Suchergebnisse

The EOSCpilot project has recently published draft policy recommendations (deliverable 3.3) as a step towards establishing the required policy environment to support the European Open Science Cloud (EOSC). The inclusion of ethical principles and policies are of fundamental importance to the EOSC, but it is difficult to anticipate all the ethical issues that may emerge as the scientific, technical, social and political landscape evolves. Therefore, a survey was performed to collect feedback on the proposals made from the different key stakeholder groups, plus explore how the draft recommendations can be integrated into the 'policy supporting services' that now need to be developed. This document summarises methods and results of the EOSCpilot ethics survey.

EOSC-Life is a 4-year project funded under the European Union's Horizon 2020 programme. It aims to bring together the 13 Research Infrastructures in the Health and Food domain of the ESFRI Roadmap to create an open, collaborative digital space for life sciences in the European Open Science Cloud (EOSC). In March 2020, after the COVID-19 pandemic outbreak and as a rapid response to it EOSC-Life added to its work plan two new work packages to help tackle the pandemic. In EOSC-Life WP14, the European Clinical Research Infrastructure Network (ECRIN, https://ecrin.org/) has partnered with the University of Oslo (UiO, https://www.uio.no/english/) in order to commonly design, develop, implement and operate a repository for individual participant data (IPD) from COVID-19 clinical research studies that is compliant with European regulations and in particular with the GDPR. For the storage of the IPD, the TSD infrastructure of the University of Oslo will be used, which is a multitenant remote access system with a strong set of built-in security measures. The present document highlights the Data Sharing Policy of the COVID-19 repository under development in EOSC-Life WP14. A model Data Transfer Agreement for further discussions with Data Object Providers can also be made available on request (contact maria.panagiotopoulou@ecrin.org).

This paper discusses how an ethical dimension can best be included within the policies, structures and services of the developing European Open Science Cloud (EOSC). Although the inclusion of ethical principles and policies are seen as of fundamental importance to the EOSC, it is difficult to anticipate all the ethical issues that may emerge as the scientific, technical, social and political landscape evolves. It is therefore seen as crucially important to have governance mechanisms in place that can ensure ethical issues are appropriately dealt with in the future, however and whenever they are presented, as well as identifying and proposing responses to current issues. An analysis of ethical issues relating to organisational conduct and policies, research conduct, research decision making, the use of data, especially sensitive personal data, and the interaction between science and society, serves to underline the complexity and diversity of potential issues.

Background: Clinical trials remain key to the development of evidence-based medical practice. However, they are becoming increasingly complex, mainly in a multinational setting. To address these challenges, the European Union (EU) adopted the Clinical Trial Regulation EU No. 536/2014 (CTR). Once in force, the CTR will lead to more consistent rules and simplification of procedures for conducting clinical trials through-out the EU. Existing harmonization initiatives and "research infrastructures" for clinical trials may facilitate this process. This publication offers a snapshot of the current level of harmonization activities in academic clinical research in Europe. Methods: A survey was performed among the member and observer countries of the European Clinical Research Infrastructure Network (ECRIN), using a standardized ; publishersversion ; published

BACKGROUND: Clinical trials remain key to the development of evidence‐based medical practice. However, they are becoming increasingly complex, mainly in a multinational setting. To address these challenges, the European Union (EU) adopted the Clinical Trial Regulation EU No. 536/2014 (CTR). Once in force, the CTR will lead to more consistent rules and simplification of procedures for conducting clinical trials throughout the EU. Existing harmonization initiatives and "research infrastructures" for clinical trials may facilitate this process. This publication offers a snapshot of the current level of harmonization activities in academic clinical research in Europe. METHODS: A survey was performed among the member and observer countries of the European Clinical Research Infrastructure Network (ECRIN), using a standardized questionnaire. Three rounds of data collection were performed to maximize completeness and comparability of the received answers. The survey aimed to describe the harmonization of academic clinical research processes at national level, to facilitate the exchange of expertise and experience among countries, and to identify new fields of action. RESULTS: Most scientific partners already have in place various working groups and harmonization activities at national level. Furthermore, they are involved in and open to sharing their know‐how and documents. Since harmonization was mainly a bottom‐up approach up until now, the extent and topics dealt with are diverse and there is only little cross‐networking and cross‐country exchange so far. CONCLUSIONS: Currently, the ECRIN member countries offer a very solid base and collaborative spirit for further aligning processes and exchanging best practices for clinical research in Europe. They can support a smooth implementation of the EU CTR and may act as single contact with consolidated expertise in a country.