BBMRI-ERIC is a joint European platform for biobanking that will provide a workable research infrastructure to process, share and store human biological samples, including associated medical data.
One of the biggest hurdles for biobank research today is the differences in regulatory frameworks for biobanking within the EU. BBMRI-ERIC is a European Research Infrastructure Consortium, or 'ERIC', for biobanking.Part of this work is providing a common service for the ethical, legal and societal issues.
This ELSI service service facilitates and supports cross-border exchanges of human biological resources and data attached for research uses, collaborations and sharing of knowledge, experiences and best practices.
BBMRI-ERIC ELSI Policy
As a step toward a BBMRI-ERIC ELSI policy, the ELSI Common Service arranged a workshop on sharing and access to data and human biospecimens for the benefit of patients. The workshop was held in September 2015.
CRB's ELSI-Service team
Our expert team is part of the ELSI service with:
- Mats G. Hansson, Professor of biomedical ethics
- Heidi C. Howard, PhD Neurogenetics
- Moa Kindström Dahlin, LLD public law
The service is directed by Anne Cambon Thomsen at the French national centre for scientfic research (CNRS) and co-directed by Mats G. Hansson at CRB, Marialuisa Lavitrano from the Milano-Bicocca University and Jasper Adriaan Bovenberg, founder of the Legal Pathways Institute.
Biobanks and registries in research
We aim for a biobank and registry management that satisfies ethical and legal demands from the research community, the public and the individual.
ELSI-Service for BBMRI.se
We have run ELSI-Services for BBMRI.se (BioBanking and Molecular Resource Infrastructure of Sweden): a national effort for efficient and automated collection of biological material funded by the Swedish Research Council. Now replaced by Biobank Sweden.
B3Africa will harmonise ethical and legal frameworks between European and African partner institution and provide an informatics solution for data management, processing and sharing that works with limited Internet access.
Biobank and registry ethics & law
For many years, researchers at CRB have provided constructive advise on how to deal with ethical and legal aspects of research using human tissue material and personal data. We have collaborated with biomedical scientists and published our findings in peer reviewed journals. As a summary of this research we have compiled a list of publications with abstracts. We have grouped them thematically to help you find the ones you might be interested in reading. Our publications deal with ethical frameworks and policy, regulatory aspects of biobank and registry research, informed consent, ethical review, integrity concerns, trust, genetic testing, indicental findings, commercialization, public and patient perceptions, rare diseases, children & biobanks & genetics, and biobank studies.
Biobank perspectives: Current issues in ethics and law
We have worked with the ethical and legal aspects of biboank and registry research for more than a decade. With the aid of BBMRI.se we are able to share our perspectives with the biobank community through the biobank perspectives newsletter.
Biobank perspectives 1:2017
In this issue of Biobank Perspectives you can read about some of the challenges that arise when biobanking stem cells in relation to a new project on the legal and ethical aspects of using stem cells to treat type 1 diabetes. We also offer an progress update from the B3Africa project and present the new Swedish legal officer BBMRI-ERIC ELSI helpdesk. You can also read about the Swedish Government Inquiry that was presented recently, proposing a new legal framework for handling and investigating research misconduct, with a new act is suggested to enter into force on 1st of January 2019.
Biobank perspectives 4:2016
We live in a global society, which means there are several actors that regulate both research and services directed at consumers. In this issue of Biobank Perspectives, you can read about the legal aspects of direct-to-consumer genetic testing. Santa Slokenberga writes about her doctoral dissertation in law from Uppsala University and how the Council of Europe and the EU interact with each other and the legal systems in the member states. She believes direct-to-consumer genetic testing can be seen as a 'test' of the European legal orders, showing us that there is need for formal cooperation and convergence as seemingly small matters can lead tolarge consequences.
To follow up from the last issue where Anna-Sara Lind reported on the General Data Protection Regulation in a Swedish perspective, we give you more information about the Swedish Research Data Inquiry. We are also happy to announce that a group of researchers from the University of Oxford, University of Iceland, University of Oslo and CRB at Uppsala University received a Nordforsk grant to find solutions for governance of the 'health cyberspace' that is emerging from assembling and using existing data for new purposes.
Biobank perspectives 3:2016
If you did not get your fill during the biobank week in Vienna, we give you more biobank related news. In this issue, Moa Kindström Dahlin describes what BBMRI-ERIC’s new federated Helpdesk for ELSI-issues can offer. We invite you discuss public-private partnerships in research in Uppsala this November. The legislative process on data protection in the EU might be over for now but there is still activity in government offices. Anna-Sara Lind gives you her view on the consequences for Sweden. We are also happy to announce that the guidelines for informed consent in collaborative rare disease research have received the IRDiRC Recognized Resources label.
Biobank perspectives 2:2016
In this issue, Anna-Sara Lind gives us an update on the what the final results of the negotiations for a general data protection regulation in the European Union. You can also read about two papers: The first compares the risks associated with handling personal data in research to the benefits in terms of patient safety if individuals can be identified. The other suggests that it is not (yet) feasible for European research to give feedback of individual results. One reason is the lack of legal frameworks, guidelines and resources to support the feedback process.You can also read about the BBMRI-ERIC call for ELSI experts and find out how to choose good bioethics journals.
We have provided constructive advise on how to deal with the ethical and legal aspects of research on samples and data for more than a decade. This makes us proud to also present an updated version of our report on ethical and legal aspects of biobank and registry research with abstracts of what we have published so far.
Biobank perspectives 1:2016
In this issue, Jane Reichel gives us her view on how the EU-US Privacy Shield will ensure safe harbours for data transfer in the future. We also report how direct-to-consumer genetic testing companies lack clear consent procedures for biobanking and research. Soon, these tests might become difficult to market and offer in Europe, with the European Commission proposing changes to the European Directive on in vitro diagnostic medical devices.
You can also read about challenges to informed consent posed by rare disease research and how RD-Connect researchers proposes to meet them. Finally, on behalf of the CHIPme COST Action network, we invite you to a workshop on genetic data in public research databases in Bolzano this spring.
Biobank perspectives 4:2015
In this issue, Moa Kindström Dahlin gives her perspective on the ELSI common service BBMRI-ERIC provides and how legal frameworks are interconnected with ethical and social issues. Anna-Sara Lind gives an update about what happens now that the European Court of Justice ruled that the Safe Harbour Clause is not a legally valid ground for sharing data between EU and the US. You can also read about two PhD projects looking at how participants in the Swedish SCAPIS study perceive risk information and what and how they would like to know about their potential individual risks for disease and disorders.
Biobank perspectives 3:2015
In this issue you can read about a statement paper in the American Journal of Bioethics that suggests using broad consent for biobank research. We take you through the European Union’s efforts to agree on data protection and the launch of B3Africa that will bridge European and African biobanking and biomedical research. We are also happy to announce that the International Charter of principles for sharing bio-specimens and data has received a recommendation from the International Rare Diseases Research Consortium IRDiRC.
Biobank perspectives 2:2015
This time you can read about a new book "Information and law in transition" that deals with the legal, ethical and political concerns that new information and communication technologies create in different fields, including welfare, health and research. But there is more: Anna-Sara Lind provides an update on the development of Swedish research database legislation. Mats G. Hansson introduces us to based consent as a model for informed consent that could protect the integrity and interests of participants, future patients and researchers. You can also read about a recent paper in Bioethics that discusses returning risk information to people who participate in genetic research.
Biobank perspectives 1:2015
In this issue you can read about the European data protection regulation, new books with collections of texts and reflections from the Ethics Blog, an anthology about the regulation of biobank research and a new type of online research ethics training for medicine & the life sciences.
Biobank perspectives 3:2014
In this issue you can read about an article in the European Journal of Human Genetics on a new charter for sharing biospecimens and data. We write about the report from the Swedish Government committee on legal conditions for registry based research and the proposed ELSI common service for BBMRI-ERIC. Anna-Sara Lind also writes about LifeGene: Case closed?
Biobank perspectives 2:2014
In this issue you can read more about a new international research collaboration on genetic risk information. We give you an update on the new Swedish law for registers for research on the health implications of heritage and environment that makes it possible for the LifeGene project to continue. The EU Data protection regulation is on the way and we give you some information on the legislative process.
Biobank perspectives 1:2014
The first issue of Biobank Perspectives offers an analysis of the proposed EU Data Protection Regulation’s articles 81 and 83 by Anna-Sara Lind and Jane Reichel. We also cover the Finnish Act on Biobanks that entered into force on September 1, 2013. You can also read about the return of incidental findings and possible policy pathways for biobanks.