Tag: biobanks (Page 6 of 9)

Being human; representing life

10 September, 2013 / Pär Segerdahl / 0 Comments

A new article reconsiders Henrietta Lacks and the immortal HeLa cells that were obtained from her rare cancer tumor in the 1950s; cells that still replicate and are used in biomedical laboratories all over the world:

“Representing life as opposed to being: the bio-objectification process of the HeLa cells and its relation to personalized medicine”

The article is written by Anna Lydia Svalastog and Lucia Martinelli, both members of the Culture, Health and Bioethics network at CRB.

There is a lot going on in the article, making it difficult to summarize. As I understand it, though, the article focuses on two fields of tension when biological samples from humans are used in biomedical research – tensions between:

being human; and representing biological life,
the value of the one; and the value of the many.

Both fields of tension intersect in the case of Henrietta Lacks:

Henrietta Lacks was a human being, existing in a human world; but HeLa cells function as “bio-objects” representing biological life.
Henrietta Lacks was one unique individual; but HeLa cells have come to represent humanity.

These tensions highlight the interchange between research and society. We exist as human beings; but by donating samples to research, we also contribute to representing biological life. We are unique individuals; but through our samples, we also contribute to representing what is general.

The authors cite the European biobank infrastructure, BBMRI, as an approach to governance and ownership of knowledge and property that begins to address these tensions in interesting, new ways. The article also speaks in favour of interdisciplinary collaboration between the life sciences, the social sciences, and the humanities, to understand the fields of tension that arise when individual human beings contribute to medical research.

Pär Segerdahl

Characterizing reality

14 August, 2013 / Pär Segerdahl / 0 Comments

Reality is on the move, and so are we. Therefore, we are continuously challenged to characterize it, and us, anew. What is it like today? What have we become?

I believe that Nietzsche made such a renewed characterization of reality, or of what we became in the nineteenth century, when he said: God is dead.

How does such a characterization work? Is it a statement of fact? Did Nietzsche go out into the backyard and found God lying dead on the ground, as one can discover a dead bird? Hardly, Nietzsche’s characterization of reality can be contested in a way that the death of a bird cannot.

Is it an ideological position, then, one that Nietzsche invented out of the blue and tried to impose on reality? Hardly, for it is connected with numerous factual features of nineteenth-century life, such as the steam-engine, newspapers, industry, exploration expeditions, science, democracy… I’m not enough of a historian to enumerate them all.

Taking the issue to our own times: Can you imagine a Bach writing music for the glory of God alone… living in a suburban row house area, with the car parked outside, just after shopping in the mall? It is difficult to imagine such a Bach, and Nietzsche’s statement could be said to characterize that difficulty.

If we accept Nietzsche’s statement as a striking characterization of the difficulty of imagining a modern suburban Bach, it appears almost factual. It is what reality is like; what we have become. And yet, someone could contest the characterization, and that reality, and see it as a degenerated frame of mind to resist.

So what do statements of Nietzsche’s kind do? Do they describe reality or do they merely express individual perspectives?

I find the task of characterizing our characterizations of reality as one of the most challenging philosophical problems. Its urgency is obvious in bioethics, which deals with realities that certainly are on the move. New biomedical practices continuously challenge our characterizations of embryos, of stem cells, of health and disease, of research participation…

As I indicated on The Ethics Blog last week, research participation is “on the move,” due to developments in biobanking. It no longer solely means participation in specific studies. It will more and more mean also contributing to biobank infrastructures that are constructed to support future, not yet specified studies.

Is that a fact or a position? I think we need a more nuanced characterization of our continuously renewed characterizations of reality!

Pär Segerdahl

The specific study misconception of biobank infrastructure

5 August, 2013 / Pär Segerdahl / 0 Comments

It is comprehensible that a patient who agrees to participate in a clinical trial expects to get access to a new effective therapy that will restore health. It is comprehensible that it is difficult to convey objective, dispassionate information that such an expectation is unrealistic, given randomization and other features of clinical trials.

Participation in biobank research ought to be simpler to understand. How can you expect to get healthy by giving a blood sample and allowing future research to combine the genetic data that can be obtained from the sample with data accumulating over time in health registries? The therapeutic misconception ought to be less tempting in biobank research, making the relationship between researchers and participants more straightforward.

For this reason, I was surprised to read on the Science Codex Blog about a study indicating difficulties to understand participation in biobank research; difficulties similar to those that more comprehensibly arise for participation in clinical trials.

What surprised me even more, however, was the discussion about this finding that was quoted on the blog. The fact that participants in biobank studies cannot expect a new and better therapy was presented as a shortcoming vis-à-vis clinical trials, as if such an expectation was not a misconception. Moreover, hopes were expressed that a change is underway:

“Some new models for biobank studies are more inclusive of the research subject, offering on-going contact and return of results that may impact their health, says Dr. McBride.”

I do not exclude that such models might work for some restricted biobank studies about specific diseases, which might require on-going contact with a particular patient group to get the research done.

But biobanking is more and more about building infrastructures where samples are stored indefinitely for future research that cannot be specified in advance. Making participation in such infrastructures more like participation in specific clinical trials – supporting the therapeutic misconception where it ought to be most distant! – appears fundamentally misguided.

The infrastructural nature of modern biobanking remains to be understood. It needs to be freed from what might be termed the specific study misconception.

Pär Segerdahl

HandsOn: Biobanks 2013

20 June, 2013 / Pär Segerdahl / 0 Comments

The interactive conference, HandsOn: Biobanks, organized for the first time in Uppsala last year, attracted participants from 27 countries. The “movie version” of the event can be viewed on BBMRI.se.

This stimulating interactive concept will be repeated on 21-22 November 2013, in The Hague.

HandsOn: Biobanks focuses this year on the interaction between disciplines, and on questions like (quoting from the website):

“How to deal with issues that evolve from the connections with other disciplines? How do we strengthen and optimize these connections, so all communities will benefit?”

For information about the program and registration, visit HandsOn: Biobanks 2013.

Early bird registration is open!

Pär Segerdahl

Unhappy approach behind policy for incidental findings

24 April, 2013 / Pär Segerdahl / 0 Comments

Should individual research participants be informed if biobank researchers incidentally discover increased genetic disease risks through analysis of their samples?

At a seminar, Jennifer Viberg recently discussed a well-known recommendation for when participants should be informed about incidental findings:

Managing Incidental Findings in Human Subjects Research: Analysis and Recommendations

During the seminar it became increasingly clear how the authors of the recommendation were proceeding. They started out from how one already handles incidental findings in a more familiar field, namely, imaging studies of the internal organs of the human body. They then generalized that policy to the less familiar case of genomic biobank research.

When researchers produce images of the internal organs of the human body they may accidentally discover, for example, tumors in individual research participants. It is obvious that participants should be contacted about such findings so that action can be taken.

The problem when one generalizes from a field with developed policy to a less familiar field, however, is the risk that false analogies govern the generalized policy. By treating imaging studies as paradigm case of individual findings, it might look as if biobank researchers produce images; images of the genome that incidentally reveal individual divergences against which action can be taken – like when a tumor is operated.

The article does not emphasize the fact that incidental findings in biobank research more typically would concern highly complex and difficult to interpret information about increased individual genetic disease risks.

If I have a tumor, it exists within my body and it can be surgically removed. But if I have an increased genetic disease risk, what do I have and in what sense can it be removed? Does “actionability” have the same meaning for diseases and for increased disease risks?

These and related questions about differences are not emphasized in the article. On the contrary, one seems to be in a hurry to generalize a familiar routine to a new field.

Transferring lessons from familiar to less familiar fields seems reasonable. If one neglects the one-way nature of the approach, however, it easily inflicts blindness to essential differences. In her dissertation work, Jennifer Viberg wants to avoid this pitfall.

Pär Segerdahl

Don’t shoot at the patient (or at the messenger)

2 April, 2013 / Pär Segerdahl / 0 Comments

The newly proposed European Data Protection Directive overprotects research participants and exposes patients to greater risks of contracting illness and dying.

Thus dramatically a recent article in The Lancet Oncology can be summarized, written by Mats G. Hansson at CRB together with Gert Jan van Ommen, Ruth Chadwick and Joakim Dillner.

People who provide data to research registers are not exposed to physical risks, like participants in interventional research. The risks associated with register-based research are informational: unauthorized release of information about participants. One might ask if it even makes sense to say that people “participate in research” when researchers process large data sets.

Patients (and people in general) have significant protection from disease thanks to register-based research. For example, it is estimated that the HPV vaccine will save about 200 women from dying in cervical cancer each year, in Sweden alone. This cancer-preventive treatment became possible because researchers had access to samples dating back to the 1960s providing evidence for a causal connection between a certain virus infection and cervical cancer later in life.

Despite this vital value in biobanks and registers,
despite the fact that risks are only informational,
despite rigorous safety routines to prevent unauthorized spread of information,
despite the fact that researchers don’t study individuals but statistical patterns, and
despite the question if people really are “participants” in register-based research,

the EU committee proposing the new directive treats the integrity of “research participants” as so pivotal that researchers who process data not only must be subjected to the same ethical review process as for invasive research, but also must obtain informed consent from each and every one who once gave their data to the register, whenever the researchers want to study a new disease pattern.

Data protection efforts easily lose their sense of proportions, it seems, at least concerning register-based research. Not only is one prepared to expose patients to greater physical risks in order to protect research participants from (already rigorously controlled) informational risks.

One also is prepared to disturb data providers who hardly can be described as “participating” in research, by forcing researchers to recontact them about informed consent. Not only on one occasion, but time and again, year after year, each time a new disease pattern is explored in the registers. That’s what I call privacy intrusion!

Pär Segerdahl

Biobank research on the Sámi people should be more transparent

20 March, 2013 / Pär Segerdahl / 0 Comments

Ethnicity is a sensitive issue, so sensitive that one might want to remain silent about it.

Anna Lydia Svalastog at CRB recently published an article about genetic research on the Sámi people in Sweden. She highlights ethical problems associated with the fact that the Sámi focus in these studies is not made transparent.

Svalastog was surprised to discover that 50 years of genetic research on the Sámi people was invisible in the biobank register at the Swedish National Board of Health and Welfare. The reason, she guesses, is that ethnicity is considered unacceptable as a basis for creating registers and biobanks.

Still, some registers and biobanks are in practice Sámi, since data collection was carried out in traditional Sámi areas like Karesuando. When Svalastog studied the way research was carried out she found further tendencies to downplay ethnicity, although it was central in practice.

The Sámi focus of the research was downplayed by a more neutral vocabulary of people living in certain geographic areas. Also the questionnaires downplayed ethnicity. Questions could instead concern livelihood, which, however, can function as an indicator of Sámi ethnicity, since reindeer herding is an exclusively Sámi occupation.

Ethnicity can be reconstructed from the answers, then, but in a manner that risks reinforcing old stereotypes, since many see themselves as Sámi without being reindeer herders.

I don’t think that Svalastog is opposed to biobank research about the Sámi people, but her point is that ethnicity, and the fact that the Sámi is a native people, must be made transparent. Otherwise it becomes difficult to discuss and handle the ethical problems that ethnicity can imply.

The article is published in New Genetics and Society. Svalastog highlights the importance of talking about ethnicity, because it is sensitive.

Pär Segerdahl

Dissertation on trust in biobank research

6 March, 2013 / Pär Segerdahl / 0 Comments

On Saturday, March 9, Linus Johnsson at CRB defends his dissertation:

Trust in Biobank Research: Meaning and Moral Significance

The dissertation is based on four studies. The first two scrutinize empirical evidence concerning public trust in biobank research. They indicate that people do trust biobank researchers, at least in Sweden.

Such findings might give rise to complacency. The ethical regulatory system obviously works and promotes trust. Biobankers can relax.

The third study, however, is a conceptual investigation showing such a reaction to be mistaken. Trust creates obligations in the person who is being trusted. If a doctor collects samples from patients and suspects that their trust is mistaken in one way or another, the doctor has an obligation to handle that mistaken trust appropriately. (I’ve written about this study on The Ethics Blog.)

Public trust doesn’t merely indicate trustworthiness. It creates a moral demand. The proper response to public trust in biobank researchers, then, is taking increased moral responsibility.

The fourth study strives in the same direction. It critiques prevalent faith that trustworthiness is best quaranteed by an extensive ethical regulatory system (ethical review, guidelines, etc.). The opposite may very well be the case. Such a system may foster moral complacency and failure among researchers to deal with ethical issues that are not addressed by the system.

If I interpret Linus Johnsson right, the current widespread trust in ethical regulatory systems is mistaken, and his dissertation is an attempt to take responsibility for that mistaken trust by intellectually highlighting and critiquing it.

As this brief summary shows, the dissertation is original and presents some very thought-provoking results, empirically and above all conceptually. For more information about the dissertation, see News from Uppsala University.

If you are in Sweden and want to visit the public examination, it takes place in Auditorium Minus, Museum Gustavianum, Uppsala, Saturday, March 9, 2013, at 09:15.

Pär Segerdahl

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Tag: biobanks (Page 6 of 9)

Being human; representing life

Characterizing reality

HandsOn: Biobanks 2013

Unhappy approach behind policy for incidental findings

Biobank research on the Sámi people should be more transparent

Dissertation on trust in biobank research

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