What does it do?
BBMRI-ERIC provides support on ethical, legal and societal issues related to biobanking activities through its Common Service ELSI. Among other things, the ELSI-group is offering practical interpretation on new legislation. It also monitors relevant ethical and legal frameworks in development and communicates publications, research results, surveys, and informs about relevant meetings. We are also setting up a federated Helpdesk. The vision and aim is to make the Helpdesk available, feasible, practical, usable, reliable, verifiable and sustainable.
This Helpdesk will provide general information on topics that are crucial for biobanking, regarding for example informed consent, data protection and support on ethical questions. It will also offer customised help. The practical tools to help provide this service are currently under development together with IT experts.
Who is it for?
The Helpdesk offers support on ethical, legal and societal issues related to biobanking activities. It is primarily intended for users located in Member Countries of BBMRI-ERIC.
The challenges:
Offering this service is faced with some challenges. The field covers many questions intimately connected to fundamental legal rights, and involves ethical and societal issues that often are politically controversial. Different countries have different regulations, professionals bring different perspectives and different expertise, and the knowledge of genetics and genomics is uncertain. Researchers will always have to reflect upon, and be responsible for, their practice themselves: both legally and ethically. But the BBMRI-ERIC Common Service ELSI will provide tools and expertise to navigate within this landscape of reflection.
What have we achieved so far?
Updated version of the FAQs on the General Data Protection Regulation
Contribution to the draft WMA Declaration on ethical considerations regarding health databases and biobanks
Comments to the draft Council of Europe’s Recommendation (2006)4 on research on biological materials of human origin
Tools
Who to contact?
elsi@helpdesk.bbmri-eric.eu
Which standard contracts to take into consideration?
MTA/DTA templates can be found under Publications: Standard Contracts (e.g., MTA/DTAs)
Which ethical/legal instruments to take into consideration?
Overview of binding and non-binding instruments in Europe, in addition to the national laws and requirements in the respective country of your research. Consider that additional instruments might be of relevance in the context of your specific research project.
Binding instruments:
- European Convention for the Protection of Human Rights and Fundamental Freedoms, 1950;
- Charter of Fundamental Rights of the European Union, OJC 326, 26 October 2012
- 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; as well as relevant additional protocols such as Additional Protocol on the Prohibition of Cloning Human Beings, 12 January 1998;
- Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells;
- 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;
- 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;
- Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions;
- EU General Data Protection Regulation;
- Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector.
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Non-binding instruments:
- WMA Declaration of Helsinki, Brazil, 2013;
- OCDE Guidelines for Human Biobanks and Genetic Research Databases (HBGRDs), 2009;
- Council of Europe Rec(2004)10 concerning the Protection of the Human Rights and Dignity of Persons with Mental Disorder;
- Recommendation CM/Rec(2016)6 of the Committee of Ministers to member States on research on biological materials of human origin;
- ISBER Best practices for repositories: collection, storage, retrieval, and distribution of biological materials for research, third edition, 2012;
- EGE, European Group on Ethics in Science and New Technologies relevant Opinions;
- Article 29 Data Protection Working Party opinions and recommendations;
- EuroBioBank SOPs;
- OECD Principles and Guidelines for Access to Research Data from Public Funding, 2007;
- Global alliance, International code of conduct for genomic and health-related data sharing;
- HUGO Ethics Committee Statement on benefit sharing, 2009;
- Singapore Statement on Research Integrity, 2010;
- WMA Declaration of Taipei 2016.
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