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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Ethics, human rights and responsible innovation

October 31, 2017

josepine-fernow2It is difficult to predict the consequences of developing and using new technologies. We interact with smart devices and intelligent software on an almost daily basis. Some of us use prosthetics and implants to go about our business and most of us will likely live to see self-driving cars. In the meantime, Swedish research shows that petting robot cats looks promising in the care of patients with dementia. Genetic tests are cheaper than ever, and available to both patients and consumers. If you spit in a tube and mail it to a US company, they will tell you where your ancestors are from. Who knows? You could be part sub Saharan African, and part Scandinavian at the same time, and (likely) still be you.

Technologies, new and old, have both ethical and human rights impact. Today, we are closer to scenarios we only pictured in science fiction a few decades ago. Technology develops fast and it is difficult to predict what is on the horizon. The legislation, regulation and ethical guidance we have today was developed for a different future. Policy makers struggle to assess the ethical, legal and human rights impact of new and emerging technologies. These frameworks are challenged when a country like Saudi Arabia, criticized for not giving equal rights to women, offers a robot honorary citizenship. This autumn marks the start of a research initiative that will look at some of these questions. A group of researchers from Europe, Asia, Africa and the Americas join forces to help improve the ethical and legal frameworks we have today.

The SIENNA project (short for Stakeholder-informed ethics for new technologies with high socio-economic and human rights impact) will deliver proposals for professional ethics codes, guidelines for research ethics committees and better regulation in three areas: human genetics and genomics, human enhancement, and artificial intelligence & robotics. The proposals will build on input from stakeholders, experts and citizens. SIENNA will also look at some of the more philosophical questions these technologies raise: Where do we draw the line between health and illness, normality and abnormality? Can we expect intelligent software to be moral? Do we accept giving up some of our privacy to screen our genome for genetic disorders? And if giving up some of our personal liberty is the price we have to pay to interact with machines, are we willing to pay it?

 The project is co-ordinated by the University of Twente. Uppsala University’s Centre for Research Ethics & Bioethics contributes expertise on the ethical, legal and social issues of genetics and genomics, and experience of communicating European research. Visit the SIENNA website at www.sienna-project.eu to find out more about the project and our partners!

Josepine Fernow

The SIENNA projectStakeholder-informed ethics for new technologies with high socio-economic and human rights impact – has received just under € 4 million for a 3,5 year project under the European Union’s H2020 research and innovation programme, grant agreement No 741716.

Disclaimer: This text and its contents reflects only SIENNA’s view. The Commission is not responsible for any use that may be made of the information it contains.

SIENNA project

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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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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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Notebook, not Facebook

March 30, 2016

Pär SegerdahlI take the liberty of striking a blow for the notebook.

I miss the voices people develop when they use to keep their own notes. The conversation with yourself gives depth – “I have thought about this” – to your conversation with others.

The erosion of collegial structures at universities is worrisome. But what especially concerns me is the notebook culture, which I believe needs to be rediscovered. Without own notebooks, no real education and no real knowledge.

It isn’t about withdrawing to one’s study to write esoteric notes. It is about developing one’s own groundwork in the life with others. It is developed in (temporary) seclusion, in response to life with others. Then you can converse, because you will have something to say, something of your own.

Cultures deepen through the rumination in diaries and notebooks. Without this simple practice, cultures erode and voices sound thinner. We need to carry culture on our own shoulders.

Kafka recorded in one of his notebooks a picture that I often think of. It is the image of messengers rushing around with messages that they received from other messengers. But it turns out that there is no author of these messages. There are only messengers. I see this as an image of a world without notebooks.

Kant spoke of human authority and autonomy. In Kafka’s picture there is no authority and no autonomy, for no one is the author of their own words: just the messengers of words from other messengers. For once being the author, not only the messenger of what other messengers passed on: wouldn’t that be something!

Become the author of your own words by taking notes! The notebook is the origin of all messages worth communicating. I am a notebook individualist.

To think and reflect is not only about having time. It is about using the time to converse with yourself. That conversation is lifelong. When you converse with others, you convey the lifelong conversation with yourself.

Artists have probably more than others retained the practice of using sketchbooks, of regularly practicing music more informally and privately, of making drafts of stories and novels. That practice gives them a basis to create. We have much to learn from the artists. They are the last to maintain culture, through the sketchbooks in which they constantly scribble.

Nothing is more responsible and authoritative than keeping your own notes. The notes don’t have to be brilliant or groundbreaking. Only your own sincere words with yourself. That is originality! Through the notebook you develop the integrity that is worth defending. And that is worth sharing with others, who of course also have notebooks.

I don’t want to read your Facebook updates, but perhaps your notes. You read mine here. So get a notebook if you don’t already have one. It is the most radical thing you can do today.

Pär Segerdahl

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Critique of the motivation for dynamic consent to biobank research

March 23, 2016

Pär SegerdahlBiobank research has undeniably challenged research ethics and the requirement for informed consent. We are after all dealing with collection of biological samples for future, yet unspecified research. Thus, one cannot give donors specific information about the research in which their samples will be used. It might seem like asking them to consent to unknown research projects x, y, z.

While some argue that broad consent for future research is specific enough to be genuine consent to something – one can inform about the framework that applies to the research – others argue that biobank research undermines the autonomy of research participants. Something must therefore be done about it.

Dynamic consent is such a proposed measure. The idea is that participants in biobank research, through a website, will be kept continuously informed about planned research, and continually make decisions about their participation. Through this IT measure, participants are placed at the center of decision making process rather than transferring all power to the researchers. Dynamic consent empowers research participants and supports their autonomy, it is claimed.

In an article in the journal Bioethics, Linus Johnsson and Stefan Eriksson critically examine the understanding of autonomy in the debate on dynamic consent.

First, the authors argue that autonomy is misunderstood as a feat. Autonomy is rather a right people have to decide for themselves what to do in situations that matter to them.

Second, they argue that the concept of autonomy is used too broadly, hiding important distinctions. In fact, three different ways of respecting people are conflated:

  1. Autonomy: respecting people’s right to decide for themselves about what to do.
  2. Integrity: respecting people’s right to draw the lines between private and social life.
  3. Authority: respecting people’s right to take responsibility for themselves, for their families, and for their relations to society.

Authority is respected by empowering people: by giving them the tools they need to live responsibly. In dynamic consent, the website is such a tool. It empowers participants to act as responsible citizens concerning the planning and carrying out of research in society.

By separating three forms of respect which are confused as “autonomy,” the authors can propose the following critical analysis of the motivation for dynamic consent. Rather than respecting people’s right to decide for themselves about what to do, the aim is to empower them. But if the empowerment forces them to sit in front of the computer to be informed, it violates their integrity.

Such intrusion could be justified if medical research were a suitable arena for people’s empowerment as citizens – an assumption which the authors point out is doubtful.

Pär Segerdahl

Johnson, L. and Eriksson, S. 2016. “Autonomy is a right, not a feat: How theoretical misconceptions have muddled the debate on dynamic consent to biobank research.” Bioethics, DOI: 10.1111/bioe.12254

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Second issue of our newsletter about biobanks

June 2, 2015

Pär SegerdahlNow you can read the second newsletter this year from CRB and BBMRI.se:

The newsletter contains four news items:

1. Anna-Sara Lind presents a new book, Information and Law in Transition, and the contributions to the book by CRB researchers.

2. Anna-Sara Lind describes the situation for the temporary Swedish law on research registries.

3. Mats G. Hansson reports on a modified version of broad consent for future research.

4. Josepine Fernow presents a new article by Jennifer Viberg on the proposal to give research participants freedom of choice about incidental findings.

(Link to PDF version of the newsletter)

Pär Segerdahl

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