Global data sharing, national oversight bodies

November 8, 2017

Pär SegerdahlScience has an international character and global research collaboration is common. For medical research, this means that health data and biological samples linked to people in one nation often are transferred to researchers in other nations.

At the same time, the development of new information and communication technology increases the importance of people’s data protection rights. To provide satisfying data protection in the new internet world, data protection regulations are tightening, especially within the EU.

In an article in Health and Technology, lawyer Jane Reichel discusses challenges that this development poses for biomedical research.

I am not a lawyer, but if I understand Reichel right, legislation can accompany personal data across national borders. For example, the EU requires that the foreign receiver of European data subjects’ personal data will handle the data in accordance with EU legislation – even if the receiver is a research group in the United States or Japan.

The fact that one nation may need to follow a foreign nation’s legislation not only challenges concepts of sovereignty and territoriality. It also challenges the responsibility of research ethics committees. These committees operate administratively at national level. Now it seems they might also need to monitor foreign rights and global standards. Do these national bodies have the expertise and authority for such an international task?

Read the article about these exciting and unexpected legal issues!

Pär Segerdahl

Reichel, J. Health Technol. (2017). https://doi.org/10.1007/s12553-017-0182-6

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Thinking about law - the Ethics Blog


Acknowledging the biobank and the people who built it

October 16, 2017

Pär SegerdahlBiomedical research increasingly often uses biological material and information collected in biobanks. In order for a biobank to work efficiently, it is important not only that the biological material is stored well. The material must also be made available to science so that researchers easily and responsibly can share samples and information.

Creating such a biobank is a huge effort. Researchers and clinicians who collect bioresources might even be reluctant to make the biobank openly available. Why make it easy for others to access to your biobank if they do not give you any recognition?

In an article in the Journal of Community Genetics, Heidi C. Howard and Deborah Mascalzoni, among others, discuss a system that would make it more attractive to develop well-functioning biobanks. It is a system for rewarding researchers and clinicians who create high quality bioresources by making their work properly acknowledged.

The system, presented in the article, is called the Bioresource Research Impact Factor (BRIF). If I understand it, the system may work the following way. A biobank is described in a permanent “marker” article published in a specific bioresource journal. Researchers who use the biobank then quote the article in their publications and funding grants. In this way, you can count citations of bioresources as you count citations of research articles.

The article also describes the results of a study of stakeholders’ awareness of BRIF, as well as an ethical analysis of how BRIF can contribute to more responsible biobanking.

If you are building a biobank, read the article and learn more about BRIF!

Pär Segerdahl

Howard, H.C., Mascalzoni, D., Mabile, L. et al. “How to responsibly acknowledge research work in the era of big data and biobanks: ethical aspects of the Bioresource Research Impact Factor (BRIF).” J Community Genet (2017). https://doi.org/10.1007/s12687-017-0332-6

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We want to be just - the Ethics Blog


Research data, health cyberspace and direct-to-consumer genetic testing

December 14, 2016

josepine-fernow2We live in a global society, which means there are several actors that regulate both research and services directed at consumers. It is time again for our newsletter on current issues in biobank ethics and law. This time, Biobank Perspectives  lets you 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 to large consequences.

We also follow up from a previous report on the General Data Protection Regulation in a Swedish perspective with 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 the Centre for Research Ethics & Bioethics 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. To read more, download a pdf of the latest issue (4:2016), or visit the Biobank Perspectives site for more ethical and legal perspectives on biobank and registry research.

Josepine Fernow

This post in Swedish

Approaching future issues - the Ethics Blog


More biobank perspectives

September 27, 2016

If you did not get your fill during the Europe biobank week in Vienna, we give you more biobank related news in the latest issue of Biobank Perspectives, our newsletter on current issues in biobank ethics and law.

This time, Moa Kindström Dahlin describes what BBMRI-ERIC’s new federated Helpdesk for ELSI-issues can offer. We also invite you discuss public-private partnerships in research at a workshop in Uppsala on 7-8 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.

You can read the newsletter on our website, or download a pdf version.

Josepine Fernow & Anna-Sara Lind

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We recommend readings - the Ethics Blog

 

 

bbmri.se


Identifying individuals while protecting privacy

August 24, 2016

Pär SegerdahlResearch ethics is complex and requires considering issues from several perspectives simultaneously. I’ve written about the temptation to reduce research ethics to pure protection ethics. Then not as much needs to be kept in mind. Protection is the sole aim, and thinking begins to resemble the plot of an adventure film where the hero finally sets the hostages free.

Protection is of course central to research ethics and there are cases where one is tempted to say that research participants are taken hostage by unscrupulous scientists. Like when a group of African-American men with syphilis were recruited to a research study, but weren’t treated because the researchers wanted to study the natural course of the disease.

Everyday life is not one big hostage drama, however, which immediately makes the issues more complex. The researcher is typically not the villain, the participant is not the victim, and the ethicist is not the hero who saves the victim from the villain. What is research ethics in everyday situations?

There is currently a growing concern that coding of personal data and biospecimens doesn’t sufficiently protect research participants from privacy invasions. Hackers hired to test the security of research databases have in some cases been able to identify the individuals who provided their personal data to research (in the belief that the link to them had been made inaccessible to outsiders through advanced coding procedures). Such re-identified information can obviously harm participants, if it falls into the wrong hands.

What is the task of research ethics here? Suddenly we can begin to discern the outlines of a drama in which the participant risks becoming the victim, the researcher risks becoming the villain’s accomplice, and the ethicist rushes onto the scene and rescues the victim by making personal data in research databases completely anonymous, impossible to identify even for researchers.

But everyday life hasn’t collapsed yet. Perhaps we should keep a cool head and ask: Why are personal data and biological samples not fully anonymized, but coded so that researchers can identify individual patients/research participants? The answer is that it’s necessary to achieve scientific results (and to provide individual patients the right care). Discovering relationships between genetics, lifestyle and disease requires running several registries together. Genetic data from the biobank may need to be linked to patient records in healthcare. The link is the individual, who therefore must be identifiable to the research, through the use of advanced code keys.

The need to identify participants is particularly evident in research on rare diseases. Obviously, there is only scant data on these diseases. The data needs to be shared between research groups, often in different countries, in order to collect enough data for patterns to appear, which can lead to diagnoses and treatments.

An overly dramatic heroic effort to protect privacy would have its own victims.

In an article in the European Journal of Human Genetics, Mats G. Hansson and co-authors develop a different, more sustainable ethical response to the risk of re-identification.

Respecting and protecting participants’ privacy is, of course, a central concern in the article. But protection isn’t the only perspective, since science and health care are ethical values too. And here you need to be able to identify participants. The task the authors assume, then, is that of discussing the risks of re-identification, while simultaneously considering the needs for identifiable data.

The authors are, in other words, looking for a balance between different values: simply because identifiable data are associated with both risks and benefits.

You can read a summary of the article on the CRB website. What I focus on in this post is the authors’ overall approach to research ethics, which doesn’t emphasize the hero/villain/victim opposition of certain dramatic situations.

The public image of research ethics is very much shaped by its function in response to research scandals. But research ethics is usually, and less dramatically, about making everyday life function ethically in a society which contains research. Making everyday life run smoothly is a more complex and important task than playing the hero when everyday life breaks down. In this work, more values and challenges need to be taken into account simultaneously than in emergency scenarios where ethicists, very naturally, focus on protection.

Everyday life may not be as exciting as a research scandal, but if we don’t first and foremost take responsibility for making everyday life work smoothly, as a complex whole, then we can expect more drama.

Keep a cool head and consider the issues from a variety of perspectives!

Pär Segerdahl

Hansson, M. G. et al. The risk of re-identification versus the need to identify individuals in rare disease research. European Journal of Human Genetics, advance online publication, 25 May 2016; doi: 10.1038/ejhg.2016.52

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Approaching future issues - the Ethics Blog


Fourth issue of our newsletter about biobanks

December 22, 2015

Now you can read the fourth newsletter this year from CRB and BBMRI.se about ethical and legal issues in biobanking:

The newsletter contains three news items:

  1. Moa Kindström Dahlin describes the work on ethical and legal issues in the European platform for biobanking, BBMRI-ERIC, and reflects on what law is.
  2. Josepine Fernow features two PhD projects on research participants’ and patients’ preferences and perceptions of risk information.
  3. Anna-Sara Lind discusses the ruling of the European Court of Justice against the Safe Harbour agreement with the United States.

(Link to PDF version of the newsletter)

And finally, a link to the December issue of the newsletter from BBMRI.se:

Merry Christmas and a Happy New Year!

Pär Segerdahl

We recommend readings - the Ethics Blog


Open data access is regulated access

November 11, 2015

Pär SegerdahlWe usually associate open access with the publication of scientific articles that anyone with internet access can read, without price barrier.

The concept “open access” is now being used also for research data. I have written about this trend towards open data earlier on the Ethics Blog: Openness as a norm.

In many cases, research data are made as freely available as the open access articles that anyone can read; often in connection with the publication of results based on the data. This occurs, for example, in physics.

There is a strong trend towards open data also in medical research; but here the analogy with articles that anyone can read is no longer valid. Biobank and register-based research work with sensitive personal data, to which a number of laws regulating data access apply.

Yet one could speak of a trend towards open data also in this domain. But it then means something different. It’s about making data as accessible as possible for research, within the regulations that apply to this type of data.

Since the relevant laws and ethical frameworks are not only opaque but also differ between countries, the work is largely about developing common models for researchers to work within. One such attempt is made in an article by, among others, Deborah Mascalzoni and Mats G. Hansson at CRB:

The article formulates 15 principles for sharing of biological samples and personal data between researchers. It also includes a template of the written agreements that scientists can make when one research group transfers data or materials to another research group.

Take a look at these principles, and the template of the agreements, and you’ll soon get an idea of how many strict conditions that must be met when biological samples and personal data are shared for research purposes.

Given how open access often is associated with the possibility for anyone at any time to read articles without price barrier, one should perhaps avoid using the term in this context. It may mislead, since this form of data access is heavily regulated, although the aim is to support researchers to share their data and samples.

Pär Segerdahl

This post in Swedish

Minding our language - the Ethics Blog


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