Suchergebnisse

"Die Frage, ob wir Eigentum an unserem Körper haben, würden viele intuitiv bejahen. Doch der Körper ist keine Sache wie alle anderen. Wie sollen wir mit Körpermaterialien umgehen, die aus dem menschlichen Körper entfernt werden?" (Autorenreferat)

Grundsätzlich wirft die Tatsache, dass menschliche Gewebe und die daran geknüpften Daten kommerzielle Interessen wecken, die Frage nach einer angemessenen "Entgeltung" der Spender auf. Während diese ihre Proben und Daten zumeist aus Altruismus oder Solidarität mit anderen Patienten heraus spenden und verschiedene Forschungsprotokolle zudem einen expliziten Gewinnverzicht seitens der Spender vorsehen, ist es kaum ersichtlich, warum lediglich andere oder gar kommerzielle Akteure von der Forschung profitieren sollten, nicht jedoch die Spender selbst. Wie sich diese Asymmetrie abmildern lässt, ist daher eine wichtige Frage, die es im Rahmen einer zukünftigen Regelung der Biobankforschung zu klären gilt. Im vorliegenden Beitrag werden zunächst einige grundsätzliche Überlegungen zum Wert des menschlichen Körpers angestellt. Es folgt eine Darstellung von Regelungen zur "Kommodifizierung" des Körpers und seiner Teile, die folgende Fragen aufwerfen: Inwiefern können Körpermaterialien und -teile in verschiedenen sozialen Kontexten in den Bereich der "Dinge" übergehen? Wer kann überhaupt Rechte am menschlichen Körper sowie gegebenenfalls an abgetrennten Körperteilen oder -materialien ausüben oder erwerben? Weiterhin wird geklärt, was überhaupt unter dem Phänomen der Kommerzialisierung im Bereich menschlicher Gewebe und Organe zu verstehen ist, bevor die Kommerzialisierung und die Forschung mit Biobanken näher beschrieben und analysiert werden. (ICI2)

The European Medicines Agency and the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use are powerful international institutions for the regulation of biomedical research. Although not directly concerned with the ethical aspects of research, both institutions have disseminated position papers on ethical issues relating to the use of placebos in clinical trials. What appears initially to be guidance on the methodology of placebo-controlled trials (with very technical content) clearly has some far-reaching implications for the extent of risk patients can be expected to be subjected to in such trials. On the basis of this guidance, this article questions how much additional harm to patients would be acceptable in placebo-controlled trials in comparison with active-control trials. The article will show that the instruments provided in the guidance are unsuitable, remaining unclear on vital points and thereby leaving patients, researchers and research ethics committees without appropriate direction. In conclusion, placebo-controlled trials urgently need more. © The Author(s) 2014.

For more than 20 years the off-label use of drugs has been an essential part of the ethical and legal considerations regarding the international regulation of drug licensing. Despite a number of regulatory initiatives in the European Union, there seems to remain a largely unsatisfactory situation following a number of critical descriptions and statements from actors in the field. The present article gives an overview of the ethical and legal framework and developments in European countries and identifies existing problems and possible pathways for solutions in this important regulatory area. In addition to the presentation of the ethical and legal foundations, some attention is given to criticisms from medical practitioners to the current handling of off-label drug use. The review also focuses on the situation confronted by patients and physicians when off-label prescriptions are necessary. Through legal descriptions from a number of countries, possible solutions for future discussion of European health care policy are selected and explained.

Christian Lenk,1 Gunnar Duttge2 1Institute for History, Theory and Ethics of Medicine, Ulm University, Ulm, Germany; 2Center for Medical Law, Göttingen University, Göttingen, Germany Abstract: For more than 20 years the off-label use of drugs has been an essential part of the ethical and legal considerations regarding the international regulation of drug licensing. Despite a number of regulatory initiatives in the European Union, there seems to remain a largely unsatisfactory situation following a number of critical descriptions and statements from actors in the field. The present article gives an overview of the ethical and legal framework and developments in European countries and identifies existing problems and possible pathways for solutions in this important regulatory area. In addition to the presentation of the ethical and legal foundations, some attention is given to criticisms from medical practitioners to the current handling of off-label drug use. The review also focuses on the situation confronted by patients and physicians when off-label prescriptions are necessary. Through legal descriptions from a number of countries, possible solutions for future discussion of European health care policy are selected and explained. Keywords: ethics, law, Europe, health care policy

For more than 20 years the off-label use of drugs has been an essential part of the ethical and legal considerations regarding the international regulation of drug licensing. Despite a number of regulatory initiatives in the European Union, there seems to remain a largely unsatisfactory situation following a number of critical descriptions and statements from actors in the field. The present article gives an overview of the ethical and legal framework and developments in European countries and identifies existing problems and possible pathways for solutions in this important regulatory area. In addition to the presentation of the ethical and legal foundations, some attention is given to criticisms from medical practitioners to the current handling of off-label drug use. The review also focuses on the situation confronted by patients and physicians when off-label prescriptions are necessary. Through legal descriptions from a number of countries, possible solutions for future discussion of European health care policy are selected and explained. ; peerReviewed

This book presents a comprehensive overview of the field of biobanks and human tissue research, including ethical and legal challenges, regulatory issues, the rights of donors and patients, and examples and recommendations for the future of tissue research.

Human tissue and biobank research is of increasing importance for understanding the causes of widespread diseases and developing effective therapies. However, while the success of biobank research depends on the availability of a large number of samples and the consolidation of collections across country borders is very desirable from the perspective of researchers, the legal and ethical requirements for the procurement, storage and use of human tissue samples are rather heterogeneous across different countries. Moreover, the lack of comprehensive supranational regulation on human tissue and biobanking can be seen as posing a serious threat to transnational biomedical research. Against this background, it was one of the aims of the EU-funded Tiss.EU project ("Evaluation of Legislation and Related Guidelines on the Procurement, Storage and Transfer of Human Tissues and Cells in the European Union – an Evidence-Based Impact Analysis") to analyse the ethical and legal regulation of human tissue and biobank research across the 27 European Member States plus Switzerland. The results of nine international workshops and three conferences are gathered in this volume. While the country reports evaluate the implementation of ethical and legal guidelines at a national level, point out their strengths and deficits, and, where required, create an evidence base for the revision of said legislation, the conference reports address more general ethical and legal issues in this field. The volume is completed by a final presentation of project's results. - Human tissue and biobank research is of increasing importance for understanding the causes of widespread diseases and developing effective therapies. However, while the success of biobank research depends on the availability of a large number of samples and the consolidation of collections across country borders is very desirable from the perspective of researchers, the legal and ethical requirements for the procurement, storage and use of human tissue samples are rather heterogeneous across different countries. Moreover, the lack of comprehensive supranational regulation on human tissue and biobanking can be seen as posing a serious threat to transnational biomedical research. Against this background, it was one of the aims of the EU-funded Tiss.EU project ("Evaluation of Legislation and Related Guidelines on the Procurement, Storage and Transfer of Human Tissues and Cells in the European Union – an Evidence-Based Impact Analysis") to analyse the ethical and legal regulation of human tissue and biobank research across the 27 European Member States plus Switzerland. The results of nine international workshops and three conferences are gathered in this volume. While the country reports evaluate the implementation of ethical and legal guidelines at a national level, point out their strengths and deficits, and, where required, create an evidence base for the revision of said legislation, the conference reports address more general ethical and legal issues in this field. The volume is completed by a final presentation of project's results.

"Evidence-based Medicine (EBM) is feared to become a kind of cook-book medicine that has nothing to do with the traditional skills and ethics. This volume shows the contribution EBM makes and might make to medical practice and health policy. It describes as many viewpoints as possible with a focus on the ethical issues that are at stake in this process. It shows how EBM has developed from an internal medical issue to an instrument for health policy. It is the outcome of the European Project ""Ethical Issues of Evidence Based Practice in Medicine and Health Care"" and gives insight into the ethical background of the debate on the role of EBM in various areas of medicine, including clinical practice, medical education, medical research, health policy and medical sociology."