Biobanks are proliferating rapidly worldwide because they are powerful tools and organisational structures for undertaking medical research. By linking samples to data on the health of individuals, it is anticipated that biobanks will be used to explore the relationship between genes, environment and lifestyle for many diseases, as well as the potential of individually-tailored drug treatments based on genetic predisposition. However, they also raise considerable challenges for existing legal frameworks and research governance structures. This book critically examines the (...) current governance structures in place for biobanks in England and Wales. It shows that the technologies, techniques and practices involved in biobanking do not always conform neatly to existing legal principles and frameworks that apply to other areas of medical research. Using a socio-legal approach, including interview data gathered from the scientific community, this book provides unique insights and makes recommendations about appropriate governance mechanisms for biobanking in the future. It also explores the issues around the secondary use of information, such as consent and how to protect privacy, when biobanks are accessed by a number of different third parties. These issues have relevance both within England and Wales and to a wide international audience, as well as for other areas where large datasets are used.--Back cover. (shrink)

While the possibility of enacting a sui generis Biobank Act has been debated in Germany at great length, as of yet the country has not implemented any biobankspecific legislation. Instead, oversight is available via a network of research and privacy laws, including those of the European Union. The Nationale Kohorte, Germany's large-scale, population-based epidemiological research biobank, is funded by the Federal Ministry of Education and Research, and there are currently 108 registered bio-banks throughout Germany. The current system, including the (...) structure and study design of the Nationale Kohorte, privileges the protection of personal information even at the cost of socially desirable research; it remains to be seen if forthcoming legislation will shift this balance. (shrink)

Large-scale, interoperable biobanks are an increasingly important asset in today's life science research and, as a result, multiple types of biobanks are being established around the globe with very different financial, organizational and legal set-ups. With interdisciplinary chapters written by lawyers, sociologists, doctors and biobank practitioners, Global Genes, Local Concerns identifies and discusses the most pressing issues in contemporary biobanking.This timely book addresses pressing questions such as: how do national biobanks best contribute to translational research?; What are (...) the opportunities and challenges that current regulations present for translational use of biobanks?; How does inter-biobank coordination and collaboration occur on various levels?; and how could academic and industrial exploitation, ownership and IPR issues be addressed and facilitated? Identifying that biobanks' foundational and operational set-ups should be legally and ethically sound, while at the same time reflecting the hopes and concerns of all the involved stakeholders, this book contributes to the continued development of international biobanking by highlighting and analysing the complexities in this important area of research.Academics in the fields of law and ethics, health law and biomedical law, as well as biobank managers and policymakers will find this insightful book a stimulating and engaging read. (shrink)

Both the European Union and the Council of Europe have a bearing on privacy in genomic databases and biobanking. In terms of legislation, the processing of personal data as it relates to the right to privacy is currently largely regulated in Europe by Directive 95/46/EC, which requires that processing be “fair and lawful” and follow a set of principles, meaning that the data be processed only for stated purposes, be sufficient for the purposes of the processing, be kept only (...) for so long as is necessary to achieve those purposes, and be kept securely and only in an identifiable state for such time as is necessary for the processing. The European privacy regime does not require the de-identification of personal data used in genomic databases or biobanks, and alongside this practice informed consent as well as governance and oversight mechanisms provide for the protection of genomic data. (shrink)

This article focuses on whether a certain form of consent used by biobanks – open consent – is compatible with the Proposed Data Protection Regulation. In an open consent procedure, the biobank requests consent once from the data subject for all future research uses of genetic material and data. However, as biobanks process personal data, they must comply with data protection law. Data protection law is currently undergoing reform. The Proposed Data Protection Regulation is the culmination of this (...) reform and, if voted into law, will constitute a new legal framework for biobanking. The Regulation puts strict conditions on consent – in particular relating to information which must be given to the data subject. It seems clear that open consent cannot meet these requirements. 4 categories of information cannot be provided with adequate specificity: purpose, recipient, possible third country transfers, data collected. However, whilst open consent cannot meet the formal requirements laid out by the Regulation, this is not to say that these requirements are substantially undebateable. Two arguments could be put forward suggesting the applicable consent requirements should be rethought. First, from policy documents regarding the drafting process, it seems that the informational requirements in the Regulation are so strict in order to protect the data subject from risks inherent in the use of the consent mechanism in a certain context – exemplified by the online context. There are substantial differences between this context and the biobanking context. Arguably, a consent transaction in the biobanking does not present the same type of risk to the data subject. If the risks are different, then perhaps there are also grounds for a reconsideration of consent requirements? Second, an argument can be made that the legislator drafted the Regulation based on certain assumptions as to the nature of ‘data’. The authors argue that these assumptions are difficult to apply to genetic data and accordingly a different approach to consent might be preferable. Such an approach might be more open consent friendly. (shrink)

On January 18, 2006, the United States Supreme Court unanimously held that the constitutional challenge to New Hampshire's Parental Notification Prior to Abortion Act would be remanded to the United States Court of Appeals for the First Circuit, to determine whether the Court of Appeals could, consistent with New Hampshire's legislative intent, formulate a narrower remedy than a permanent injunction against enforcement of the parental notification law in its entirety.In 2003, New Hampshire enacted the Parental Notification Prior to Abortion Act. (...) The Act specifies, in pertinent part, that “No abortion shall be performed upon an unemancipated minor or upon a female for whom a guardian or conservator has been appointed… until at least 48 hours after written notice of the pending abortion has been delivered....” The Act allows for three exceptions where a physician may perform an abortion on a minor child without parental or guardian notification. (shrink)

This paper argues that the demands of respect for autonomy in the context of biobanking are fewer and more limited than is often supposed. It discusses the difficulties of agreeing a concept of autonomy from which duties can easily be derived, and suggests an alternative way to determine what respect for autonomy in a biobanking context requires. These requirements, it argues, are limited to provision of adequate information and non-coercion. While neither of these is in itself negligible, this is a (...) smaller set of demands than is often suggested. In particular, it is argued here that securing ‘one time consent’ is consistent with respect for autonomy. Finally, the paper notes that while the demands of respect for autonomy may be less than some suppose, respecting autonomy is not the only way in which biobanks and their users may have moral duties to donors. (shrink)

On January 18, 2006, the United States Supreme Court unanimously held that the constitutional challenge to New Hampshire's Parental Notification Prior to Abortion Act would be remanded to the United States Court of Appeals for the First Circuit, to determine whether the Court of Appeals could, consistent with New Hampshire's legislative intent, formulate a narrower remedy than a permanent injunction against enforcement of the parental notification law in its entirety.In 2003, New Hampshire enacted the Parental Notification Prior to Abortion Act. (...) The Act specifies, in pertinent part, that “No abortion shall be performed upon an unemancipated minor or upon a female for whom a guardian or conservator has been appointed… until at least 48 hours after written notice of the pending abortion has been delivered....” The Act allows for three exceptions where a physician may perform an abortion on a minor child without parental or guardian notification. (shrink)

Biobanks represent an invaluable research tool and, as a result of their intrinsic and extrinsic nature, may be looked upon as archives or repositories largely made up of libraries, or collections of content where the content is the biological material derived from different individuals or species, representing valuable tangible assets. Biobanks analyses aspects of the commons and common intellectual property relating to the concepts of private property, not only concerning data but biological materials as well, and the advantages (...) and disadvantages of patents in scientific research. Several recent initiatives in biomedical research have attempted to make their data freely available to others, so as to foster innovation. Many of these initiatives have adopted the open source model, which has gained widespread recognition in the computer industry. This title is structured into eight chapters and begins with an introduction, which is followed by chapters that discuss how the term 'biobank' came about in scientific literature; legal matters relating to biobanks; and intellectual and physical property. Later chapters comprehensively analyse the intellectual property of biobanks within the sphere of copyright; biotechnological inventions and research patentability; open data sharing in biobanks; and biobanks as commons or vault. Considers biobanks as both repositories and as collections of tangible assets Argues that the data in biobanks represents a high value intangible asset Explores regulatory gaps exploited by the private sector. (shrink)

Congress's national-security legislation will often require clear and specific congressional authorization before the executive can undertake certain actions. The War Powers Resolution, for example, prohibits any law from authorizing military hostilities unless it "specifically authorizes" them. And the Foreign Intelligence Surveillance Act of 1978 required laws to amend FISA or repeal its "exclusive means" provision before they could authorize warrantless electronic surveillance. But efforts to legislate clear-statement regimes in national-security law have failed to induce compliance. The Clinton Administration inferred (...) congressional "authorization" for the 1999 Kosovo War from an appropriations statute that failed to specifically authorize the conflict. And the Bush Administration inferred congressional "authorization" for the NSA surveillance program from ambiguous language in the post-September 11th Authorization to Use Military Force. In both situations, executive-branch lawyers employed expansive theories of implied repeal and constitutional avoidance to evade the codified clear-statement requirements, and Congress and the courts acquiesced to the President's actions. Recent proposals to strengthen the clear-statement requirements in Congress's national-security framework legislation are unlikely to be effective without institutional mechanisms, such as points of order, that can deter future legislators from enacting vague or ambiguous legislation from which the executive might claim implicit congressional "authorization," and that can induce Congress to confront Presidents that act without specific congressional authorization. Simply enacting more narrow or explicit clear-statement requirements, or adding funding restrictions to Congress's framework legislation, fails to counter the aggressive interpretive doctrines that executives of both political parties have used to concoct congressional "authorization" from vague or ambiguous statutory language. (shrink)

This paper surveys the conceptions of law and of legislation to be found in the philosophy of Julian the Emperor. A hierarchy of levels of law is described, going from transcendent divine orders and paradigmatic laws down to the laws of nature, laws innate in human souls and regional laws. Julian’s ideal legislator is discussed, as inspired by transcendent, paradigmatic laws and as subordinate to law and its protector. An example of Julian’s legislation is discussed. Attention is paid (...) to Julian’s use of Plato’s Republic, Statesman, and Laws. (shrink)

Finland has aimed to make itself an international leader in genomic research and related business and, in working towards that goal, has enacted biobank legislation. The Biobank Act requires biobanks to gain approval, be supervised, and register at the national level. Numerous other laws may also apply in any given research setting, such as the Personal Data Act, the Medical Research Act, and the Act on Medical Use of Human Organs and Tissues. In terms of privacy protection, anonymization (...) is generally not permitted under Finnish law and therefore most biobanks pseudonomize data and samples. However, the broad understanding of what is identifiable data in Finland has created difficulties in sharing with non-EU countries. Furthermore, consent to biobank research is only applicable to the sample and related data, not to data stored in other health-related registries, and consent is only to the field of research for that particular biobank. These restrictions impede the sharing of samples and data for research. (shrink)

Biobank research and genomic information are changing the way we look at health and medicine. Genomics challenges our values and has always been controversial and difficult to regulate. In the future lies the promise of tailored medical treatments and pharmacogenomics but the borders between medical research and clinical practice are becoming blurred. We see sequencing platforms for research that can have diagnostic value for patients. Clinical applications and research have been kept separate, but the blurring lines challenges existing regulations and (...) ethical frameworks.Then how do we regulate it? This book contains an overview of the existing regulatory landscape for biobank research in the Western world and some critical chapters to show how regulations and ethical frameworks are developed and work. How should international sharing work? How design an ethical informed consent? An underlying critique: the regulatory systems are becoming increasingly complex and opaque. The international community is building systems that should respond to that. According to the authors in fact, it is time to turn the ship around. Biobank researchers have a moral responsibility to look at and assess their work in relation to the bigger picture: the shared norms and values of current society. Research ethics shouldn't only be a matter of bioethicists writing guidelines that professionals have to follow. Ethics should be practiced through discourse and regulatory frameworks need to be part of that public discourse. Ethics review should be then not merely application of bureaucracy and a burden for researchers but an arena where researchers discuss their projects, receive advice and practice their ethics skills. (shrink)

Although the concept of biobanking is not new, the open and evolving nature of biobanks has created profound ethical, legal, and social implications, including issues around informed consent, community engagement, secondary uses of materials over time, ownership of materials, data sharing, and privacy. Complexities also emerge because of increasing international collaborations and differing national positions. In addition, the degrees and topics of concern vary as legislative, ethical, and social frameworks differ across developed and developing countries. Implementing national laws in (...) an internationally consistent manner is also problematic. However, these concerns should not cause countries, especially developing countries, to lag behind as this novel wave of research gains momentum, particularly while several biobank initiatives are already underway in the developing world. As the law has always struggled to keep up with the fast-evolving scientific arena, this article seeks to identify the ethico-legal frameworks in place in the United Kingdom, Australia, Uganda, and South Africa, for human biobank research, in an attempt to compare and contextualize the approaches to human biobanking in specific developed and developing countries. (shrink)

Australia is second only to Israel in being the world’s most culturally diverse nation, based largely on high levels of immigration in the second part of the 20th century. From the 1970s onwards, Australia formally recognized the massive social changes brought about by postwar immigration, and provided legislation to incorporate cultural diversity into everyday lives. One such ‘legislative’ enactment saw the establishment of multicultural broadcasting in Australia, as arguably a world-first, both in its comprehensiveness and diversity. Today, Australia has (...) a public sector corporation, the Special Broadcasting Service, administering five radio services in 68 languages. Also, the Community Radio sector produces multicultural programming in 100 languages through a number of its 330 broadcast and 207 narrowcast stations. This article examines the relationship between radio and its communities. It argues that despite the ‘profile’ of SBS television, radio is much closer to its constituent communities, and therefore plays a greater role in enabling those communities to speak their own histories, beyond the confines of a consensual Anglophile paradigm. (shrink)

Laws in the 20 jurisdictions studied for this project display many similar approaches to protecting privacy in biobank research. Although few have enacted biobank-specific legislation, many countries address biobanking within other laws. All provide for some oversight mechanisms for biobank research, even though the nature of that oversight varies between jurisdictions. Most have some sort of controlled access system in place for research with biobank specimens. While broad consent models facilitate biobanking, countries without national or federated biobanks have (...) been slow to adopt broad consent. International guidelines have facilitated sharing and generally take a proportional risk approach, but many countries have provisions guiding international sharing and a few even limit international sharing. Although privacy laws may not prohibit international collaborations, the multi-prong approach to privacy unique to each jurisdiction can complicate international sharing. These symposium issues can serve as a resource for explaining the sometimes intricate privacy laws in each studied jurisdiction, outlining the key issues with regards to privacy and biobanking, and serving to describe a framework for the process of harmonization of privacy laws. (shrink)

Written by one of Ireland's leading medical law academics, this practical book comprehensively covers case law and regulations regarding the healthcare system, the law relating to human reproduction, and the key issues of consent and treatment. Designed to be used by lawyers and healthcare professionals, Medicine, Ethics and the Law in Ireland provides an invaluable reference tool for anybody who requires accurate information and guidance on this area of Irish law. This new edition includes: Medical research and clinical trials; Organ (...) donation and transportation; Patient safety and QA; and Biobanking. (shrink)

This paper describes the different dimensions of the relation between moral reflection and legislative processes. It discusses some examples of the institutionalisation of moral reflection. It is argued that the relation between ethics and law is still an actual and relevant question. Ethics also has to reflect on its own role in political life. The paper defends the relevance of a theological perspective on the relation between law and ethics. In the last part it is argued that the modality of (...) relation between ethics and law depends on the specific character of social domain. (shrink)

Privacy is protected in biobank-based research in the US primarily by the Health Insurance Portability and Accountability Act Privacy Rule and the Federal Policy for Protection of Human Subjects. Neither rule, however, was created to function in the unique context of biobank research, and therefore neither applies to all biobank-based research. Not only is it challenging to determine when the HIPAA Privacy Rule or the Common Rule apply, but these laws apply different standards to protect privacy. In addition, many other (...) federal and state laws may be applicable to a particular biobank, researcher, or project. US law also does not directly address international sharing of data or specimens outside of the EU–US Safe Harbor Agreement, which only applies to receipt of data by certain US entities from EU countries, and is in the process of revision. Although new rules would help clarify privacy protections in biobanking, any implemented changes should be studied to determine the sufficiency of the protections as well as its ability to facilitate or hinder international collaborations. (shrink)

Biobanks are precariously situated at the intersection of science, genetics, genomics, society, ethics, the law and politics. This multi-disciplinarity has given rise to a new discourse in health research involving diverse stakeholders. Each stakeholder is embedded in a unique context and articulates his/her biobanking activities differently. To researchers, biobanks carry enormous transformative potential in terms of advancing scientific discovery and knowledge. However, in the context of power asymmetries in Africa and a distrust in science born out of historical (...) exploitation, researchers must balance the scientific imperative of collecting, storing and sharing high quality biological samples with obligations to donors/participants, communities, international collaborators, regulatory and ethics authorities. To date, researcher perspectives on biobanking in South Africa have not been explored and documented. In-depth qualitative interviews were conducted with a purposive sample of 21 researchers – 8 in the Western Cape, 3 in Gauteng and 10 in Kwa-Zulu Natal. Interviews lasted approximately 40–60 min and were audiotaped with consent. Thematic analysis of the transcribed interviews was conducted by the co-authors. Researchers articulated serious concerns over standardised regulatory approaches that failed to consider the heterogeneity of biobanks. Given that biobanks differ considerably, guidelines and RECs need to stratify risk accordingly and governance processes and structures must be flexible. While RECs were regarded as an important component of the governance structure researchers expressed concern about their expertise in biobanking. Operational management of biobanks was regarded as an ethical imperative and a pre-requisite to building trust during consent processes. While broad general consent was preferred, tiered consent was thought to be more consistent with respect for autonomy and building trust. Material Transfer Agreements were often lacking when biosamples were exported and this was perceived to impact negatively on trust. On the other hand, researchers believed that authentic community engagement would help to build trust. Building trust will best be achieved via a system of governance structures and processes that precede the establishment of a biobank and monitor progress from the point of sample collection through to future use, including export. Such governance structures must be robust and must include comprehensive national legislation, policy and contextualised guidelines. Currently such governance infrastructure appears to be lacking in many African countries including South Africa. Capacity development of all stakeholders including REC members will enhance expeditious and efficient review of biobanking protocols which in turn will reinforce trust in the researcher-donor relationship. Science translation and community engagement in biobanking is integral to the success of biobanking in South Africa. (shrink)

Law, often neglected in treatments of the Republic, is essential to the philosopher-kings’ rule. Only law accomplishes the partial divinization of citizens at which philosophical politics aims. Socrates’ interrogation of Thrasymachus and Glaucon reveals law to be a command whereby citizens participate in philosophical knowledge and limit the pleonexia congenital to humanity. Law does so primarily by instilling in souls a true opinion resistant to pleonectic passion, producing a state of political virtue. This primary work is supported by the musical (...) and poetical education, itself shaped by law for the sake of law. Law persuades and compels the soul by appealing to both reason and spiritedness, enabling them to overcome the appetites. The soul’s consequent acceptance of truth and resistance to the passions indeed makes it resemble divinity. In so transforming the citizens through the law, the philosopher-king also unifies the city and makes it happy under his rule. (shrink)

The Netherlands does not have any specific legislation pertaining to human biological materials and data collection by biobanks. Instead, these issues are governed by a patchwork of laws, codes of practices, and other ethical instruments, where special emphasis is given to the right to privacy and self-determination. While draft legislation for biobanking was scheduled to enter into force in 2007, as of mid-2015 such legislation was still under consideration, with the intent that it would focus particularly (...) on individual self-determination, the interests of research, the use of bodily materials collected by biobanks for criminal law purposes, and dilemmas around results that are clinically relevant for biobank participants. Under the current framework, the amount of privacy protection afforded to data is linked to its level of identifiability. International sharing of personal data to non-EU/European Economic Area countries is allowed if these countries provide adequate protection. (shrink)

Denmark is a constitutional monarchy resting on the founding Constitution of 1849 and later amendments. The 179 members of parliament are democratically elected, and the government is formed on the basis of parliamentary principles. The queen functions as head of state without any power to intervene in legislative or executive matters. Greenland and the Faroe Islands are part of the kingdom, but self-governing. In total, the population is around 5.6 million. The country is divided into five regions and 98 municipalities. (...) Members of both regional and municipal councils are democratically elected. (shrink)

Legislation for dementia care needs to be continually rethought, if the rights of older persons and other persons with dementia are to be addressed properly. We propose a theoretical framework for understanding vulnerability and dependency, which enables us to problematize the currently prevailing legal conception of adults as always able — irrespective of health or age — to act autonomously in their everyday lives. Such an approach gives rise to difficult dilemmas when persons with dementia are forced to make (...) decisions on their own about basic living conditions, such as housing and care, without decision-making support. In Sweden, for example, such matters are frequently left to the person him- or herself to decide, often without any assistance from social workers, and with family members serving as caregivers of last resort.Using vulnerability theory as the framework for our discussion, we argue that policymakers should not apply a group-oriented approach (based on factors like age, legal status, or mental capacity) to persons suffering from dementia. The needs of such individuals are as complex and varied as they themselves are. We discuss our findings from an interdisciplinary (law/social work) research project in which we examine the dilemma that social workers face when they are required, under the terms of the Swedish Social Services Act, to determine whether persons with dementia are to be granted support.We argue further that a cross-disciplinary approach — in which vulnerability theory furnishes the framework — opens up for new ways of understanding and developing social welfare law and practice. This, we believe, can help us better address the rights, interests, and needs of people with dementia, of their families, and of professionals in the social welfare system. Finally, many of the problems faced by ageing societies in general can be understood on the basis of such an approach. (shrink)

Estonia is a democratic, parliamentary republic with a health care system that is built on the principle of compulsory, solidarity-based insurance and the all-round availability of services of private service providers. Estonia has specific biobank legislation as well as oversight via data protection laws. Its population-based biobank, the Estonian Genome Center, established in 2001, is one of the largest biobanks in Europe, and its database may be used only for scientific research, public health research, and statistics. The EGCUT (...) can issue data to a third party, but only in coded form. This comprehensive database of genotypic, phenotypic, health, and genealogical information represents about 5% of Estonia's adult population, and is the largest cohort ever gathered in Estonia. Government approval is required for international data sharing, and sharing can be further limited by the requirement of ethics approval and permission from Estonian government. (shrink)

As Alexander D’Entrees observed over forty years ago, the case for natural law “is not an easy one to put clearly and convincingly.” Furthermore, even if one can make the case for natural law in a clear and convincing manner, one should not expect such an argument to be clear and convincing for all time. Instead, the case for natural law must be an ongoing argument, addressing itself perpetually to the needs of the time as these needs shift and change. (...) In short, the case for natural law “must needs appear in a different light according to the angle in time or in place from which it is looked at.” With this precept in mind, I seek to examine Thomas Aquinas’s natural law teaching on the legislation of virtue in light of concerns that are especially acute from the perspective of contemporary liberalism. (shrink)

Section One - Principles and concepts of healthcare law and ethics -- Section Two - Complaints, disciplinary proceedings and indemnity insurance -- Section Three - Confidentiality, disclosure and apologies -- Section Four - Alternative dispute resolution and relationship with colleagues -- Section Five - Liabilities beyond healthcare practices.

This paper aims to clarify the nature and contents of 'civil ethics' and the source of the binding force of its obligations. This ethics should provide the criteria for evaluating the moral validity of social, legal and morally valid law. The article starts with observing that in morally pluralist Western societies civil ethics already exists, and has gradually started to play the role of guiding the law. It is argued that civil ethics should not be conceived as 'civic morals' which (...) is in fact rather 'state ethics', nor as 'public ethics' which is said to reach its perfection when it becomes law, nor as ethics applicable primarily to the basic structure of a society, but instead as a citizens' ethics. Subsequently the paper attempts to show what the contents of this ethics are, and which ethical theory would be able to ground its obligations. (shrink)

The application of the latest technologies in biology and medicine has brought them to a qualitatively new level of possibilities. Worldwide, biobanking is actively developing through the creation of biobanks of various types and purposes, whose resources are used to solve therapeutic or scientific problems. Legal science remains an open question concerning the boundary that runs between the right to data protection and the scope of disclosure of data needed for medical purposes. In this article, the author considers peculiarities (...) of data processing in the context of biobanking activity on the example of Austria and its national legislation. In addition, the article reveals features of the approaches of the European Court of Human Rights (ECtHR) and the Council of Europe to the issue of biobanking in general, its characteristics in the context of data, and legal regulation of this phenomenon in the national law of states. The author devoted an important part of the study to the role of Austria’s experience in the context of data processing for scientific purposes and the development of biobanking for a number of other European states. The aim of the article is to analyze the Austrian legislation on data processing for scientific research and biobanking, the attitude of the Council of Europe to this phenomenon, and the practice of the ECtHR, as well as to consider the impact of the current world situation on these activities. The leading method of research used in the article is the formal-legal method. The article analyzes the Austrian law in the context of data processing in medical research, the relationship of the specifics of personal data protection, and the need to disclose them for scientific purposes. The author pays special attention to the influence of Austrian law on the legislation of other countries, which is reflected in the conclusions to the article. In addition, based on an analysis of the application of the Austrian experience to the legislation of Poland and Ukraine, the author points out the necessary changes that should be made in the laws of these countries. (shrink)

Repositories of tissues, cell lines, blood samples, and other biological specimens are crucial to genomics, proteomics, and other emerging forms of biomedical research. Creation of these repositories by individual researchers and their affiliated organizations, commercial entities, and even governments has been labeled “biobanking” in the bioethics literature. Biobanking as a metaphor for the collection, transfer, and use of these specimens suggests a framework for the legal response to conflicts that may arise - one embedded in principles of contract law and (...) property ownership with an overlay of legislatively authorized regulation of the “industry.”. (shrink)

The ongoing efforts to establish biobanks in Africa envisage the availability of biological samples and data in accordance with relevant national legislation and ethical principles. Current literature has established that many African countries “do not have national legislation or guidelines on the use of stored biological samples” or if such guidelines are in place, then “disparities exist in relation to informed consent and export and import requirements.” In this regard, this article considers the extent to which the (...) available legal and ethical regulatory frameworks in South Africa are capable of governing the use of stored biological samples in a manner that facilitates health research while at the same time protecting the interests of sample donors. (shrink)

This paper connects to Jon Bing’s great vision of an integrated national legal information system. The intention of this paper is to variegate Bing’s vision of an integrated information system by shifting the focus to the lay users, thus to those, who are subject to the law. The modified vision is an integrated information system that supports intelligible access to law for the citizens. This presupposes however an unambiguous and transparent legal system. Accordingly, it is also stressed that intelligent legal (...) knowledge engineering has high potential to increase precision and rationality in law, and hence safeguard the predictability of law and legal certainty. The central hypothesis is that putting the person who is subject to the law at the centre provides more rational reason to aim for the greatest possible precision of law by exploiting the means and technologies of our time than to uphold strategic vagueness. On this basis, the paper proposes the development of a basic set of controllable and justiciable basic legal drafting standards on EU and on national level, and promotes a transparency by design approach for legal knowledge engineering in order to enhance precision, integrity, comprehensibility and accessibility of law. Similarly to Jon Bing’s vision, this modified vision of an integrated legal information systems is, most probably, also likely to remain unfulfilled. However, what would science be without visions and (science) fictions? (shrink)

Partial proceedings of the 17th World Congress, International Association for Philosophy of Law and Social Philosophy, Bologna, 1995.

Great hope has been placed on biobank research as a strategy to improve diagnostics, therapeutics and prevention. It seems to be a common opinion that these goals cannot be reached without the participation of commercial actors. However, commercial use of biobanks is considered morally problematic and the commercialisation of human biological materials is regulated internationally by policy documents, conventions and laws. For instance, the Council of Europe recommends that: “Biological materials should not, as such, give rise to financial gain”. (...) Similarly, Norwegian legislation reads: “Commercial exploitation of research participants, human biological material and personal health data in general is prohibited”. Both articles represent kinds of common moral intuitions. A problem, however, is that legislative documents are too vague and provide room for ample speculation. Through the use of focus group interviews with Norwegian biobank donors, we have tried to identify lay intuitions and morals regarding the commercial use of biobanks. Our findings indicate that the act of donation and the subsequent uses of the samples belong to two different spheres. While concerns around dignity and commodification were present in the first, injustice and unfairness were our informants’ major moral concerns in the latter. Although some opposition towards commercial actors was voiced, these intuitions show that it is possible to render commercial use of biobanks ethically acceptable based on frameworks and regulations which hinder commodification of the human body and promote communal benefit sharing. (shrink)

As with many other countries, Malaysia is also developing and promoting biomedical research to increase the understanding of human diseases and possible interventions. To facilitate this development, there is a significant growth of biobanks in the country to ensure continuous collection of biological samples for future research, which contain extremely important personal information and health data of the participants involved. Given the vast amount of samples and data accumulated by biobanks, they can be considered as reservoirs of precious (...) biomedical big data. It is therefore imperative for biobanks to have in place regulatory measures to ensure ethical use of the biomedical big data. Malaysia has yet to introduce specific legislation for the field of biobanking. However, it can be argued that its existing Personal Data Protection Act 2010 has laid down legal principles that can be enforced to protect biomedical big data generated by the biobanks. Consent is a mechanism to enable data subjects to exercise their autonomy by determining how their data can be used and ensure compliance with legal principles. However, there are two main concerns surrounding the current practice of consent in biomedical big data in Malaysia. First, it is uncertain that the current practice would be able to respect the underlying notion of autonomy, and second, it is not in accordance with the legal principles of the PDPA. Scholars have deliberated on different strategies of informed consent, and a more interactive approach has recently been introduced: dynamic consent. It is argued that a dynamic consent approach would be able to address these concerns. (shrink)

This thoroughly updated third edition lays a solid foundation for understanding the intersection of law, ethics and the rights of the patient, in the context of everyday nursing and health care practice.

The focus of this book is on the epistemological and hermeneutic implications of data science and artificial intelligence for democracy and the Rule of Law. How do the normative effects of automated decision systems or the interventions of robotic fellow 'beings' compare to the legal effect of written and unwritten law? To investigate these questions the book brings together two disciplinary perspectives rarely combined within the framework of one volume. One starts from the perspective of 'code and law' and the (...) other develops from the domain of 'law and literature'. Integrating original analyses of relevant novels or films, the authors discuss how computational technologies challenge traditional forms of legal thought and affect the regulation of human behavior. Thus, pertinent questions are raised about the theoretical assumptions underlying both scientific and legal practice. (shrink)

Graeme Laurie stepped down from the Chair in Medical Jurisprudence at the University of Edinburgh in 2019. This edited collection pays tribute to his extraordinary contributions to the field. Graeme has often spoken about the importance of 'legacy' in academic work and has forged a remarkable intellectual legacy of his own, notably through his work on genetic privacy, human tissue and information governance, and on the regulatory salience of the concept of liminality. The essays in this volume animate the concept (...) of legacy as lens of analysis for the study and practice of medical jurisprudence. In this light, legacy reveals characteristics of both benefit and burden, as both an encumbrance to and facilitator of the development of law, policy and regulation. Overall, the contributions reconcile the ideas of legacy and responsiveness and show that both dimensions are critical to achieve and sustain the health of medical jurisprudence itself as a dynamic, interdisciplinary and policy-engaged field of thinking. (shrink)

Spain occupies an area of 504.645 km, and it has a population of 46.5 million people, out of which 4,538,503 are immigrants. Life expectancy is 82.5 years. Its economy grew 1.4 % in 1014. Its current Constitution was enacted in 1978. It has been part of the European Union since 1986. Spain is a social and democratic state subject to the rule of law. Liberty, justice, equality, and political pluralism are the highest values of the legal order of the rule (...) of law. Spain is a constitutional monarchy with a parliamentary government. The legislative power rests upon two chambers: the Congress and Senate. The government exercises the executive powers and the regulatory powers. There have been six presidents since 1978 from all parties, socialist, centrist, and conservative. The judicial power rests upon the courts and tribunals established by law. (shrink)

Examining the ways and extent to which systemic factors affect health outcomes with regard to quality, affordability and access to curative healthcare, this explorative book compares the relative merits of tax-funded Beveridge systems and insurance-based Bismarck systems. The Law and Policy of Healthcare Financing charts and compares healthcare system outcomes throughout 11 countries, from the UK to Colombia. Thematic chapters investigate the economic and legal explanations for the relevant similarities, variations and trends across the globe. Concluding that systemic factors may (...) be less significant than previously believed, this comprehensive book notes that no one system consistently outperforms the others, yet incentives and funding improvements may lift performances across all curative healthcare systems. Analytical and comparative, this book will be of interest to academics working in the fields of health law and health economics. Public authorities including health ministries, policymakers and international health organisations will also find this to be an invaluable resource. (shrink)

Drawing on Sir Ian Kennedy's extensive experience in healthcare law, ethics and public policy-making, this book explores vital issues in the law surrounding healthcare and regulation. The book contains a range of published and unpublished essays and speeches with the addition of notes and commentaries by the author that bring the pieces up to the present day. Those who want to understand developments, from transplants to confidentiality, from COVID-19 to public inquiries to regulation will find a rich seam of rigorous, (...) informed analysis. The author's unique range of experience allows him to share insights on a variety of issues; from the conduct of the disgraced breast surgeon, Ian Paterson, to research at Porton Down, to the economics of innovation in drug development at NICE. His abiding interest in the welfare of children informs his trenchant forensic examination of how children fare in the NHS. Those involved in or with an interest in law, moral philosophy, and public policy will find much food for thought. (shrink)

This valuable resource provides academic and student affairs practitioners with the tools to make informed legal and ethical decisions in their college and university contexts. Law is constantly changing and is interpreted differently from campus to campus based on institutional culture and history. This text provides higher education practitioners with tools to anticipate practical and responsible action, engaging readers in anticipatory and reflective practice. In this text, Boettcher and Salinas introduce the Institutional Intelligence Model, a helpful framework that guides practitioners (...) in examining a wide variety of campus issues. Throughout the book, readers can explore perspectives from current practitioners and utilize case studies to examine specific topics including admissions, academics, student living, confidential resources, and graduate student experiences. By using the strategies in this book, practitioners will be equipped to successfully navigate legal and ethical issues on their campuses. This text is ideal for graduate students, student and academic affairs professionals, and those in leadership positions responsible for working with and supporting students and staff teams. (shrink)