The Ethics Blog

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

Tag: biobanks (Page 7 of 9)

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

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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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Solidarity and biobanking

6 February, 2013 / / 0 Comments

The concept of solidarity is currently receiving attention in bioethics and inspires new approaches to ethical problems.

The Nuffield Council on Bioethics recently published a report – Solidarity: reflections on an emerging concept in bioethics – initiating the development of a systematic solidarity framework for approaching difficult ethical questions in biobanking, biosecurity and health inequalities.

Concerning biobank participation, for example, one of the authors of the report makes this interesting statement:

  • “In the spirit of solidarity, we believe that it is acceptable to ask participants to agree to their sample being used in any future research that is within the broad aims of the biobank and has been approved by a research ethics committee. The risks to the participant are very low yet it would save valuable time and resources for the biobank.”

It is furthermore suggested that participation agreements should replace traditional consenting procedures. – I will study this suggestion and hope I can comment on it soon.

Continuing the work in the report, the Nuffield Council on Bioethics and the Brocher Foundation organize an international symposium:

The report and the symposium appear very interesting!

Pär Segerdahl

We recommend conferences - the ethics blog

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Public ethics and human morality

16 January, 2013 / / 0 Comments

Is ethics universally valid or can we act differently as moral individuals than as ethical representatives of public institutions?

I just read a well-argued article in Science Policy Forum, discussing whether patients should be paid for their tissue. As their point of departure, the authors cite the (by now) famous case of Henrietta Lacks.

Contrary to the many readers and reviewers of the bestseller who thought that Henrietta Lacks was exploited by the medical establishment, the authors arrive at the following conclusion. In cases similar to that of Henrietta Lacks, patients (or their families) are NOT entitled to payment for their tissue. – Why not?

First of all, there are no property rights for human bodies, people don’t own the tissue they leave: no one has the right to demand payment for their tissue.

People should, however, be compensated for the effort of giving the tissue. But there is no such effort associated with patient samples, since the samples were taken for the sake of caring for the patients. There is no effort to compensate for.

But what about the revenue generated by the tissue? Can people make millions of dollars on patients’ cells, as in the Henrietta Lacks case, without sharing the profits with the patients (or with their families)?

Once again, the authors argue convincingly that patients have no right to demand payment or part of revenue streams. The tissues are only raw material for developing cell lines. It is the intellectual work of the investigators that creates value. Moreover, since so few donors have tissue that can be used to generate profitable medical products, the end result of trying to be fair by sharing profits with these few lucky donors would be injustice vis-à-vis the majority of donors.

What interests me here is that although I consider the ethical policy proposed in the article as well-argued and right, I can still understand if a morally concerned individual saw injustice in a case like that of Henrietta Lacks and decided to donate money to her family.

Consider this passage from the article:

  • “Christoph Lengauer, a cancer drug developer and former Hopkins faculty member, articulated this sense of inequity when he reportedly told Lacks’s daughter that he thought Hopkins had ‘screwed up’ by not sharing some of the proceeds from the HeLa cell line with the Lacks family.”

The Science Policy Forum article demonstrates that this accusation is not as reasonable as it might seem.

Still, if a concerned individual (like Lengauer) saw injustice in a destiny like that of Henrietta Lacks and personally donated money to the family, I think I could see that as a perfect moral action and not necessarily as deluded.

Can one appreciate the ethical arguments for a policy not to pay patients for their tissue, and still, as an individual, experience injustice and personally donate money?

Unless we demand that human beings should be like representatives of public institutions through and through, I think we can admit such a possibility. It would even make me uncomfortable if we didn’t acknowledge such freedom.

Pär Segerdahl

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Logical laws and ethical principles: appendices to human reasoning

15 November, 2012 / / 0 Comments

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

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Wanted: two researchers to join our team

7 November, 2012 / / 0 Comments

The Centre for Research Ethics and Bioethics (CRB) is currently recruiting two researchers. We are looking for creative persons who like multi-disciplinary collaboration and are fluent in English.

1. Researcher in health economics (UFV-PA 2012/2684): We are looking for a person with a doctoral degree in health economics with documented skills in Discrete Choice Experiments.

2. Researcher in ethics/biobank/registry research regulations (UFV-PA 2012/2683): We are looking for a person with a doctoral degree in ethics or law, or someone with a doctoral degree in medicine or life sciences with an interest in ethical issues.

Both positions are 2-year appointments, with possible prolongation.

Application deadline: November 29, 2012.

(Job descriptions and information about the applications in the links above.)

Pär Segerdahl

We transgress disciplinary borders - the Ethics Blog

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Commercial gene tests and incidental findings

25 October, 2012 / / 0 Comments

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

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No consent for maintaining high-quality health care?

21 September, 2012 / / 0 Comments

Collecting biological samples and health information from healthy donors in the construction of biobanks and research registers obviously requires the donors’ informed consent.

But is a similar demand for consent reasonable when patients provide their doctor with samples for diagnosis, undergo medical examination and treatment, and answer the doctor’s questions? Or can patients be expected to accept that their traces in the health care system – for example, data about experienced side effects – are monitored to optimize the quality of medical diagnosis and treatment?

A recent article by Mats G. Hansson at CRB discusses the issue. The article in Theoretical Medicine and Bioethics is well-argued and challenges common assumptions.

The basic argument is that quality registers and biobanks within the health care system play such a decisive role in optimizing the quality of the care that we expect as patients, that no consent should be required for collecting and studying our traces as patients (provided that the purpose is maintenance of high-quality health care, and nothing else).

Consent is associated with costs, in the form of drop-out of data. This impairs the value of the information in quality registers and biobanks, and thereby also the conditions for optimizing medical diagnosis and treatment.

Privacy is not the only ethical concern. Quality of care carries moral weight too.

Perhaps we are prepared to accept certain access to our patient histories, if such access is a precondition to maintaining and developing high standards of health care?

Pär Segerdahl

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How unspecific is broad consent?

13 September, 2012 / / 0 Comments

In response to an informative article on personalized medicine and biobanking in Nature Biotechnology, a recent letter to the Editor defends broad consent for biobanking.

The three letter writers emphasize the patient and donor perspective:

  • “…patient donors actually express concern that study-specific consent can be burdensome and impede research.”

Given these donors’ desire to give so-called broad consent, I want to highlight two problematic aspects of the distinction between specific and broad consent.

The first is that the word “broad” consent may give rise to the impression that the consent is so general and vague that it cannot be seen as informed consent to anything specific at all. But broad consent is not “broad” in such an absolute sense, akin to vagueness. It is “broad” only in a relative sense: in relation to the historically more prevalent case of consenting to individual research projects.

The distinction between specific and broad consent is a distinction between two ways of being specific. One of these ways of being specific dominated the scene first. It therefore functioned as a linguistic standard. The other way of being specific had to put up with being called “broad.”

Specific consent, then, is specific only in a specific sense: one that is historically conditioned and changeable. It is not the golden standard of exactitude. Consent can therefore be “broad” without being vague.

The second problematic aspect is that when people donate samples to biobanks, the exact nature of the individual research projects that might use their samples is less relevant to them than when they consent to invasive procedures in clinical trials.

The risks are minimal in biobank research. Donors therefore look more to the practical utility of the research than to the research itself. Forcing them to consider the purposes and questions and procedures of individual research projects is forcing them to attend to a level of medical research that is less relevant to them as donors.

In short, a historically and linguistically insensitive demand for “specific consent” in biobanking may hinder donors from giving the kind of specific consent they authentically want to give in this new but more and more prevalent context.

Pär Segerdahl

Minding our language - the Ethics Blog

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Research for the sake of the patient

7 September, 2012 / / 0 Comments

We regularly tell strangers about sensitive aspects of our lives. We do it every time we visit the doctor. We do it without hesitating, in spite of the fact that the information won’t stay with the doctor to whom we give it.

The information is archived and will be read by health care staff in the future, when we visit a hospital again. As patients, we are satisfied with this state of affairs. Typically, we are happy that our samples are saved for future use, and that research is being done on our data to improve the quality of the care.

It is obvious to us that these actions are taken for our sake as patients, or as future patients.

However, when the same kind of data is collected for similar overall purposes, but outside of the health care sector, in the construction of biobanks and registers for future medical research, it suddenly becomes more tempting to worry about the safety of our data.

In spite of the fact that the researchers’ information about us

  1. normally is less comprehensive than in the doctor’s journal,
  2. is coded so that the connection to us is as safe as in a bank vault,
  3. isn’t used to do research on us individually, but to explore human patterns of disease,

a tendency to imagine nightmarish scenarios of surveillance appears. – Why?

One reason could be an assumption that researchers only want to answer their own questions. They don’t do research for our sake. They are curious and need our support to realize their own research goals.

Another reason could be an assumption that if medical research has commendable purposes related to health and health care, these purposes are very general and societal: Improved Public Health; Decreased Health Care Costs; A Flourishing Pharmaceutical Sector etc.

Who cares about little me?

When I visit the doctor, the connection to my own health and care is obvious. When I donate blood to the biobank for future research, on the other hand, the connection to me as a patient, or as a future patient, is less obvious.

Still, today’s health care depends on yesterday’s research.

The information I give the doctor would not help me a bit as a patient, if millions had not already provided medical research with their data. My doctor wouldn’t even be able to suggest a diagnosis, or recommend an effective treatment.

I believe we need to defuse the issue of personal data in biobanks and research registers; calm down our tendency to think that the information is collected without regard to us, and for wholly different purposes than in health care. Even in research, our data are collected for our sake: so that we, the day we visit the hospital and tell the doctor about our troubles, can expect well-founded diagnoses and effective treatments.

If you want to reflect more about our interest as future patients that there is ongoing biobank and register research, I want to recommend a coming dissertation:

  • Biobank Research – Individual Rights and Public Benefit

Author is Joanna Stjernschantz Forsberg at CRB, who defends her dissertation the 6th of October in Uppsala.

I also want to recommend the interactive conference, HandsOn: Biobanks, in Uppsala 20-21 September, which tries to illuminate the values of biobanking. You can register for the conference until the 11th of September.

Pär Segerdahl

We challenge habits of thought : the Ethics Blog

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