The governance of human genetic research databases in mental health research

The field of mental health offers a valuable context in which to examine new challenges presented by human genetic research databases to the legal, ethical and regulatory frameworks for human genetic research. Longitudinal prospective genetic research of psychiatric disorders often involves access to human genetic research databases and to stored tissue for future uses that cannot be specified at the time the patient consents to their collection. The potential of such research to contribute to an improved understanding and treatment of complex genetic diseases such as schizophrenia presupposes sound ethical, legal and regulatory frameworks to ensure public trust and preparedness to participate in such research. This article provides a brief overview of some of the ethical and legal challenges posed by human genetic research databases and their implications for how genetic research should be conducted in the field of mental health.     

“Regulation,I presume?” said the robot – Towards an iterative regulatory process for robot governance

This article envisions an iterative regulatory process for robot governance. In the article, we argue that what lacks in robot governance is actually a backstep mechanism that can coordinate and align robot and regulatory developers. In order to solve that problem, we present a theoretical model that represents a step forward in the coordination and alignment of robot and regulatory development. Our work builds on previous literature, and explores modes of alignment and iteration towards greater closeness in the nexus between research and development (R&D) and regulatory appraisal and channeling of robotics’ development. To illustrate practical challenges and solutions, we explore different examples of (related) types of communication processes between robot developers and regulatory bodies. These examples help illuminate the lack of formalization of the policymaking process, and the loss of time and resources that the waste of knowledge generated for future robot governance instruments implies. We argue that initiatives that fail to formalize the communication process between different actors and that propose the mere creation of coordinating agencies risk being seriously ineffective. We propose an iterative regulatory process for robot governance, which combines the use of an ex ante robot impact assessment for legal/ethical appraisal, and evaluation settings as data generators, and an ex post legislative evaluation instrument that eases the revision, modification and update of the normative instrument. In all, the model breathes the concept of creating dynamic evidence-based policies that can serve as temporary benchmark for future and/or new uses or robot developments. Our contribution seeks to provide a thoughtful proposal that avoids the current mismatch between existing governmental approaches and what is needed for effective ethical/legal oversight, in the hope that this will inform the policy debate and set the scene for further research.     

Melting Moments: The Future of Polar Oceans Governance in a Warming World

Climate change poses significant physical, ecological, social and economic challenges to environmental, human and national security in polar regions. From an oceans governance perspective, increased human access to formerly ice-covered areas, and the potential for increased activities such as fishing, shipping, tourism, bioprospecting, off-shore mining, and oil and gas exploration, present significant legal challenges. While the issues are not unique to polar areas, the geopolitical, geographical and physical characteristics of the polar regions provide a unique and demanding framework in which to identify and address jurisdictional issues and issues relating to the protection of polar marine environments. This article attempts to identify the legal challenges ahead and to provide preliminary observations as to how the polar oceans governance regime might develop in the future.     

“‘Novel food’ for thought” on law and policymaking in the global creative economy

Law and policymaking form a central theme of the global governance debate. In these times of an emerging global creative economy the debate is becoming increasingly complex as global governance is faced with serious challenges of a political, economic, cultural, environmental, social, technological and, last but not least, legal nature. Against the backdrop of a global food crisis, both in terms of food security and food safety for all, the present article explores some of the broader regulatory aspects of these challenges by looking at the regulation of food and notably novel food as engineered by the use of bio- and nano-technologies. It aims to show how the preservation of the integrity of law over time, and with it the objectives of providing legal predictability and legal certainty, are threatened by deficiencies in the institutional design of the current international legal framework as well as in the conceptual understanding underlying the legal instruments adopted by these institutions. The analysis at the international level is complemented by a brief look at the domestic level exemplified by the situation in the European Union and the People’s Republic of China against the backdrop of their attempts to formulate and successfully implement policies enhancing their competitive advantages in the creative economy.     

Post-‘Brexit’ Financial Governance: Which Dispute Settlement Framework Should Be Utilised?

This contribution to the ongoing Brexit discussions addresses topical legal and regulatory issues in the post-Brexit policy debate, especially the questions surrounding the important area of financial governance and dispute resolution. Specifically, a number of future UK/EU legal disputes with respect to financial services may emerge post-Brexit. The article examines the UK's track record at the Court of Justice of the European Union, and discusses some likely future challenges. It then considers which institutional framework should be used for resolving disagreements. The article assesses the strengths and weaknesses of three potential models (the proposed Swiss/EU institutional framework; the EFTA ‘docking’ option; and the WTO system) and provides an original cross-model evaluation. It also discusses the associated design challenges that EU and UK negotiators may encounter in the attempt to devise a post-Brexit dispute settlement system.     

Genomic research and incidental findings.

The Human Genome Project showed that there is significant genetic variation within the population. Current research is accumulating large databases that may reveal genetic variations associated with disease or health risks, even if not intended as part of the study design. These incidental findings create legal, ethical, and financial challenges for researchers. Current federal and international guidelines are not adequate. Plans for dealing with incidental findings need to be established in the study design and reviewed and approved by the Institutional Review Board.     

Regulation of legal services in the e-world: a need to short circuit hot spots in ethics and novel practices?

This paper examines the professional and regulatory implications for legal practices of a rapidly evolving legal services marketplace shaped by new technologies and e-spaces. The paper focuses on three burgeoning areas in the delivery of legal services: (i) legal outsourcing; (ii) virtual law firms; and (iii) use of social media networking. The authors examine how Australian legal practitioners are utilising these new practices and technologies and the ethical implications of their use. The paper argues that the current regulatory framework in Australia does not adequately address the challenges and concerns raised by an increasingly borderless and e-based legal services market and thus calls for Australian legal regulators to remedy this deficiency as a matter of priority.     

Enabling responsible public genomics

As scientific understandings of genetics advance, researchers require increasingly rich datasets that combine genomic data from large numbers of individuals with medical and other personal information. Linking individuals' genetic data and personal information precludes anonymity and produces medically significant information--a result not contemplated by the established legal and ethical conventions governing human genomic research. To pursue the next generation of human genomic research and commerce in a responsible fashion, scientists, lawyers, and regulators must address substantial new issues, including researchers' duties with respect to clinically significant data, the challenges to privacy presented by genomic data, the boundary between genomic research and commerce, and the practice of medicine. This Article presents a new model for understanding and addressing these new challenges--a "public genomics" premised on the idea that ethically, legally, and socially responsible genomics research requires openness, not privacy, as its organizing principle. Responsible public genomics combines the data contributed by informed and fully consenting information altruists and the research potential of rich datasets in a genomic commons that is freely and globally available. This Article examines the risks and benefits of this public genomics model in the context of an ambitious genetic research project currently under way--the Personal Genome Project. This Article also (i) demonstrates that large-scale genomic projects are desirable, (ii) evaluates the risks and challenges presented by public genomics research, and (iii) determines that the current legal and regulatory regimes restrict beneficial and responsible scientific inquiry while failing to adequately protect participants. The Article concludes by proposing a modified normative and legal framework that embraces and enables a future of responsible public genomics.     

Between Law and Social Norms: The Evolution of Global Governance

Abstract.  It is commonplace that economic globalization poses new challenges to legal theory. But instead of responding to these challenges, legal scholars often get caught up in heated yet purely abstract discussions of positivist and legal pluralist conceptions of the law. Meanwhile, economics-based theories such as "Law and Social Norms" have much less difficulty in analysing the newly arising forms of private and hybrid "governance without government" from a functional perspective. While legal theory has much to learn from these approaches, we argue that they fail in one crucial point: They cannot uphold the analytical distinction between law and non-law. The reasons for this shortcoming are theory-immanent in that the economic theories' focus on efficiency and their actor-based perspective are necessarily blind to "law's own rationality." We therefore propose to further develop those functional approaches to the study of global governance by complementing them with elements from Niklas Luhmann's systems theory of law. This will provide us with a conceptual framework for analyzing the workings of global governance regimes without ignoring their potential for "legalisation" and "constitutionalisation." As we will show in three concrete examples (Corporate Social Responsibility, lex mercatoria , and internet regulation) we can thus describe the evolution of new forms of legal regulation beyond the nation-state. This will also allow us to draw some preliminary conclusions on the role of law in the context of globalization and, at the same time, show the direction for further empirical research.     

'New Governance' in European Corporate Law Regulation as Transnational Legal Pluralism

The present transformation of European corporate governance regulation mirrors the challenges that have been facing the EU's continuously evolving polity, marked by tensions between centralised integration programmes, on the one hand, and Member State's embedded capitalisms, path-dependencies and rent-seeking, on the other. As longstanding concerns with remaining obstacles to more mobility for workers, services, business entities and capital in recent years are aligned with post-Lisbon commitments to creating the world's leading competitive market, European corporate governance regulation (ECGR) has become exposed to and implicated in a set of highly dynamic regulatory experiments. In this context, 'New Governance' offers itself as both a tentative label and immodest proposal for a more responsive and innovative approach to European law making. The following article assesses the recently emerging regulatory forms in ECGR as illustrations of far-reaching transformations in market governance. The arguable parallels between the EU's regulatory transformation in response to growing legitimacy concerns and the recurring question about whose interests a business corporation is intended to serve, provide the framework for an exploration of current regulatory trajectories in European corporate law that can most adequately be understood as a telling example of transnational legal pluralism.     

PGTandMe: social networking-based genetic testing and the evolving research model

The opportunity to use extensive genetic data, personal information, and family medical history for research purposes may be naturally appealing to the personal genetic testing (PGT) industry, which is already coupling direct-to-consumer (DTC) products with social networking technologies, as well as to potential industry or institutional partners. This article evaluates the transformation in research that the hybrid of PGT and social networking will bring about, and--highlighting the challenges associated with a new paradigm of "patient-driven" genomic research--focuses on the consequences of shifting the structure, locus, timing, and scope of research through genetic crowd-sourcing. This article also explores potential ethical, legal, and regulatory issues that arise from the hybrid between personal genomic research and online social networking, particularly regarding informed consent, institutional review board (IRB) oversight, and ownership/intellectual property (IP) considerations.     

Meeting common environmental challenges: the co-evolution of policies and practices

This article proposes an analytical framework for exploring policy responses to common challenges of environmental governance. Observing that governance involves multiple processes, I begin by identifying a conceptual platform for studying unilateral learning and adaptation as well as international cooperation as integral and interacting components of a complex governance system. I propose the concept of co-evolution as the cornerstone of this platform and distinguish between two modes of co-evolution: diffusion and cooperation. The article draws findings and propositions from recent literature to identify the mechanisms at work and the conditions under which they foster mutually beneficial solutions. Indicating how important governance challenges differ with respect to these conditions, I build the case for a diagnostic and differential approach that matches capacity-building and policy strategies with the challenge in focus.     

A nation's genes for a cure to cancer: evolving ethical, social and legal issues regarding population genetic databases

The advent of the human genome sequence has focused research on understanding underlying genetic links to complex diseases such as cancer, asthma and heart disease. In the past few years, individual countries, such as Iceland, Estonia, Singapore and the United Kingdom, have created national databases of their citizens' DNA for comparative research. Most recently, an international consortium including Nigeria, Japan, China and the United States launched a $100 million project called the International HapMap to map the human genome according to haplotypes, blocks of DNA that contain genetic variation. Such population genetic databases present challenging ethical, social and legal issues, yet regulation of genetic information has developed sporadically, from region to region, without a consistent international standard. Without a clear understanding of the consequences of genetic research in terms of individual and community-wide discrimination and stigmatization, genetic databases raise concerns about the protection of genetic information. This Note provides a survey of the evolving landscape of population genetic databases as a legislative and public policy tool for national and international regulators. It compares different approaches to regulating the collection and use of population genetic databases in order to understand what areas of consensus are formulating a foundation for an international standard. As the first population genetics project that will span multiple countries for the collection of DNA, the International HapMap has the potential to become an influential standard for the protection of population genetic information. This Note highlights issues among the national databases and the HapMap project that raise ethical, social and legal concerns for the future and recommends further protections for both individual donors and community interests.     

China's campaign-style Internet finance governance: Causes,effects, and lessons learned for new information-based approaches to governance,

China's Internet companies and citizens are now world leaders in developing and using the Internet and related information technologies for financial transactions. Accordingly, it is important that China becomes a world leader in identifying challenges posed by Internet finance, and providing law and governance solutions to address these challenges. While the Internet and its associated technologies are now globally available, a core question is whether, and to what extent, regulatory challenges and opportunities are common across different jurisdictions, or whether they reflect local circumstances. In short, an interesting question is what can the world learn from China as it takes the lead in addressing Internet finance challenges, and what can China learn from the world as it seeks to do so?This article first identifies the landscape of China's burgeoning Internet finance market, including key technologies and services and government and nongovernment players. The article then turns to key regulatory challenges, with a focus on factors especially significant in China. The article then examines the “top down” “campaign style” approach to regulation, which is China government's initial response to emerging challenges. Following an analysis of the campaign, some suggestions are then made for future possible governance strategies. We explain how emerging “information” based and experiment-based approaches to governance are drawing on both global and Chinese experiences to harness the capabilities of the Internet and the collective energies of Internet finance enterprises and users to advance the regulation of the China Internet finance system in a way that is conducive to the public interest.     

Human genetic research databases and biobanks: towards uniform terminology and Australian best practice

This article examines international best practice for the establishment, maintenance and use of human genetic research databases (HGRDs), particularly focusing on large-scale population biobanks, and considers the measures that should be taken in Australia to comply with this best practice. These HGRDs play a pivotal role in basic research aimed at understanding the basis of human disease at the genetic level, and applied research aimed at putting that basic knowledge into practical application. In particular, the large-scale biobanks are vital research tools in the drive to uncover the causes and consequences of human health and disease. Biobanks are being established at regional, national and international levels throughout the world. Although their governance structures are uniformly complex, some best practices are emerging with regard to consent (particularly consent to future research and withdrawal of consent), privacy and data protection and intellectual property ownership and access. Best practices with regard to benefit-sharing are emerging much more slowly. This article reviews these international best practices with the aim of providing guidance for the development of appropriate regulatory structures in Australia.     

Sketching and validating the location-based services (LBS) regulatory framework in Australia

Location-based services (LBS) are defined as those applications that combine the location of a mobile device associated with a given entity (individual or object) together with contextual information to offer a value-added service. LBS solutions are being deployed globally, and in some markets like Australia, without appropriate regulatory provisions in place. Recent debates in Australia have addressed the need to bridge the gap between technological developments and legal/regulatory provisions. This requires an assessment of the regulatory environment within a given social context such as Australia. The core components of such an investigation include: (a) composing a conceptual framework for analysing regulation of technologies such as LBS, one that is sensitive to public policy themes and challenges, and (b) applying this conceptual framework to the Australian setting in order to sketch and define the components of the present framework, and identify areas for improvement through a process of validation. This paper addresses these aims, demonstrating how the current regulatory framework in Australia is bound by legislation with respect to privacy, telecommunications, surveillance, and national security (that is, anti-terrorism), in addition to a set of industry guidelines for location-service providers (LSPs). The existing Australian framework, however, is lacking in its coverage and treatment of LBS and location data, and does not adequately address the themes and challenges in the defined conceptual framework.     

Developing regulatory standards for the concept of security in online dispute resolution systems

Online dispute resolution (ODR) has improved access to justice in the digital world. ODR users benefit from faster and cheaper dispute resolution mechanisms compared to traditional litigation and Alternative Dispute Resolution. There are few and quite varied regulatory systems for ODR.This research aims to develop a set of standards to measure the concept of security and to increase the consistency of security in ODR systems. An exploratory mixed method approach is used, involving a quantitative (survey) and mainly qualitative approach (face-to-face interviews) for gathering data. We identify three elements of information security, privacy, and authentication as standards for an appropriate ODR legal framework. Finally, these findings led to practical implications for policy makers and regulators.     

Can legitimate interest be an appropriate lawful basis for processing Artificial Intelligence training datasets?

Precision and effectiveness of Artificial Intelligence (AI) models are highly dependent on the availability of genuine, relevant, and representative training data. AI systems tested and validated on poor-quality datasets can produce inaccurate, erroneous, skewed, or harmful outcomes (actions, behaviors, or decisions), with far-reaching effects on individuals' rights and freedoms.Appropriate data governance for AI development poses manifold regulatory challenges, especially regarding personal data protection. An area of concern is compliance with rules for lawful collection and processing of personal data, which implies, inter alia, that using databases for AI design and development should be based on a clear and precise legal ground: the prior consent of the data subject or another specific valid legal basis.Faced with this challenge, the European Union's personal data protection legal framework does not provide a preferred, one-size-fits-all answer, and the best option will depend on the circumstances of each case. Although there is no hierarchy among the different legal bases for data processing, in doubtful cases, consent is generally understood by data controllers as a preferred or default choice for lawful data processing. Notwithstanding this perception, obtaining data subjects' consent is not without drawbacks for AI developers or AI-data controllers, as they must meet (and demonstrate) various requirements for the validity of consent. As a result, data subjects' consent could not be a suitable and realistic option to serve AI development purposes. In view of this, it is necessary to explore the possibility of basing this type of personal data processing on lawful grounds other than the data subject's consent, specifically, the legitimate interest of the data controller or third parties. Given its features, legitimate interests could help to meet the challenge of quality, quantity, and relevance of data curation for AI training.The aim of this article is to provide an initial conceptual approach to support the debate about data governance for AI development in the European Union (EU), as well as in non-EU jurisdictions with European-like data protection laws. Based on the rules set by the EU General Data Protection Regulation (GDPR), this paper starts by referring to the relevance of adequate data curation and processing for designing trustworthy AI systems, followed by a legal analysis and conceptualization of some difficulties data controllers face for lawful processing of personal data. After reflecting on the legal standards for obtaining data subject's valid consent, the paper argues that legitimate interests (if certain criteria are met) may better match the purpose of building AI training datasets.     

Territorializing Regulation: A Case Study of "Social Housing" in England

This article shows that the legislative creation of new regulatory regimes can be approached as a process that carves out new territories of governance. Specifically, using the theoretical framework of social space, it explores the formation of a regulatory community arising out of the United Kingdom's Housing Act 1974, a community made up of the regulatees—not-for-profit housing associations—and the state regulator. The article demonstrates that the process of carving out a new territory of governance and the "spatial practices" of the occupiers of this new territory both enable the community to establish a large element of control of the regulatory regime. This analysis challenges an understanding of law as top-down, substituting a more nuanced, three-dimensional understanding of the production of norms and "common sense." Regulatees are not just subject to regulation but shape the space through their expertise and social relations.     

Treating or Tracking? Regulatory Challenges of Nano‐Enabled ICT Implants

The increasing commercialisation of human ICT implants has generated debate over the ethical, legal, and social implications of their use. The convergence of nanotechnologies with ICT is likely to further challenge the current legal frameworks that regulate them. The aim of this article is to examine the effectiveness of the European data protection legal framework for regulating this “next generation” of nano‐enabled ICT human implantable devices. The article highlights the potential regulatory challenges posed by the applications and makes a series of recommendations as to how the current European legal framework on data protection will respond to them.