Edward (Ted) Dove is Lecturer in Risk and Regulation at the School of Law, University of Edinburgh, and Deputy Director of the J Kenyon Mason Institute for Medicine, Life Sciences and Law.
His PhD (as part of the Wellcome Trust-funded Liminal Spaces Project, PI: Graeme Laurie) at the University of Edinburgh School of Law explored from a legal-anthropological perspective the role of NHS research ethics committees in a changing health research regulatory environment.
From 2011 until 2014, Ted was an Academic Associate at the Centre of Genomics and Policy at McGill University in Montreal. He holds a Bachelor of Arts degree (BA) in Political Science and Civil Law and Common Law degrees (BCL, LLB) from McGill University, and a Master of Laws degree (LLM) from Columbia University in New York City.
Ted’s primary research interests are in the areas of regulation of biomedical research, research ethics oversight, health-related data access and sharing, and governance of international research collaboration.
He is the Editor-in-Chief of SCRIPTed, an online, peer-reviewed open access journal dedicated to law, medicine, science and technology; he is also the Case Comments Editor for Medical Law International. From 2013 until 2016, Ted was a Section Editor of BMC Medical Ethics, an online, peer-reviewed open access journal.
From 2013-2015, he served as Coordinator for the Regulatory and Ethics Working Group of the Global Alliance for Genomics and Health (GA4GH), and from 2014-2017, Coordinator of the GA4GH's Ethics Review Equivalency Task Team. From 2011-2015, Ted was a member of the International Cancer Genome Consortium’s (ICGC) Identifiability and Privacy Subgroup. Currently, he is a member of the Data Access Committee of METADAC (Managing Ethico-social, Technical and Administrative issues in Data ACcess), which is a multi-agency, multi-study data access structure that services several of the UK’s major cohort studies.
Ted has published his work in journals such as Science; The Lancet; BMJ; European Journal of Human Genetics; Bioethics; Journal of Law, Medicine & Ethics; McGill Journal of Law and Health; Medical Law Review; and Medical Law International.
2013 LLM, Columbia University, Columbia Law School (James Kent Scholar)
2010 BCL, LLB, McGill University, Faculty of Law (Great Distinction)
2006 BA (Political Science), McGill University, Faculty of Arts (Great Distinction)
Current Research Interests
health research regulation; law and genetics; research ethics committees
Convenor, Empirical Legal Research Network, University of Edinburgh (2017 – )
SSRN Editor, Edinburgh Law School (2017 – )
Member, Research Ethics and Integrity Committee, Edinburgh Law School (2017 – )
Member, Equality and Diversity Committee, Edinburgh Law School (2017 – )
Member, Athena SWAN Committee, Edinburgh Law School (2016 – 2017)
Books and Reports
Adrian Thorogood, Howard Simkevitz, Mark Phillips, Edward S. Dove, Yann Joly, Protecting Privacy in Cloud-Based Genomic Research: Discussion Document, (Office of the Privacy Commissioner of Canada, 2015)
M. J Taylor, Edward S. Dove, Graeme Laurie, D Townend, 'When can the child speak for herself? The limits of parental consent in data protection law ', (2017), Medical Law Review, pp 1-12
Abstract: Draft regulatory guidance suggests that if the processing of a child’s personal data begins with the consent of a parent, then there is a need to find and defend an enduring consent through the child’s growing capacity and on to their maturity. We consider the implications for health research of the UK Information Commissioner’s Office’s (ICO) suggestion that the relevant test for maturity is the Gillick test, originally developed in the context of medical treatment. Noting the significance of the welfare principle to this test, we examine the implications for the responsibilities of a parent to act as proxy for their child. We argue, contrary to draft ICO guidance, that a data controller might legitimately continue to rely upon parental consent as a legal basis for processing after a child is old enough to provide her own consent. Nevertheless, we conclude that data controllers should develop strategies to seek fresh consent from children as soon as practicable after the data controller has reason to believe they are mature enough to consent independently. Techniques for effective communication, recommended to address challenges associated with Big Data analytics, might have a role here in addressing the dynamic relationship between data subject and processing. Ultimately, we suggest that fair and lawful processing of a child’s data will be dependent upon data controllers taking seriously the truism that consent is ongoing, rather than a one-time event: the core associated responsibility is to continue to communicate with a data subject regarding the processing of personal data.
Mark Phillips, Edward S. Dove, Bartha M. Knoppers, 'Criminal prohibition of wrongful re-identification: Legal solution or minefield for big data?', (2017), Journal of Bioethical Inquiry, pp 1-13
Abstract: The collapse of confidence in anonymization (sometimes also known as de-identification) as a robust approach for preserving privacy of personal data has incited an outpouring of new approaches that aim to fill the resulting trifecta of technical, organizational, and regulatory privacy gaps left in its wake. In the latter category, and in large part due to the growth of Big Data–driven biomedical research, falls a growing chorus of calls for criminal and penal offences to sanction wrongful re-identification of “anonymized” data. This chorus cuts across the fault lines of polarized privacy law scholarship that at times seems to advocate privacy protection at the expense of Big Data research or vice versa. Focusing on Big Data in the context of biomedicine, this article surveys the approaches that criminal or penal law might take toward wrongful re-identification of health data. It contextualizes the strategies within their respective legal regimes as well as in relation to emerging privacy debates focusing on personal data use and data linkage and assesses the relative merit of criminalization. We conclude that this approach suffers from several flaws and that alternative social and legal strategies to deter wrongful re-identification may be preferable.
Edward S. Dove, D Townend, 'Reimagining the ethics and governance of Biomedicine: Introduction to the special issue', (2017), Medicine and Law
Edward S. Dove, David Townend, 'Applying mutual recognition to international research ethics review ', (2017), Medicine and Law, Vol 36
Edward S. Dove, 'Solidarity in Biomedicine and Beyond ', (2017), SCRIPTed
M Shabani, Edward S. Dove, M Murtagh, Bartha M. Knoppers, P Borry, 'Oversight of genomic data sharing: What roles for ethics and data access committees?', (2017), Biopreservation and biobanking, Vol 15, pp 469-474
Abstract: Discussions regarding responsible genomic data sharing often center around ethical and legal issues such as the consent, privacy, and confidentiality of individuals, families, and communities. To ensure the ethical grounds of genomic data sharing, oversight by both research ethics and Data Access Committees (DACs) across the research lifecycle is warranted. In this article, we review these oversight practices and argue that they reveal a compelling need to clarify the scope of ethical considerations by oversight bodies and to delineate core elements such as “objectionable” data uses. Ethical oversight of genomic data sharing would be considerably improved if the relevant ethical considerations by research ethics and DACs were coordinated. We therefore suggest several mechanisms to achieve greater clarification of ethical considerations by these committees, as well as greater communication and coordination between both to ensure robust and sustained ethical oversight of genomic data sharing.
Edward S. Dove, 'Juridification in Bioethics: Governance of Human Pluripotent Cell Research ', (2017), American journal of bioethics
Graeme Laurie, Edward S. Dove, Isabel Fletcher, Agomoni Ganguli-Mitra, Catriona McMillan, Nayha Sethi, Annie Sorbie, 'Charting regulatory stewardship in health research: Making the invisible visible?', (2017), Cambridge quarterly of healthcare ethics
Abstract: This article analyses a hitherto largely obscured feature of regulatory environments in health research, namely, the role of regulatory stewardship. Through examples drawn from research ethics committees, emerging technologies, and governance of research resources, it outlines the essential features of regulatory stewardship, and argues that this concept can demonstrate considerable added value for all parties in delivering and benefiting from efficient and effective navigation of regulatory landscapes. It offers an exposition of the normative principles and associated responsibilities of the concept. The extant invisibility of regulatory stewardship requires fuller recognition and better integration of the approach into the effective functioning of law and regulation in the health research context.
Vasiliki Rahimzadeh, Edward S. Dove, Bartha Maria Knoppers, 'The sIRB system: A single beacon of progress in the revised common rule?', (2017), American journal of bioethics, Vol 17, pp 43-46
Edward S. Dove, Chiara Garattini, 'Expert perspectives on ethics review of international data-intensive research: Working towards mutual recognition', (2017), Research Ethics, pp 1-25
Abstract: Life sciences research is increasingly international and data-intensive. Researchers work in multi-jurisdictional teams or formally established research consortia to exchange data and conduct research using computation of multiple sources and volumes of data at multiple sites and through multiple pathways. Despite the internationalization and data intensification of research, the same ethics review process as applies to single-site studies in one country tends to apply to multi-site studies in multiple countries. Because of the standard requirement for multi-jurisdictional or multi-site ethics review, international research projects are subjected to multiple ethics reviews of the same research protocol. Consequently, the reviews may be redundant and resource-consuming, whilst the opinions delivered by ethics committees may be inconsistent both within and across jurisdictions. In this article, we present findings based on interviews conducted with international experts in research ethics on the topic of ethics review mutual recognition. We explore the issues associated with ethics committee review of multi-jurisdictional data-intensive research projects, identifying current problems, real-life experiences, and potential solutions that are both bottom-up (via researchers, participants and publics) and top-down (via statutory regulation), as well as challenges in achieving both. On the whole, participants recommended multiple changes to the current ethics review regime for data-intensive international research with the aim of reducing inefficiency and inconsistency. But, the changes recommended differ in terms of degree and scope. In general, participants stressed that key drivers of success in a reformed system should be strong leadership (on the ground and in government) and demonstration of value.
Edward S. Dove, 'Medical Experimentation: Personal Integrity and Social Policy: New Edition ', (2017), SCRIPTed, Vol 14, pp 152-157
Edward S. Dove, 'Privacy and Healthcare Data: ‘Choice of Control’ to ‘Choice’ and ‘Control’ ', (2017), SCRIPTed, Vol 14, pp 158-163
Edward S. Dove, Susan E Kelly, Federica Lucivero, Mavis Machirori, Sandi Dheensa, Barbara Prainsack, 'Beyond individualism: Is there a place for relational autonomy in clinical practice and research?', (2017), Clinical Ethics, pp 1-16
Abstract: The dominant, individualistic understanding of autonomy that features in clinical practice and research is underpinned by the idea that people are, in their ideal form, independent, self-interested and rational gain-maximising decision-makers. In recent decades, this paradigm has been challenged from various disciplinary and intellectual directions. Proponents of ‘relational autonomy’ in particular have argued that people’s identities, needs, interests – and indeed autonomy – are always also shaped by their relations to others. Yet, despite the pronounced and nuanced critique directed at an individualistic understanding of autonomy, this critique has had very little effect on ethical and legal instruments in clinical practice and research so far. In this article, we use four case studies to explore to what extent, if at all, relational autonomy can provide solutions to ethical and practical problems in clinical practice and research. We conclude that certain forms of relational autonomy can have a tangible and positive impact on clinical practice and research. These solutions leave the ultimate decision to the person most affected, but encourage and facilitate the consideration of this person’s care and responsibility for connected others.
Edward S. Dove, 'Richard Huxtable and Ruud Ter Meulen (eds), The Voices and Rooms of European Bioethics ', (2017), Medical Law Review, pp 175-179
Agomoni Ganguli Mitra, Edward S. Dove, Graeme Laurie, Samuel Taylor-Alexander, 'Reconfiguring social value in health research through the lens of liminality ', (2017), Bioethics, pp 87-96
Abstract: Despite the growing importance of ‘social value’ as a central feature of research ethics, the term remains both conceptually vague and to a certain extent operationally rigid. And yet, perhaps because the rhetorical appeal of social value appears immediate and self-evident, the concept has not been put to rigorous investigation in terms of its definition, strength, function, and scope. In this article, we discuss how the anthropological concept of liminality can illuminate social value and differentiate and reconfigure its variegated approaches. Employing liminality as a heuristic encourages a reassessment of how we understand the mobilization of ‘social value’ in bioethics. We argue that social value as seen through the lens of liminality can provide greater clarity of its function and scope for health research. Building on calls to understand social value as a dynamic, rather than a static, concept, we emphasize the need to appraise social value iteratively throughout the entire research as something that transforms over multiple times and across multiple spaces occupied by a range of actors.
D Townend, Edward S. Dove, 'Approaching ethics review equivalency through natural justice and a ‘sounding board’ model for research ethics committees ', (2017), Medicine and Law, Vol 36, pp 61-86
Abstract: In this article, we ask what it might be about the process of research ethics review in research ethics committees (RECs) that makes "ethics review equivalency" (ERE) between RECs so difficult to achieve, and suggest possible solutions from administrative law and theoretical ethics. First, we consider why the European Union's Clinical Trials Regulation - a regulatory instrument that should achieve ERE - does not do so. We then approach the problem of ERE through a reflection on the purpose of RECs. This leads us to consider how two different approaches - "gatekeeper" and "sounding board"might assist in producing a platform that could help to move towards ERE. RECs as "gatekeepers" suggests that they are similar to (or indeed are) tribunals, and as such should follow principles of natural justice. Natural justice in the ethics review context requires both procedural and substantive ethics harmonisation. Substantive ethics harmonisation is an intractable challenge, however. The "sounding board" model, based on a discourse approach, moves beyond the substantive ethics harmonisation challenge by shifting the focus to researchers, who ought to a) defend a robust ethics grounding fortheir research, and b) demonstrate "ethics by design" throughout their proposals. Taken together, a natural justice grounding and sounding board model, we suggest, would begin to address the fundamental problems of ERE.
Edward S. Dove, 'Book review: Patents, Human Rights and Access to Science ', (2016), SCRIPTed, Vol 13, pp 405-409
Samuel Taylor-Alexander, Edward S. Dove, Agomoni Ganguli Mitra, Graeme Laurie, Isabel Fletcher, Catriona McMillan, 'Beyond regulatory compression: Confronting the liminal spaces of health research regulation', (2016), Law, Innovation and Technology, Vol 8, pp 149-176
Abstract: Biomedicine and the life sciences continuously rearrange the relationship between culture and biology. In consequence, we increasingly look for a suitable regulatory response to reduce perceived uncertainty and instability. This article examines the full implications of this ‘regulatory turn’ by drawing on the anthropological concept of liminality. We offer the term ‘regulatory compression’ to characterise the effects of extant regulatory approaches on health research practices. With its focus on transformation and the ‘in-between’, liminality allows us to see how regulatory frameworks rely on a silo-based approach to classifying and regulating research objects such that they: (1) limit the flexibility necessary in clinical and laboratory research; (2) result in the emergence of unregulated spaces that lie between the bounded regulatory spheres; and (3) and curtail modes of public participation in the health research enterprise. We suggest there is a need to develop the notion of ‘processual regulation’, a novel framework that requires a temporal-spatial examination of regulatory spaces and practices as these are experienced by all actors, including the relationship of actors with the objects of regulation.
Edward S. Dove, 'Book review: Medical Law and Ethics, 6th Edition ', (2016), SCRIPTed, Vol 13, pp 401-404
Edward S. Dove, 'Principles of Medical Law, 4th edition ', (2016), Medical Law Review
Stephanie Dyke, Edward S. Dove, Bartha M. Knoppers, 'Sharing health-related data: A privacy test?', (2016), npj Genomic Medicine, Vol 1, pp 1-6
Abstract: Greater sharing of potentially sensitive data raises important ethical, legal and social issues (ELSI), which risk hindering and even preventing useful data sharing if not properly addressed. One such important issue is respecting the privacy-related interests of individuals whose data are used in genomic research and clinical care. As part of the Global Alliance for Genomics and Health (GA4GH), we examined the ELSI status of health-related data that are typically considered ‘sensitive’ in international policy and data protection laws. We propose that ‘tiered protection’ of such data could be implemented in contexts such as that of the GA4GH Beacon Project to facilitate responsible data sharing. To this end, we discuss a Data Sharing Privacy Test developed to distinguish degrees of sensitivity within categories of data recognised as ‘sensitive’. Based on this, we propose guidance for determining the level of protection when sharing genomic and health-related data for the Beacon Project and in other international data sharing initiatives.
David Townend, Edward S Dove, Dianne Nicol, Jasper Bovenberg, Bartha M Knoppers, 'Streamlining ethical review of data intensive research ', (2016), BMJ, Vol 354, pp 1-2
Abstract: Unfounded concerns about local liability should not delay urgent reform Research that crosses international borders and analyses large volumes of data from multiple sources is growing. Such data intensive research—for example, precision medicine studies driven by genomic research and DNA sequencing—creates difficult governance challenges, one of which is repetitive and inefficient ethical review. There is no clear evidence that review of the same study by multiple research ethics committees better protects participants, particularly for research analysing large aggregate datasets. International, data intensive research may require different assessment from research that risks physical harm to participants.1 2 However, concerns about liability mean that local ethics committees—and their administrators and institutional lawyers—tend to insist on reviewing research protocols themselves, rather than “delegating” review to another ethics committee or otherwise recognising outside reviews. These concerns are some of the main barriers to reform of the ethics review system for international research.3 We argue that the concerns are more perception than reality.The first concern is that mutual …
Edward S. Dove, Isabel Fletcher, Agomoni Ganguli Mitra, Graeme Laurie, Catriona McMillan, Nayha Sethi, Annie Sorbie, Samuel Taylor-Alexander, 'Conference report: 13th World Congress of the International Association of Bioethics, Edinburgh 14-17 June 2016 (IAB2016)', (2016), SCRIPTed, Vol 13, pp 202-209
Edward S. Dove, 'Book review: Governing Public Health: EU Law, Regulation and Biopolitics ', (2016), SCRIPTed, Vol 13, pp 224-227
Edward S. Dove, 'Book review: The Clinic and The Court: Law, Medicine and Anthropology ', (2016), SCRIPTed, Vol 13, pp 228-231
Yann Joly, Shahad Salman, Ida Ngueng Feze, Palmira Granados Moreno, Michèle Stanton-Jean, Jacqueline Lacey, Micheline Labelle, Janet Dench, Edward S. Dove, Idil Atak, Coline Bellefleur, Torsten Heinemann, Hugues Langlais, Roger Love, 'DNA testing for family reunification in Canada: Points to consider', (2016), Journal of International Migration and Integration, Vol 18, pp 391-404
Abstract: Countries have adopted different laws, policies, and practices that allow immigration officers to request in certain cases DNA tests to confirm biological relationships in the context of family reunification. In Canada, Citizenship and Immigration Canada has adopted a policy of suggesting DNA testing only as a last resort in cases where no documentary evidence has been submitted or where the evidence provided is deemed unsatisfactory. However, in practice, there have been concerns on the increasing use of DNA tests in family reunification processes of nationals from certain regions including Africa, Asia, and Latin America. Moreover, the Immigration and Refugee Protection Regulations (IRPR) presents a biological definition of family as a determinant of parenthood in the context of family reunification that is inconsistent with the psychosocial definition used in provincial family laws. Although there are cases that can justify the request for DNA tests, there are also significant social, legal, and ethical issues, including discrimination and unfair practices, raised by this increasing use of genetic information in immigration. This policy brief identifies points to consider for policymakers regarding the use of DNA testing in Canadian family reunification procedures. These include (1) the need to refine the policy of “using DNA testing as a last resort” and its implementation, (2) the need to modify the definition of “dependent child” under the IRPR to reflect the intrinsic reality of psychosocial family ties, and (3) the importance of conducting more research on the use of DNA testing in other immigration contexts.
Edward S Dove, Beth Thompson, Bartha M Knoppers, 'A step forward for data protection and biomedical research ', (2016), The Lancet, Vol 387, pp 1374-1375
Christine Aicardi, Lorenzo Del Savio, Edward S. Dove, Federica Lucivero, Niccolò Tempini, Barbara Prainsack, 'Emerging ethical issues regarding digital health data. On the World Medical Association Draft Declaration on Ethical Considerations Regarding Health Databases and Biobanks ', (2016), Croatian Medical Journal, Vol 57, pp 207–213
Edward S. Dove, Agomoni Ganguli Mitra, Graeme Laurie, Catrinona McMillan, Samuel Taylor-Alexander, 'Elberte v. Latvia: Whose tissue is it anyway – Relational autonomy or the autonomy of relations?', (2016), Medical Law International, Vol 15, pp 77-96
Abstract: A European Court of Human Rights decision rendered in January 2015 (Elberte v. Latvia) has raised a curious question regarding the nature and scope of the right for relatives to consent to or to oppose the removal of a deceased person’s tissues. The decision suggests that Council of Europe member states must clearly define the scope of the right for relatives to express their preferences for removal of a deceased’s tissue or organs – provided such a right has been created in law – and member states must define the corresponding obligation or margin of discretion conferred on experts or other authorities to explain these rights to the relatives. Notwithstanding, this article asks whether the decision could open the door to a free-standing right for relatives to oppose removal of their deceased relative’s tissues or organs, regardless of the deceased person’s own wishes, in the name of the relatives’ human ‘right to respect for private life’.
Edward S. Dove, 'ABC v St George’s healthcare NHS Trust and others: Should there be a right to be informed about a family member’s genetic disorder?', (2016), Law and the Human Genome Review, Vol 44, pp 91-112
Kean Birch, Edward S. Dove, Margaret Chiappetta, Ulvi K. Gürsoy, 'Biobanks in oral health: Promises and implications of post-neoliberal science and innovation', (2016), OMICS: A Journal of Integrative Biology, Vol 20, pp 36-41
Abstract: While biobanks are established explicitly as scientific infrastructures, they are de facto political-economic ones too. Many biobanks, particularly population-based biobanks, are framed under the rubric of the bio-economy as national political-economic assets that benefit domestic business, while national populations are framed as a natural resource whose genomics, proteomics, and related biological material and national health data can be exploited. We outline how many biobanks epitomize this ‘neoliberal’ form of science and innovation in which research is driven by market priorities (e.g., profit, shareholder value) underpinned by state or government policies. As both scientific and political-economic infrastructures, biobanks end up entangled in an array of problems associated with market-driven science and innovation. These include: profit trumping other considerations; rentiership trumping entrepreneurship; and applied research trumping basic research. As a result, there has been a push behind new forms of ‘post-neoliberal’ science and innovation strategies based on principles of openness and collaboration, especially in relation to biobanks. The proliferation of biobanks and the putative transition in both scientific practice and political economy from neoliberalism to post-neoliberalism demands fresh social scientific analyses, particularly as biobanks become further established in fields such as oral health and personalized dentistry. To the best of our knowledge, this is the first analysis of biobanks with a view to what we can anticipate from biobanks and distributed post-genomics global science in the current era of oral health biomarkers.
Adrian Thorogood, Howard Simkevitz, Mark Phillips, Edward S. Dove, Yann Joly, 'Protecting the privacy of Canadians’ health information in the Cloud ', (2016), Canadian Journal of Law and Technology, Vol 14, pp 173–213
Edward S. Dove, 'Biobanks, data sharing, and the drive for a global privacy governance framework ', (2015), Journal of Law, Medicine and Ethics, Vol 43, pp 675-689
Abstract: Biobanks are a key emerging biomedical research infrastructure. They manifest the turn towards greater global sharing of genomic and health-related data, which is considered by many to be an ethical and scientific imperative. Our collective interests lie in improving the health and welfare of individuals, communities, and populations; improving health and welfare requires access to, and use of, widely dispersed quality data. But sharing these individual and familial data requires in turn that due thought be given to the ethical and legal interests at stake. Most critically, data sharing must occur in an environment whereby privacy interests are safeguarded throughout the lifecycle of biobank initiatives, and regardless of the locations where the data are stored, to which they are sent, and where they are ultimately processed. In this article, I outline the complex dimensions of data privacy regulation that challenge data sharing within the biobanking context. I discuss how harmonization may be a remedy for the gaps and marked differences of approach in data privacy regulation. Finally, I encourage the development of foun- dational responsible data sharing principles set within an overarching governance framework that provides assurance that reasonable expectations of privacy will be met.
Vural Özdemir, Edward S. Dove, Ulvi K. Gürsoy, Semra Şardaş, Arif Yıldırım, Şenay Görücü Yılmaz, İ. Ömer Barlas, Kıvanç Güngör, Alper Mete, Sanjeeva Srivastava, 'Personalized medicine beyond genomics: Alternative futures in big data—proteomics, environtome and the social proteome', (2015), Journal of neural transmission, Vol 124, pp 25-32
Abstract: No field in science and medicine today remains untouched by Big Data, and psychiatry is no exception. Proteomics is a Big Data technology and a next generation biomarker, supporting novel system diagnostics and therapeutics in psychiatry. Proteomics technology is, in fact, much older than genomics and dates to the 1970s, well before the launch of the international Human Genome Project. While the genome has long been framed as the master or “elite” executive molecule in cell biology, the proteome by contrast is humble. Yet the proteome is critical for life—it ensures the daily functioning of cells and whole organisms. In short, proteins are the blue-collar workers of biology, the down-to-earth molecules that we cannot live without. Since 2010, proteomics has found renewed meaning and international attention with the launch of the Human Proteome Project and the growing interest in Big Data technologies such as proteomics. This article presents an interdisciplinary technology foresight analysis and conceptualizes the terms “environtome” and “social proteome”. We define “environtome” as the entire complement of elements external to the human host, from microbiome, ambient temperature and weather conditions to government innovation policies, stock market dynamics, human values, political power and social norms that collectively shape the human host spatially and temporally. The “social proteome” is the subset of the environtome that influences the transition of proteomics technology to innovative applications in society. The social proteome encompasses, for example, new reimbursement schemes and business innovation models for proteomics diagnostics that depart from the “once-a-life-time” genotypic tests and the anticipated hype attendant to context and time sensitive proteomics tests. Building on the “nesting principle” for governance of complex systems as discussed by Elinor Ostrom, we propose here a 3-tiered organizational architecture for Big Data science such as proteomics. The proposed nested governance structure is comprised of (a) scientists, (b) ethicists, and (c) scholars in the nascent field of “ethics-of-ethics”, and aims to cultivate a robust social proteome for personalized medicine. Ostrom often noted that such nested governance designs offer assurance that political power embedded in innovation processes is distributed evenly and is not concentrated disproportionately in a single overbearing stakeholder or person. We agree with this assessment and conclude by underscoring the synergistic value of social and biological proteomes to realize the full potentials of proteomics science for personalized medicine in psychiatry in the present era of Big Data.
Edward S. Dove, 'Schneider, C.E.: 2015, The censor’s hand: the misregulation of human-subject research. Cambridge: MIT Press. 296 pages. ISBN: 978-0-262-02891-2, Price: 35 USD ', (2015), Medicine, Health Care & Philosophy, Vol 19, pp 485-486
Abstract: from "Short literature notices"
Edward S. Dove, 'Bioscience, Governance and Politics ', (2015), Medical Law Review, Vol 23, pp 694-698
Paul R. Burton, Madeleine J. Murtagh, Andy Boyd, James B. Williams, Edward S. Dove, Susan E. Wallace, Anne-Marie Tassé, Julian Little, Rex L. Chisholm, Amadou Gaye, Kristian Hveem, Anthony J. Brookes, Pat Goodwin, Jon Fistein, Martin Bobrow, Bartha M. Knoppers, 'Data Safe Havens in health research and healthcare ', (2015), Bioinformatics, Vol 31, pp 3241-3248
Abstract: Motivation: The data that put the ‘evidence’ into ‘evidence-based medicine’ are central to developments in public health, primary and hospital care. A fundamental challenge is to site such data in repositories that can easily be accessed under appropriate technical and governance controls which are effectively audited and are viewed as trustworthy by diverse stakeholders. This demands socio-technical solutions that may easily become enmeshed in protracted debate and controversy as they encounter the norms, values, expectations and concerns of diverse stakeholders. In this context, the development of what are called ‘Data Safe Havens’ has been crucial. Unfortunately, the origins and evolution of the term have led to a range of different definitions being assumed by different groups. There is, however, an intuitively meaningful interpretation that is often assumed by those who have not previously encountered the term: a repository in which useful but potentially sensitive data may be kept securely under governance and informatics systems that are fit-for-purpose and appropriately tailored to the nature of the data being maintained, and may be accessed and utilized by legitimate users undertaking work and research contributing to biomedicine, health and/or to ongoing development of healthcare systems.Results: This review explores a fundamental question: ‘what are the specific criteria that ought reasonably to be met by a data repository if it is to be seen as consistent with this interpretation and viewed as worthy of being accorded the status of ‘Data Safe Haven’ by key stakeholders’? We propose 12 such criteria.Contact:email@example.com
Edward S. Dove, 'Human Population Genetic Research in Developing Countries: The Issue of Group Protection ', (2015), Medical Law Review, Vol 23, pp 490-494
Vural Özdemir, Edward S. Dove, Sanjeeva Srivastava, 'Social innovation with proteomics technology ', (2015), Nature India, pp 16-17
Edward S. Dove, Vural Özdemir, 'What role for law, human rights, and bioethics in an age of big data, consortia science, and consortia ethics? The importance of trustworthiness ', (2015), Laws, Vol 4, pp 515-540
Abstract: The global bioeconomy is generating new paradigm-shifting practices of knowledge co-production, such as collective innovation; large-scale, data-driven global consortia science (Big Science); and consortia ethics (Big Ethics). These bioeconomic and sociotechnical practices can be forces for progressive social change, but they can also raise predicaments at the interface of law, human rights, and bioethics. In this article, we examine one such double-edged practice: the growing, multivariate exploitation of Big Data in the health sector, particularly by the private sector. Commercial exploitation of health data for knowledge-based products is a key aspect of the bioeconomy and is also a topic of concern among publics around the world. It is exacerbated in the current age of globally interconnected consortia science and consortia ethics, which is characterized by accumulating epistemic proximity, diminished academic independence, “extreme centrism”, and conflicted/competing interests among innovation actors. Extreme centrism is of particular importance as a new ideology emerging from consortia science and consortia ethics; this relates to invariably taking a middle-of-the-road populist stance, even in the event of human rights breaches, so as to sustain the populist support needed for consortia building and collective innovation. What role do law, human rights, and bioethics—separate and together—have to play in addressing these predicaments and opportunities in early 21st century science and society? One answer we propose is an intertwined ethico-legal normative construct, namely trustworthiness. By considering trustworthiness as a central pillar at the intersection of law, human rights, and bioethics, we enable others to trust us, which in turns allows different actors (both nonprofit and for-profit) to operate more justly in consortia science and ethics, as well as to access and responsibly use health data for public benefit.
S. Birko, E.S. Dove, V. Özdemir, K. Dalal, 'Evaluation of nine consensus indices in delphi foresight research and their dependency on delphi survey characteristics: A simulation study and debate on delphi design and interpretation', (2015), PLoS One, Vol 10, pp 1-14
Abstract: The extent of consensus (or the lack thereof) among experts in emerging fields of innovation can serve as antecedents of scientific, societal, investor and stakeholder synergy or conflict. Naturally, how we measure consensus is of great importance to science and technology strategic foresight. The Delphi methodology is a widely used anonymous survey technique to evaluate consensus among a panel of experts. Surprisingly, there is little guidance on how indices of consensus can be influenced by parameters of the Delphi survey itself. We simulated a classic three-round Delphi survey building on the concept of clustered consen-sus/dissensus. We evaluated three study characteristics that are pertinent for design of Delphi foresight research: (1) the number of survey questions, (2) the sample size, and (3) the extent to which experts conform to group opinion (the Group Conformity Index) in a Delphi study. Their impacts on the following nine Delphi consensus indices were then examined in 1000 simulations: Clustered Mode, Clustered Pairwise Agreement, Conger's Kappa, De Moivre index, Extremities Version of the Clustered Pairwise Agreement, Fleiss' Kappa, Mode, the Interquartile Range and Pairwise Agreement. The dependency of a consensus index on the Delphi survey characteristics was expressed from 0.000 (no dependency) to 1.000 (full dependency). The number of questions (range: 6 to 40) in a survey did not have a notable impact whereby the dependency values remained below 0.030. The variation in sample size (range: 6 to 50) displayed the top three impacts for the Interquartile Range, the Clustered Mode and the Mode (dependency = 0.396, 0.130, 0.116, respectively). The Group Conformity Index, a construct akin to measuring stubbornness/flexibility of experts' opinions, greatly impacted all nine Delphi consensus indices (dependency = 0.200 to 0.504), except the Extremity CPWA and the Interquartile Range that were impacted only beyond the first decimal point (dependency = 0.087 and 0.083, respectively). Scholars in technology design, foresight research and future(s) studies might consider these new findings in strategic planning of Delphi studies, for example, in rational choice of consensus indices and sample size, or accounting for confounding factors such as experts' variable degrees of conformity (stubbornness/flexibility) in modifying their opinions. © 2015 Birko et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Stanislav Birko, Edward S. Dove, Vural Özdemir, 'A Delphi technology foresight study: Mapping social construction of scientific evidence on metagenomics tests for water safety', (2015), PLoS One, Vol 10
Abstract: Access to clean water is a grand challenge in the 21st century. Water safety testing for pathogens currently depends on surrogate measures such as fecal indicator bacteria (e.g., E. coli). Metagenomics concerns high-throughput, culture-independent, unbiased shotgun sequencing of DNA from environmental samples that might transform water safety by detecting waterborne pathogens directly instead of their surrogates. Yet emerging innovations such as metagenomics are often fiercely contested. Innovations are subject to shaping/construction not only by technology but also social systems/values in which they are embedded, such as experts’ attitudes towards new scientific evidence. We conducted a classic three-round Delphi survey, comprised of 107 questions. A multidisciplinary expert panel (n = 24) representing the continuum of discovery scientists and policymakers evaluated the emergence of metagenomics tests. To the best of our knowledge, we report here the first Delphi foresight study of experts’ attitudes on (1) the top 10 priority evidentiary criteria for adoption of metagenomics tests for water safety, (2) the specific issues critical to governance of metagenomics innovation trajectory where there is consensus or dissensus among experts, (3) the anticipated time lapse from discovery to practice of metagenomics tests, and (4) the role and timing of public engagement in development of metagenomics tests. The ability of a test to distinguish between harmful and benign waterborne organisms, analytical/clinical sensitivity, and reproducibility were the top three evidentiary criteria for adoption of metagenomics. Experts agree that metagenomic testing will provide novel information but there is dissensus on whether metagenomics will replace the current water safety testing methods or impact the public health end points (e.g., reduction in boil water advisories). Interestingly, experts view the publics relevant in a “downstream capacity” for adoption of metagenomics rather than a co-productionist role at the “upstream” scientific design stage of metagenomics tests. In summary, these findings offer strategic foresight to govern metagenomics innovations symmetrically: by identifying areas where acceleration (e.g., consensus areas) and deceleration/reconsideration (e.g., dissensus areas) of the innovation trajectory might be warranted. Additionally, we show how scientific evidence is subject to potential social construction by experts’ value systems and the need for greater upstream public engagement on metagenomics innovations.
Vural Özdemir, Hakan Kılıç, Arif Yıldırım, Effy Vayena, Edward S. Dove, Kıvanç Güngör, Adrian LLerena, Semra Şardaş, 'A code of ethics for ethicists: What would Pierre Bourdieu say? “Do not misuse social capital in the age of consortia ethics”', (2015), American journal of bioethics, Vol 15, pp 64-67
Edward S. Dove, Barbara Prainsack, 'Ethical Standards for Research Biobank Donation ', (2015), JAMA: the Journal of the American Medical Association, Vol 313, pp 1573-1574
Graeme Laurie, Edward S. Dove, 'Consent and anonymisation: Beware binary constructions', (2015), BMJ, Vol 350, pp 350
Kamile Erciyas, Kemal Üstün, Edward S. Dove, Kean Birch, Lotte M.G. Steuten, Fares Zeidán-Chuliá, Mervi Gürsoy, Eija Könönen, Eugene Kolker, Vural Özdemir, Ulvi K. Gürsoy, 'Personalized dentistry meets OMICS and "One Health": From Cinderella of healthcare to mainstream?', (2015), OMICS: A Journal of Integrative Biology, Vol 19, pp 145-146
Edward S. Dove, İ. Ömer Barlas, Kean Birch, Catharina Boehme, Alexander Borda-Rodriguez, William M. Byne, Florence Chaverneff, Yavuz Coşkun, Marja-Liisa Dahl, Türkay Dereli, Shyam Diwakar, Levent Elbeyli, Laszlo Endrenyi, Belgin Eroğlu-Kesim, Lynnette R. Ferguson, Kıvanç Güngör, Ulvi Gürsoy, Nezih Hekim, Farah Huzair, Kabeer Kaushik, Ilona Kickbusch, Olcay Kıroğlu, Eugene Kolker, Eija Könönen, Biaoyang Lin, Adrian Llerena, Faruk Malhan, Bipin Nair, George P. Patrinos, Semra Şardaş, Özlem Sert, Sanjeeva Srivastava, Lotte M.G. Steuten, Cengiz Toraman, Effy Vayena, Wei Wang, Louise Warnich, Vural Özdemir, 'An appeal to the Global Health Community for a tripartite innovation: An “essential diagnostics list,” “health in all policies,” and “see-through 21stCentury science and ethics”', (2015), OMICS: A Journal of Integrative Biology, Vol 19, pp 435-442
Edward S. Dove, 'Reflections on the concept of open data ', (2015), SCRIPTed, Vol 12, pp 154–166
Edward S. Dove, M. H. Zawati, 'Amendments to the Civil Code of Québec’s research provisions: A legislative comment', (2015), McGill Journal of Law and Health, Vol 8, pp 79-110
Edward S. Dove, Anne-Marie Tassé, Bartha M. Knoppers, 'What are some of the ELSI challenges of international collaborations involving biobanks, Global sample collection, and genomic data sharing and how should They be addressed? ', (2014), Biopreservation and biobanking, Vol 12, pp 363-364
Edward S. Dove, 'Book review: Ethics, Law and Society: Volume VEthics, Law and Society: Volume V, PriaulxNickyWrigleyAnthony (eds.) (Surrey, UK: Ashgate Publishing Limited, 2013), ISBN 9781409419167, 352 pp, £80. ', (2014), Medical Law International, Vol 14, pp 100-105
Deborah Mascalzoni, Edward S Dove, Yaffa Rubinstein, Hugh J S Dawkins, Anna Kole, Pauline McCormack, Simon Woods, Olaf Riess, Franz Schaefer, Hanns Lochmüller, Bartha M Knoppers, Mats Hansson, 'International Charter of principles for sharing bio-specimens and data ', (2014), European Journal of Human Genetics, Vol 23, pp 721-728
Abstract: There is a growing international agreement on the need to provide greater access to research data and bio-specimen collections to optimize their long-term value and exploit their potential for health discovery and validation. This is especially evident for rare disease research. Currently, the rising value of data and bio-specimen collections does not correspond with an equal increase in data/sample-sharing and data/sample access. Contradictory legal and ethical frameworks across national borders are obstacles to effective sharing: more specifically, the absence of an integrated model proves to be a major logistical obstruction. The Charter intends to amend the obstacle by providing both the ethical foundations on which data sharing should be based, as well as a general Material and Data Transfer Agreement (MTA/DTA). This Charter is the result of a careful negotiation of different stakeholders' interest and is built on earlier consensus documents and position statements, which provided the general international legal framework. Further to this, the Charter provides tools that may help accelerate sharing. The Charter has been formulated to serve as an enabling tool for effective and transparent data and bio-specimen sharing and the general MTA/DTA constitutes a mechanism to ensure uniformity of access across projects and countries, and may be regarded as a consistent basic agreement for addressing data and material sharing globally. The Charter is forward looking in terms of emerging issues from the perspective of a multi-stakeholder group, and where possible, provides strategies that may address these issues.
Edward S. Dove, Yann Joly, Anne-Marie Tasse, Public Population Project in Genomics and Society (P3G) International Steering Committee, International Cancer Genome Consortium (ICGC) Ethics and Policy Committee, Bartha M Knoppers, 'Genomic cloud computing: Legal and ethical points to consider', (2014), European Journal of Human Genetics, Vol 23, pp 1271–1278
Abstract: The biggest challenge in twenty-first century data-intensive genomic science, is developing vast computer infrastructure and advanced software tools to perform comprehensive analyses of genomic data sets for biomedical research and clinical practice. Researchers are increasingly turning to cloud computing both as a solution to integrate data from genomics, systems biology and biomedical data mining and as an approach to analyze data to solve biomedical problems. Although cloud computing provides several benefits such as lower costs and greater efficiency, it also raises legal and ethical issues. In this article, we discuss three key /`points to consider/' (data control; data security, confidentiality and transfer; and accountability) based on a preliminary review of several publicly available cloud service providers/' Terms of Service. These /`points to consider/' should be borne in mind by genomic research organizations when negotiating legal arrangements to store genomic data on a large commercial cloud service provider/'s servers. Diligent genomic cloud computing means leveraging security standards and evaluation processes as a means to protect data and entails many of the same good practices that researchers should always consider in securing their local infrastructure.
Edward S Dove, David Townend, Bartha M Knoppers, 'Data protection and consent to biomedical research: a step forward? ', (2014), The Lancet, Vol 384, pp 855
P. Kosseim, E.S. Dove, C. Baggaley, E.M. Meslin, F.H. Cate, J. Kaye, Jennifer R. Harris, B.M. Knoppers, 'Building a data sharing model for global genomic research ', (2014), Genome Biology, Vol 15, pp 1-7
Abstract: Data sharing models designed to facilitate global business provide insights for improving transborder genomic data sharing. We argue that a flexible, externally endorsed, multilateral arrangement, combined with an objective third-party assurance mechanism, can effectively balance privacy with the need to share genomic data globally. © 2014 Kosseim et al.
Nezih Hekim, Yavuz Coşkun, Ahmet Sınav, Alaa H. Abou-Zeid, Mehmet Ağırbaşlı, Simisola O. Akintola, Şükrü Aynacıoğlu, Mustafa Bayram, Nicola Luigi Bragazzi, Collet Dandara, Türkay Dereli, Edward S. Dove, Levent Elbeyli, Laszlo Endrenyi, Kamile Erciyas, Jack Faris, Lynnette R. Ferguson, Fahrettin Göğüş, Kıvanç Güngör, Mervi Gürsoy, Ulvi K. Gürsoy, M. Asım Karaömerlioğlu, Ilona Kickbusch, Türker Kılıç, Metin Kılınç, Tanıl Kocagöz, Biaoyang Lin, Adrián LLerena, Vangelis G. Manolopoulos, Bipin Nair, Bülent Özkan, Tikki Pang, Semra Şardaş, Sanjeeva Srivastava, Cengiz Toraman, Kemal Üstün, Louise Warnich, Ambroise Wonkam, Mustafa Cengiz Yakıcıer, Ümit Yaşar, Vural Özdemir, 'Translating biotechnology to knowledge-based innovation, peace, and development? Deploy a science peace corps: An open letter to world leaders', (2014), OMICS: A Journal of Integrative Biology, Vol 18, pp 415-420
Abstract: Scholarship knows no geographical boundaries. This science diplomacy and biotechnology journalism article introduces an original concept and policy petition to innovate the global translational science, a Science Peace Corps. Service at the new Corps could entail volunteer work for a minimum of 6 weeks, and up to a maximum of 2 years, for translational research in any region of the world to build capacity manifestly for development and peace, instead of the narrow bench-to-bedside model of life science translation. Topics for translational research are envisioned to include all fields of life sciences and medicine, as long as they are linked to potential or concrete endpoints in development, foreign policy, conflict management, post-crisis capacity building, and/or peace scholarship domains. As a new instrument in the global science and technology governance toolbox, a Science Peace Corps could work effectively, for example, towards elucidating the emerging concept of “one health”—encompassing human, environmental, plant, microbial, ecosystem, and planet health—thus serving as an innovative crosscutting pillar of 21st century integrative biology. An interdisciplinary program of this caliber for development would link 21st century life sciences to foreign policy and peace, in ways that can benefit many nations despite their ideological differences. We note that a Science Peace Corps is timely. The Intergovernmental Panel on Climate Change (IPCC) of the United Nations released the Fifth Assessment Report on March 31, 2014. Worrisomely, the report underscores that no person or nation will remain untouched by the climate change, highlighting the shared pressing life sciences challenges for global society. To this end, we recall that President John F. Kennedy advocated for volunteer work that has enduring, transgenerational, and global impacts. This culminated in establishment of the Peace Corps in 1961. Earlier, President Abraham Lincoln aptly observed, “nearly all men can stand adversity, but if you want to test a man's character, give him power.” We therefore petition President Barack Obama, other world leaders, and international development agencies in positions of power around the globe, to consider deploying a Science Peace Corps to cultivate the essential (and presently missing) ties among life sciences, foreign policy, development, and peace agendas. A Science Peace Corps requires support by a credible and independent intergovernmental organization or development agency for funding, and arbitration in the course of volunteer work when the global versus local (glocal) value-based priorities and human rights intersect in synergy or conflict. In all, Science Peace Corps is an invitation to a new pathway for competence in 21st century science that is locally productive and globally competitive. It can open up scientific institutions to broader considerations and broader inputs, and thus cultivate vital translational science in a world sorely in need of solidarity and sustainable responses to the challenges of 21st century science and society.
Vural Özdemir, Robin Ann Downey, Biaoyang Lin, Edward S. Dove, Bülent Özkan, Louise Warnich, Lynnette R. Ferguson, 'Special Issue “OMICS IN AFRICA”: Power to the people—Moving 21st century integrative biology from lab to village to innovation ecosystems', (2014), OMICS: A Journal of Integrative Biology, Vol 18, pp 399-401
M. Taylor, Edward S. Dove, D Townend, 'Protecting privacy and the public interest?: A note for those negotiating the general data protection regulation', (2014), Hub, Vol 8
Djims Milius, Edward S Dove, Donald Chalmers, Stephanie O M Dyke, Kazuto Kato, Pilar Nicolas, BF Francis Ouellette, Brad Ozenberger, Laura L Rodriguez, Nikolajs Zeps, Yann Joly, 'The International Cancer Genome Consortium's evolving data-protection policies ', (2014), Nature Biotechnology, Vol 32, pp 519–523
E. S. Dove, V. Ozdemir, 'The epiknowledge of socially responsible innovation ', (2014), EMBO Reports, Vol 15, pp 462-463
Edward S. Dove, Vural Özdemir, 'Glocal bioethics: When international IRB collaboration confronts local politics', (2014), American journal of bioethics, Vol 14, pp 20-23
Vural Özdemir, Laszlo Endrenyi, Şükrü Aynacıoğlu, Nicola Luigi Bragazzi, Collet Dandara, Edward S. Dove, Lynnette R. Ferguson, Christy Jo Geraci, Ernst Hafen, Belgin Eroğlu Kesim, Eugene Kolker, Edmund J.D. Lee, Adrian LLerena, Muradiye Nacak, Kazutaka Shimoda, Toshiyuki Someya, Sanjeeva Srivastava, Brian Tomlinson, Effy Vayena, Louise Warnich, Ümit Yaşar, 'Bernard Lerer: Recipient of the 2014 Inaugural Werner Kalow Responsible Innovation Prize in Global Omics and Personalized Medicine (Pacific Rim Association for Clinical Pharmacogenetics)', (2014), OMICS: A Journal of Integrative Biology, Vol 18, pp 211-221
Abstract: This article announces the recipient of the 2014 inaugural Werner Kalow Responsible Innovation Prize in Global Omics and Personalized Medicine by the Pacific Rim Association for Clinical Pharmacogenetics (PRACP): Bernard Lerer, professor of psychiatry and director of the Biological Psychiatry Laboratory, Hadassah-Hebrew University Medical Center, Jerusalem, Israel. The Werner Kalow Responsible Innovation Prize is given to an exceptional interdisciplinary scholar who has made highly innovative and enduring contributions to global omics science and personalized medicine, with both vertical and horizontal (transdisciplinary) impacts. The prize is established in memory of a beloved colleague, mentor, and friend, the late Professor Werner Kalow, who cultivated the idea and practice of pharmacogenetics in modern therapeutics commencing in the 1950s. PRACP, the prize's sponsor, is one of the longest standing learned societies in the Asia-Pacific region, and was founded by Kalow and colleagues more than two decades ago in the then-emerging field of pharmacogenetics. In announcing this inaugural prize and its winner, we seek to highlight the works of prize winner, Professor Lerer. Additionally, we contextualize the significance of the prize by recalling the life and works of Professor Kalow and providing a brief socio-technical history of the rise of pharmacogenetics and personalized medicine as a veritable form of 21st century scientific practice. The article also fills a void in previous social science analyses of pharmacogenetics, by bringing to the fore the works of Kalow from 1995 to 2008, when he presciently noted the rise of yet another field of postgenomics inquiry—pharmacoepigenetics—that railed against genetic determinism and underscored the temporal and spatial plasticity of genetic components of drug response, with invention of the repeated drug administration (RDA) method that estimates the dynamic heritabilities of drug response. The prize goes a long way to cultivate transgenerational capacity and broader cognizance of the concept and practice of responsible innovation as an important criterion of 21st century omics science and personalized medicine. A new call is presently in place for the 2016 PRACP Werner Kalow prize. Nominations can be made in support of an exceptional individual interdisciplinary scholar, or alternatively, an entire research team, from any region in the world with a record of highly innovative contributions to global omics science and/or personalized medicine, in the spirit of responsible innovation. The application process is straightforward, requiring a signed, 1500-word nomination letter (by the applicant or sponsor) submitted not later than May 31, 2015.
B.M. Knoppers, J.R. Harris, I. Budin-Ljøsne, E.S. Dove, 'A human rights approach to an international code of conduct for genomic and clinical data sharing ', (2014), Human Genetics, Vol 133, pp 895-903
Abstract: Fostering data sharing is a scientific and ethical imperative. Health gains can be achieved more comprehensively and quickly by combining large, information-rich datasets from across conventionally siloed disciplines and geographic areas. While collaboration for data sharing is increasingly embraced by policymakers and the international biomedical community, we lack a common ethical and legal framework to connect regulators, funders, consortia, and research projects so as to facilitate genomic and clinical data linkage, global science collaboration, and responsible research conduct. Governance tools can be used to responsibly steer the sharing of data for proper stewardship of research discovery, genomics research resources, and their clinical applications. In this article, we propose that an international code of conduct be designed to enable global genomic and clinical data sharing for biomedical research. To give this proposed code universal application and accountability, however, we propose to position it within a human rights framework. This proposition is not without precedent: international treaties have long recognized that everyone has a right to the benefits of scientific progress and its applications, and a right to the protection of the moral and material interests resulting from scientific productions. It is time to apply these twin rights to internationally collaborative genomic and clinical data sharing. © 2014 The Author(s).
E. S. Dove, B. M. Knoppers, M. H. Zawati, 'Towards an ethics safe harbor for global biomedical research ', (2014), Journal of Law & the Biosciences, Vol 1, pp 3-51
Abstract: Although increasingly global, data-driven genomics and other ‘omics’-focused research hold great promise for health discoveries, current research ethics review systems around the world challenge potential improvements in human health from such research. To overcome this challenge, we propose a ‘Safe Harbor Framework for International Ethics Equivalency’ that facilitates the harmonization of ethics review of specific types of data-driven international research projects while respecting globally transposable research ethics norms and principles. The Safe Harbor would consist in part of an agency supporting an International Federation for Ethics Review (IFER), formed by a voluntary compact among countries, granting agencies, philanthropies, institutions, and healthcare, patient advocacy, and research organizations. IFER would be both a central ethics review body, and also a forum for review and follow-up of policies concerning ethics norms for international research projects. It would be built on five principle elements: (1) registration, (2) compliance review, (3) recognition, (4) monitoring and enforcement, and (5) public participation. The Safe Harbor would create many benefits for researchers, countries, and the general public, and may eventually have application beyond (gen)omics to other areas of biomedical research that increasingly engage in secondary use of data and present only negligible risks.
Edward S. Dove, Graeme Laurie, Bartha M. Knoppers, 'Data sharing and privacy ' in Geoffrey Ginsburg, Huntington Willard (ed.) Genomic and Personalized Medicine (Elsevier 2016) 143-160
Abstract: As various stakeholders in biomedical research and clinical practice laudably move toward a data sharing culture, challenges arise. In particular, privacy and data privacy regulation play a large role in defining the proper contours of global data sharing. In this chapter, we outline the practices and benefits of genomic and clinical data sharing; the dimensions of privacy and data privacy regulation that challenge data sharing; and the ways in which one organization, the Global Alliance for Genomics and Health, is addressing these challenges.
Edward S. Dove, Yann Joly, Bartha M. Knoppers, 'International genomic cloud computing ‘Mining’ the terms of service' in Anne S.Y. Cheung, Rolf H. Weber (ed.) Privacy and Legal Issues in Cloud Computing (Edward Elgar 2015)
Edward S. Dove, Mark Phillips, 'Privacy law, data sharing policies, and medical data A comparative perspective' in Aris Gkoulalas-Divanis, Grigorios Loukides (ed.) Medical Data Privacy Handbook (Springer International Publishing 2015) 639-678
Abstract: The sharing and linking of medical data across borders is now a key enabler of new medical discoveries. Data are no longer simply collected and used at a single physical site, such as a laboratory or a research institute. Instead, communication flows between research teams within and across national borders bring together the necessary data and expertise to clarify previously unknown disease aetiologies. Integration of medical data and secure health records systems now allows clinicians to develop early treatment strategies tailored to a specific patient. As policymakers, patient advocacy groups, and biomedical researchers gravitate toward recognizing the benefits of global data sharing, they may be challenged by regulatory systems that were developed when the norm was using and sharing medical data only within a single jurisdiction. This chapter describes and compares key data privacy legal frameworks (Canada, US, UK, EU, Council of Europe, OECD) and discusses data sharing policies adopted by major biomedical research funding organisations (the NIH, Canadian Institutes of Health Research, Genome Canada, Wellcome Trust) in the context of their impact on medical data privacy. In so doing, the chapter explains not only the content, significance, and practical usefulness of these laws, regulations, and policies as they relate to medical data, but also identifies lingering barriers to global data sharing and suggests ways to overcome them while maintaining robust data privacy protection.
Edward S. Dove, 'Scotland’s Turn Towards ‘Realistic Medicine’: What’s in a Name?' 2017
Christine Aicardi, Lorenzo Del Salvio, Edward S. Dove, Federica Lucivero, Brent Mittelstadt, Maartje Niezen, Barbara Prainsack, Michael Reinsborough, Tamar Sharon, 'Shortcomings of the Revised “Helsinki Declaration” on Ethical Use of Health Databases ' 2016
Adrian Thorogood, Howard Simkevitz, Mark Phillips, Edward S. Dove, Yann Joly, 'Policy Brief: Points to Consider for Protecting Privacy in Cloud-Based Genomic Research' 2015
Edward S. Dove, 'Elberte v. Latvia: A curious case of tissue, relatives and the ‘right to private life' 2015
Edward S. Dove, 'Legal Issues Regarding International Data Sharing ' 2014