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

Year: 2013 (Page 2 of 5)

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

Human existence and biological life: what is most fundamental?

My post last week tried to highlight a tension between human existence and biological life, using Henrietta Lacks as an example. She was a unique human being, existing in a human world; but the HeLa cells obtained from her cancer tumor function in laboratories all over the world as “bio-objects” representing biological life more generally.

This tension between a human world and a laboratory world, between human existence and biological life, could be questioned (as in a comment to the Swedish version of the post): There is no tension, for humans owe their “existence” to the biological processes of life. If cells didn’t organize human brains, there simply would be no “human existence.”

Biological life is fundamental: human existence should bow and scrape to its biological origins.

The tension could be questioned also from a humanistic perspective, however. On this view, the biological perspective is formed by humans. Human existence is the unnoticed condition for the biological notion of life. Once again there is no tension, for the biological notions of “cells” and “brains” owe whatever meaning and function they have to human existence.

Human existence is fundamental: the biological perspective should bow and scrape to its human origins.

Both attempts to reject the tension by determining who should bow humbly backfire. The tension is rejected by each party, but in opposed ways, making the tension surface instead as total intellectual war.

So let’s face the tension instead, and perhaps that’s what the article mentioned last week tried to do.

Pär Segerdahl

The Ethics Blog - Thinking about thinking

Being human; representing life

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:

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:

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

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

  1. Henrietta Lacks was a human being, existing in a human world; but HeLa cells function as “bio-objects” representing biological life.
  2. 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

Part of international collaborations - the Ethics Blog

The diversified uses of biological samples

As a reminder of how diversified the collection and use of biological samples is, I recommend a paper by Takako Tsujimura-Ito, Yusuke Inoue (currently a guest researcher at CRB), and Ken-ichi Yoshida:

Departments of forensic medicine obtain samples from autopsies in order to secure evidence that can be used in court. These samples, often whole organs, typically need to be stored for long periods, since cases sometimes require re-examination of the evidence. The samples are stored also for secondary use in research advancing both clinical and forensic medicine.

The problem addressed in the paper concerns the communication with bereaved families. Families are often not contacted by the forensic departments in Japan, since such contacts can be seen to threaten the neutrality of the evaluation of the evidence.

Emphasizing that stored samples from autopsies benefit bereaved families, patients and society as a whole, the paper recommends more effective ways of communicating with families, to avoid damage to public confidence when families inadvertently get to know that samples from deceased family members are stored or used in research.

Pär Segerdahl

We recommend readings - the Ethics Blog

Save humanity from the human

We must enhance the human; or else humanity will come to an end. Thus dramatically one could summarize the bioethicist Julian Savulescu’s TEDx-talk in Barcelona in July.

The talk lasts fifteen minutes; you can watch and listen to it yourself: The Need for Moral Enhancement.

The idea is that we urgently need medicine and technology to enhance our moral skills; otherwise we will not be able to handle the global threats that we ourselves created: climate change, nuclear weapons, terrorism, starvation, escalating violence.

Globalization, in short, created a world with dimensions to which our hunter-gatherer morality isn’t adapted. Only a moral pill can save us now.

Listening to the talk, I’m struck by how archaic it sounds, despite references to modern medicine and technology. Thus fire-and-brimstone preachers always made people feel the proximity of the end of the world. Thus fire-and-brimstone preachers always made people feel that the cause of the despicable state of the world is their own moral failure. Thus preachers always forced a new awakening:

  • “You’re on the wrong path; I can show you the way!”

The difference is the use of what could be termed the modern rhetoric of empirical justification, in which all claims must be supported by evidence… that is to say, by PowerPoint slides. The rhetoric seems to direct the use of evidence, however, for evidence pointing in undesired directions isn’t cited.

Neither does Savulescu explore alternative ways of thinking. Has globalization really produced a world so big that we cannot handle it? Couldn’t one just as well claim that globalization created a world so miserably tiny and manageable that one might grieve for the death of all that is great?

In the talk, the most archaic form of moralizing is provided with a modernized rhetorical façade, in order to persuade us that only conversion to a biomedically perfected morality can save us now. It is slightly paradoxical.

No wonder the audience looks dejected.

Pär Segerdahl

The temptation of rhetoric - the ethics blog

Characterizing reality

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

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

The specific study misconception of biobank infrastructure

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

We challenge habits of thought : the Ethics Blog

Jumping over our own shadow

There are things that an educated human is supposed to know about the world. Like that the Earth is spherical and that it revolves around the sun.

But there are things we are supposed to know also about ourselves. Most prominently, we are supposed to know that we are animals, one of the primate species.

The question I’m pondering is this:

  • Can we have knowledge about ourselves in the same way that we have knowledge about the world?

I have noticed a tendency among those who straightforwardly answer this question in the affirmative. They marvel at the fact that evolution produced a species that understands the evolutionary process that produced that species.

It is as if the world finally bit its own human tail and thereby became closed as a natural world and nothing but that natural world.

And since the bite was achieved by the science that the human species produced, the closure of the world as nothing but a natural world is celebrated also as the closure of science. Science finally knows itself as a product of the world it knows.

Science is the world’s self-knowledge.

I’ve been reading Martin Heidegger, who has a different kind of answer to the question under discussion. His answer is: yes and no, depending who “we” are; for there are two ways of being human.

In one way, human beings are among the living beings that inhabit the world, and they can be scientifically studied as such. Heidegger would hardly reject biological knowledge about life and about human beings as one of the animal species on Earth.

But does biology also reveal a more profound fact, namely, that the world is nothing but a natural world so that all the things we are supposed to know about the world must be reinterpreted as the world’s self-knowledge? – Reinterpreted by whom? By the world? Can the world think? Can it rethink science as its own self-knowledge?

“No one can jump over his own shadow,” Heidegger wrote (in a slightly different context). But that is the weird feat that is celebrated when the world finally is supposed to understand itself.

Heidegger reminds that we are not just one of the living beings on Earth. We are also the beings for whom there is world; for whom there is Earth and sky; and for whom there is science accumulating knowledge about the world. Talking about this nearest way of being human, he emphasizes not closures but openings.

The nearest human is the opening up of a world (with living beings that can be studied scientifically).

The alleged completion of the history of the universe through the world’s self-knowledge is not produced by evolution, or by the science that a product of evolution produced. It is produced by people who forget the simplest and nearest way of being human, and who thus are led to such old-fashioned metaphysical absurdities as “the world’s self-knowledge.”

– And yet, Heidegger’s “nearest” human being can hardly be purified as unaffected by the world, or by what is known about human beings as part of the world.

Heidegger identifies a vital problem, but I believe that the relation between the two ways of being human is messier than in Heidegger’s elegant philosophical poetry.

I do not quite recognize the connections with the world, and with the animals, in Heidegger’s attempt to uncover the authentic way of being human in the age of science.

Who dares a renewed attack on these messy relationships?

Pär Segerdahl

The Ethics Blog - Thinking about thinking

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