The Ethics Blog

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

Author: Pär Segerdahl (Page 37 of 44)

Unhappy approach behind policy for incidental findings

24 April, 2013 / / 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:

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

We challenge habits of thought : the Ethics Blog

Morality as a problem

9 April, 2013 / / 0 Comments

Friedrich Nietzsche made this enigmatic remark about moral philosophy:

  • “In all ‘science of morals’ so far one thing was lacking, strange as it may sound: the problem of morality itself; what was lacking was any suspicion that there was something problematic here.”

What did Nietzsche mean? He seems to have been thinking of a very human tendency, namely, that of assuming that we already know what morality demands, at least roughly. The tendency, then, is to treat morality as given. Every sane person knows it intuitively!

The task of moral philosophy, identified on the basis of this tendency, becomes the following: dig deep enough to find the ultimate foundation of morality; or, fly high enough to catch sight of the ultimate moral principles.

How could Nietzsche view this daring work of digging and flying as being naïve to morality as a problem? People generally don’t ask these ultimate questions about morality. They don’t venture uncertain digging and flying expeditions. Asking the ultimate questions about morality seems anything but naïve.

Although daring on the assumption that morality is given, these ethical expeditions come too late, Nietzsche suggests. If we had been digging and flying a little bit earlier in the research process, we would have discovered that morality isn’t given:

  • “Just because our moral philosophers… were poorly informed and not even very curious about different peoples, times, and past ages – they never laid eyes on the real problems of morality; for these emerge only when we compare many moralities.”

We don’t live in a lukewarm condition of moral unity and certainty. There are different forms of moral sensitivity and we occasionally experience crises of uncertainty. We change our firmest certainties and even view each other’s (and our own earlier) certainties as absurd.

You may think what you like about Nietzsche’s own moral tendency, but he helps us identify morality as a philosophical problem in a more comprehensive way than if we defined the problem on the basis of the human tendency of moral introversion described above.

Morality has two faces. It consists not only of familiar certainties apparently in need of foundations. It consists also of uncertainty, change, and diversity. Certainty turns into uncertainty; and uncertainty into certainty. There is a dynamics here that we fail to see when we give in to the temptation to assume that morality already is given as a set of intuitive certainties.

I want to change Nietzsche’s notion of the task on one point. “Comparing many moralities” may not be the most useful ethical expedition if it is not combined with other investigations, since it may overemphasize facts that make all expressions of moral certainty seem idle; as a deceitful facade that we ought to get rid of once and for all.

The work we need to do rather is describing the two faces of morality simultaneously: achieving an overview of the movements back and forth between certainty and uncertainty.

Morality is stability and certainty and it is change and uncertainty.

Pär Segerdahl

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

2 April, 2013 / / 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

We participate in debates - the Ethics Blog

Two PhD positions at the Centre for Research Ethics and Bioethics

27 March, 2013 / / 0 Comments

We are recruiting two new PhD students:

1. PhD position in the field of Research Ethics/Bioethics. This position has two possible research focuses:

2. PhD position in the field of bioethics/philosophy of mind. This position has the following possible research focuses:

  • (a) Conceptual and empirical analyses of the nature and function of consciousness in the light of modern neuroscience and philosophy of mind.
  • (b) How consciousness can be accessed neurotechnologically.
  • (c) Clinical studies of consciousness of patients with disorders of consciousness and ethical analyses of the results.

Read more about the PhD projects and the application in the links above. If you are interested we look forward to receiving your application no later than April 22, 2013.

Pär Segerdahl

We transgress disciplinary borders - the Ethics Blog

Biobank research on the Sámi people should be more transparent

20 March, 2013 / / 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

Minding our language - the Ethics Blog

Life scientists’ responsibility when their research has dual use

13 March, 2013 / / 0 Comments

Do life scientists have moral responsibility when their research can be used not only to do good (like preventing pandemics) but also to harm others (like developing biological weapons)?

It could be tempting to think that researchers’ only responsibility is the advancement of scientific knowledge. The use and practical application of that knowledge is the responsibility of others.

The September 11 attacks made that idea much less tenable. Since then, the security sector has pushed the scientific community to take more extensive responsibility for research that could be used to develop, for example, biological weapons.

Do scientists have such a responsibility for how others might use their findings? If they do have responsibility, how is it most appropriately approached in practice? These questions are investigated by Frida Kuhlau at CRB in a dissertation that she defends on March 23:

Kuhlau argues that researchers do have a moral responsibility for research with dual use and she tries to specify the content of that responsibility. It includes, for example, always considering possible negative implications of one’s research; reporting activities of concern; being prepared to occasionally delimit the dissemination of results.

How is such responsibility best approached in practice? The traditional way of taking ethical responsibility for research is by imposing ethical regulatory systems (guidelines, codes, ethical review).

Like Linus Johnsson who defended his dissertation last Saturday, Frida Kuhlau doubts such bureaucratic attempts to ethically regulate research. Researchers need to shoulder the responsibility themselves, learning how to deliberate and take action concerning research with dual use.

Shouldering responsibility does not mean, however, doing it alone. Individual researchers normally don’t have all the competencies needed to reasonably assess possible risks of research. The scientific community and the security sector are dependent on each other. What is required to take proper responsibility, Frida Kuhlau suggests, is therefore an ethic of conversation and deliberation.

Taking moral responsibility for research with dual use presupposes ongoing communicational processes. These processes need organizational support, platforms. A novel suggestion in the dissertation is that ethical review boards could function as such platforms.

Rather than only reviewing, as ethical review boards normally do, these boards would support an ethical culture of conversation and deliberation about dual-use research.

For more information about this important 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 23, 2013, at 09:15.

Pär Segerdahl

We recommend readings - the Ethics Blog

Dissertation on trust in biobank research

6 March, 2013 / / 0 Comments

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

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

We recommend readings - the Ethics Blog

Fruitful uncertainty

27 February, 2013 / / 3 Comments

We tend to imagine the minds of great thinkers and scientists as fountains of knowledge, intelligence and certainty. That is what their brilliant works make us believe. The products are perfect; therefore, the minds that produced them must have been perfect.

Well, the opposite may also be true. Brilliant works can stem from an ability to endure ignorance, lack of clear-sightedness, and uncertainty – because such shortcomings motivate serious counter-attacks and hard work. Striving to overcome uncertainty and shortcomings can result in the most brilliant works.

These so-called “great minds” may have been people who loved their uncertainty because it alerted them to what requires more attention: “Here is a difficulty I must take more seriously!” But that is a moral quality rather than an intellectual one!  I just read some fascinating quotations from Linnaeus in Giorgio Agamben’s book, The Open, making me sense that moral quality in Linnaeus.

It must have been confusing for Linnaeus that he couldn’t find a given characteristic that clearly separates humans from apes. Still, he seemed to enjoy this uncertainty about our humanness and even teased those who couldn’t accept it by suggesting that the only difference he could find was a ridiculous dental detail without systematic significance:

  • “… just as the shoemaker sticks to his last, I must remain in my workshop and consider man and his body as a naturalist, who hardly knows a single distinguishing mark which separates man from the apes, save for the fact that the latter have an empty space between their canines and their other teeth.”

Linnaeus’ ability to stay with this uncertainty is further reflected in the name he gave our species: he didn’t add a given identifying characteristic to the generic name Homo.

I always believed that sapiens was meant as a given characteristic, just as Aristotle saw rationality as the distinguishing mark of the human. Agamben points out, however, that Linnaeus used the philosophical imperative nosce te ipsum, know yourself. The name Homo sapiens doesn’t appear until in the tenth edition of Systema naturae, and probably retains the sense of an imperative rather than a given characteristic.

In the absence of a given distinguishing mark, being human was for Linnaeus a task, Agamben suggests. The breathtaking name that Linnaeus originally gave our species, then, was:

  • Homo-know-yourself!

Only someone who is at home in uncertainty and is able to think in it would dare to “classify” our species as an imperative.

Although I’m sure that Descartes had the same moral character and derived nourishment from his own doubts, he was confident about what separates him as a human from the animals. He had mind, reason, while the animals were automata.

Linnaeus couldn’t share Descartes’ confidence and teasingly wrote:

  • “Surely, Descartes never saw an ape” (Cartesius certe non vidit simios.)

Don’t be ashamed of your uncertainty but value it as an asset!

Pär Segerdahl

The Ethics Blog - Thinking about thinking

Ethical principles causing moral hallucinations

20 February, 2013 / / 0 Comments

I want to continue the discussion in my previous blog post. It concerned an article raising the question whether researchers in genomics have a duty to actively look for incidental findings.

Joanna Forsberg aptly remarked that the notion of looking for findings that one isn’t looking for is strange. She also pointed out that healthcare doesn’t have a duty to look for incidental findings:

  • “In fact, in the context of healthcare incidental findings are (in general) deliberately avoided, by not doing tests when there is no clinical reason to do them. Is the duty of care more extensive in biobank research?”

This pertinent remark ought to worry ethicists. How can the ethical debate have reached a point where it is asked if researchers have duties to provide more healthcare than healthcare itself?

I couldn’t free myself from this problem that Joanna’s remark revealed.

I now believe it has do with the professionalization of ethics. It has become the ethicists’ professional duty to apply ethical principles to medical research. This works tolerably as long as it is possible to identify the traits that make the principles applicable. The application of the principle of beneficence, for example, presupposes that one can identify beneficial traits.

The reason why incidental findings in biobank research are debated so hotly, it seems to me, is precisely the difficulty of identifying traits in this complex terrain to which relevant ethical principles are applicable. Ethicists try hard to find aspects of genetic risk information and participation in biobank research that would make it possible to apply the principles of

  • respect for persons
  • beneficence
  • non-maleficence
  • reciprocity

so that the ethicists can fulfill their professional duty to guide biobankers by proposing an ethical policy for incidental findings.

The risk, however, when ethical principles are applied in desperation precisely because their application is unclear is that the principles begin to steer the description of reality… and to such an extent that they make us hallucinate moral duties.

I think that Joanna’s remark should act as a reminder of that risk.

Pär Segerdahl

We challenge habits of thought : the Ethics Blog

An obligation to look for incidental findings in genomics research?

13 February, 2013 / / 0 Comments

A new article in The American Journal of Bioethics attempts to take the discussion about incidental findings in genomics research a step further by asking:

  • “Assuming there is a duty to disclose significant incidental findings, might there be an obligation for researchers to actively look for these findings?”

The authors use an ancillary care model as a framework for their discussion. Ancillary care means care for research participants that is not required directly by sound science; not required to conduct a trial safely, for example, or to manage subject injury. The model was originally developed for research in developing countries.

The authors see ancillary care as the best perspective on incidental findings: a duty to disclose incidental findings is best justified as an ancillary-care obligation. The question in the article, then, is the following. If the ancillary care model implies a duty to disclose stumbled-upon incidental findings, does it imply also a duty to actively look for such findings?

To answer the question, three criteria are formulated all of which must be satisfied simultaneously to support a duty to look for incidental findings:

  1. Benefit: the genetic information sought must be beneficial for the patient.
  2. Uniqueness of access: researchers must be in a unique position to look for, assess and provide the genetic information.
  3. Burden: analyzing the genome for incidental findings must not take too much time, effort and resources from research.

Using these criteria, the authors conclude that currently there is no obligation to look for incidental findings in genomics research. Although uniqueness of access is high (genomic techniques are available primarily through research), benefit is low and burden high.

This may change in the future, the authors speculate, when better knowledge and technology make benefit high and burden low, and the technology still is available primarily through research. In such a scenario there would be an obligation to look for incidental findings. In the distant future, however, when genomic techniques are available also in clinical care, the obligation to look for incidental findings once again disappears.

In my view, this attempt to take the discussion a step further suffers from two major shortcomings that pertain already to the assumption that the ancillary care model could imply an obligation to disclose stumbled-upon incidental findings in genomics research.

Genomics research often is carried out as biobank research where the researcher’s relation to participants does not resemble a doctor-patient relationship. The researcher is not necessarily a physician and may work with samples collected years ago by others. The basic idea in the ancillary care model that “medical researchers must strike a balance between their obligations to medicine and those to research” is not obvious in many forms of large-scale biobank research.

Moreover, incidental findings in genomics research typically mean highly complex genetic risk information. It is not entirely clear, at least not to me, if the notion of, for example, actionability, has the same meaning for a discovered disease as for a discovered increased genetic disease risk.

An illuminating and realistic discussion about incidental findings in genomics research must, I believe, specifically address the biobank-infrastructural context of much genomics research, and the complex nature of genetic risk information.

If the ancillary care model generally is the best perspective on incidental findings, the applicability of this model to characteristic forms of genomics research would have deserved more careful attention.

Pär Segerdahl

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