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

Month: December 2012

LifeGene and participation of minors in biobank research

One of the issues preceding the Swedish Data Inspection Board’s decision to stop the population-based biobank LifeGene concerned participation of minors.

LifeGene had planned to collect samples from half a million Swedes, including children. A regional ethical review board, however, decided against collecting data from children. Only data collection from adults was approved of.

LifeGene saw participation of minors as essential to their purposes and therefore appealed against the decision.

Unfortunately for LifeGene, the central ethical review board took the fateful decision that LifeGene couldn’t even undergo ethical review. LifeGene’s broad purpose – “future research” – indicated that LifeGene was infrastructure for research and not a specific research project. (According to the law, only research projects are ethically reviewed.)

The broad future-oriented nature of LifeGene’s purpose later became the main reason for the Data Inspection Board to stop LifeGene.

The fact that the stopping of LifeGene was preceded by the issue of children’s participation in biobank research makes a recent publication on this problematic all the more relevant for biobankers to read.

The article by Kristien Hens, Kris Dierickx and colleagues, published in the European Journal of Human Genetics, aims towards an ethical policy for minors’ participation in biobank research.

The authors emphasize that relevant ethical concerns differ from those of adult participation in biobank studies as well as from those of children’s participation in clinical trials. There is therefore a need for principles that apply uniquely to minors’ participation in biobank research.

I will not summarize the authors’ conclusions since they are so neatly summarized at the end of the article in the form of eight principles about, for example, subsidiarity and consent.

The eighth and final principle, however, deserves special mentioning, since it introduces a new policy concerning return of individual results. If I understand it right, the principle states that parents have a limited right to decide not to receive genetic information about their children. If an incidental finding concerns a preventable or treatable early-onset disease and it has clinical validity and utility, then parents should be informed about the finding regardless of their wishes.

The right not to know is overruled in this particular case.

The article is well worth reading as a constructive discussion of concerns that need to be addressed when children are included in biobank research.

Pär Segerdahl

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Extended deadline for Researcher in Health Economics: January 7, 2013

Ethical questions about health care and medical research often require empirical input, to make arguments valid for real conditions.

Many of the future issues that engage us at CRB need empirical basis in so called Discrete Choice Experiments (DCE). We are therefore recruiting a researcher with a doctoral degree in health economics and documented skills in DCE.

We are looking for a creative person who likes multidisciplinary collaboration and is fluent in English, and who can start working as soon as possible.

Read more and submit your application!

Pär Segerdahl

ethics needs empirical input - the ethics blog

Moral tipping points

Yesterday, I read a thought-provoking article about biosecurity. It suggested novel ways of thinking about infectious diseases. According to traditional thinking, infectious diseases strike us from outside. Therefore, we protect us from such external threats by building more effective borders. We secure pure healthy spaces and protect these spaces from impure, diseased ones.

The alternative thinking is less geometrically oriented and does not make a sharp distinction between “pure” and “diseased” spaces. Here is an illustration. If I understood the article right, a certain microbe, Campylobacter, is typically present in the microbial flora of farmed chickens. This bacterium does not become a health threat until there is a balance shift in the chickens’ intense relations with their farm circumstances.

Campylobacter “infection” in chickens, then, does not necessarily occur from outside, since the microbe always is present, but through balance shifts at what the authors called “tipping points.”

I was struck by the notion of tipping points. They remind me of processes of moral change:

It is well-known, to most of us at least, that our moral perceptions sometimes undergo dramatic change. Consider the following example, discussed in our CRB seminar series earlier this autumn: sex disambiguation surgery on newborns, when their sex cannot be unequivocally determined by a doctor.

Our present social circumstances are such that being boy or girl, being man or woman is profoundly significant. Being neither, or both, is being in trouble. Legally, for example, you must be male or female, and that’s only one aspect of the demand.

If we live in happy balance with these circumstances, sex disambiguation surgery might strike us as a blessing. Through surgery, the child is “helped” towards becoming unambiguously boy or girl. This is of such importance that “correction surgery” can be allowed even on newborns that haven’t yet developed their way of being in the world. Early surgery might even be preferable.

If, in the other hand, there is a balance shift; if we open ourselves to the possibility that present circumstances can be troublesome and changed – must we legally be male or female? – a tipping point may occur where the helpful correction of a bodily deformation can start to look like… genital mutilation performed to adapt newborns to our culture’s heterosexual norms and dualistic beliefs.

The new ideas may appear foreign to the old ones, as if they came from outside: what have we been reading lately? But they need not be as foreign as they appear and they need not enter our thinking “from outside.” Moral thinking is in dynamic relationships with our circumstances: if these relationships shift, so may our moral perceptions.

At moral tipping points what previously was perceived as “helping” may suddenly look like “mutilating.” What previously was “reality” may turn into “culture” and further into “norms and beliefs.” Changes at moral tipping points can be dramatic, which fools us into thinking that the new ideas necessarily entered our territory from another moral space. But they emerged right here, in our exchanges with our own circumstances.

Why is this important?  I think it suggests paths beyond the age-old relativism-versus-absolutism controversy.

We habitually view opposed moralities as distinct; simply distinct. You have one view on the matter; I have another. When I heard about tipping points, it struck me that opposed moral views often are dynamically connected: one view becomes the other at the tipping point.

Thinking in terms of tipping points can negotiate some sort of peace between standpoints that otherwise are exaggerated as if they belonged to opposed metaphysics.

Someone who speaks of male and female as realities is not necessarily in the grips of the metaphysics of substance, as Judith Butler supposes, but may speak from the point of view of being in untroubled balance with present circumstances.

Someone who speaks of male and female as produced by norms is not necessarily in the grips of relativistic anti-metaphysical doctrines, as realist philosophers would suppose, but may speak at a tipping point where the balance with present circumstances shifted and became troubled.

My proposed tipping point negotiation of peace between apparently foreign moral views and stances does not make the opposition less real; it only avoids certain intellectualist exaggerations and purifications of it.

Moral language functions differently when the circumstances are untroubled compared to when they are troubled. Moral thinking is in dynamic relationships with the world (and with how we inhabit it).

Pär Segerdahl

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