A blog from the Centre for Research Ethics & Bioethics (CRB)

Tag: register-based research (Page 3 of 5)

The Swedish Data Protection Authority rejects extension of temporary law on registry research

Pär SegerdahlSince the new Swedish law on research databases is delayed, there is a proposal to extend the current temporary law on certain registries for research about what heredity and environment mean for human health (until December 31, 2017).

The Swedish Data Protection Authority rejects extension, because major deficiencies noted previously have not been addressed and since the requirements for purpose identifications are not sufficiently specific and explicit.

Regarding specific and explicit purposes, the Authority gives special weight to a statement by the European so-called Article 29 Working Party, cited in the opinion:

  • “The purpose of the collection must be clearly and specifically identified: it must be detailed enough to determine what kind of processing is and is not included within the specific purpose, and to allow that compliance with the law can be assessed and data protection safeguards be applied. For these reasons a purpose that is vague and general, such as for instance ‘improving user’s experience’, ‘marketing purposes’, ‘IT-security purposes’ or ‘future research’ will – without more detail – usually not meet the criteria of being ‘specific’.”

This I regard as problematic in two ways.

First: In the cited statement the Article 29 Working Party equates the purpose “future research” with purposes like “improving the user experience” and “marketing purposes”. It is unclear if one can equate research purposes with such purposes, since researchers do not intend to return to the persons whose data are collected, to give them specifically profiled consequences. Personal data circulate in a categorically different way in research.

Secondly: The website of the Article 29 Working Party begins with a disclaimer. The group emphasizes that all material on the website solely reflects the group’s views, not the position of the European Commission. The group only has an advisory status and acts independently.

The group’s reasoning about research purposes can be questioned, and it seems to relinquish at least some of the authority that the Data Protection Authority ascribes to it in its opinion.

Pär Segerdahl

Approaching future issues - the Ethics Blog

Experts on assignment in the real world

Pär SegerdahlExperts on assignment in the real world cease in part to be experts. Just consider computer experts who create a computer system for the tax authorities, or for a bank, or for a hospital.

In order for these systems to work on location, the computer experts need to be open to what they don’t know much about: the unique activities at the tax authorities, or at the bank, or at the hospital.

Computer experts who aren’t open to their non-expertise on the site where they are on assignment perform worse as experts and will deliver inferior systems.

Experts can therefore not in practice be only experts. If one exaggerates one’s role as an expert, one fails on assignment in the real world.

This should apply also to other forms of expertise. My guess is that legal experts almost always find themselves in this precarious situation of being experts in a reality that constantly forces them to open themselves to their non-expertise. In fact, law appears to be an occupation that to an unusually high degree develops this openness systematically. I admire how legal experts constantly learn about the multifarious realities they act in.

Jurists should be a role model for computer experts and economic experts: because they methodically manage their inevitable non-expertise.

This post indicates the spirit in which I (as legal non-expert) took the liberty to question the Swedish Data Inspection Board’s shutting down of LifeGene and more recent rejection of a proposed law on research databases.

Can one be an expert “purely” on data protection? I think not. My impression is that the Data Inspection Board, on assignment in the world of research, didn’t open itself to its non-expertise in this reality. They acted (it seems to me) as if data protection issues could be handled as a separate field of expertise, without carefully considering the unique conditions of contemporary research and the kinds of aims that research initiatives can have.

Perhaps the temptation resides in the Board’s role as a public body: as an authority with a seemingly “pure” mission.

Pär Segerdahl

We like broad perspectives : www.ethicsblog.crb.uu.se

Openness as a norm

Pär SegerdahlWhy should scientists save their code keys as long as 20 years after they conducted their study, the Swedish Data Inspection Board apparently wonders. In its opinion to a proposed new Swedish law on research databases, it states that this seems too long a period of time.

Yet, researchers judge that code keys need to be saved to connect old samples to new registry data. The discovery of a link between HPV infection and cervical cancer, for example, could not have been made with newly collected samples but presupposed access to identifiable samples collected in the 1960s. The cancer doesn’t develop until decades after infection.

New generations of researchers are beginning to perceive it as an ethical duty to make data usable for other scientists, today and in the future. Platforms for long-term data sharing are being built up not only in biobank research, but also in physics, in neuroscience, in linguistics, in archeology…

It started in physics, but has now reached the humanities and the social sciences where it is experienced as a paradigm shift.

A recent US report suggests that sharing data should become the norm:

Research is obviously changing shape. New opportunities to manage data mean that research is moving up an IT-gear. The change also means a norm shift. Data are no longer expected to be tied to specific projects and research groups. Data are expected to be openly available for a long time – Open Access.

The norm shift raises, of course, issues of privacy. But when we discuss those issues, public bodies can hardly judge for researchers what, in the current vibrant situation, is reasonable and unreasonable, important and unimportant.

Perhaps it is profoundly logical, in today’s circumstances, to give data a longer and more open life than in the previous way of organizing research. Perhaps such long-term transparency really means moving up a gear.

We need to be humbly open to that possibility and not repeat an old norm that research itself is leaving behind.

Pär Segerdahl

Approaching future issues - the Ethics Blog

Biobank news

Pär SegerdahlThe first newsletter for 2015 from CRB and BBMRI.se is now available for reading:

The main news item, by Anna-Sara Lind, is about the still unclear status for a new European data protection regulation (intended to replace the old directive).

You’ll also find items by Josepine Fernow about our blog books, about a newly released anthology on biobank regulation (edited by Debora Mascalzoni), and information about a new online course in research ethics (developed by Stefan Eriksson and given for the first time next autumn).

You’ll also find a link to the PDF version of the newsletter.

Pär Segerdahl

We recommend readings - the Ethics Blog

The need of a bird’s-eye view

Pär SegerdahlIn the previous blog post I wrote about the tendency in today’s research to build common research platforms where data are stored and made open: available for future research, meta-analysis and critical scrutiny of published research.

The tendency is supported at EU level, by bodies responsible for research. Simultaneously, it is obstructed at EU level, by other bodies working with data protection.

The same hopeless conflict can be seen in Sweden, where the Swedish Data Inspection Board time and again stops such efforts or criticizes suggestions for how to regulate them. This month the Data Inspection Board criticized a proposed law on research databases.

It may seem as if the board just dryly listed a number of points where the proposal is inconsistent with other laws or allowed unreasonable infringement of privacy. At the same time, the Data Inspection Board seems alien to the new way of organizing research. Why on earth should researchers want to save so much data so damn long?

How can we handle these conflicts between public bodies that each has his own little mission and thus its own limited field of vision?

Pär Segerdahl

We want to be just - the Ethics Blog

Open research platforms and open data

Pär SegerdahlToday, I recommend reading about two major changes in current research. Both changes are reflected in the December issue of the newsletter:

The changes concern researchers’ relation to their material.

The first change has been discussed on the Ethics Blog. It is that samples and data that individual research groups collect begin to be saved, documented and analyzed in joint biobanks. The material is then made available to other researchers, both nationally and internationally.

This requires an attitude change among researchers who are used to store their data material locally and then use it locally. Now, one sends the material to the biobank instead, which takes care of it and provides service to researchers in the form of analysis, access to more data, advice, and more. Perhaps researchers need not always collect their own material, if relevant data are available via the biobank infrastructure.

This change is discussed in the editorial by Joakim Dillner, Acting director of BBMRI.se, and in an interview with Mark Divers, Head of the biobank facility that BBMRI.se built up at Karolinska Institutet.

The second change has not been discussed on this blog. It is featured in an interview in the newsletter with a researcher in cognitive neurophysiology, Gustav Nilsonne. It is closely related to the first, but requires a change in attitude to what it means to make research available through publication in scientific journals.

The change is about making research open not only through Open Access publication of scientific articles, but also by making raw data available. Such a change is significant in several ways:

  1. Data collected with efforts of many research participants can be used multiple times instead of disappearing in forgotten archives.
  2. Published findings can be critically examined; it becomes more difficult to cheat or be negligent.
  3. It becomes easier to make meta-analysis of data from many studies.

These changes can of course be seen as two sides of the same coin. Researchers seeking services from the biobank facility must accept that other researchers apply for access to “their” data … which thereby become open.

Pär Segerdahl

We recommend readings - the Ethics Blog

Rare diseases need international research infrastructure

Pär SegerdahlThere are a few thousand diseases that you never heard the name of. They affect so few people and have no names in the common language.

These diseases are usually called rare diseases (or orphan diseases). They often (but not always) have genetic origin. They often affect children, are disabling and can even be life-threatening, and in many cases organ systems in the body degenerate.

Because the diseases are rare, they are difficult for doctors to diagnose. Even if one manages to make a diagnosis, treatments are often lacking. It’s hard to do research and develop treatments when the patient groups are small and scattered across the world.

In recent years one has begun to prioritize research on rare diseases, not least in the EU. A background to this trend is the development of biobank research. It starts to make it possible to do research on rare diseases, even though the patient groups are small and scattered across the world.

How? Since one can collect samples and data from such patient groups in biobanks that are linked with each other in international networks. Biobank networks thus give researchers access to large enough material to identify genetic and other origins of rare diseases. In this way, one can begin to develop diagnoses and treatments for small patient groups spread across the world.

In an article in the Journal of Biorepository Science for Applied Medicine,

twenty researchers, among them Mats G. Hansson, describe trends in research on rare diseases. They mention several international biobank networks developed to make such research possible, and describe the challenges that they have to deal with.

One challenge is to develop a common standard for how to, for example, document and code samples for rare diseases. Otherwise it is difficult to locate relevant samples in biobanks in different parts of the world and use them in research. One also needs to link the samples to electronic health records. Otherwise, the patterns behind the diseases will not be visible to the research.

Another challenge is that ethical review and governance operate at a national level, and often in different ways in different countries. In one case, mentioned in the article, where the researchers needed to use data from 130 patients from 30 different countries (and collaborate with 103 clinical centers), it took two years to get ethical approval of the project.

The project was not ethically controversial: 97% of the ethical review committees approved the project without requiring changes or further information. The time delay was due to problems of coordination between the governance systems in the different countries.

Another challenge mentioned in the article is to make researchers, doctors and patients aware of the existence of biobanks for research on rare diseases, and the importance of contributing to these biobank networks by collecting samples and updating databases.

The trend to link biobanks in networks has been clear for a while, even independently of the research on rare diseases. But this research really highlights a key feature in today’s biobanking: its infrastructural nature. Research on rare diseases, needing data from patients spread across the world, can therefore also likely accelerate the development of biobanks as infrastructures for future research.

Pär Segerdahl

Part of international collaborations - the Ethics Blog

Our publications on biobanks and registries

PÄR SEGERDAHL Associate Professor of Philosophy and editor of The Ethics BlogBiomedical research does not always require research subjects who are prepared to experimentally try new treatments or diets. Increasingly, research on health and disease is carried out on stored biological samples and personal data in different registries.

Handling human biological material and personal data raises unique ethical issues. People who volunteer as participants in such research are unlikely to be harmed by experimental treatments, but their samples and data are stored for a long time. Samples and data can also be shared by several groups, and be used in different research projects.

One can therefore speak of unique ethical challenges in biobank and registry research. At the Centre for Research Ethics and Bioethics, we have long been working to clarify these challenges and discuss ways to deal with them responsibly. Our work has resulted in numerous publications, often together with biomedical researchers and in international collaborations.

In May 2014, we published an updated compilation of these publications:

The above link will take you to the online version, which also contains further links to the articles that are available online. A printed report can be ordered from crb@crb.uu.se.

The report contains abstracts of all the publications. What is new is that we now arranged the publications thematically:

  1. Ethical frameworks and policy
  2. Regulatory aspects
  3. Informed consent
  4. Ethical review
  5. Integrity concerns
  6. Trust
  7. Genetic testing
  8. Incidental findings
  9. Commercialization
  10. Public and patient perceptions
  11. Rare diseases
  12. Children & biobanks & genetics

We hope you take a look at the report and find something that interests you!

Pär Segerdahl

Part of international collaborations - the Ethics Blog

Building European infrastructures for research

PÄR SEGERDAHL Associate Professor of Philosophy and editor of The Ethics BlogThe European Union is traditionally about creating an internal market, where goods, services, labor and capital can move freely between member states.

Lately there have been efforts to create also European infrastructures for research, where researchers in the different member states can collaborate more efficiently, and compete on a global “research market.” A new tool for such European governance of research is the European Research Infrastructure Consortium, abbreviated ERIC.

If at least three member states hand in a joint application, the Commission can establish an ERIC – an international organization where the involved member states jointly fund and manage a European infrastructure for research in some area. In November 2013, an ERIC was established for biobank research: BBMRI-ERIC, placed in Graz, Austria.

Understanding what an ERIC is and whether BBMRI-ERIC has tools to make the diverse regulations for biobanking in different EU member states more uniform, is not easy. However, a “Letter” in the European Journal of Human Genetics addresses both issues:

The letter is written by Jane Reichel, Anna-Sara Lind, Mats G. Hansson, and Jan-Eric Litton who is the Director General of BBMRI-ERIC.

The authors write that although the ERIC lacks substantial tools to make the regulative framework for biobanking more uniform, it provides a platform where researchers and member states can collaborate developing better ways of navigating the complex legal and ethical landscape. The ERIC also facilitates administration, owning and running of equipment and employment of staff on a long-term basis, thus enabling a time perspective proper to research infrastructures (rather than individual research projects). It also provides opportunities to develop common standards for biobanking activities (e.g., handling of samples) that make biobanks function better together.

Finally, because of the required regular contacts with the Commission and representatives of all EU member states, channels are opened up through which the interests of research can be communicated and influence policy areas like data protection.

Read the letter if you are interested to know more about this new way of building European infrastructures for research.

Pär Segerdahl

Part of international collaborations - the Ethics Blog

Open biobank landscapes

PÄR SEGERDAHL Associate Professor of Philosophy and editor of The Ethics BlogLast week I wrote about the transition from organizing science as a tree of knowledge that once in a while drops its fruits onto society, to organizing research as part of knowledge landscapes, where the perspective of harvesting, managing and using the fruits is there from the beginning.

That the proud tree is gone might seem sad, but here we are – in the knowledge landscape, and I believe the development is logical. As a comment to the previous post made clear, many fruits fell from the old tree without coming into use.

The notion of knowledge landscapes sheds light on the attempt by BBMRI.se to build infrastructure for biobank research. The initiative can be viewed as an attempt to integrate research in broader knowledge landscapes. Supporting research with an eye to the interests of patients is a new way of managing research, more oriented towards the fruits and their potential value for people than in the era of the tree of knowledge.

The novelty of the infrastructural approach to biobanking isn’t always noticed. In Sweden, for example, the biobank initiative LifeGene was met with suspicion from some quarters. In the debate, some critics portrayed LifeGene as being initiated more or less in the interest of a closed group of researchers. Researchers wanted to collect samples from the population and then climb the tree and study the samples for god knows which purposes.

Those suspicions were based on the old conception of science as a high tree, inaccessible to most of us, in which researchers pursue “their own” interests. The aim with LifeGene, I believe, is rather to integrate research in a knowledge landscape, in which research is governed more by the interests of patients.

We mustn’t underestimate the challenges such a reorganization of research has to deal with, the forces that come into play. I merely want to suggest a new way of surveying and thinking about the transition – as a change from approaching science as a high tree of knowledge to integrating research in open knowledge landscapes.

If you want to read more about research in knowledge landscapes, you find Anna Lydia Svalastog’s article here, and the network where these ideas originated here.

In September 2014, the third conference, HandsOn: Biobanks, is organized, now in Helsinki. Academics, industry, doctors, patient groups, policy makers, public representatives and legislators are invited to share knowledge and experiences. As in previous conferences in the series, there is an interactive part, The Route, in which biobanking processes can be followed from start to finish, with ample opportunities for discussion.

View the conference as part of maintaining open biobank landscapes, with research as one of several integrated components.

Registration is open.

Pär Segerdahl

We like broad perspectives : www.ethicsblog.crb.uu.se

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