Direct-to-consumer genetic testing companies lack clear consent processes for biobanking and research

A new large European research project will fill the knowledge gaps when it comes to medical treatments of pregnant and nursing women. To be able to evaluate the effects of drugs during pregnancy and breast feeding, Uppsala biobank will collect and store breast milk and blood samples form pregnant and nursing women currently under medical treatment. The samples will be collected from women around Europe. In addition, the drug analysis platform UDOPP at the SciLifeLab’s Uppsala site will develop methods and technology to analyze drug residues in milk and blood.

The Swedish Research Council-funded research infrastructure Biobank Sweden supports healthcare providers and universities with medical faculties working towards national harmonization in biobanking.

Should researchers inform research participants, if they discover genetic disease risks in the participants? Yes, many would say, if the information is helpful to the participants. However, the value of complex genetic risk information for individuals is uncertain. In a PhD thesis from Uppsala University, Jennifer Viberg Johansson suggests that this uncertainty needs to be acknowledged by both geneticists and ethicists.

Despite the fact that the European General Data Protection Regulation (GDPR) provides ways to transfer data, it is difficult to find ways to share data between Europe and Africa. The feasible routes rely on EU enforcement. This means the possibilities for oversight are limited, leading to considerable data privacy risks.

We are looking for a legal project coordinator for the Swedish ELSI-helpdesk that will provide service for researchers connected to the Swedish research infrastructure Biobank Sweden. Apply by February 20, 2018.
 

The likelihood of disease is not always informative to research participants. The numeric sense of genetic risk does not always correspond to their understanding of risk information. Instead, research participants tend to understand genetic risk as a binary concept: you either are at risk, or you are not.

The focus on Public Private Partnership (PPP) emerged as PPPs are strongly endorsed as a model by EU grant funding schemes. The stakeholders workshop Ethically and legally sustainable partnership between industry and public funded research initiatives: PPP and Rare diseases as a case study took place at Uppsala University, organized by the Centre for Research Ethics & Bioethics (CRB), RD-Connect and the COST Action CHIP ME on 7-8 November 2016. A wide range of Stakeholders took part to the event creating a very interesting and challenging discussion from different perspectives.

Stem cells are perhaps not what first springs to mind as biobank material. Yet, even stem cells can be biobank material and there are biobanks that focus on stem cells. The use of this biobank material, however, has some unique features.

Recently, a Swedish Government Inquiry  proposed a new legal framework for handling and investigating research misconduct. A new act is suggested to enter into force on 1st of January 2019. Here, Anna-Sara Lind presents the main novelties in the proposal.

In its first 18 months, B3Africa has taken two essential steps: the development of a technical solution for biobank research, and the design of a culture sensitive ethical and legal framework to ensure the rights of the sample donors are safeguarded.

From February 1 2017, LL.D. Santa Slokenberga is taking over Moa Kindström Dahlin’s obligations at the BBMRI-ERIC ELSI Common Service.

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.

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.

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.

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.

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.

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. 

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.

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.

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.

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.

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.

The BBMRI-ERIC ELSI Common Service relies on input from experts. They are now calling for your expertise!

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.

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.

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.

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.

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.

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.

The International Charter of principles for sharing bio-specimens and data has received a recommendation from the International Rare Diseases Research Consortium IRDiRC.

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.

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?

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.

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?

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.

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.

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.

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 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.

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.

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.

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.

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 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.

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.

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.