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Home
  • About
    • National Nodes
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    • Directory
    • Sample/Data Negotiator
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    • Quality Management
    • ELSI: Ethical, Legal and Social Issues in Biobanking
    • GDPR Code of Conduct
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    • ADOPT BBMRI-ERIC
      • Colorectal Cancer Cohort
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I am looking for information as

Researcher

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Industry

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Patient

  • Working with patient organisations
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Citizen

  • FAQs (what is a sample, what is a biobank)
  • Looking for biobanks in your country

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ELSI Library

Feel free to browse our library – please note that it is currently under development.

All Download Categories

FAQs

The EU General Data Protection Regulations: Answers to Frequently Asked Questions (Mar 2017)

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

Completing the Ethics Self-Assessment for H2020 Proposals – Introduction Part I (October 2019)

Material and Data Transfer Agreements (Apr 2019)

The GDPR – Anonymisation and Pseudonymisation (June 2018)

The GDPR and Health Research (Apr 2018)

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

Other Resources

MRC Regulatory Support Centre – Resources

CORBEL Innovation Helpdesk

AEGLE Legal – Processing Health Data after the GDPR

Overview of EU National Legislation on Genomics, JRC Science for Policy Report, European Commission

You may also be interested in

National Nodes

National Nodes & contact points for local biobanks

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and contact points for local biobanks.

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Projects

Partner up with us

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

The website was co-funded within ADOPT BBMRI-ERIC, a project that has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 676550.

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