Suchergebnisse

Lessons learned from the arena of other genetic 'resources' (such as plants and animals) together with the past decade of experience in human genetic research requires a rethinking of policy approaches. Whether at the level of whole populations, the family or the individual, the determination of rights and responsibilities is necessarily situated in the context of relationships. From an appreciation of these relationships emerge ethical principles that reflect the complexity of both the human person and new technologies. The elaboration of principles such as individuality, mutuality, reciprocity, solidarity, equity, citizenry and universality foster the possibility that traditional human rights and bioethic principles can be interpreted in a new way so as to promote and protect human well-being.

The majority of international or national guidelines, specific to human genetics concentrate on actual or potential clinical applications. In contrast, the Ethics Committee of the Human Genome Organisation (HUGO) attempts to provide guidance to the bench scientists engaged in fundamental research in genomics prior to any clinical applications. Often confused as constituting the Human Genome Project (HGP) itself, HUGO's (Human Genome Organization) ultimate goal is to assist in the worldwide collaboration underpinning the HGP. It is an international organisation with 1,229 members in approximately 60 countries. The Ethics Committee is one of HUGO's six international advisory committees. Composed of experts from a number of countries and disciplines, the HUGO Ethics Committee promotes discussion and understanding of social, legal, and ethical issues as they relate to the conduct of, and knowledge derived from, the Genome Initiative. Currently, it has 13 members from 11 different countries. It has produced statements on the conduct of genetic research, on cloning, and, has most recently presented a 'Statement on Benefit-Sharing', April 11, 2000. The Intellectual Property Committee of HUGO has been active in the controversial area of patenting. The issue of benefit-sharing is one that has its source in the mandate of both committees. How to avoid both commodification of the person through payment for access to DNA and biopiracy with no return of benefits to the families or community? While patents are a legitimate form of recognition for innovation, there seems to be no therapeutic exception to some of its stringent rules and the 'morality' exclusion has lain dormant. The HUGO 'Statement on Benefit-Sharing' examines the issues of defining community, common heritage, distributive justice and solidarity before arriving at its conclusions in benefit-sharing. This communication reviews some of these issues.

Abstract In genomic research, cohort and large-scale population studies are proliferating along with accompanying infrastructures (databases and biobanks). Population-based research links samples and data from multiple sources often obtained for other purposes. The normative frameworks of many countries are largely based on 1980 OECD principles which limit the uses of personal data, especially for secondary purposes. These limits, now found in legislation, policies and research guidelines, pose major barriers to population-based research. This text examines similarities and differences between epidemiology, public health research and genomics. It also distinguishes between primary and secondary uses of personal information. In a comparative and critical analysis of the normative landscapes of five countries, Québec (Canada), Germany, Australia, the United States and the United Kingdom, three barriers are identified: the impracticability of re-consent; the shortcomings of the review process (ethics and privacy) and certain multi-jurisdictional issues. Recommendations are proposed.

"Increasingly globalization has meant that decisions made regarding medical care and health in one country may influence health and disease outcomes in other parts of the world. Recognizing that medical law should not be confined to national silos this handbook approaches medical law and ethics from a global perspective. Whilst respecting and analyzing national developments the chapters take a concerted international approach, looking comparatively at developments within each area. The book brings together leading scholars from both medical law and ethics backgrounds who have contributed specially commissioned pieces in order to present a critical overview and analysis of the current state of the field. The Handbook offers comprehensive coverage of longstanding and traditional topics in medical law and ethics, as well as providing dynamic insights into contemporary and emerging issues in this heavily debated field. Topics covered include: "Human-animal" medicine and medical research Public Health Access to resources and medicines Traditional, complementary and alternative medicines Regenerative Medicine This advanced level reference work will prove invaluable to scholars, students and researchers in the disciplines of law, medicine, dentistry, nursing, ethics and theology "--

"Increasingly globalization has meant that decisions made regarding medical care and health in one country may influence health and disease outcomes in other parts of the world. Recognizing that medical law should not be confined to national silos this handbook approaches medical law and ethics from a global perspective. Whilst respecting and analyzing national developments the chapters take a concerted international approach, looking comparatively at developments within each area. The book brings together leading scholars from both medical law and ethics backgrounds who have contributed specially commissioned pieces in order to present a critical overview and analysis of the current state of the field. The Handbook offers comprehensive coverage of longstanding and traditional topics in medical law and ethics, as well as providing dynamic insights into contemporary and emerging issues in this heavily debated field. Topics covered include: "Human-animal" medicine and medical research Public Health Access to resources and medicines Traditional, complementary and alternative medicines Regenerative Medicine This advanced level reference work will prove invaluable to scholars, students and researchers in the disciplines of law, medicine, dentistry, nursing, ethics and theology "--

"Increasingly globalization has meant that decisions made regarding medical care and health in one country may influence health and disease outcomes in other parts of the world. Recognizing that medical law should not be confined to national silos this handbook approaches medical law and ethics from a global perspective. Whilst respecting and analyzing national developments the chapters take a concerted international approach, looking comparatively at developments within each area. The book brings together leading scholars from both medical law and ethics backgrounds who have contributed specially commissioned pieces in order to present a critical overview and analysis of the current state of the field. The Handbook offers comprehensive coverage of longstanding and traditional topics in medical law and ethics, as well as providing dynamic insights into contemporary and emerging issues in this heavily debated field. Topics covered include: "Human-animal" medicine and medical research Public Health Access to resources and medicines Traditional, complementary and alternative medicines Regenerative Medicine This advanced level reference work will prove invaluable to scholars, students and researchers in the disciplines of law, medicine, dentistry, nursing, ethics and theology "--

Abstract
The right to benefit from science and its applications is one of the least studied, discussed and applied human rights. In the current time of globalization, characterized by the rapid advancement of science and its technological applications, as well as by increased flows of scientific data, there is a growing need to fully awaken the right of everyone to enjoy the benefits of science. This would enable science to better serve the humanitarian purposes of the law as well as foster scientific and technological development through data sharing. This article contributes to the awakening of the right by exploring it doctrinally with the aim of ascertaining its normative content by reference to the preparatory works of Article 15 of the International Covenant on Economic, Social and Cultural Rights and, especially, the subsequent state practice in its application. Based on the evidence, it will be argued that, today, the right to benefit from science has two aspects – first, the right to access scientific knowledge and information and, second, the right to benefit from scientific applications. It will be shown that the first aspect of the right is increasingly reflected in the practice of states and international organizations and has important implications for the regulation and sharing of big genomic data.

The Centre of Genomics and Policy at McGill University has conducted an analysis of the ethico-legal requirements enshrined in data privacy law and research ethics guidance in Canada and the European Union. This Points-to-Consider document is intended to synthesize the elements of that research that are of relevance to the secondary use of health data by the cohorts of the euCanSHare project. In this summary, we have provided a general overview of our research. In Part 1, we assess the sources of the ethico-legal requirements discussed. In Part 2, we consider a number of regulatory requirements in the laws of Canada and the European Union. Elements discussed include legal prerequisites to data use, individual rights in data, and prerequisites to the international transfer of data. In Part 3, the identifiability of data, and the use of safeguards to protect data, are considered. In Part 4, the foregoing ideas are synthesized into holistic proposals for data governance. The conclusions of this Points-to-Consider document reprise the contents of recent and forthcoming academic publications that elaborate our findings in further detail. ; This deliverable has been produced in the context of the euCanSHare (An EU-Canada joint infrastructure for next-generation multi-Study Heart research) Research and Innovation Action, funded by the European Union's Horizon 2020 programme (grant agreement No 825903), the Canadian Institutes of Health Research (CIHR) and the Fonds de recherche du Québec – Santé under the framework of Canada‐EU Commission Flagship Collaboration for Human data storage, integration and sharing.