Biobank perspectives: Current issue
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: Current issues in ethics and law
Swedish research data inquiry on exceptions
The Swedish Government has decided to commission a Research Data Inquiry to review regulations regarding the processing of personal data for research. The reference group includes three researchers from CRB: Mats G. Hansson, Anna-Sara Lind and Jane Reichel.
New research on cyber governance of health data
Digital technology creates both a chance and a pressure to use health data for research and commercial purposes. But this emerging ‘health cyberspace’ needs to be handled in a way that meets our social expectations on governance, security and privacy. And at the same time allows data to be used in ways that are beneficial to society. This is what a project supported by Nordforsk is setting out to do.
Legal aspects of direct-to-consumer genetic testing
Regulating health services is challenging because of the multitude of legal questions it raises. Not only do they relate to the quality of the service and protection of its users, but also to the competence and authority of actors involved. Here Santa Slokenberga, LLD, offers insights from her research on regulating direct-to-consumer genetic testing at the European level.
Managing data protection in practice – Swedish perspectives
The legislative process regarding the General Data Protection Regulation (GDPR) is closed within the European Union as the Regulation was decided in April this year. The activity at the Government Offices of Sweden has, however, not ceased. Here, Anna-Sara Lind gives us her view on the consequences for Sweden.
Public-private research partnerships: Workshop
In recent years, universities have done a lot of work to promote research partnerships with industry. Medical schools are encouraging their research faculties to pursue entrepreneurial strategies (start ups) to start companies and partnerships with industry. Together with RD-Connect and CHIPme, we invite you to discuss these issues in a two day workshop looking at current practices for public private collaborations and especially initiatives on rare diseases on November 7-8 this year.
Informed consent guidelines listed among IRDiRC Recognized Resources
We are pleased to announce that a set of guidelines for informed consent in international collaborative rare disease research developed within the RD-Connect framework has received the IRDiRC Recognized Resources” label.
ELSI Helpdesk: What does it do?
The organisation of the ELSI Helpdesk is coordinated by the Swedish node. It gathers input from various sources and collaboration is ensured with other ELSI experts from the national nodes from the BBMRI-ERIC member states. LL.D. Moa Kindström Dahlin is the Chief Responsible Officer. Here, she offers her thoughts on the process of setting up a federated Helpdesk.
Data Protection Regulation: final result
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.
Risk of re-identification vs the need to identify individuals
There are risks associated with handling personal data in research. Unauthorised re-identification can cause harm. But there are clear benefits in terms of patient safety related to diagnosis and treatment if researchers are able to distinguish between individuals by identification.
It is your DNA, you should have a say
Genetic research depends on people donating their samples, allowing their genetic data to travel the world to be compared to data from other individuals. The policy that governs this process needs to be informed by what people really think. To find out, a unique research project is launching an online survey, YourDNAYourSay, to explore global public attitudes and beliefs around sharing genetic information.
Feedback of individual genetic results in Europe still not feasible
When it comes to genetic research, there is a growing consensus that research participants could be offered their individual results. Provided that they are scientifically robust, analytically valid and there is some clinical action people can take to prevent disease. Despite this, it is not common practice to do this in European genetic research. The reasons are many, one being the lack of legal frameworks, guidelines and resources to support feedback processes in research.
Call for ELSI experts
The BBMRI-ERIC ELSI Common Service relies on input from experts. They are now calling for your expertise!
EU-US Privacy Shield to once again ensure safe harbours for data transfers
The annulled Safe Harbour agreement puts research collaborations in a peculiar position. Here, Jane Reichel, Professor of Administrative Law, gives an update on the negotiations.
Effective consent for effective research
New sequencing techniques and the increasing sharing of data in international research consortia challenges the informed consent process, adding complexities that need to be co-ordinated. Rare diseases challege informed consent procedures.
Direct-to-consumer genetic testing companies lack clear consent processes for biobanking and research
Whole genome and exome sequencing are becoming cheaper and more available. High throughput techniques are no longer for research only. Today, both patients and consumers can have their genome sequenced. But the information consumers receive about this is often inadequate and could undermine the validity of the consent process.
ELSI: Inter-connecting legal frameworks, ethical and social issues
BBMRI-ERIC is a joint European platform for biobanking where ELSI service is considered a key asset. Moa Kindström Dahlin, doctor of public law, is the legal expert in the Uppsala team. Here she offers an update.
Unsafe harbours for researchers
There are many research projects in Europe that have safe harbour as a legal ground for sharing data between the EU and the US. These projects could now be in a peculiar situation as a judgment from the Court of Justice of the European Union concludes that Safe Harbour is not anymore a legally valid ground for sharing data between countries in the EU and the US.
How people value risk information
The Swedish SCAPIS study will identify individual risk factors for heart and lung disease. But how do research participants and patients perceive risk? And what do they want to know? Right now, two doctoral students are looking at people's preferences and perceptions.
Guideline for sharing specimens and data receives IRDiRC recommendation
The International Charter of principles for sharing bio-specimens and data has received a recommendation from the International Rare Diseases Research Consortium IRDiRC.
Renewed European effort to agree on data protection
The European Data Protection Regulation keeps moving through the administrative and legislative process. This summer, The Council, The European Parliament and the European Commission started the 'trilogue' negotiations. Here, Anna-Sara Lind gives her comments on the process.
Bioethicists suggest broad consent for biobank research
It is still unclear what kind of consent should be used when collecting biological samples for future research. Different forms of consent are practiced. This creates another uncertainty: which research is actually permitted with the collected samples?
Global research infrastructure for biobanking
The University of the Western Cape in South Africa just hosted the first meeting of B3Africa – a Horizon2020 CSA Action to bridge European and African biobanking and biomedical research.
Genetic risk: people might not know if they want to know
Biobank studies and genetic research aim at finding out the relationship between our genetic code and our diseases. Sometimes researchers find unexpected information about a participant. Asking people if they want this kind of risk information returned to them seems like a good idea. But is it fair to leave them to make that decision?
Trust based consent looks promising
Finding a model for informed consent that protects the integrity and interests of participants, future patients and researchers isn't easy. Recently, a group in Milano tested a trust based consent that I think looks promising.
Swedish research database legislation: update
Research databases like the Swedish Life Gene project have proven problematic and the Swedish Government has tried to find solutions for collections of samples and data for 'future research', a purpose that is not considered specific enough by the Data Inspection Board.
Information and law in transition
New information and communication technologies have created exciting new possibilities for connecting individuals across borders and continents but also significant legal, ethical and political concerns.
Regulating biobank research: new book
Biobank research and genomic information are changing the way we look at health and medicine. So how can we regulate it? A recent book published by Springer shows us how the regulatory systems work and raises a critical voice.
Research ethics for medicine and the life sciences
Research ethics and research integrity is not just following regulation. Researchers
need the ability to identify ethical aspects in their own research. And to do something about them.
The principles for sharing
To improve health care and validate research, we need to provide easier access to samples and data: Access that at the same time is ethical. This is the guiding principle in a new charter for sharing of biospecimens and data published by an international group of researchers in the European Journal of Human Genetics.
LifeGene: Case closed?
The LifeGene project has been heavily discussed among biobank researchers in the last couple of years. The project gave rise to a number of both scientific and legal matters.
ELSI common service for BBMRI-ERIC
BBMRI-ERIC is a platform for long term research collaborations between EU countries. Within the platform, groups can develop standards for technical, legal and ethical purposes and set up criteria for biobanks. It could also offer new possibilities for researchers to communicate with policymakers.
New law for research databases?
The Swedish Government considers national registries a unique and important resource. But the legal situation for these registries is unclear and could stand in the way of research.
What can ERIC do for biobanking?
What can the EU research governance tool ERIC do for biobanking? The answer to that can be found in the European Journal of Human Genetics where Jane Reichel, Anna-Sara Lind and Mats G. Hansson from CRB provides an analysis together with Jan-Eric Litton from BBMRI-ERIC.
Data protection update – A word on the legislative process
On March 12, the European Parliament accepted the Data Protection regulation. When it comes to EU regulation, this is only the beginning of the process. Anna-Sara Lind, Associate Professor of Public Law, gives us her word on the legislative process.
Dealing with genetic risk information
How do we evaluate and handle genetic risk information? For the coming six years, the Centre for Research Ethics & Bioethics (CRB) will co-ordinate an international research project to support health care, patients and decision makers.
Trust takes more than guidelines and review
Research ethics has developed into an extra legal regulatory system. Guidelines serve as steering documents, committees oversee and consent procedures are formal.
New law for Biobank researchers
The decision taken by the Swedish Data Inspection Board to stop the Life Gene research project was the point of departure for a lively nationwide debate on the legal criteria for biobank research projects in Sweden. The Data Inspection Board based its decision on the fact that Life Gene’s research purpose was not specific enough: This made it incompatible with the requirements of both the EU Data protection directive and the Swedish Personal Data Act.
We offer current issues in biobank ethics and law from the Centre for Research Ethics & Bioethics (CRB) and BBMRI.se.
News from CRB
- New study on children’s rights in biomedicine 2017-01-24
- New research ethics training for supervisors 2016-12-20
- Swedish radio about genetics, ethics and law 2016-11-10
- Funding for ethical and legal aspects of stem cell research 2016-11-02
- Giving patients a voice in drug development 2016-10-18
- Parent’s views on genetic screening before pregnancy 2016-10-17
- We need to discuss equity in health care 2016-10-04
- Preconception genetic screening: What health care professionals think 2016-05-31
- Age, education and health literacy affects understanding of risk 2016-05-19
- New book on direct brain communication 2016-05-13
- Help to choose good bioethics journals 2016-04-19
- Debate: Macchiarini scandal - speech of grey-zone lacks foundation 2016-03-10
- Play helps children with cancer 2016-03-07
- Debate: We need new ethical review legislation 2016-02-09
- Interview with Kathinka Evers in 3:AM Magazine 2015-12-20
The Ethics Blog
- Commercialization, but not at any price 2017-02-14
- Not just facts, ideas are also needed 2017-02-08
- How should we think about it? 2017-01-24
- The pharmaceutical industry and altruism 2017-01-16
- Ethics and law of stem cell treatment of diabetes 2016-12-21
- Research data, health cyberspace and direct-to-consumer genetic testing 2016-12-14
- Two researchers in neuroethics 2016-12-05
- The apparent academy 2016-11-29
- The brain develops in interaction with culture 2016-11-16
- What is the risk? 2016-11-02
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.