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

Tag: legislation (Page 3 of 5)

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

Bioethics behind the facade: research and new thinking

Pär SegerdahlThe finished result easily becomes a picture of the process of achieving it. For example: We hear a Beethoven symphony and think that the genius had this magnificent composition in his head. He just needed to write it down.

As if the result existed from the beginning and only needed to be put on paper. I don’t know much about Beethoven’s working process, but doubt that it consisted in writing down already completed symphonies. Maybe, during a walk, a tiny idea entered his mind: a theme that made an impression on him, but that definitely was not the finished symphony. Thereafter, he explored the theme, attentive to where it wanted to go and letting it evolve in different forms and variations. Maybe he examined the theme at the piano.

Only gradually did this creative work shift to actually sitting down and composing. But still, as an exploration of the theme, albeit in the final phase of the process. And maybe it turned out that the theme worked better for a string quartet instead.

Bioethics is often misunderstood as we misunderstand Beethoven. We identify bioethics (and research ethics) with the finished result: with ethical guidelines, with the declaration of Helsinki, with models of consent, with the system of ethical review etcetera.

Bioethicists then appear like people who just put ethical rules on paper and establish bureaucratic systems to check that they are followed by researchers.

Bartha M. Knoppers recently questioned that image, in an article with the significant title:

Ethical frameworks for biomedical research originate in processes of ethical research and thinking, often in dialogue with researchers in the field, and with patients and the public. Behind the facade, bioethics is an art of conversation as well as explorative research and new thinking. This work is not the least self-critical, for the ethical frameworks need to be constantly modified and sometimes partially dismantled.

An example of this work behind the facade is a new book on the regulation of biobanking, edited by Deborah Mascalzoni at CRB:

In this book, a number of researchers present their explorations. It gives you insight into the work processes and the conversations and debates behind the regulation of research.

One principal problem raised in the book is that regulatory systems have become increasingly complex and opaque. Should we then create even more regulation?

Deborah Mascalzoni thinks that ethical research is more than just researchers following rules written by bioethicists. Instead of facing new challenges with even more regulation, she points out that all of us can think ethically, and that scientists have a moral responsibility to reflect on how they develop their research practices.

Ethics need not be a burden for research but can be a living concern within it. It can grow and flourish with the research practices, if we dare to do what Beethoven did: trust that seemingly insignificant thoughts and ideas can grow into something beautiful and real.

Pär Segerdahl

We think about bioethics : www.ethicsblog.crb.uu.se

Direct to consumer genetic tests: soon history?

PÄR SEGERDAHL Associate Professor of Philosophy and editor of The Ethics BlogMore and more companies are selling genetic tests directly to consumers. You don’t need a prescription. Just go online and order a test and you’ll get a cotton swab with which you scrape the inside of your cheek.

You then send the cotton swab to a laboratory and await the answer: What do your genes have to say about your disease risks?

These tests may seem harmless. It’s only a bit of information. No one can be harmed by some information, it may seem.

But the information is sensitive and can have consequences. For example, the test can provide information about genetic predispositions that you can transfer to your children. Paternity can be determined. You can get information that you are at risk for a certain form of cancer or can suffer side effects from the drug that your doctor prescribed. In addition, information about risk of disease can cause you to begin to exhibit symptoms prematurely!

Are the tests reliable? How should the information be interpreted in your case? What should you do with it? – Can one really market such tests directly to consumers as any commercial product?

No, it looks like it soon will be impossible. The US Food and Drug Administration (FDA) recently informed a number of companies that sell genetic tests directly to consumers that the tests will from now on be treated as medical devices. Such devices must meet specific quality requirements and be approved product by product.

Also in Europe a change is underway, going even further. The European Parliament is proposing a regulation that would more or less ban selling genetic tests directly to consumers.

This EU proposal is described and discussed in an article in Science, written by Louiza Kalokairinou, Heidi Howard (from CRB) and Pascal Borry:

From having been regarded as harmless, the authors write, genetic tests are now proposed to be classified as medical devices on risk level C (on a scale from A to D). In addition, a medical prescription will be required to get a genetic test, and the test must be ordered by a physician. Genetic counseling must also be given.

Genetic tests are here to stay, but presumably in a different context than today. The proposed EU regulation requires a medical context for genetic testing, the authors write: a patient-doctor relationship.

The article ends asking: Will doctors’ waiting rooms soon to be filled by people who want prescriptions for genetic tests? Can doctors keep up with the rapid development of the field, which is required to interpret new genetic tests and assess how these can benefit individual users?

Whereupon I ask: If it is unclear if even doctors can manage the genetic tests, how could one have assumed that individual consumers could do it?

Pär Segerdahl

Approaching future issues - 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

Biobank news: ethics and law

The second issue of the newsletter from CRB and BBMRI.se is now available:

This April issue contains four interesting news items about:

  1. New international research cooperation on genetic risk information.
  2. The new Swedish law on registers for research on heritage, environment and health.
  3. The legislative process of developing a European data protection regulation.
  4. A new article on trust and ethical regulation.

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

Pär Segerdahl

We recommend readings - the Ethics Blog

Readings on biobank regulation

PÄR SEGERDAHL Associate Professor of Philosophy and editor of The Ethics BlogToday I recommend three short and instructive readings on biobanking:

The European Parliament voted in October 2013 on an amended proposal for a new European Data Protection Regulation. In a newsletter from CBR and BBMRI.se, the legal scholars Jane Reichel and Anna-Sara Lind explain implications for biobank research:

A new law on biobanks entered into force in Finland in September 2013. The law allows broad consent for future research and enables use of already collected samples. It also gives donors a stronger position and better protection of their integrity, Joanna Forsberg and Sirpa Soini write in Nature:

International guidelines on biobank research diverge, not least concerning the specificity of the consent and the use of already collected samples and waiver of consent. These ambiguities are discussed in the European Journal of Epidemiology, in an article by Joanna Forsberg, Mats G. Hansson and Kathinka Evers:

These texts help clarifying the complicated regulatory framework.

Pär Segerdahl

We recommend readings - the Ethics Blog

Overview of the regulatory framework of European biobanking

Unless you have an education in law, it is almost impossible to find your way through the regulatory landscape of European biobanking, or to understand the motives behind the proposed new general data protection regulation.

However, a helpful overview and discussion can be found in this article by Evert-Ben van Veen:

The article also contains some interesting thinking on a number of important issues, like the concept of personal data, the need for a third category of data between personal data and anonymous data, and the role of trust in institutions.

Pär Segerdahl

We recommend readings - the Ethics Blog

Vaccine prioritization and the new Japanese pandemic law (by Yusuke Inoue)

Yusuke InoueFor many years, balancing individual human rights against social benefits has been the standard theme for public health ethics. Here I would like to update you on a recent discussion in Japan.

Last month a new law was introduced in Japan. Originally the enactment was planned later, but it was speeded up because of the recent series of death cases from emerging bird flu in neighboring Asian countries. This new law is entitled,

  • Act in response to new flu strains and other diseases

Unlike existing laws, such as the Immunization Act and the Act on Infectious Diseases, this new law is clearly intended to empower national and areal authorities to take substantial action. For example, in order to,

  • “prevent the spread of a disease,”
  • “protect a citizen’s rights or health,” or
  • “avoid social and economic confusion,”

these authorities can close public spaces or meetings, take special actions to sustain infrastructures, and direct medical staff to treat patients. This law was mainly drafted by bureaucrats and passed lacking sufficient explanation and public debate on the draft.

Based on the act, a national plan for prioritizing vaccine has become a matter of discussion. There are more than one hundred million people living in Japan, and securing vaccine for them quickly has been regarded as difficult. Therefore, this topic can be understood as a matter of distributive justice, and various methods for achieving justice have been discussed.

According to the recent draft plan, medical and caring staff, public officers, and manpower to sustain infrastructure are included in the prioritized class. It is not surprising that the longer the discussion goes on, the more people insist that they should be included in this class. For example, food industry workers are also suggested to be added to the class. Until now the targeted population has already reached more than 20 million! There was a similar discussion during the A/H1N1 swine flu “pandemic” in 2009, and many groups argued that they should have priority getting immunized.

Discussion on vaccine allocation is not unique to Japan. Until now, various ways of rationing, such as utility-based or justice-based allocation, have been suggested, as recently summarized by Buccieri and Gaetz in Public Health Ethics.

The nature of virus complicates the problem. It is difficult to know the nature of each flu virus just after outbreak of the pandemic. At least we can say that the scientific validity of a vaccine rationing plan should be continually tested, and flexible and practical interpretation will be needed. Furthermore, whichever principle for rationing we chose, the principle has to be shared and understood by the society in order to be effective in a real situation. On this point, today’s planning concerning the “prioritized class” in Japan needs further transparency about the evidence of setting the class – for rational policy making.

I also consider that cooperation between northern and southern countries should be more in focus. We remember concerns shown by some southern countries that pandemic vaccine was mainly occupied by the developed countries, and it was difficult for them to secure vaccine for their own citizens. Some emerging flu viruses lead to fatal conditions in developing countries, but do not have so serious consequences in developed countries. Nevertheless, vaccine allocation has been independently coped with by many countries.

Considering the global context of pandemic flu, I think that rationing vaccine as a domestic matter cannot be morally justified from the “justice” or “utility” point of view.

We are not sure that a pandemic will come or what will it be like. Fickle viruses haunt our thinking and test core value of our civilized society and the way of justice.

Yusuke Inoue

We want to be just - the Ethics Blog

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