More biobank related news First European biobank for research on breast milk and medicines <p>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&rsquo;s Uppsala site will develop methods and technology to analyze drug residues in milk and blood.</p> Wed, 05 Jun 2019 07:15:00 GMT 2019-06-05T07:15:00Z Biobank Sweden launches ELSI Helpdesk <p>The Swedish Research Council-funded research infrastructure Biobank Sweden supports healthcare providers and universities with medical faculties working towards national harmonization in biobanking.</p> Mon, 29 Oct 2018 09:10:00 GMT 2018-10-29T09:10:00Z Genetic risk: Should researchers let people know? <p>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.</p> Mon, 24 Sep 2018 08:30:00 GMT 2018-09-24T08:30:00Z Transferring biobank research data between the EU and African countries <p>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.</p> Thu, 23 Aug 2018 07:14:00 GMT 2018-08-23T07:14:00Z Looking for legal project coordinator <p>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 <em>Biobank Sweden</em>. Apply by February 20, 2018.<br /> &nbsp;</p> Tue, 19 Dec 2017 09:24:00 GMT 2017-12-19T09:24:00Z Likelihood not always informative when making sense of genetic risk <p>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.</p> Thu, 23 Nov 2017 19:11:00 GMT 2017-11-23T19:11:00Z Report from Uppsala workshop on Public Private Partnerships <p>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 &amp; 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.</p> Wed, 04 Oct 2017 07:20:00 GMT 2017-10-04T07:20:00Z New Swedish legal officer in the BBMRI-ERIC ELSI helpdesk <p>From February 1 2017, LL.D. Santa Slokenberga is taking over Moa Kindström Dahlin’s obligations at the BBMRI-ERIC ELSI Common Service.</p> Fri, 03 Mar 2017 07:56:00 GMT 2017-03-03T07:56:00Z B3Africa: first 18 months <p>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.</p> Fri, 03 Mar 2017 16:55:00 GMT 2017-03-03T16:55:00Z A new Swedish legal framework for handling alleged misconduct <p>Recently, a Swedish Government Inquiry&nbsp; 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.</p> Mon, 06 Mar 2017 07:36:00 GMT 2017-03-06T07:36:00Z Stem cells: a new type of biobank material? <p>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.</p> Mon, 06 Mar 2017 07:54:00 GMT 2017-03-06T07:54:00Z Swedish research data inquiry on exceptions <p>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.</p> Tue, 13 Dec 2016 16:54:00 GMT 2016-12-13T16:54:00Z New research on cyber governance of health data <p>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.</p> Fri, 09 Dec 2016 13:16:00 GMT 2016-12-09T13:16:00Z Legal aspects of direct-to-consumer genetic testing <p>Regulating health services is challenging because of the multitude of legal questions it raises.&nbsp; 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.</p> Wed, 07 Dec 2016 08:54:00 GMT 2016-12-07T08:54:00Z Managing data protection in practice – Swedish perspectives <p>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.</p> Mon, 26 Sep 2016 07:27:00 GMT 2016-09-26T07:27:00Z Informed consent guidelines listed among IRDiRC Recognized Resources <p>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.&nbsp;</p> Thu, 22 Sep 2016 11:34:00 GMT 2016-09-22T11:34:00Z Public-private research partnerships: Workshop <p>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.</p> Fri, 23 Sep 2016 08:56:00 GMT 2016-09-23T08:56:00Z ELSI Helpdesk: What does it do? <p>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.</p> Thu, 22 Sep 2016 08:43:00 GMT 2016-09-22T08:43:00Z Data Protection Regulation: final result <p>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.</p> Mon, 20 Jun 2016 11:10:00 GMT 2016-06-20T11:10:00Z Risk of re-identification vs the need to identify individuals <p>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.</p> Tue, 14 Jun 2016 11:05:00 GMT 2016-06-14T11:05:00Z It is your DNA, you should have a say <p>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.</p> Fri, 27 May 2016 09:33:00 GMT 2016-05-27T09:33:00Z Feedback of individual genetic results in Europe still not feasible <p>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.</p> Mon, 09 May 2016 12:25:00 GMT 2016-05-09T12:25:00Z Call for ELSI experts <p>The BBMRI-ERIC ELSI Common Service relies on input from experts. They are now calling for your expertise!</p> Wed, 04 May 2016 13:35:00 GMT 2016-05-04T13:35:00Z EU-US Privacy Shield to once again ensure safe harbours for data transfers <p>The annulled Safe Harbour agreement puts research collaborations in a peculiar position.&nbsp; Here, Jane Reichel, Professor of Administrative Law, gives an update on the negotiations.</p> Tue, 15 Mar 2016 13:58:00 GMT 2016-03-15T13:58:00Z Effective consent for effective research <p>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.</p> Mon, 14 Mar 2016 12:29:00 GMT 2016-03-14T12:29:00Z Direct-to-consumer genetic testing companies lack clear consent processes for biobanking and research <p>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.</p> Mon, 14 Mar 2016 10:28:00 GMT 2016-03-14T10:28:00Z ELSI: Inter-connecting legal frameworks, ethical and social issues <p>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.</p> Wed, 09 Dec 2015 10:06:00 GMT 2015-12-09T10:06:00Z Unsafe harbours for researchers <p>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.</p> Wed, 09 Dec 2015 10:02:00 GMT 2015-12-09T10:02:00Z How people value risk information <p>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.</p> Wed, 09 Dec 2015 10:00:00 GMT 2015-12-09T10:00:00Z What can ERIC do for biobanking? <p>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.</p> Wed, 21 May 2014 09:39:00 GMT 2014-05-21T09:39:00Z Data protection update – A word on the legislative process <p>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.</p> Mon, 28 Apr 2014 09:16:00 GMT 2014-04-28T09:16:00Z Trust takes more than guidelines and review <p>Research ethics has developed into an extra legal regulatory system. Guidelines serve as steering documents, committees oversee and consent procedures are formal.</p> Fri, 25 Apr 2014 09:14:00 GMT 2014-04-25T09:14:00Z New law for Biobank researchers <p>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.</p> Fri, 25 Apr 2014 09:13:00 GMT 2014-04-25T09:13:00Z Dealing with genetic risk information <p>How do we evaluate and handle genetic risk information? For the coming six years, the Centre for Research Ethics &amp; Bioethics (CRB) will co-ordinate an international research project to support health care, patients and decision makers.</p> Mon, 28 Apr 2014 08:55:00 GMT 2014-04-28T08:55:00Z The principles for sharing <p>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.</p> Tue, 23 Sep 2014 08:49:00 GMT 2014-09-23T08:49:00Z New law for research databases? <p>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.</p> Fri, 12 Sep 2014 08:48:00 GMT 2014-09-12T08:48:00Z LifeGene: Case closed? <p>The LifeGene project has been heavily discussed among biobank researchers in the last couple of years.&nbsp; The project gave rise to a number of both scientific and legal matters.</p> Mon, 15 Sep 2014 08:47:00 GMT 2014-09-15T08:47:00Z ELSI common service for BBMRI-ERIC <p>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.</p> Mon, 15 Sep 2014 08:43:00 GMT 2014-09-15T08:43:00Z Guideline for sharing specimens and data receives IRDiRC recommendation <p><strong><img alt="" class="image-right" src="/digitalAssets/496/c_496820-l_1-k_irdic-recommended100.jpg" style="border-style:solid; border-width:0px" />The </strong><strong>International Charter of principles for sharing bio-specimens and data</strong><strong> has received a recommendation from the International Rare Diseases Research Consortium IRDiRC. </strong></p> Mon, 28 Sep 2015 08:08:00 GMT 2015-09-28T08:08:00Z Renewed European effort to agree on data protection <p><strong>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.</strong></p> Mon, 28 Sep 2015 08:06:00 GMT 2015-09-28T08:06:00Z Global research infrastructure for biobanking <p>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.</p> Sun, 27 Sep 2015 08:03:00 GMT 2015-09-27T08:03:00Z Bioethicists suggest broad consent for biobank research <p>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?</p> Mon, 28 Sep 2015 07:57:00 GMT 2015-09-28T07:57:00Z Regulating biobank research: new book <p><strong>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. </strong></p> Tue, 24 Feb 2015 11:03:00 GMT 2015-02-24T11:03:00Z Research ethics for medicine and the life sciences <p><strong>Research ethics and research integrity is not just following regulation. Researchers<br /> need the ability to identify ethical aspects in their own research. And to do something about them.</strong></p> Tue, 24 Feb 2015 11:01:00 GMT 2015-02-24T11:01:00Z Swedish research database legislation: update <p><strong>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.</strong></p> Tue, 02 Jun 2015 09:35:00 GMT 2015-06-02T09:35:00Z Information and law in transition <p><strong>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. </strong></p> Tue, 02 Jun 2015 09:32:00 GMT 2015-06-02T09:32:00Z Genetic risk: people might not know if they want to know <p><strong>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? </strong></p> Mon, 15 Jun 2015 11:28:00 GMT 2015-06-15T11:28:00Z Trust based consent looks promising <p><strong>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. </strong></p> Tue, 02 Jun 2015 11:25:00 GMT 2015-06-02T11:25:00Z