It depends whose data are being shared: considerations for genomic data sharing policies

There is an urgent need for consistent data sharing policies that promote the advancement of science while respecting the values and interests of those providing their genetic data for research. Responding to the article of Jalayne J. Arias, Genevieve Pham-Kanter, and Eric G. Campbell, ‘The Growth and Gaps of Genetic Data Sharing Policies in the United States’, this commentary further explores the challenges of human subjects’ protection in existing data sharing policies. We will elaborate on the need for data sharing policies to accommodate variation in individual and group preferences around data sharing and privacy concerns by comparing our previously published data on patients’ and parents’ consent to data sharing and attitudes about privacy to data from focus groups with HIV-positive, underserved individuals who were asked about their willingness to participate in genetic research and share their data broadly. These studies support the observation of Arias, Pham-Kanter, and Campbell that researchers, and funding agencies will need to balance the privacy interests of groups as well as individuals in future genomic data sharing policies.     

Trust,vulnerable populations,and genetic data sharing

Recent policies and proposed regulations, including the Notice of Proposed Rulemaking for the Common Rule and the 2014 NIH Genetic Data Sharing Policy, seek to improve research subject protections. Protections for subjects whose genetic data is shared are critical to reduce risks such as loss of confidentiality, stigma, and discrimination. In the article ‘It depends whose data are being shared: considerations for genomic data sharing policies’, Robinson et al. provide a response to our article, ‘The Growth and Gaps of Genetic Data Sharing Policies’. Robinson et al. highlight the importance of individual and group preferences. In this article, we extend the conversation on models for improving protections which will mitigate consequences for individuals and groups that are vulnerable to stigma and discrimination.     

Towards an ethics safe harbor for global biomedical research

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.     

Big genetic data and its big data protection challenges

The use of various forms of big data have revolutionised scientific research. This includes research in the field of genetics in areas ranging from medical research to anthropology. Developments in this area have inter alia been characterised by the ability to sequence genome wide sequences (GWS) cheaply, the ability to share and combine with other forms of complimentary data and ever more powerful processing techniques that have become possible given tremendous increases in computing power. Given that many if not most of these techniques will make use of personal data it is necessary to take into account data protection law. This article looks at challenges for researchers that will be presented by the EU's General Data Protection Regulation, which will be in effect from May 2018. The very nature of research with big data in general and genetic data in particular means that in many instances compliance will be onerous, whilst in others it may even be difficult to envisage how compliance may be possible. Compliance concerns include issues relating to ‘purpose limitation’, ‘data minimisation’ and ‘storage limitation’. Other requirements, including the need to facilitate data subject rights and potentially conduct a Data Protection Impact Assessment (DPIA) may provide further complications for researchers. Further critical issues to consider include the choice of legal base: whether to opt for what is often seen as the ‘default option’ (i.e. consent) or to process under the so called ‘scientific research exception’. Each presents its own challenges (including the likely need to gain ethical approval) and opportunities that will have to be considered according to the particular context in question.     

Innovation in the public sphere: reimagining law and economics to solve the National Institutes of Health publishing controversy

The National Institutes of Health (NIH) are responsible for the largest proportion of biological science funding in the United States. To protect the public interest in access to publicly funded scientific research, the NIH amended terms and conditions in funding agreements after 2009, requiring funded Principal Investigators to deposit published copies of research in PubMed, an Open Access repository. Principal Investigators have partially complied with this depository requirement, and the NIH have signaled an intent to enforce grant agreement terms and conditions by stopping funding deposits and engaging in legal action.The global economic value of accessible knowledge offers a unique opportunity for courts to evaluate the impact of enforcing ‘openness’ contract terms and conditions within domestic and international economies for public and economic benefit. Through judicial enforcement of Open Access terms and conditions, the United States can increase economic efficiency for university libraries, academic participants, and public consumers, while accelerating global innovation, improving financial returns on science funding investments, and advancing more efficient scientific publishing models.     

The Challenge of Universal Norms: Securing Effective Defence Rights Across Different Jurisdictions and Legal Cultures

This article considers the contribution of comparative empirical research in shaping best practice norms for custodial legal advice, and helping to address challenges in their implementation. It traces the role of ECtHR decisions and EU Directives in developing transnational norms to strengthen suspects’ right to legal assistance. Recognizing how these norms are translated into the national context, it considers the value of comparative empirical and socio‐legal research in helping to develop legislative and training measures; how roles and responsibilities are shared out in different legal systems and traditions; and practical arrangements that facilitate or inhibit the effectiveness of custodial legal advice in practice. There is a tension between framing transnational norms that are sufficiently universal to attract support, without being so broad as to lack any transformational force, and sufficiently detailed to ensure respect for core protections without imposing legal requirements too rigid and difficult to be absorbed into diverse processes of criminal justice.     

Civil Asset Forfeiture Laws and Equitable Sharing Activity by the Police

Research Summary

For several decades, critics have argued that civil forfeiture laws create incentives for law enforcement to increase departmental revenue by “policing for profit.” By using data on federal equitable sharing payments to nearly 600 local law enforcement agencies between 2000 and 2012, we examine the relationship between the characteristics of state forfeiture laws and equitable sharing payments to local agencies. Our results indicate that agencies in states with state laws that are more restrictive or less rewarding to police collect more in federal equitable sharing. This finding supports the critics’ argument that police behavior in regard to forfeiture activities is influenced by the financial rewards and burdens involved.

Policy Implications

Our results reveal that the findings of investigative journalism and case study research, that is, that police forfeiture activities are influenced by financial rewards, may be more generalizable to law enforcement than previously thought. Despite recent state‐level reforms, federal equitable sharing and most state forfeiture laws provide limited due process protections and have minimal accountability or reporting requirements. Concerns about the impact of civil forfeiture practices on perceptions of procedural justice and police legitimacy are discussed, and possible policy reforms are reviewed.     

Roadmap to solving security and privacy concerns in RFID systems

This paper focuses on privacy and security concerns in Radio Frequency IDentification (RFID) systems and paves the way towards a roadmap for solving security and privacy concerns in RFID systems. RFID systems have captured much interest around the World. The technology has many advantages and applications in a real world situation. Examples of such scenarios will be discussed in this paper.This paper reviews privacy and security concerns within the context of the advantages the technology offers and reviews solutions to overcome the privacy and security challenges. However, this research found that many proposed technological solutions are not “bullet proof” and policy regulations have to be employed as well. Few such RFID policies have been proposed. However, this paper argues that users/consumers of RFID systems should be given the mandate to have control over their products and systems and in order to fully address solution to the security concerns.     

Data sharing

The sharing of research data to permit secondary analyses is rooted in the collegial tradition of science. Recently there has been a gradual shift from viewing data sharing as a voluntary activity to considering sharing as an obligation of researchers. This paper identifies two important dimensions of data sharing: the degree to which the primary investigators may determine whether they will share their data and the reason for which the data set is being requested. In addition to discussing the dimensions of data sharing, the negative aspects of viewing data sharing as an obligation are discussed. These negative factors are increased burden on the primary investigator; lack of incentive to share data; and loss of control over the use of data and negative effects on scientific progress. Recommendations regarding data sharing policies are made in light of these negative effects.     

Executive Environmental Law

The Draft Environment (Principles and Governance) Bill published by DEFRA in late 2018 is part of a process of reimagining environmental law in light of Brexit. The Draft Bill creates frameworks for policy statements on environmental principles and environmental implementation plans, as well as creating a new enforcement body – the Office for Environmental Protection. This Draft Bill is, at the very least, an ineffectual response to the challenges of environmental law post-Brexit. More alarmingly, it raises the possibility of a legal future in which the executive dominates how the norms, ambitions, and accountabilities of environmental law are defined. These are matters of concern for environmental and public lawyers alike.     

EU citizens: Challenging the notion of German National Political Community, 1990–2005

This article assesses the extent to which Germany's adaptation of European Union legal norms through altering the criteria for access to territory and rights has challenged the judicial and conceptual boundaries of its notion of national political community. It compares the policies that directly affected EU citizens’ and other immigrant groups’ access to German territory, citizenship and social integration programs. It may be seen that, in enjoying a unique and privileged position between Germans and the other foreigners, this group not only challenges and undermines the justification for this very distinction, but also transforms the concept of ‘otherness’.     

Reconfiguring the Animal/Human Boundary: The Impact of Xeno Technologies

The focus of this paper is on the symbolic and cultural as well as practical implications of what I term xeno technologies. I argue that these biomedical technologies, which aim to prolong individual human lives through the sacrifice of animal bodies, generate considerable anxiety and pose many intriguing issues for health care lawyers. In part, the concerns engendered by xeno technologies are attributable to the incalculable risks they may pose. This, coupled with public distrust of scientific evaluations of risk, undermines scientific attempts to present them as benign technologies. In this paper, however, I suggest that xeno technologies provoke a deeper cultural unease by raising, in acute new forms, historical and religious concerns about bodily mixing and rejection which challenge traditional notions of (human) self identity. The various ways in which xeno technologies render human and non-human bodies vulnerable and penetrable, pose multiple challenges to the animal/human boundary. In my view, they should force a radical re-thinking of notions of kinship, which should extend beyond the ȁ8easy caseȁ9 of human kinship with other great apes. Rather than addressing this issue, however, healthcare law makes valiant attempts to shore up the animal/human boundary. Such efforts at boundary maintenance may be traced at various sites, including the regulatory regime under the Human Fertilisation and Embryology Act 1990. I argue that lawȁ9s efforts to grapple with the ethical challenges posed by biotechnologies are doomed to incoherence unless it confronts the unreflective speciesism underpinning law, which designates animals as property and serves to obscure our kinship with them. My suggestion is that health care ethicists and lawyers should instead seek to expose the myriad ways in which biotechnologies may prove oppressive rather than liberatory for those who are made their human and animal subjects.     

物权法立法思维之批判

改革开放至今,我国虽在法学研究、法学教育及法制建设上取得了突出成就,但由《物权法(草案)》所揭示的诸多问题看,立法者之思维仍停留于重经验轻逻辑、重实用轻法理、重“诸法合体”轻物权法之私法性的守旧状态。《物权法(草案)》的推迟颁布,为反思物权法的立法提供了难得的机会。只有以私法的观念、裁判规范的特性以及物权法自身的逻辑结构为基础,才能制定一部科学的物权法。     

Evoking equity as a rationale for solar geoengineering research? Scrutinizing emerging expert visions of equity

This paper examines how notions of equity are being evoked by expert advocates of more research into solar geoengineering. We trace how specific understandings of equity figure centrally—although not always explicitly—in these expert visions. We find that understandings of equity in such “vanguard visions” are narrowly conceived as epistemic challenges, answerable by (more) scientific analysis. Major concerns about equity are treated as empirical matters, requiring scientific assessment of feasibility, risks, or “win–win” distributive outcomes and optimizations, with concurrent calls to delimit risk or reduce scientific uncertainties. We argue that such epistemic framings sidestep, inter alia, the inequality in resources available to diverse non-experts—including the “vulnerable” evoked in expert visions—to project their own equity perspectives onto imagined technological pathways of the future. These may include concerns relating to moral or historical responsibility and/or lack of agency in shaping the directions of innovation. We conclude that the performative power and political implications of specific expert visions of equity, evoked as a rationale to undertake solar geoengineering research, require continued scrutiny.     

Back to first principles: a new model for the regulation of drug promotion

The US Food and Drug Administration''s (‘FDA’ or the ‘Agency’) current regulatory framework for drug promotion, by significantly restricting the ability of drug manufacturers to communicate important, accurate, up-to-date scientific information about their products that is truthful and non-misleading, runs afoul of the First Amendment and actually runs counter to the Agency''s public health mission. Our article proposes a New Model that represents an initial proposal for a modern, sustainable regulatory framework that comprehensively addresses drug promotion while protecting the public health, protecting manufacturers’ First Amendment rights, establishing clear and understandable rules, and maintaining the integrity of the FDA approval process. The New Model would create three categories of manufacturer communications—(1) Scientific Exchange and Other Exempt Communications, (2) Non-Core Communications, and (3) Core Communications—that would be regulated consistent with the First Amendment and according to the strength of the government''s interest in regulating the specific communications included within each category. The New Model should address the FDA''s concerns related to off-label speech while protecting drug manufacturers’ freedom to engage in truthful and non-misleading communications about their products.     

Intelligence-sharing in the context of policing transnational serious and organized crime: a note on policy and practice in an Australian setting

ABSTRACT

An increasingly globalised world brings with it unprecedented complexities in international intelligence sharing. The continual integration of international markets and services, amid the ongoing disruption of digital technologies, is driving the need for greater collaboration and cooperation between countries. The flows of people, goods, ideas and information are increasing each year in tandem with the global reach of terrorism. Global reliance on the internet for commerce and communication also exposes countries and organizations to cyber-attack. Significant increases in borderless crime, the rising incidence of global political fragility, and shifts in multi-jurisdictional crime all compel law enforcement, intelligence and security agencies to continually re-evaluate existing approaches and policies. The ability of police to attack transnational organized crime at its source, or at a transit point that offers opportunities for effective disruption, is now more important than ever. This essay describes a study conducted by the Australian Strategic Policy Institute that identified a number of crucial issues with Australia’s criminal intelligence efforts offshore. It explains why it is important to foster a culture of offshore criminal intelligence, looks at challenges associated with the current system, and suggests ways to overcome those challenges. The research confirms that Australia’s efforts to collect and disseminate criminal intelligence, as distinct from routine international liaison, is ripe for improvement.     

Bridging philosophical and practical implications of incidental findings in brain research

Empirical studies and ethical-legal analyses have demonstrated that incidental findings in the brain, most commonly vascular in origin, must be addressed in the current era of imaging research. The challenges, however, are substantial. The discovery and management of incidental findings vary, at minimum, by institutional setting, professional background of investigators, and the inherent differences between research and clinical protocols. In the context of human subjects protections, the challenges of disclosure of unexpected and potentially meaningful clinical information concern privacy and confidentiality, communication, and responsibility for follow-up. Risks, including a blurring of boundaries between research and clinical practice, must be weighed against the possible benefit to subjects and a moral duty to inform. Identification and examination of these challenges have been met by scientific interest and a robust, interdisciplinary response resulting in the pragmatic recommendations discussed here.     

Justifications for the sharing of social science data

Starting with the premise that voluntary sharing of social science data is a desirable professional behavior, this article discusses a variety of justifications for data sharing. These justifications are found to be grounded in the scientific process itself—in the need for science that is more accurate, more open, more knowledgeable, and has more resources at its disposal. Although it is evident that the costs and benefits of data sharing are now unevenly distributed, and that primary researchers currently bear most of the burden and risks, it is argued that the adoption of a data-sharing norm in the social sciences would go a long way to remedy the imbalance. In this regard, the author supports the 1985 data-sharing recommendations put forth by the Committee on National Statistics.This article is based on a presentation at the annual meeting of the American Psychological Association, Washington, D.C., August 23, 1986.U.S. General Accounting Office. The views expressed in this article are the author's and do not necessarily represent the opinions or policies of the GAO.     

Technological innovation within the Spanish tax administration and data subjects' right to access: An opportunity knocks

In this paper, we analyse the data subjects' right to access their personal data in the context of the Spanish Tax Administration and the legal consequences of the upcoming General Data Protection Regulation. The results show that there are still difficulties related to the scope of this right, the establishment of proper storage criteria, and in the procedures used by the data controllers to provide accurate information to the data subjects. This situation highlights the necessity to incorporate such technological innovation as metadata labelling and automatic computerised procedures to ensure an optimum management of the data subjects' access to their tax related personal information.