Letting people choose isn’t always the same as respecting them

May 5, 2015

Jennifer Viberg, PhD Student, Centre for Research Ethics & Bioethics (CRB)Sequencing the entire genome is cheaper and faster than ever. But when researchers look at people’s genetic code, they also find unexpected information in the process. Shouldn’t research participants have access to this incidental information? Especially if it is important information that could save a life if there is treatment to offer?

The personal benefits of knowing genetic information can vary from individual to individual. For one person, knowledge might just cause anxiety. For another, genetic risk information could create a sense of control in life. Since different people have different experiences, it could seem tempting to leave it for them to decide for themselves whether they want the information or not.

Offering participants in genetic research a choice to know or not to know is becoming more common. Another reason for giving a “freedom of choice” has to do with respecting people by allowing them to make choices in matters that concern them. By letting the participant choose, you acknowledge that he or she is a person with an ability to make his or her own choices.

But when researchers hand over the decision to participants they also transfer responsibility: A responsibility that could have consequences that we cannot determine today. I recently wrote an article together with colleagues at CRB about this in Bioethics. We argue that this freedom of choice could be problematic.

Looking at previous psychological research on how people respond to probabilities, it becomes clear that what they choose depends on how the choice situation is presented. People choose the “safe” outcome before taking a risk in cases where the outcome is phrased in a positive way. But they are more prone to taking a risk when the result is phrased in a negative way, despite the fact that the outcome is identical. If a participant is asked if he or she wants information that could save their life, there is a risk that they could be steered to answering “yes” without considering other important aspects, such as having to live with anxiety or subjecting themselves to medical procedures that might be unnecessary.

The benefit of incidental findings for individual participants is hard to estimate. Even for experienced and knowledgeable genetic researchers. If we know how difficult the choice situations are, even for them, and if we know how psychological processes probably will steer the participants’ choices, then it seems that it is hardly respectful to give the participants this choice.

There are good intentions behind giving participants freedom to choose, but it isn’t respectful if we can predict that the choices won’t be free and well grounded.

If you want to learn more, you find further reading on CRB’s web, and here is a link to our article: Freedom of choice about incidental findings can frustrate participants’ true preferences

Jennifer Viberg

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


Intellectualizing morality

June 4, 2014

There is a prevalent idea that moral considerations presuppose ethical principles. But how does it arise? It makes our ways of talking about difficult issues resemble consultations between states at the negotiating table, invoking various solemn declarations:

  1. “Under the principle of happy consequences, you should lie here; otherwise, many will be hurt.”
  2. “According to the principle of always telling the truth, it is right to tell; even if many will be hurt.”

This is not how we talk, but maybe:

  1. “I don’t like to lie, but I have to, otherwise many will be hurt.”
  2. “It’s terrible that many will suffer, but the truth must be told.”

As we actually talk, without invoking principles, we ourselves take responsibility for how we decide to act. Lying, or telling the truth, is a burden even when we see it as the right thing to do. But if moral considerations presuppose ethical principles of moral rightness, there is no responsibility to carry. We refer to the principles!

The principles give us the right to lie, or to speak the truth, and we can live on with a self-righteous smile. But how does the idea of moral principles arise?

My answer: Through the need to intellectually control how we debate and reach conclusions about important societal issues in the public sphere.

Just as Indian grammarians made rules for the correct pronunciation of holy words, ethicists make principles of correct moral reasoning. According to the first principle, the first person reasons correctly; the other one incorrectly. According to the second principle, it’s the other way round.

But no one would even dream of formulating these principles, if we didn’t already talk as we do about important matters. The principles are second-rate goods, reconstructions, scaffolding on life, which subsequently can have a certain social and intellectual control function.

Moral principles may thus play a significant role in the public sphere, like grammatical rules codifying how to write and speak correctly. We agree on the principles that should govern public negotiations; the kind of concerns that should be considered in good arguments.

The problem is that the principles are ingeniously expounded as the essence and foundation of morality more generally, in treatises that are revered as intellectual bibles.

The truth must be told: it’s the other way round. The principles are auxiliary constructions that codify how we already bear the words and the responsibility. Don’t let the principles’ function in the public sphere distort this fact.

Pär Segerdahl

We challenge habits of thought : the Ethics Blog


The risk with knowing the risk

March 5, 2014

PÄR SEGERDAHL Associate Professor of Philosophy and editor of The Ethics BlogInforming individuals about their genetic risks of disease can be viewed as empowering them to make autonomous decisions about their future health.

But we respond to risk information not only as rational decision makers, but also with our bodies, feelings and attitudes.

An American study investigated elderly people whose genetic test results showed a predisposition for Alzheimer’s disease. One group was informed about the risk; the other group was not.

In subsequent memory tests, those who were informed about the risk performed markedly worse than those who weren’t informed.

Knowing the genetic risk thus increased the risk of a false positive diagnosis of dementia. The informed participants performed as if they already were on the verge of developing Alzheimer’s.

The risk with knowing the risk is thus a further complication to take into consideration when discussing biobank researchers’ obligation to return incidental genetic findings to individual participants.

Returning information about genetic risks cannot be viewed only as empowering participants, or as giving them valuable information in exchange for contributing to research.

It can also make people worse, it can distort research results, and it can lead to false diagnoses in clinical care.

Pär Segerdahl

We like challenging findings - The ethics blog


Idling biobank policy?

October 9, 2013

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


Unhappy approach behind policy for incidental findings

April 24, 2013

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


Ethical principles causing moral hallucinations

February 20, 2013

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?

February 13, 2013

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

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


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