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

Year: 2012 (Page 1 of 5)

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

We recommend readings - the Ethics Blog

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

The Ethics Blog - Thinking about thinking

Logical laws and ethical principles: appendices to human reasoning

We tend to view logical laws and ethical principles as foundational: as more basic than ordinary discourse, and “making possible” logical and ethical reasoning. They set us on the right intellectual path, so to speak, on the most fundamental level.

I want to suggest another possibility: logical laws and ethical principles are derived from ordinary discourse. They constitute a schematic, ideal  image of what it means to make truth claims, or ethical claims, in our language. They don’t make the claims and forms of reasoning possible, however, but reflect their familiar presence in daily discourse.

Consider the logical law of non-contradiction, which states that a proposition and its negation cannot both be true simultaneously. Does this law implicitly set us on the path of non-contradictory talk, from morning to night? Or does it have another function?

Here is an alternative way of thinking about this “law of thought”:

The impression that others contradict themselves is not uncommon. When this occurs, we become uncertain what they actually say. We ask for clarifications until the sense of contradiction disappears. Not until it disappears do we recognize that something is being said.

The law of non-contradiction reflects this general feature of language. As such a reflection, however, it is derived from language and doesn’t function as a foundation of human truth-telling.

I want to make a similar proposal for ethical principles. Ethical principles – for example, of beneficence or respect for persons – reflect how people already view certain aspects of life as morally important and use them as reasons.

Ethical principles don’t “make” these aspects of life moral reasons. They just highlight, in semi-bureaucratic language, the fact that they are such reasons for people.

Consider this way of reasoning, which is perfectly in order as it stands:

  • (A) “I helped you; therefore you should help me.”

This moral reasoning is familiar to all of us. Its presence could be acknowledged in form of an ethical principle, P; a Principle of Reciprocity (“Sacrifices require services in return” etc.).

According to the view I want to leave behind, the fact that I helped you doesn’t constitute a reason until it is linked to the ethical principle P:

  • (B) “I helped you; according to Principle P, you therefore should help me.”

Ethicists typically reason the latter way, (B). That is alright too, as long as we are aware of its derived nature and don’t believe that (B) uncovers the hidden form of (A).

Ethical principles summarize, in semi-legislative language, how humans already reason morally. They function as appendices to moral reasoning; not as its backbone.

Why do we need to be aware of the derived nature of ethical principles? Because when we genuinely don’t know how to reason morally – when there are no convincing arguments of kind (A) – it is tempting to use the principles to extrapolate moral arguments of kind (B)… appendices to claims that no one makes.

Viewing ethical principles as foundational, we’re almost forced to turn to them for guidance when we are in genuine moral uncertainty. But perhaps we should rather turn to the real-life features that are at stake. Perhaps we should focus our attention on them, try to understand them better, engage with them… and wait for them to become moral reasons for us in ways we might not be able to anticipate.

As a result of this open-ended process of attentive and patient moral thinking, ethicists may discover a need for new ethical principles to reflect how forms of moral reasoning change in the process, because new aspects of life became moral reasons for us when we attended to them.

Consider as an example the ethical problem whether incidental findings about individual participants in biobank research should be returned to them. At this very moment, ethicists are working hard to help biobankers solve this genuinely difficult problem. They do it by exploring how our present canon of ethical principles might apply to the case.

Is that not a little bit like consulting a phrase book when you discover that you have nothing to say?

Pär Segerdahl

We challenge habits of thought : the Ethics Blog

Wanted: two researchers to join our team

The Centre for Research Ethics and Bioethics (CRB) is currently recruiting two researchers. We are looking for creative persons who like multi-disciplinary collaboration and are fluent in English.

1. Researcher in health economics (UFV-PA 2012/2684): We are looking for a person with a doctoral degree in health economics with documented skills in Discrete Choice Experiments.

2. Researcher in ethics/biobank/registry research regulations (UFV-PA 2012/2683): We are looking for a person with a doctoral degree in ethics or law, or someone with a doctoral degree in medicine or life sciences with an interest in ethical issues.

Both positions are 2-year appointments, with possible prolongation.

Application deadline: November 29, 2012.

(Job descriptions and information about the applications in the links above.)

Pär Segerdahl

We transgress disciplinary borders - the Ethics Blog

Commercial gene tests and incidental findings

I read Arthur Caplan’s criticism of the personalized gene tests that some companies insist we must buy to gain control over our future health. I could not help wondering if his criticism is applicable also to the idea that biobanks should inform research participants about incidental findings about their genes.

Caplan rejects the crystal ball view of genetic information that is utilized in the marketing for commercial gene tests: the image that genetic information is uniquely predictive about YOUR future health.

The crystal ball image is a prejudice. It is a gene myth that makes people believe they MUST get genetic information to control their future health. It is a myth that makes people think they have a RIGHT to look into the crystal ball, now that this uniquely powerful instrument is available.

But disease risk is the result of complex interactions between genes and environment, and “no one knows how a single person’s lifestyle, upbringing and environment interacts with their particular genes to create risks,” Caplan writes.

If this is true and genetic information in abstraction is far from predictive, then I cannot avoid worrying about how the crystal ball image shapes also the ethical discussion about incidental findings in genomic biobank research.

In this discussion, accidentally discovered individual genetic variation is sometimes described as a good that participants have a right to be informed about, in return for the biological material they donate to the biobank.

If Caplan is right and such information typically is not worth the money, how can it be a good that participants have a right to receive such information from the biobank in return for their sample?

Do well-meant ethical arguments sometimes resemble unethical marketing campaigns?

Pär Segerdahl

Approaching future issues - the Ethics Blog

Is there a need for a retractions database?

I wrote a while ago about drug companies as whistle blowers. Evidently, the pharmaceutical industry wastes more and more resources unsuccessfully trying to replicate published research studies.

The amount of irreproducible published research surprised me. If there is such a trend, questions accumulate. Are researchers becoming increasingly careless, or even fraudulent? Are researchers acting under too heavy pressure to publish positive results? Do many researchers lack sufficient skills in statistics?

Or has research in the life sciences entered such complex terrain that it has become virtually inhuman to survey all factors that may influence the results?

I’m not competent to answer these questions and welcome helpful comments.

A way to handle at least part of the problem has been suggested: set up a centralized retractions database. Such a resource would help scientists and the industry to exclude at least some of the most unsuitable candidates for replication.

An ambitious study of retractions used secondary sources when the journals’ own reasons for the retractions seemed incomplete or vague. According to this study, fraud or suspected fraud caused 43% of the retractions. Duplication accounted for 14% of the retractions, and plagiarism for 10%; only 21% of the retractions had to do with error.

If you want to read more about the study on retractions, it is summarized in this recent Nature News article.

Pär Segerdahl

Following the news - the ethics blog

Project Nim: a tragedy that was interpreted as science?

Last week I wrote about the significance of negative results in science. This week I saw one of the saddest documentaries I’ve ever seen, featuring the tragic context of an often cited negative result in science.

The documentary, Project Nim (2011), was about the psychologist Herb Terrace’s attempt in the 1970:s to teach American sign language to a young chimpanzee, in a specially designed classroom at Columbia University in New York City. “Specially designed” here meant bare and small in order to avoid suggesting activities that are more exciting for a young ape than reproducing the teacher’s hand movements.

Terrace’s personal stance to the language project struck me as odd. Scientifically, he wanted to test the hypothesis that an ape can be taught to construct sentences. This would disprove Chomsky’s view that language is an innate and uniquely human trait. From a more “personal” point of view, what excited Terrace most was the prospect of experiencing a nonhuman animal communicate ape thoughts.

It would be like meeting an alien from outer space who miraculously communicated foreign thoughts to humankind. Treating young Nim as such an alien research subject strikes me opposed to the very idea of human language and communication.

The whole project was a mess, ill-planned and dysfunctional from the start. And yet there were happy moments where good relationships developed between Nim and responsible caretakers/teachers/surrogate parents outside the classroom.

In these more “distractive” real-life situations, where the point wasn’t about reproducing the teacher’s signs but about doing meaningful things together and communicating about them while doing them, it seemed Nim used signs to talk. The caretakers were optimistic, as was Terrace.

However, as Nim got bigger and stronger and approached adolescence, new problems appeared. He began to attack and bite his teachers, and Terrace feared being sued. These troublesome behaviors developed more rapidly than Nim’s signing abilities, and Terrace was worried.

One day, Terrace called his staff to a meeting and declared that the project was over. They had collected suffient data, and Nim could be sent back to the primate research center in Oklahoma where he was born.

The rest of Nim’s life was was awful, terrifying (although responsible caretakers did try to make a difference).

Simultaneously, Terrace started reporting the project; in a book as well as in an article published in Science. He sat down, watched videotaped interactions between Nim and his teachers, and came to the conclusion that Nim had not acquired the ability to use signs linguistically in genuine communication with humans. He was merely mirroring the teacher’s signs (or begging for things).

The negative result that Terrace published perhaps received more attention than any other scientifically published negative result. In spite of the fact that the project was dysfunctional from the start, Terrace’s publications were welcomed as presenting hard scientific evidence that apes cannot learn to communicate in language.

I’m not so sure what conclusions can be drawn from a research project that could just as well be described as a dysfunctional family history ending in tragedy. Moreover, as Peter Singer observed when he watched the documentary, Terrace could hardly end the project and send Nim away without reporting negative results.

Can we trust Terrace’s judgment when we watched the videotapes and decided that the ape he sent away did not speak with the fellow humans with whom he interacted?

Anyway, the book that Terrace wrote, Nim: a Chimpanzee Who Learned Sign Language (1979), is fascinating and well worth reading. It contains vivid descriptions of Nim’s life with humans; recollections that often seem to contradict the conclusions that Terrace finally reached.

Pär Segerdahl

Understanding enculturated apes - the ethics blog

Drug companies as whistleblowers

Some years ago, John Ioannidis warned that most published research findings probably are false.

More recently, the drug companies Bayer and Amgen reported that their attempts to replicate scientifically published studies that could be a basis for new drug development most often fail. Amgen, for example, failed to replicate 47 of 53 oncology and hematology results that they initially deemed interesting for their purposes.

We are used to seeing drug companies under attack by right-minded critics. Now they are in the position of delivering the critique. They invalidate most scientifically published findings in the field of medicine. By going public about this embarrassing fact, they act as whistleblowers revealing emptiness in current scientific practices and ways of supporting and awarding high quality research.

A solution to the problem is now being proposed, though not by the research community, but by a company: Science Exchange. They offer researchers a new service. For a fee, they attempt to reproduce the researchers’ studies. If the studies can be successfully replicated, the company issues a certificate of reproducibility.

Can such a proposal contribute to a transformation of current scientific practices, towards an order where peers not merely read and assess papers, but practically try to validate results?

But shouldn’t validation be internal to the research work, rather than outsourced?

If I interpret Karl Popper right, a scientist should actively try to achieve negative results. Only by failing to produce negative results can she tentatively claim positive results.

Do current ways of measuring and awarding scientific quality undermine the self-critical spirit of scientific work?

Pär Segerdahl

Following the news - the ethics blog

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