Centre for Research Ethics & Bioethics (CRB)

BBMRI.se - Biobanking and Molecular Resource Infrastructure of Sweden : Ethical and legal aspects

BBMRI.se is a national effort for efficient and automated collection of biological material. We are responsible for WP 7 that deals with pressing ethical and legal questions rising from biobank related research. 

There are a number of ethical and legal aspects of research conducted on human tissue samples that need to be addressed in a professional and constructive manner. The proposed new act on biobanks, existing laws on personal data and public access to information and secrecy, exert an influence on what can and can’t be done with biobanks and data. A major obstacle for researchers is that laws in part overlap, but provide slightly different answers to some questions and fail to address certain aspects of research activities. This poses major challenges for the scientific community in their strife to produce knowledge that can benefit patients

CRB's role in BBMRI.se - ELSI service

Our commitment in BBMRI.se includes providing ELSI service to the research community. We are part of a larger network of people with expertise in different legal and ethical fields.

ELSI Services include:

  • Advice on specific ethical issues for researchers, for example how to interpret Swedish legislation on data protection or ethical review in relation to specific projects.
  • Investigations of ethical and legal issues associated with biobank and registry-based research. The results are published in reports and peer-reviewed publications.
  • Dissemination of research in bioethics and law to the research community through our Biobank Perspectives newsletter and the Ethics Blog.
  • Training on ELSI issues and research ethics.
  • Participation in research projects where we can assume responsibility for ELSI work packages and pa part of an integrated approach.
  • Providing preparatory material to help guide universities, research consortia and research funders in their dialogue with governmental agencies on referrals or policy documents.
  • Exchange of information and discussion with policy makers and the public, for example through the Ethics Blog (available both in English and Swedish).

How to get access to the BBMRI.se ELSI service

Large projects involving international partners often require help from European nodes, where national laws are covered by national experts. We are building a network for this within the BBMRI-ERIC ELSI common service, a so called “help desk for ethics check”.

We handle Swedish projects within BBMRI.se. We prefer to get involved early on to be able to predict the ethical and legal issues that could arise. The best option is for us to handle a separate ELSI work package, but in smaller projects an integrated approach is sometimes better.

To request ELSI service, contact Mats G. Hansson

Researchers

The ELSI Service is led by Mats G. Hansson at the Centre for Research Ethics and Bioethics  (CRB) at Uppsala University. In March 2010 two collaborators were recruited to work with the ethical issues at hand:  Kathinka Evers,  Associate professor of theoretical philosophy and Joanna Forsberg, former PhD student and MD, both from CRB.

In September 2011, legal competence was added to the group: Jane Reichel, Associate  professor of  administrative law, and Anna-Sara Lind, Associate professor of public law, both from the Department of Law at Uppsala university and now tied part-time  to CRB to work with WP7.

In October 2011 Pär Segerdahl, Associate professor of theoretical philosophy was added to the team to work with research communication. 

In April 2012, Jennifer Viberg joined the group with her PhD project: How should incidental findings in biobank research and genome sequencing studies be handled?.

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.

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Biobank and registry ethics & law, report

Thinking about ethics

Why would a cancer patient agree to test a drug that might not be effective on their own disease? And are researchers responsible if their research can be used to develop biological weapons? This collection of texts might not provide the answers, but at least give you some food for thought.

Pär Segerdahl invites you on a journey through some of the issues that the Ethics Blog has dealt with in the recent years. He writes about researchers’ responsibilities, about participating in research and about information and integrity. But he also writes about ethics as such: What is it today, really? In this book you can read about data protection and population based biobank studies. But you can also read about apes writing articles and about the risk with knowing the risk.

This book contains a collection of Pär Segerdahl's posts from the Ethics Blog (ISBN: 978-91-506-2433-5). There is also a Swedish version of the book: Tänker om etik

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Thinking about ethics - Pär Segerdahl

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 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.

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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.

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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.

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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.

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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.

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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. 

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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.

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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.

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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?

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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.

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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.

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