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

Tag: LifeGene

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

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UK Biobank invites researchers

After many years of data collection, UK Biobank is now open for research on human health and disease.

Like the Swedish biobank investment LifeGene, the British investment is big and prospective. Blood and urine samples were collected from 500 000 participants aged 40-69. Participants also underwent medical examinations and answered questions about health, disease and lifestyle.

The news is that researchers can now start planning projects using these data. Nevertheless, it will probably be a long time before interesting findings are reported…

It may seem cynical, but before UK Biobank can support valuable research, sufficiently many participants must develop various diseases, while others remain healthy. This is what will allow researchers to go back to the original data and identify patterns in how genetic and environmental factors contribute to health and disease.

The value of biobank infrastructure, like UK Biobank, increases with time, as participants develop cancer, depression, diabetes, or heart disease… while others remain in good health.

The fact that biobank infrastructure initially has unclear scientific value and reveals its potential only with time tends to invite skepticism. In the UK as well as in Sweden, investments in biobank infrastructure were interpreted by some as if they concerned unusually obscure research projects, lacking proper scientific goals and procedures.

I think that this is a misunderstanding.

As the recent opening of UK Biobank shows, it is not until now that clearly defined research projects can start being planned. If I am right, however, we might even have to wait somewhat longer…

The data collected between 2006 and 2012 might not support much interesting research until 2022, if I understand the temporality of these research processes. Since the research concerns health and disease in ageing humans, the significance of the research cannot develop any faster than humans grow older.

Rather than holding the initial lack of scientific prosperity against investments like UK Biobank or LifeGene, I am struck by the patience and foresightedness of those who planned and decided about these investments.

Understanding the infrastructural preconditions of biobank research seems to require an attitude to the pace of human life that I thought had become extinct in an age obsessed with short-term agendas.

Sometimes, we have to wait for the future to reveal itself. Only when the time is ripe can the goals and procedures of scientifically interesting biobank projects be defined.

Pär Segerdahl

Approaching future issues - the Ethics Blog

The Swedish government announced new rules for research registers

Will new Swedish rules for research registers enable LifeGene to continue?

In December 2011, the Swedish Data Inspection Board (DI) decided that the large biobank investment LifeGene is against the law.

In its motivation, DI focused on the purpose of the data collection and the information to participants about this purpose. According to DI, LifeGene’s purpose – “future research” – is too unspecific to be in accordance with the Personal Data Act.

Yesterday (February 28), the Swedish government announced new rules for research registers. These rules are supposed to enable LifeGene to continue. If you read Swedish, you might want to study the government’s press release.

I am not a legal expert, but it seems to me that even if the government’s new rules can make LifeGene lawful as a research register, other laws become relevant when the register is being used in research… for example, the Personal Data Act, surveyed by DI.

I happen to believe that LifeGene’s purpose can be interpreted as being sufficiently specific even for the demands of the Personal Data Act. LifeGene does not bluntly state “future research” as its purpose, but specifies the kind of diseases that will be studied, as well as the goal of creating new tools to prevent, diagnose, and treat these diseases.

Karolinska Institutet (that administers LifeGene) has appealed against DI’s decision to stop LifeGene. If DI does not withdraw its decision, my uncertain layman guess is that the result of this legal process might still be relevant for the possibility of continuing LifeGene as planned.

Pär Segerdahl

Following the news - the ethics blog

The Swedish Data Inspection Board stops large biobank

Swedish biobank research suffered serious defeat last week. The Swedish Data Inspection Board decided that the ongoing collection of biological samples and health data to the large biobank LifeGene is against the law.

Karolinska Institutet (that runs LifeGene) must now stop collecting further data and is not allowed use already collected data. The reason for the decision is said to be the loosely formulated purpose of LifeGene: “future research.” Participants cannot give consent to anything that vague, the Data Inspection Board argues.

Well, that openness happens to be the point of this new type of biobank!

LifeGene is not a research project, nor is it part of a research project. LifeGene is intended as infrastructure of future biobank projects. Researchers are invited to apply for access to the biobank within specific studies of, for example, genetic and environmental risk factors for widespread diseases.

The more specifically formulated research purposes enter later in the process!

Collecting hundreds of thousands of biological samples and health data anew, each time researchers want to ambitiously study widespread diseases, is unfeasible. Therefore, LifeGene was developed as standing infrastructure of such biobank research in the future.

… And now it has been decided that developing such infrastructure is illegal. Because the purpose cannot be specified as in the research projects that later use the biobank!

This is a category mistake, as philosophers say when what is fundamentally distinct is conflated. In this case, research infrastructure is conflated with research projects.

Other posts about biobanks on this blog are directly related to the risk of the decision that the Swedish Data Inspection Board made:

My views can be summarized in two simple points:

  1. Infrastructure for biobank research must not be treated as if it were one of the projects meant to use it.
  2. My given blood sample does not make me a research participant (who must give consent each time the sample is used).

LifeGene represents a new reality in the making. It remains for the authorities, for legislators, and for all of us to better understand it!

Pär Segerdahl

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