Editorial : Plant Genome Editing – Policies and Governance

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Humanbiobanken

Wie aus „sensiblen Daten“ „Big Data“ wird - Biobanken im Humanbereich sind Sammlungen von Proben menschlicher Körpersubstanzen (etwa Gewebe, Blut, genetisches Material), die mit sensiblen personenbezogenen Daten und insbesondere gesundheitsbezogenen Informationen über die Spender digital verknüpft sind. Sie stellen eine bedeutende Ressource für die biomedizinische Forschung dar, um Ursachen und Mechanismen zahlreicher Erkrankungen besser zu verstehen und deren Diagnose und Behandlung weiterzuentwickeln. Bei der Errichtung und Handhabung von Humanbiobanken sind das Interesse an medizinischer Forschung und die Forschungsfreiheit einerseits mit den Rechten und Interessen der Probenspender und Patienten andererseits in Einklang zu bringen. Daher werfen Biobanken ethische und rechtliche Fragen auf, die vom Schutz individueller Persönlichkeitsrechte bis hin zur globalen Regulierung von Forschungsinfrastrukturen reichen. Der Sachstandsbericht führt in dieses Gebiet ein und informiert über die biomedizinischen Grundlagen der Handhabung von Humanbiobanken, ihre rechtlichen Regelungen und die mit ihnen verbundenen ethischen Debatten.How “sensitive data” becomes “big data” - Human biobanks are collections of samples of human bodily substances (such as tissue, blood and genetic material) which are digitally linked to individual donor data and especially health-related information. Human biobanks constitute an essential resource for biomedical research on causes and mechanisms of numerous diseases and their diagnosis and treatment. In the building and management of human biobanks, the objectives of medical research and freedom of research are to be brought into accordance with the rights and interests of donors and patients. As a consequence, biobanks raise ethical and legal questions ranging from the protection of individual personal rights to the global regulation of research infrastructures. This expert report is an introduction to this field and informs about the biomedical basic principles of managing human biobanks, their legal regulations and the associated ethical debates

An EU comparative analysis of the regulation of clinical trials supervisory bodies in the aftermath of Regulation 536/2014

The new EU regulation on clinical trials is intended to promote a greater level of harmonization of European Union rules in this area. However, it does not elaborate a common normative framework regarding the functioning of research ethics committees, leaving this responsibility to the Member States. This article offers a comparative analysis of the resulting regulatory situation. It demonstrates that this scenario is defined by considerable variability in the regulation of ethics monitoring between the EU Member States. We argue that this disparity should not necessarily be a negative factor for the optimization of the trial supervision regime in the EU. Moreover, we consider that it may be a stimulus for the achievement of excellence in the performance of this monitoring task. On the other hand, we also highlight risks for the rights of participants if an adequate monitoring framework is not ensured. Under these circumstances, we observe how the EU faces a dilemma. On the one hand, it may promote a rigid uniformity between the regulation of ethics committees between Member States, but this might diminish the quality of their performance. On the other hand, it may opt for maintaining the current situation, but this might increase differences in the performance of the ethics committees between Member States, including the number trials performed by country. A third option would be to allow the competitive framework to remain for a set period of time, in order to learn from the best practices reached in individual Member States before finally harmonizing national legislative provisions on this basis.This work was supported by Eusko Jaurlaritza [grant number Ayudas a grupos de investigación IT-1066-16]; H2020 Science with and for Society [grant number GRANT AGREEMENT NUMBER — 788039 — PANELFIT]

An EU Comparative Analysis of the Regulation of Clinical Trials Supervisory Bodies in the Aftermath of Regulation 536/2014

status: publishe

An EU Comparative Analysis of the Regulation of Clinical Trials Supervisory Bodies in the Aftermath of Regulation 536/2014

The new EU regulation on clinical trials is intended to promote a greater level of harmonization of European Union rules in this area. However, it does not elaborate a common normative framework regarding the functioning of research ethics committees, leaving this responsibility to the Member States. This article offers a comparative analysis of the resulting regulatory situation. It demonstrates that this scenario is defined by considerable variability in the regulation of ethics monitoring between the EU Member States. We argue that this disparity should not necessarily be a negative factor for the optimization of the trial supervision regime in the EU. Moreover, we consider that it may be a stimulus for the achievement of excellence in the performance of this monitoring task. On the other hand, we also highlight risks for the rights of participants if an adequate monitoring framework is not ensured. Under these circumstances, we observe how the EU faces a dilemma. On the one hand, it may promote a rigid uniformity between the regulation of ethics committees between Member States, but this might diminish the quality of their performance. On the other hand, it may opt for maintaining the current situation, but this might increase differences in the performance of the ethics committees between Member States, including the number trials performed by country. A third option would be to allow the competitive framework to remain for a set period of time, in order to learn from the best practices reached in individual Member States before finally harmonizing national legislative provisions on this basis.This work was supported by Eusko Jaurlaritza [grant number Ayudas a grupos de investigación IT-1066-16]; H2020 Science with and for Society [grant number GRANT AGREEMENT NUMBER — 788039 — PANELFIT]