Revised European data protection will make data about rare diseases even rarer

April 30, 2013

EU is currently discussing changes to the European privacy laws. The intention is to strengthen the protection of privacy and to give people more control over their data.

The problem, which I highlighted on The Ethics Blog, is that the new proposal applies also to research. Presently there is an exception for scientific research about health and disease. The proposed revision of the privacy regulation, however, allows no exceptions.

Every person who has given data to a register must according to the new proposal be asked for consent each time researchers want to study some new disease pattern. Patient data can never be used in research without specific consent, and not even historical registers and data from diseased persons are given exception in the new proposal.

A recent article in Nature Reviews Genetics by Deborah Mascalzoni et al. highlights a patient group that is especially vulnerable to the proposed revision: patients suffering from rare diseases. In Sweden a disease is defined as rare if it affects less than a hundred persons in a million.

Data on rare diseases are, as a matter of course, rare. We therefore know little about these diseases and it is difficult to develop effective medical treatments. To achieve statistically significant analyses, researchers must typically share data over national borders. Every lost piece of data about rare diseases can mean dramatically impaired prospects of new drugs and treatments for these patient groups.

Rare diseases are thus a further strong reason for maintaining the current exception for scientific research in the data protection legislation. Read more on the CRB website.

Pär Segerdahl

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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

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

April 2, 2013

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

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Biobank research on the Sámi people should be more transparent

March 20, 2013

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

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Dissertation on trust in biobank research

March 6, 2013

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

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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

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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

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Solidarity and biobanking

February 6, 2013

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

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Public ethics and human morality

January 16, 2013

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

November 15, 2012

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

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