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

Tag: incidental findings (Page 2 of 2)

Ethical principles causing moral hallucinations

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?

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

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

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

“The Route” is taking shape

Our plans for the interactive part of the conference program for HandsOn: Biobanks, in Uppsala 20-21 September 2012, are taking shape. This part of the program is called “the Route.”

During coffee and lunch breaks, participants can walk through an interactive exhibition illustrating the process of informed consent, data and sample sharing, and new legislation.

Within the Route, participants can also meet law scholars, ethicists, biobank researchers and journalists. They can listen to and participate in conversations on a broad range of issues, such as the role or trust in biobank research, handling of incidental findings, patents, and regulatory processes.

Finally, the LifeGene debate will be discussed with representatives from LifeGene, EpiHealth, the Swedish Data Inspection Board, and the Central Ethical Review Board.

Curious? Do you want to partake in the Route?

Registration is open until September 11.

Pär Segerdahl

I want to contribute to research, not subscribe to genetic information

What do researchers owe participants in biobank research?

One answer is that researchers should share relevant incidental findings about participants with these helpful individuals. Returning such information could support a sense of partnership and acknowledge participants’ extremely valuable contribution to research.

I’m doubtful about this answer, however. I’m inclined to think that return of information might estrange participants from the research to which they want to contribute.

Certainly, if researchers discover a tumor but don’t identify and contact the participant, that would be problematic. But incidental findings in biobank research typically concern difficult to interpret genetic risk factors. Should these elusive figures be communicated to participants?

Samples may moreover be reused many times in different biobank projects. A relevant incidental finding about me may not be made until a decade after I gave the sample. By then I may have forgotten that I gave it.

Do I want to be seen as a biobank partner that long after I gave the sample? Do I want my contribution to research to be acknowledged years afterwards in the form of percentages concerning increased disease risks? Wasn’t it sufficient with the attention and the health information that I received when I gave the sample: when I actually MADE my contribution?

Personally, I’m willing to contribute to research by giving blood samples, answering questions, and undergoing health examinations. But if that means also getting a lifelong subscription to genetic information about me, I’m beginning to hesitate.

That’s not what I wanted, when I wanted to contribute to research.

Realizing that my blood sample rendered a lifelong subscription to genetic information would estrange me from what I thought I was doing. Can’t one simply contribute to research?

But other participants might want the information. Should biobank research then offer them subscription services?

Pär Segerdahl

We like challenging questions - the ethics blog

Research before health care

Last week I blogged about the unique status that personal data have in science. Researchers are not interested in the persons behind the data and they have no intention of returning to them; an intention that most other personal data collectors have.

In an age of increasing integrity threats, it is uplifting that biobanks and research registers function like depersonalized scientific spaces where our data can orbit between research projects without tendency to return to us and disturb us.

Scientific aims disentangle us from our data.

Simultaneously with my blogging on this topic, Mats G. Hansson here at CRB wrote a letter to Nature on almost the same subject.

Nature recently reported on recommendations to US biobanks to inform participants about medically relevant incidental findings about their DNA. Mats G. Hansson warns that following such recommendations would be irresponsible.

Genetic risk information is highly complex. It is often unclear what the discovery of a particular genotype variant actually says about an individual’s disease risk. And even if increased disease risk can be proven, further research is needed to ascertain which preventive measures would be efficient.

Research must be allowed run ahead of attempts to provide (what looks like) health care services. Reporting incidental findings that have not been validated “could be putting the cart before the horse,” Hansson warns.

Making sure that biobank research runs ahead of (what looks like) health care services has one further function. It sustains the depersonalized status of personal data in research.

I believe this is important when data protection legislation is about to be sharpened to meet new perceived integrity threats. Research might be unduly affected by the new legislation, especially if the unique status of personal data in research is not clear.

When authorities share personal data, the aim typically is to be able to return to individuals with these data – perhaps in court. It is in the nature of scientific data sharing, however, that the individuals behind the data are uninteresting and are not included in the purpose of the data sharing.

Biobank infrastructure is very much about facilitating scientific data sharing. If these infrastructures are well-built, they can serve as reassuring examples in times where integrity threats are assumed to hide behind every corner.

People could then say: “There actually are depersonalized spaces where personal data can circulate safely without burdening the persons behind the data. They are called biobanks.”

Pär Segerdahl

We participate in debates - the Ethics Blog

Research with my data, but not about me

It is perplexing how the websites of large internet companies continuously adapt to me. It looks like the entire business activity of Amazon was about the musical artists I listened to yesterday.

These companies evidently collect data about what I search out on their websites and automatically adapt to my computer, making the presentation of products as attractive as possible to me.

It is rather annoying to get one’s own internet history in the face like that.

The example illustrates a common property of personal data. When data about me are collected, the data sooner or later return to me: in the form of an adapted website; in the form of a demand to pay tax arrears; or in the form of more expensive insurance premiums.

No one would bother to collect my data if they did not intend to return to me on the basis of the data.

Me, me, me: my data are about me. Sooner or later they come back to me.

There is, however, one brilliant exception from my data’s stubborn tendency to return to me: research. When researchers collect my blood sample or ask questions about my health, they are not interested in my person. My data will not return to me in any form.

Researchers are interested in general patterns that can be discerned in data from thousands of people. If researchers should return to participants, it is to collect further data that (for example) can make the patterns of ageing appear.

Patterns, patterns, patterns: research is about patterns. It is not about any one of us who supplied the data.

I’m therefore inclined to see research registers as categorically distinct from the tax authorities’ data about my incomes. Researchers launch my data up into a depersonalized scientific space. Up there, my data hover weightlessly and my person cannot attract them back to me. They do research with my data. But it is not about me.

I don’t primarily have in mind the fact that researchers code my data so that the connection to me is obscured. I’m thinking of the elementary fact that they collect my data without any intention of returning to me on the basis of the data.

When the integrity of research participants is debated, it is important to keep this unique status of research registers in mind. The purpose of collecting scientific data about me is not at all about me. The purpose “scientific research” disentangles me from my own data.

Biobank research here encounters a difficulty.

Suppose that researchers discover in my blood sample a genetic disposition for a disease that can be prevented if measures are taken in advance. Should they then take down my data from their depersonalized orbit in scientific space, and inform me about the disposition?

It may seem obvious that they should inform me. But it would simultaneously be a departure from how science typically treats personal data without intention of returning to participants on the basis of the data.

How should biobank researchers handle discoveries about individual participants that may save their future health? This important and difficult question will be investigated in the dissertation work of our most recent doctoral student at CRB, Jennifer Viberg.

I’m certain that the Ethics Blog will return many times to Jennifer’s work on incidental findings in biobank research.

Pär Segerdahl

We like challenging questions - the ethics blog

Researchers’ opinions about communication of results of biobank research

One of the ethical difficulties that confront biobank and genomics research concerns the communication of results to participants.

Should biobank participants be given feedback from research? If so, under what conditions?

A recent article in the European Journal of Human Genetics reports a survey of Dutch biobank researchers’ opinions on the issue.

Here are some findings that struck me:

  1. Most of the respondents held the view that participants have to be informed about findings that are relevant at a group level.
  2. There was less agreement, however, about communication of findings that can be relevant for specific individual participants.
  3. About half of the Dutch biobank investigators found it acceptable to not communicate individual results about genetic variation.
  4. Most of the researchers (74%) answered that participants have to be informed about individual results only if there are implications for treatment or prevention.
  5. The respondents generally agreed that participants should not be informed about individual results in return for their contribution. If results are communicated, then, it is not because participation merits rights to individual feedback.
  6. Some worries among respondents concerning communication of individual results were: personal privacy will be harmed (36%); a therapeutic relation will arise (46%); participants’ insurance premiums might increase (66%); information about individual gene variation can frighten participants (81%).

What I find even more interesting, perhaps, is that the researchers’ opinions (in this study) differ from those of the general public and patients (in a comparable study).

When asked similar questions, the general public and patients want individual feedback regardless of the possibility of prevention or treatment… although they seem to change their minds after they have been recruited by biobanks as participants.

As participants, they are less interested in individual feedback than before recruitment.

This change of opinion among participants in the direction of the researchers’ opinions is fascinating. I cannot resist speculating about its cause. Is there such a thing as a “shared experience” of biobanking that shapes expectations and evaluations?

Nevertheless, according to the authors, the gap between the groups is sufficiently wide to complicate the question of how to communicate results to participants.

Pär Segerdahl

ethics needs empirical input - the ethics blog

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