellcome Trust grant #108749/Z/15/Z; A.D.Y., H.S., I.U.L., M. Courtot, H.E.P., P.F., and T.M.K. acknowledge funding from Wellcome Trust grant #201535/Z/16/Z; A.M., J.K.B., R.J.M., R.M.D., and T.M.K. acknowledge funding from Wellcome Trust grant #206194; E.B., P.F., P.G., and S.F. acknowledge funding from Wellcome Trust grant #220544/Z/20/Z; A. Hamosh acknowledges funding from NIH NHGRI grant U41HG006627 and U54HG006542; J.S.H. acknowledges funding from National Taiwan University #91F701-45C and #109T098-02; the work of K.W.R. was supported by the Intramural Research Program of the National Library of Medicine, NIH. For the purpose of open access, the author has applied a CC BY public copyright license to any Author Accepted Manuscript version arising from this submission. H.V.F. acknowledges funding from Wellcome Grant 200990/A/16/Z ‘Designing, developing and delivering integrated foundations for genomic medicine'.

Restrictive measures imposed because of the coronavirus disease 2019 (COVID-19) pandemic have resulted in severe social, economic and health effects. Some countries have considered the use of immunity certification as a strategy to relax these measures for people who have recovered from the infection by issuing these individuals a document, commonly called an immunity passport. This document certifies them as having protective immunity against severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), the virus that causes COVID-19. The World Health Organization has advised against the implementation of immunity certification at present because of uncertainty about whether long-term immunity truly exists for those who have recovered from COVID-19 and concerns over the reliability of the proposed serological test method for determining immunity. Immunity certification can only be considered if scientific thresholds for assuring immunity are met, whether based on antibodies or other criteria. However, even if immunity certification became well supported by science, it has many ethical issues in terms of different restrictions on individual liberties and its implementation process. We examine the main considerations for the ethical acceptability of immunity certification to exempt individuals from restrictive measures during the COVID-19 pandemic. As well as needing to meet robust scientific criteria, the ethical acceptability of immunity certification depends on its uses and policy objectives and the measures in place to reduce potential harms, and prevent disproportionate burdens on non-certified individuals and violation of individual liberties and rights.Les restrictions imposées dans le cadre de la lutte contre la pandémie de maladie à coronavirus 2019 (COVID-19) ont eu de lourdes conséquences économiques, sociales et sanitaires. Certains pays ont envisagé la mise en place d'une stratégie visant à alléger ces restrictions pour les individus guéris en leur octroyant un document communément appelé «passeport d'immunité». Ce document atteste qu'ils ont développé une immunité protectrice contre le coronavirus 2 du syndrome respiratoire aigu sévère (SARS-CoV-2), le virus à l'origine de la COVID-19. L'Organisation mondiale de la Santé a déconseillé l'usage du certificat d'immunité pour l'instant, car l'incertitude demeure quant à l'existence réelle d'une immunité à long terme pour ceux qui se sont remis de la COVID-19. En outre, la fiabilité des tests sérologiques censés déterminer si l'individu est immunisé n'est pas avérée. Un tel certificat ne peut être instauré que si les seuils scientifiques en matière d'immunité sont respectés, qu'ils soient fondés sur les anticorps ou sur d'autres critères. Néanmoins, même si le certificat d'immunité est désormais bien accepté par la science, il s'accompagne de nombreuses questions d'ordre éthique en ce qui concerne la limitation des libertés individuelles et la mise en œuvre. Dans le présent document, nous examinons les principales considérations à prendre en compte pour garantir l'acceptabilité éthique du certificat d'immunité visant à lever les mesures de restriction pour certaines personnes durant la pandémie de COVID-19. Cette acceptabilité éthique dépend non seulement de son degré de conformité à des critères scientifiques stricts, mais aussi de son usage, des objectifs politiques ainsi que des mesures mises en place pour atténuer les préjudices potentiels et éviter d'imposer une charge disproportionnée sur les individus dépourvus de certificat, ou de bafouer les droits et libertés de tout un chacun.Las medidas restrictivas impuestas a causa de la pandemia de la enfermedad coronavirus de 2019 (COVID-19) han tenido graves efectos sociales, económicos y sanitarios. Algunos países han considerado la posibilidad de utilizar la certificación de inmunidad como estrategia para flexibilizar dichas medidas para las personas que se han recuperado de la infección mediante la expedición a dichas personas de un documento, comúnmente denominado pasaporte de inmunidad. Este documento certifica que han desarrollado inmunidad protectora contra el coronavirus-2 del síndrome respiratorio agudo severo (SARS-CoV-2), el virus que causa la COVID-19. La Organización Mundial de la Salud ha desaconsejado la aplicación de la certificación de la inmunidad en la actualidad debido a la incertidumbre sobre si existe realmente una inmunidad a largo plazo para quienes se han recuperado de la COVID-19 y a las preocupaciones sobre la fiabilidad del método de prueba serológica propuesto para determinar la inmunidad. La certificación de la inmunidad solo puede considerarse si se cumplen los umbrales científicos para asegurar la inmunidad, ya sea que se basen en anticuerpos o en otros criterios. Sin embargo, incluso si la certificación de la inmunidad llegara a estar bien respaldada por la ciencia, tiene muchas cuestiones éticas en cuanto a las diferentes restricciones de las libertades individuales y su proceso de aplicación. Examinamos las principales consideraciones sobre la aceptabilidad ética de la certificación de la inmunidad para eximir a los individuos de las medidas restrictivas durante la pandemia de la COVID-19. Además de necesitar cumplir criterios científicos sólidos, la aceptabilidad ética de la certificación de inmunidad depende de sus usos y objetivos de política y de las medidas que se apliquen para reducir los posibles daños y evitar que se impongan cargas desproporcionadas a las personas que no cuenten con dicha certificación y se violen las libertades y derechos individuales.الإجراءات التقييدية المفروضة نظراً لأن جائحة مرض فيروس كورونا 19 (كوفيد 19) قد أدت إلى آثار اجتماعية واقتصادية وصحية وخيمة. اعتبرت بعض الدول استخدام شهادة المناعة كاستراتيجية لتخفيف هذه الإجراءات للأشخاص الذين تعافوا من الإصابة، وذلك بإصدار مستند لهؤلاء الأفراد، يُطلق عليها بصورة شائعة مصطلح: جواز المناعة. يشهد هذا المستند على أنهم يتمتعون بمناعة وقائية ضد المتلازمة التنفسية الحادة الوخيمة لفيروس كورونا 2 (SARS-CoV-2)، الفيروس المسبب لكوفيد 19. وقد نصحت منظمة الصحة العالمية بعدم تطبيق شهادة المناعة في الوقت الحالي بسبب عدم اليقين بشأن ما إذا كانت المناعة طويلة المدى موجودة بالفعل لدى هؤلاء الذين تعافوا من كوفيد 19، فضلاً عن المخاوف بشأن موثوقية طريقة الاختبار المصلي المقترحة لتحديد المناعة. لا يمكن النظر لشهادة المناعة بعين الاعتبار إلا إذا تم تلبية الشروط العلمية لضمان المناعة، سواء بناءً على الأجسام المضادة أو معايير أخرى. ومع ذلك، حتى إذا أصبحت شهادة المناعة مدعومة جيدًا من جانب العلم، فإنها تواجه العديد من القضايا الأخلاقية فيما يتعلق بالقيود المختلفة على الحريات الفردية وعملية تنفيذها. نحن ندرس الاعتبارات الرئيسية للقبول الأخلاقي لشهادة المناعة لإعفاء الأفراد من الإجراءات التقييدية أثناء جائحة كوفيد 19. وفضلاً عن الحاجة إلى تلبية معايير علمية صارمة، فإن القبول الأخلاقي لشهادة المناعة يعتمد على استخداماتها وأهدافها السياسة، والتدابير المتبعة لتقليل الأضرار المحتملة، ومنع الأعباء غير المتناسبة على الأفراد غير الحاصلين على الشهادة، وانتهاك الحريات والحقوق الفردية.因新型冠状病毒肺炎（新冠肺炎）大流行而强制实施的限制性措施已造成严重的社会、经济和健康影响。有些国家已考虑采用免疫认证策略来放松这些限制性措施，即，向感染后康复的人员发放一份通常被称为免疫通行证的证件。该证件证明此类人员对引起新冠肺炎的病毒——严重急性呼吸综合征冠状病毒-2 (SARS-CoV-2)——具有保护性免疫力。世界卫生组织建议目前不要实施免疫认证，因为尚不确定感染新冠肺炎后康复的人员是否切实存在长期免疫力，且对计划用于测定免疫力的血清学检测方法的可靠性尚存疑虑。仅当达到确保免疫的科学阈值（无论是基于抗体还是其他标准）时，才可以考虑采取免疫认证。然而，即使免疫认证得到了科学的充分支持，也仍存在许多伦理问题，包括对个人自由的不同限制及其实施过程。对于在新冠肺炎大流行期间准许某些人员无需遵守限制性措施的免疫认证，我们研究了这种认证在伦理上予以接受的主要考虑因素。免疫认证不仅需要满足严格的科学标准，而且在伦理上是否予以接受还取决于免疫认证的用法、实施对象以及是否采取措施以降低对未获得认证的人员造成的潜在伤害，防止对其产生过重的压力以及违反个人自由和权利方面的规定。.Ограничительные меры, введенные с началом пандемии коронавирусного заболевания 2019 года (COVID-19), привели к серьезным социальным и экономическим последствиям, а также неблагоприятно отразились на здоровье населения. Некоторые страны рассматривают возможность использования сертификации иммунитета в качестве стратегии по ослаблению таких мер для людей, перенесших заболевание, посредством выдачи этим лицам документа, именуемого «паспорт иммунитета». Данный документ подтверждает, что эти лица обладают защитным иммунитетом к тяжелому острому респираторному синдрому коронавируса-2 (SARS-CoV-2) — вирусу, вызывающему COVID-19. Всемирная организация здравоохранения не рекомендует внедрять сертификацию иммунитета в настоящее время по причине неуверенности в формировании длительного иммунитета у лиц, переболевших COVID-19, а также ввиду опасений в отношении надежности предлагаемого метода серологического тестирования для определения иммунитета. Сертификацию иммунитета можно рассматривать только при условии соблюдения научных пороговых значений для обеспечения иммунитета, основанных на антителах или других критериях. Однако, даже если сертификация иммунитета получит широкую поддержку со стороны науки, она имеет массу этических проблем с точки зрения различных ограничений индивидуальных свобод и процесса реализации этих ограничений. Авторы исследуют основные соображения этической приемлемости сертификации иммунитета для освобождения людей от ограничительных мер во время пандемии COVID-19. Этическая приемлемость сертификации иммунитета зависит не только от необходимости соответствовать строгим научным критериям, но и от ее использования, целей политики и принимаемых мер по снижению потенциального вреда и предотвращению непропорционального бремени для не имеющих сертификата лиц и нарушений личных свобод и прав.

Following the outbreak of what would become the COVID-19 pandemic, social distancing measures were quickly introduced across East Asia-including drastic shelter-in-place orders in some cities-drawing on experience with the outbreak of severe acute respiratory syndrome (SARS) almost two decades ago. "Smart City" technologies and other digital tools were quickly deployed for infection control purposes, ranging from conventional thermal scanning cameras to digital tracing in the surveillance of at-risk individuals. Chatbots endowed with artificial intelligence have also been deployed to shift part of healthcare provision away from hospitals and to support a number of programmes for self-management of chronic disease in the community. With the closure of schools and adults working from home, digital technologies have also sustained many aspects of both professional and social life at a pace and scale not considered to be practicable before the outbreak. This paper considers how these new experiences with digital technologies in public health surveillance are spurring digitalization in East Asian societies beyond the conventional public health context. It also considers some of the concerns and challenges that are likely to arise with rapid digitalization, particularly in healthcare.

In countries without universal health insurance systems, is it ethically acceptable for pharmaceutical companies to sell their products only to the relatively small segment of the population that can afford private insurance coverage or to pay for medications out of pocket? Are there certain drugs that companies should be expected to sell in these economies even if they are unable to do so profitably? Within a human rights framework, this paper identifies these and related ethical challenges and proposes some responses. The paper begins by considering general ethical responsibilities that arise from commitment to the Universal Health Coverage initiative as a Sustainable Development Goal. It then discusses ethical responsibilities on the part of pharmaceutical companies as distinct from those of national governments or the broader international community. Some proposals follow for thinking through specific ethical challenges that arise when making decisions about whether, and on what terms, to introduce a new drug into a particular setting. Finally, the paper considers a number of these issues and responses in the context of the sale of sofosbuvir in the Asia-Pacific region.

Background: The novel Coronavirus-2019 (COVID-19) was declared a pandemic by the World Health Association (WHO) in March 2020, impacting the lifestyles, economy, physical and mental health of individuals globally. Little is known about the relationship between the impact of COVID-19 and one’s mental health status, and thus research needs to be conducted to identify the factors involved and develop tailored evidence-based strategies in response to reduce the adverse psychological impact. Methods: From February to June 2020, we conducted an online Global Mental Health survey which recruited participants via a respondent-driven sampling country in 8 countries (China, Pakistan, Philippines, Iran, Poland, Spain, USA and Vietnam). The online survey collected information on demographic characteristics, physical symptoms and health service utilisation, contact history, knowledge and concerns regarding COVID-19, precautionary measures taken and additional health information variables among the countries involved. The psychological impact was measured by the Impact of Event Scale-Revised (IES-R) questionnaire and the mental health status was measured by the Depression, Anxiety and Stress Scale (DASS-21). Results: There were 5555 participants involved in the study, 31.4% male and 68.6% female, with an age range of 12-to above 50 years of age. There were significant differences in the mean IES-R and DASS-21 scores between the 8 countries (F(7, 55477) = 71.605, η2=0.085, p

Recognizing that antimicrobial resistance (AMR) poses a serious threat to global public health, the World Health Organization (WHO) has adopted a Global Action Plan (GAP) at the May 2015 World Health Assembly. Underscoring that systematic misuse and overuse of drugs in human medicine and food production is a global public health concern, the GAP-AMR urges concerted efforts across governments and private sectors, including pharmaceutical industry, medical professionals, agricultural industry, among others. The GAP has a threefold aim: (1) to ensure a continuous use of effective and safe medicines for treatment and prevention of infectious diseases; (2) to encourage a responsible use of medicines; and (3) to engage countries to develop their national actions on AMR in keeping with the recommendations. While the GAP is a necessary step to enable multilateral actions, it must be supported by effective governance in order to realize the proposed aims.This chapter has a threefold purpose: (1) To identify regulatory principles embedded in key WHO documents relating to AMR and the GAP-AMR; (2) To consider the legal and regulatory actions or interventions that countries could use to strengthen their regulatory lever for AMR containment; and (3) To highlight the crucial role of the regulatory lever in enabling other levers under a whole-of-system approach. Effective AMR containment requires a clearer understanding of how the regulatory lever could be implemented or enabled within health systems, as well as how it underscores and interacts with other levers within a whole-of-system approach.

Feeney and colleagues (2018) make a valid argument for restrictions on the exclusivity of foundational technologies such as CRISPR. The issue of balancing intellectual property right with access to...

Mortimer and colleagues (Mortimer et al. 2018) provide an instructive illustration of how philosophical analysis could be applied to examine the underlying values and assumptions in public policy o...

Lavazza and Reichlin (2018) provide an instructive ethical analysis of a real-life case, involving Oscar, a vegan activist living with dementia in a nursing home in Sweden, who was, by accident, se...

Technological advances in big data (large amounts of highly varied data from many different sources that may be processed rapidly), data sciences and artificial intelligence can improve health-system functions and promote personalized care and public good. However, these technologies will not replace the fundamental components of the health system, such as ethical leadership and governance, or avoid the need for a robust ethical and regulatory environment. In this paper, we discuss what a robust ethical and regulatory environment might look like for big data analytics in health insurance, and describe examples of safeguards and participatory mechanisms that should be established. First, a clear and effective data governance framework is critical. Legal standards need to be enacted and insurers should be encouraged and given incentives to adopt a human-centred approach in the design and use of big data analytics and artificial intelligence. Second, a clear and accountable process is necessary to explain what information can be used and how it can be used. Third, people whose data may be used should be empowered through their active involvement in determining how their personal data may be managed and governed. Fourth, insurers and governance bodies, including regulators and policy-makers, need to work together to ensure that the big data analytics based on artificial intelligence that are developed are transparent and accurate. Unless an enabling ethical environment is in place, the use of such analytics will likely contribute to the proliferation of unconnected data systems, worsen existing inequalities, and erode trustworthiness and trust.Les progrès technologiques en matière de big data (un terme qui désigne de grandes quantités de données extrêmement variées, provenant de différentes sources et pouvant être traitées rapidement), de sciences de l'information et d'intelligence artificielle peuvent améliorer le fonctionnement du système de santé, mais aussi promouvoir des soins personnalisés et servir l'intérêt public. Néanmoins, ces technologies ne permettront pas de remplacer les composantes fondamentales du système de santé, comme le leadership éthique et la bonne gouvernance, ni d'éviter la nécessité de créer un environnement déontologique et réglementaire solide. Le présent document se penche sur la définition de cet environnement déontologique et réglementaire solide pour l'analyse des big data dans le domaine de l'assurance maladie, et fournit à titre d'exemple les mécanismes de protection et de participation qu'il convient d'instaurer. En premier lieu, imposer un cadre de gouvernance précis et efficace est essentiel au traitement des données. Des normes juridiques doivent être promulguées, tandis que les assureurs doivent être encouragés et incités à adopter une approche centrée sur l'humain, tant dans leur conception que dans leur utilisation de l'analyse des big data et de l'intelligence artificielle. Deuxièmement, il faut mettre en place un processus clair et responsable afin d'expliquer quels types d'informations sont susceptibles d'être employés et à quelles fins. Troisièmement, les personnes concernées doivent avoir la possibilité de déterminer de quelle manière leurs données personnelles sont gérées et régies, en étant activement impliquées dans ce processus. Et quatrièmement, les assureurs et les organes de gouvernance, dont les régulateurs et législateurs, doivent collaborer pour faire en sorte que l'analyse des big data basée sur l'intelligence artificielle soit correcte et transparente. À moins d'établir un environnement éthique, l'usage d'une telle analyse entraînera probablement la prolifération de systèmes de données non connectés, l'aggravation des inégalités actuelles ainsi qu'une perte de confiance et de fiabilité.Los avances tecnológicos relativos a los macrodatos (es decir, grandes cantidades de datos muy variados de muchas fuentes diversas que pueden procesarse rápidamente), las ciencias de los datos y la inteligencia artificial pueden mejorar las funciones del sistema sanitario y promover la atención personalizada y el bien público. No obstante, estas tecnologías no sustituirán los componentes fundamentales del sistema sanitario, como el liderazgo ético y la gobernanza, ni evitarán la necesidad de un entorno ético y normativo sólido. En el presente documento se examina cómo podría ser un entorno ético y normativo sólido para el análisis de macrodatos en el ámbito de los seguros médicos, y se describen ejemplos de mecanismos de protección y participación que deberían establecerse. En primer lugar, es fundamental contar con un marco claro y eficaz de gestión de datos. Es necesario promulgar normas jurídicas y alentar e incentivar a las aseguradoras para que adopten un enfoque centrado en el ser humano en el diseño y la aplicación de análisis de macrodatos e inteligencia artificial. En segundo lugar, es necesario un proceso claro y responsable para explicar cómo y qué información se puede utilizar. En tercer lugar, se debe facultar a las personas cuyos datos puedan ser utilizados mediante su participación activa en la determinación de cómo se pueden gestionar y regular sus datos personales. En cuarto lugar, las aseguradoras y los órganos de gobierno, incluidos los reguladores y los responsables de formular políticas, deben colaborar para garantizar que los análisis de macrodatos basados en la inteligencia artificial que se elaboren sean transparentes y precisos. A menos que exista un entorno ético adecuado, el uso de esos análisis probablemente contribuirá a la proliferación de sistemas de datos sin conexión, empeorará las desigualdades existentes y reducirá la fiabilidad y la confianza.يمكن للتطورات التكنولوجية في البيانات الضخمة (وهي الكميات الكبيرة من البيانات شديدة التنوع من العديد من المصادر المختلفة والتي يمكن معالجتها بسرعة)، وعلوم البيانات والذكاء الاصطناعي، تحسين وظائف النظام الصحي وتعزيز الرعاية الشخصية والصالح العام. ومع ذلك، إلا أن هذه التقنيات لن تحل محل المكونات الأساسية للنظام الصحي، مثل القيادة والحوكمة الأخلاقية، أو تجنب الحاجة إلى بيئة أخلاقية وتنظيمية قوية. سوف نناقش في هذه الورقة كيف تبدو البيئة الأخلاقية التنظيمية القوية بالنسبة لتحليلات البيانات الضخمة في التأمين الصحي، كما نصف أمثلة للضمانات والآليات المشتركة التي يجب إنشاؤها. أولاً، يعد وجود إطار حوكمة واضح وفعال للبيانات أمراً حيوياً. يجب تفعيل المعايير القانونية كما يجب تشجيع جهات التأمين ومنحها الحوافز لاعتماد نهج يركز على الإنسان في التصميم واستخدام تحليلات البيانات الضخمة والذكاء الاصطناعي. ثانياً، من الضروري وجود عملية واضحة وخاضعة للمساءلة تهدف إلى شرح المعلومات التي يمكن استخدامها وكيف يمكن استخدامها. ثالثاً، يجب دعم الأشخاص الذين يمكن استخدام بياناتهم، وذلك من خلال انخراطهم بشكل نشط في تحديد كيفية إدارة بياناتهم الشخصية والتحكم فيها. رابعاً، تحتج جهات التأمين وهيئات الحوكمة، بما في ذلك الجهات التنظيمية وواضعي السياسات، إلى العمل معًا لضمان أن تكون تحليلات البيانات الضخمة القائمة على الذكاء الاصطناعي، والتي تم تطويرها، تتميز بالشفافية والدقة. ما لم تكن هناك بيئة أخلاقية مناسبة، فإن استخدام هذه التحليلات من المحتمل أن يسهم في انتشار أنظمة للبيانات غير المتصلة، ويزيد من سوء الحالات القائمة لعدم المساواة، ويحد من الثقة والجدارة بالثقة.大数据（即，可以快速处理大量不同来源的高度差异化数据）、数据科学和人工智能领域的技术进步可以改善医疗系统功能，促进个性化护理和公益服务。然而，这些技术不会取代医疗系统中的道德领导和治理等基本组成要素，也不会消除对稳健的道德和监管环境的需求。在本文中，我们讨论了医疗保险大数据分析中的稳健道德和监管环境可能是什么样子的，并且举例描述了应该建立的保障和参与机制。首先，一个清晰有效的数据治理框架至关重要。需要制定法律标准，并且鼓励和激励保险公司在设计和使用大数据分析和人工智能方面秉承以人为本的理念。第二，必须有一个明确的问责流程来解释可以使用哪些信息以及如何使用这些信息。第三，对于数据被采用的人员，应该通过积极参与决定如何管理和治理其个人数据的方式为其赋权。第四，保险公司和治理机构，包括监管机构和政策制定者，需携手合作，确保基于人工智能开发的大数据分析是透明且准确的。除非具备有利的道德环境，否则使用此类分析很可能会导致未连接的数据系统的分散，加剧现有的不均衡情况，并降低可靠性和可信度。.Стремительное развитие технологий в области больших данных (то есть больших объемов разнородных данных из самых разных источников, которые можно быстро обрабатывать), обработки и анализа данных и искусственного интеллекта может совершенствовать функции систем здравоохранения и способствовать разработке индивидуального подхода к оказанию медицинской помощи и обеспечению благосостояния общества. Тем не менее использование этих технологий не сможет заменить фундаментальные компоненты системы здравоохранения, такие как этика руководства и управления, или устранить необходимость создания надежной этической и нормативной среды. В этой статье авторы обсуждают, как может выглядеть надежная этическая и нормативная среда для аналитики больших данных в сфере медицинского страхования, и рассматривают примеры защитных мер и механизмов участия, которые необходимо разработать. Во-первых, важнейшее значение имеет разработка четкой и эффективной системы управления данными. Необходимо принять правовые стандарты, которые будут создавать стимулы для страховщиков использовать подход, ориентированный на нужды людей, для разработки и использования аналитики больших данных и искусственного интеллекта. Во-вторых, необходимо разработать четкий и прозрачный метод определения типа данных, которые могут использоваться, а также способ использования таких данных. В-третьих, люди, чьи данные могут использоваться, должны наделяться полномочиями посредством активного участия в определении методов управления их личными данными. В-четвертых, страховщикам и органам управления, включая директивные органы и органы регулирования, необходимо сотрудничать для обеспечения прозрачности и точности аналитики больших данных, полученной на основе разработанного искусственного интеллекта. В отсутствие благоприятной этической среды использование такой аналитики будет скорее способствовать распространению несвязанных систем данных, усугублению существующего неравенства и подрыву авторитетности этой аналитики и доверия к ней.

This chapter provides an analysis of the legal governance that applies to genome-editing technologies for human biomedical research and (somatic and germline) cell therapies in Singapore. Genome-editing technologies refer to a group of techniques that include CRISPR/Cas9, which is a technological tool by which gene locus can be altered to create a specific genetic modification at that precise locus. For the purposes of this chapter, reference to gene-editing technologies includes techniques that could modify the genetic composition of a human cell. The ability to apply such techniques to human somatic and germline cells can eventually offer therapeutic opportunities to treat severe hereditary diseases by repairing the disease-causing gene(s). With a few exceptions, gene-editing technologies remain technically challenging and complex to implement safely and effectively at the time of writing, mainly because of fundamental limitations in the ability to precisely control how genetic material can be altered or introduced into cells. In other words, safety continues to be the foremost of concerns if such technologies are to be administered as clinical practice. Apart from concerns about physical wellbeing, gene-editing technologies have also raised concerns that relate to eugenics as they can be applied for non-therapeutic purposes or otherwise for the purposes of genetic enhancement. This chapter discusses the legal responses in Singapore to these and related concerns as legal governance of an emergent biomedical technology. Legal governance refers not only to statutory laws and regulations, but also to ethical principles, recommendations and good practices that either have regulatory effect or represent the legal or regulatory ends of legal requirements that apply to the use of genome-editing technologies in Singapore.

Background:There is growing interest in advancing biobanking and genetic research in many countries, including India. Concurrently, more importance is being placed on participatory approaches involving the public and other stakeholders in addressing ethical issues and policymaking as part of a broader governance approach. We analyse the tools, purposes, outcomes and limitations of engaging people towards biobanking and genetic research governance that have been undertaken worldwide, and explore their relevance to India.Methods:Papers to be reviewed were identified through a targeted literature search carried out using ProQuest and PubMed. Retrieved papers were analysed with theRpackage forQualitative Data Analysisusing inductive coding and thematic analysis, guided by the Framework Method.Results:Empirical studies on public and community engagement in the context of biobanking and or genetic research show a predominance towards the end of the last decade, spanning 2007 to 2019. Numerous strategies—including public meetings, community durbars, focus group discussions, interviews, deliberations, citizen-expert panels and community advisory boards—have been used to facilitate communication, consultation and collaboration with people, at the level of general and specific publics. Engagement allowed researchers to understand how people’s values, opinions and experiences related to the research process; and enabled participants to become partners within the conduct of research.Conclusions: Constructs such as ‘co-production’, ‘engagement of knowledges’, ‘rules of engagement’ and ‘stewardship’ emerge as significant mechanisms that can address the ethical challenges and the governance of biobanking and genetic research in India. Given the inherent diversity of the Indian population and its varying cultural values and beliefs, there is a need to invest time and research funds for engagement as a continuum of participatory activity, involving communication, consultation and collaboration in relation to biobanking and genetic research. Further research into these findings is required to explore their effective employment within India

Unfortunately, the original version of this article has cited one of its references incorrectly. The in-text citation "Lajaunie and Morand 2018" should have been “Lajaunie and Mazzega 2018", and the correct bibliographic details are

The hype over artificial intelligence (AI) has spawned claims that clinicians (particularly radiologists) will become redundant. It is still moot as to whether AI will replace radiologists in day-to-day clinical practice, but more AI applications are expected to be incorporated into the workflows in the foreseeable future. These applications could produce significant ethical and legal issues in healthcare if they cause abrupt disruptions to its contextual integrity and relational dynamics. Sustaining trust and trustworthiness is a key goal of governance, which is necessary to promote collaboration among all stakeholders and to ensure the responsible development and implementation of AI in radiology and other areas of clinical work. In this paper, the nature of AI governance in biomedicine is discussed along with its limitations. It is argued that radiologists must assume a more active role in propelling medicine into the digital age. In this respect, professional responsibilities include inquiring into the clinical and social value of AI, alleviating deficiencies in technical knowledge in order to facilitate ethical evaluation, supporting the recognition, and removal of biases, engaging the “black box” obstacle, and brokering a new social contract on informational use and security. In essence, a much closer integration of ethics, laws, and good practices is needed to ensure that AI governance achieves its normative goals.

This paper provides an evaluation of the discussion on the concept of vulnerability in research involving children, which took place at the 10th Global Summit of National Bioethics Committees—the primary international forum for members of national bioethics (or ethics) bodies to share their experiences and discuss emerging bioethical issues. Children are generally considered to be a vulnerable population in international guidelines, hence special considerations are entailed. Ideally, children should play a role in the development of research projects, as well as in decision-making about their involvement. In research activities involving children, the level of risk that they are exposed to must be justified. Given the roles that national bioethics bodies hold in their respective societies, they are strategically positioned to identify and address vulnerabilities that occur in the context of research involving children, and to consider means by which research may be better aligned with ethical and regulatory norms. It is clear from the Global Summit that while vulnerability remains a critical concept, national bioethics bodies have an important role to play in contributing to its refinement in international policy, and in ensuring the adequate adaptation and implementation of international guidance.§

SUMMARYResearch on emerging infectious diseases calls for a work on collections of pathogens (including hosts or vectors from which the pathogens were isolated), related to human and animal health, to wildlife or on the environmental material. In this respect, the adoption of a One Health perspective is determined by the need for a common approach to consider the collection, storage and use of pathogens coming from human or non-human sources, and particularly when the same pathogen is taken from different environments. In response to this development, our purpose is to delineate a flexible regulation framework concerning collections of pathogens from various origins or hosts and their associated data in order to facilitate scientific work and research partnerships. The legal and ethical cutting-edge research on Biomedical Big Data is particularly stimulating when it comes to address challenges related to collections or biobanks of pathogens such as prior informed consent and accessibility, Material Transfer Agreement or benefit sharing.

This paper begins by considering how the revised CIOMS guidelines have progressed beyond a mere labelling approach in the handling of vulnerability.. However, progress is limited as the guidelines remain fixated on voluntariness and harm reduction or prevention. Although these are important considerations, vulnerability could also serve as a robust analytic for the evaluation of situational and pathogenic (or structural) contributions to susceptibilities to harm. They could also provide better guidance on how to differentiate among varying types and degrees of harm, rather than merely noting their presence. The paper concludes by considering vulnerability in relation to especially vulnerable children in health research.

A total of 31 sea otters Enhydra lutris nereis found dead or moribund (and then euthanized) were necropsied in California, USA. Stomach biopsies were collected and transected with equal portions frozen or placed in formalin and analyzed histologically and screened for Helicobacter spp. in gastric tissue. Helicobacter spp. were isolated from 9 sea otters (29%); 58% (18 of 31) animals were positive for helicobacter by PCR. The Helicobacter sp. was catalase- and oxidase-positive and urease-negative. By electron microscopy, the Helicobacter sp. had lateral and polar sheathed flagella and had a slightly curved rod morphology. 16S and 23S rRNA sequence analyses of all ‘H. enhydrae’ isolates had similar sequences, which clustered as a novel Helicobacter sp. closely related to H. mustelae (96-97%). The genome sequence of isolate MIT 01-6242 was assembled into a single ~1.6 Mb long contig with a 40.8% G+C content. The annotated genome contained 1699 protein-coding sequences and 43 RNAs, including 65 genes homologous to known Helicobacter spp. and Campylobacter spp. virulence factors. Histological changes in the gastric tissues extended from mild cystic degeneration of gastric glands to severe mucosal erosions and ulcers. Silver stains of infected tissues demonstrated slightly curved bacterial rods at the periphery of the gastric ulcers and on the epithelial surface of glands. The underlying mucosa and submucosa were infiltrated by low numbers of neutrophils, macrophages, and lymphocytes, with occasional lymphoid aggregates and well-defined lymphoid follicles. This is the second novel Helicobacter sp., which we have named ‘H. enhydrae’, isolated from inflamed stomachs of mustelids, the first being H. mustelae from a ferret. Keywords: Helicobacter; Gastritis; Otter, National Institutes of Health (U.S.) (Grant T32-OD010978), National Institutes of Health (U.S.) (Grant P01-CA028842), National Institutes of Health (U.S.) (Grant P30-ES002109), National Institutes of Health (U.S.) (Grant R01-CA093405)

This article discusses the establishment of a governance framework for biomedical research in Singapore. It focuses on the work of the Bioethics Advisory Committee (BAC), which has been instrumental in institutionalizing a governance framework, through the provision of recommendations to the government, and through the coordination of efforts among government agencies. However, developing capabilities in biomedical sciences presents challenges that are qualitatively different from those of past technologies. The state has a greater role to play in balancing conflicting and potentially irreconcilable economic, social, and political goals. This article analyzes the various ways by which the BAC has facilitated this.

This paper considers how ethical norms on sharing of human biological materials and related data in international policy documents diffuse from global forums to national policies and practices. With focus on the domestic policies of four countries (i.e. Guinea, Argentina, India and Malawi), this paper seeks to explain policy diffusion by broadly applying an analytical framework wherein policy learning is one of four theories used to explain how countries learn policy norms from expert epistemic communities and international organizations. While the governance structures of all four countries broadly incorporate key ethical provisions in international policy documents on sharing of biological materials and related data for biomedical research, relative emphasis on certain provisions differ among them. In three of these countries (i.e. Guinea, Argentina and India), international ethical norms have had direct influence over their domestic governance policies. Their impact has been greatest for Guinea and Argentina, whose governance policies had to be adapted in response to the Ebola virus epidemic in West Africa and the Zika virus epidemic in Latin America. In both countries, sharing of biological materials and related data with international organisations increased significantly to meet therapeutic and research needs during the outbreaks. International organisations have had a comparatively greater role in bringing about policy change in Guinea when compared with Argentina, mainly due to the fragility of the health system in Guinea in 2014. In contrast, policy in India and in Malawi occurred under less strenuous conditions. This may account for the relatively greater emphasis on control and limits to cross-border transferability in their policies when compared with those of Guinea and Argentina. While all four countries have made significant progress in establishing accountable governance arrangements, still more needs to be done to ensure that the ethical goal of equitable sharing of benefits is realised.