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

Tag: biobanks (Page 5 of 9)

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

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

How does biotechnology become real?

PÄR SEGERDAHL Associate Professor of Philosophy and editor of The Ethics BlogSeeing things with our own eyes, not just hearing about them, makes a difference. Words certainly arouse images, but they are our own images of what we never saw.

This is a challenge for the rapid development in biotechnology. Genetically modified organisms are created, in vitro fertilization is practiced, stem cells are grown, and biobanks are constructed.

For most of us this is only hearsay. The words we hear arouse images, but as I said: images of what we never saw with our eyes. When we then respond to new forms of biotechnology, perhaps with anxiety or a sense of unreality, it is often our own images we respond to.

It’s like trying to form an opinion of a person who is hidden in a cloud of rumors. What a difference it makes to actually meet the person, and not only respond to the images that the rumors create within us.

Increased popular scientific efforts don’t automatically solve the problem. On the contrary, relying too much on the visual potential of, for example, computer animation can contribute to the cloud formation. People are stimulated to create even further images of what they never saw.

So how can biotechnology be made real? I believe: by showing what can be shown. Just seeing a genetically modified tomato or a person who underwent stem cell treatment makes biotechnology more real to me than any image of the DNA helix or stem cell differentiation can.

Seeing what can be shown – often practical applications – doesn’t necessarily make me approve of all forms of biotechnology, but I can discuss the technology without being too much distracted by my own cloud of images. I can discuss what became real.

How new forms of biotechnology can become real for the public is discussed in a new article in the Croatian Medical Journal, written by Anna Lydia Svalastog, Joachim Allgaier, Lucia Martinelli, and Srecko Gajovic.

They introduce the notion of Knowledge Landscapes to think more concretely visually about communication with the public about new forms of biotechnology. They emphasize science museums as one arena where biotechnology can be discussed as a reality rather than as an urban myth.

Show what can be shown.

Pär Segerdahl

We like real-life ethics : www.ethicsblog.crb.uu.se

The risk with knowing the risk

PÄR SEGERDAHL Associate Professor of Philosophy and editor of The Ethics BlogInforming individuals about their genetic risks of disease can be viewed as empowering them to make autonomous decisions about their future health.

But we respond to risk information not only as rational decision makers, but also with our bodies, feelings and attitudes.

An American study investigated elderly people whose genetic test results showed a predisposition for Alzheimer’s disease. One group was informed about the risk; the other group was not.

In subsequent memory tests, those who were informed about the risk performed markedly worse than those who weren’t informed.

Knowing the genetic risk thus increased the risk of a false positive diagnosis of dementia. The informed participants performed as if they already were on the verge of developing Alzheimer’s.

The risk with knowing the risk is thus a further complication to take into consideration when discussing biobank researchers’ obligation to return incidental genetic findings to individual participants.

Returning information about genetic risks cannot be viewed only as empowering participants, or as giving them valuable information in exchange for contributing to research.

It can also make people worse, it can distort research results, and it can lead to false diagnoses in clinical care.

Pär Segerdahl

We like challenging findings - 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

Biobank and registry-based research: our publications

At the Centre for Research Ethics and Bioethics in Uppsala, we have since the 1990s been studying the ethics of biobank and registry-based research.

If you are interested to see what we have done in this field, you can find a recently updated list of our publications by clicking the link below:

The compilation also contains abstracts of the publications.

Pär Segerdahl

Approaching future issues - 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

Idling biobank policy?

If you allow researchers to do brain imaging on you for some research purpose, and they incidentally discover a tumor, or a blood vessel with thin walls, you probably want them to inform you about this finding. There are no doubts about the finding; the risks are well-known; it is actionable.

Suppose instead that you donate a blood sample to a biobank. Suppose that researchers studying the sample discover a genetic variant that, depending on a number of interacting factors, might result in disease in three years’ time, or in thirty years, or not at all. It is difficult to predict! Do you still want to know?

How should these incidental findings be handled that increasingly often will be made in genetic biobank research? We are all different, so finding variants with some statistical relation to disease is more or less expected.

A common approach to this question within attempts to develop a policy for incidental biobank findings is to formulate general conditions for when researchers should inform participants. Like: if the finding is analytically valid; if it has clinical significance; if it is actionable – then participants should be informed.

The problem is: we already knew that. We know what these conditions mean in imaging studies when a tumor or a damaged blood vessel is discovered. In these cases, the conditions can be assessed and they make it reasonable to inform. But what about genetic risk information, which often is more multidimensional and has unclear predictive value?

This question is discussed in a recent article in the European Journal of Human Genetics, written by Jennifer Viberg together with Mats G. Hansson, Sophie Langenskiöld, and me:

Viberg argues when we enter this new and more complex domain, we cannot rely on analogies to what is already known in a simpler domain. Nor can we rely on surveys of participants’ preferences, if these surveys employ the same analogies and describe the findings in terms of the same general conditions.

Time is not yet ripe for a policy for incidental genetic findings, Viberg and colleagues conclude. Formulating a policy through analogies to what is already known is to cover up what we do not know. The issue requires a different form of elucidation.

That form of elucidation remains to be developed.

Pär Segerdahl

We participate in debates - the Ethics Blog

Dynamic consent in biobank research: better than broad consent?

Biobanks make contributing to medical research easy: easier than when the research is performed on living human bodies.

I simply donate my sample and consent to storage for certain kinds of future research, under specified conditions like that the research is ethically reviewed and the sample is coded so that it cannot be traced to me without keys. I consent to a specific biobank framework.

Thereafter, the research is done on the sample and data in registers. What an easy way of contributing to research!

Too easy, it is sometimes objected. Broad consent to future research implies ethically problematic passivity among biobank participants, the objection goes. Participants are precluded from exercising fundamental rights and freedoms. Power is transferred from participants to researchers.

What’s the solution, then? An often proposed solution is familiar to all who make choices on the internet. Passive biobank participants can be activated by keeping themselves updated via a website. On this website, they give dynamic consent in real time, as researchers continually inform about proposed research with donated samples.

Dynamic consent would empower biobank participants, make them engaged in the decision-making process and equal partners in the research.

It sounds brilliant! What an easy solution!  In the case of large population-based biobanks, however, it would mean that hundreds of thousands would spend the rest of their lives keeping themselves updated about planned research with samples donated perhaps decades ago, and for each new project make active choices: yes or no?

Researchers would be free to come and leave the biobank, while participants are fettered to a life-long commission as ethical gate-keepers, with their own login information.

Seduced by sugary phrases? In an article last month – Broad versus dynamic consent in biobank research – Norwegian research ethicists identify six often cited reasons in favor of a dynamic consent model for biobanks. For each cited claim, they are able to adduce reminders and considerations that make the claim notably less appetizing, at least to me.

This post would become long-winded if I informed about all objections to the claims in favor of dynamic consent: who reads long texts on the internet? Two central objections, however, are that a dynamic consent model would invite people into the therapeutic misconception and that it would individualize the ethical review of public health research.

Still, it is vital that biobanks continually inform about ongoing and planned biobank activities, making the research transparent, and giving those who might want to opt-out opportunity to do so.

Pär Segerdahl

The temptation of rhetoric - the ethics blog

Making the Helsinki Declaration coherent?

The Helsinki Declaration is under revision. One suggested change concerns a paragraph about biobank and register-based research, which states:

  • “For medical research using identifiable human material or data, physicians must normally seek consent for the collection, analysis, storage and/or reuse.”

The paragraph currently continues with the following exceptions:

  • “There may be situations where consent would be impossible or impractical to obtain for such research or would pose a threat to the validity of the research. In such situations the research may be done only after consideration and approval of a research ethics committee.” (My emphasis.)

The proposed revision is to delete the exception I emphasized. – Why? I speculate that the deletion is proposed to avoid perceived conflict with an earlier paragraph, stating that

  • “the well-being of the individual research participant must take precedence over all other interests.”

In particular, the interests of research must not take precedence over the interests of the participant. But it might appear as if “…or would pose a threat to the validity of the research” does just that. The phrase seems to emphasize the interests of research.

In the latest issue of Science, CRB researchers Joanna Forsberg and Yusuke Inoue question the proposal to delete the exception. In a letter, “Beware Side Effects of Research Ethics Revision,” they point out that in biobank and register-based research, risks of participation are only minimal.

Human beings are “participants” in a markedly different sense when the research is done on their data or samples, rather than on themselves or their bodies.

The authors argue that “when the risks are minimal, it is not clear that the individual’s interests in having a say should automatically outweigh the good that can result from robust research.”

I think their views should be taken seriously. There is a risk that the effort to achieve verbal consistency neglects actual distinctions between forms of medical research. If the paragraphs that seem to conflict concern markedly different forms of research and markedly different forms of participation with markedly different risks – then an important exception might be sacrificed for the sake of an only apparent conflict.

Pär Segerdahl

We participate in debates - the Ethics Blog

« Older posts Newer posts »