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ELSI Library
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BBMRI-ERIC Position Papers & Responses to Public Consultations
Comments on Article 29 Working Party Guidelines on Consent (Jan 2018)
Comments on the EC Public Consultation: Transformation Health and Care in the Digital Single Market (Oct 2017)
Position Paper on the General Data Protection Regulations (Oct 2015)
Contribution to the WMA Declaration on Ethical Considerations Regarding Health Databases and Biobanks (Jun 2015)
Comments on the CoE Recommendation (2006)4 on Research on Biological Materials of Human Origin (Aug 2014)
Reports
Europe Biobank Week 2018: Ethics Cafe summary report (Dec 2018)
Rulemaking in the US (July 2018)
Biobanking: Ethical and Legal Issues Workshop (Jun 2017)
Ethics Review of European Biobank Research: Towards Mutual RECognition? (Sep 2016)
Sharing and Access to Data and Human Biospecimens for the Benefit fo Patients – Towards a BBMRI-ERIC Policy Workshop (Sep 2015)
Biobanks and the Public: Governing Biomedical Research Resources in Europe (2013)
Sample Templates and Guides
How to Guide - Governance in Biobanking (October 2019)
Informed Consent Matrix for Clinical Trials (July 2019)
Sample Material Transfer Agreement (Sept 2018)
Sample Data Transfer Agreement - Outgoing for Data Transfer within the EU (Sept 2018)
Data Transfer Guide for African States/EU Member States (Sept 2018)
Informed Consent Guide and Sample Template for Biobank and Registry-Based Research (Sept 2018)
BBMRI-ERIC Policy for Access to and Sharing of Biological Samples and Data
Sample Data and Material Transfer Agreement (Jan 2016)
CORBEL Innovation Helpdesk – Templates
CORBEL Innovation Helpdesk – Guidelines
RD-Connect MTA/DTA (Sep 2014)
BBMRI-ERIC Webinars
Binding Legal & Ethical Instruments
Regulation (EU) 2016/679 of the European Parliament and of the Council on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation), 27 April 2016
Charter of Fundamental Rights of the European Union, 26 October 2012
Directive 2006/86/EC implementing Directive 2004/23/EC as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells, 24 October 2006
Directive 2006/17/EC implementing Directive 2004/23/EC as regards certain technical requirements for the donation, procurement and testing of human tissues and cells, 8 February 2006
Directive 2004/23/EC of the European Parliament and of the Council on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells, 31 March 2004
Directive 2002/58/EC of the European Parliament and of the Council concerning the processing of personal data and the protection of privacy in the electronic communications sector (Directive on privacy and electronic communications), 12 July 2002
Directive 98/44/EC of the European Parliament and of the Council on the legal protection of biotechnological inventions, 6 July 1998
Additional Protocol on the Prohibition of Cloning Human Beings, 12 January 1998;
Council of Europe Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine (Oviedo Convention), 4 April 1997
European Convention on Human Rights, 1950
Non-Binding Legal and Ethical Instruments and Standards
WMA Declaration of Taipei on Ethical Considerations regarding Health Databases and Biobanks, October 2016
Council of Europe Recommendation (2016)6 of the Committee of Ministers to member States on research on biological materials of human origin, 11 May 2016
Global Alliance International Code of Conduct for Genomic and Health-related Data Sharing, 2014
WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects, October 2013
ISBER Best practices for repositories: collection, storage, retrieval, and distribution of biological materials for research, third edition, 2012
HUGO Ethics Committee Statement on benefit sharing, 9 April 2009
OECD Guidelines for Human Biobanks and Genetic Research Databases (HBGRDs), 2009
OECD Principles and Guidelines for Access to Research Data from Public Funding, 2007
Council of Europe Recommendation (2004)10 of the Committee of Ministers to member States concerning the Protection of the Human Rights and Dignity of Persons with Mental Disorder, 22 September 2004
EGE, European Group on Ethics in Science and New Technologies relevant Opinions
Article 29 Data Protection Working Party Guidelines and Opinions
Article 29 Data Protection Working Party archived opinions and recommendations between 1997 and November 2016
EuroBioBank SOPs
WCRIF Statements on Research Integrity
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Projects
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We welcome requests from individual researchers as well as research teams seeking project collaborations with BBMRI-ERIC and/or its National Nodes.
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Recent News
BBMRI-ERIC Assembly of Members Approves Work Programme for 2019
This edition of the Work Programme is the first in a series based on our Vision Paper, which sets out the strategic objectives for the years ahead...... read more
European Biobank Week 2019 in Lübeck
Europe Biobank Week 2019 will take place in Lübeck, Germany, from October 8 to 11. More details on the speakers, the programme, etc. will follow soon.... read more
