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

Approaching future issues - the Ethics Blog

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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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No consent for maintaining high-quality health care?

September 21, 2012

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?

September 13, 2012

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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Genetic exceptionalism and unforgivingness

August 30, 2012

What fuels the tendency to view genetic information as exceptionally private and sensitive? Is information about an individual’s genetic disposition for eye color more sensitive than the fact that he has blue eyes?

In Rethinking Informed Consent in Bioethics, Neil C. Manson and Onora O’Neill make heroic efforts against an avalanche of arguments for genetic exceptionalism. For each argument meant to reveal how uniquely private, how exceptionally sensitive, and how extraordinarily risky genetic information is, Manson and O’Neill find elucidating examples, analogies and comparisons that cool down tendencies to exaggerate genetic information as incomparably dangerous.

What fuels the exceptionalism that Manson and O’Neill fight? They suggest that it has to do with metaphors that tempt us to reify information; temptations that, for various reasons, are intensified when we think about DNA. Once again, their analysis is clarifying.

Another form of genetic exceptionalism strikes me, however; one that has less to do with information. I’m thinking of GMO exceptionalism. For thousands of years, humans improved plants and animals through breeding them. This traditional way of modifying organisms is not without environmental risks. When analogous risks appear with GMO, however, they tend to change meaning and become seen as extraordinary risks, revealing the ineradicable riskiness of genetic manipulation.

Why are we prepared to embrace traditionally modified organisms, TMO, when basically the same risks with GMO make us want to exterminate every genetically manipulated bastard?

Unforgivingness. I believe that this all-too familiar emotional response drives genetic exceptionalism, and many other forms of exceptionalism.

Consider the response of becoming unforgiving. Yesterday we laughed with our friend. Today we learn that he spread rumors about us. His familar smile immediately acquires a different meaning. Yesterday it was shared joy. Today it is an ugly mask hiding an intrinsically untrustworthy individual who must be put in quarantine forever. Every trait of character turns into a defect of character. The whole person becomes an objection; an exception among humans.

Manson and O´Neill are right when they analyze a tendency to reify information in genetic exceptionalism. But I want to suggest that what fuels this tendency, what makes us more than willing to yield to the temptation, is an emotional state of mind that also produces many other forms of exceptionalism.

We need to acknowledge the emotional dimension of philosophical and ethical thinking. We don’t think well when we are unforgiving towards our subject matter. We think dogmatically and unjustly.

In their efforts to think well about genetic information, Manson and O’Neill can be understood as doing forgiveness work.

They calm us down and patiently show us that our friend, although he sometimes does wrong, is not that intrinsically bad character we want to see him as, when we are in our unfortunate unforgiving state of mind.

We are helped towards a state of mind where we can think more freely and justly about the risks and benefits of genetics.

Pär Segerdahl

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What is philosophy?

August 17, 2012

Someone asked me what philosophy is. I answered by trying to pinpoint the most frequently used word when one philosophizes.

What does a philosopher most often say? I believe he or she most often says, “But…”:

  • “But is that really true?”
  • “But shouldn’t then…?”
  • “But can’t one imagine that…?”
  • “But how can anyone know such a thing?”
  • Etc.

Always some unexpected obstacle! Just at the moment when your reasoning seems entirely spotless, an annoying “but…?” knocks you to the ground and you have to start all over again.

Confronted with our spontaneous reasoning, a philosopher’s head soon fills with objections. Perplexing questions lead into unknown territory. Maps must be drawn the need of which we never anticipated. A persistently repeated “but…?” reveals challenges for which we lack preparedness.

But the goal is not that of interminably objecting. Objecting and being perplexed are not intrinsic values.

Rather the contrary. The accumulation of objections is a precondition to there being a goal with philosophizing: that of putting an END to the annoying objections.

Philosophy is a fight with one’s own objections; the goal is to silence them.

But if that is so, what point can philosophy have? An activity that first raises annoying objections, and then tries to silence them: what’s that good for!?

Try to reason about what “consent to future research” means. Then you’ll probably notice that you soon start repeating “but…?” with regard to your own attempts to reason well. Your objections will annoy you and spur you to think even more clearly. You will draw maps the need of which you had not anticipated.

Even if we prefer that we never went astray, we do go astray. It pertains to being human. THEN we see the point with persistently asking “but…?”; THEN we see the purpose with crisscrossing confusing aspects of life until we survey them, haunted by objections from an unyielding form of sincerity.

When we finally manage to silence our irritating objections, philosophy has made itself as superfluous as a map would be when we cross our own street…

…until we go astray again.

Pär Segerdahl

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What do donors need to know about future research?

July 22, 2012

I’m reading a Scientific American Guest Blog, on the ethics of future-use DNA sampling. Donating DNA to research is described as a more lasting donation than donating organs or embryos: DNA is information and information can last longer.

That donating DNA is such a lasting donation seems to imply that the future use to which the DNA can be put to use is more open. Who knows what information future researchers might be able to obtain from DNA donated today?

The author of the guest blog, Ricki Lewis, asks how consent can be obtained for DNA sampling intended for future genetic research.

She rejects the view that researchers must know in advance where the research might lead and inform donors about it; and if research takes unforeseen directions years or decades after the donation, researchers must contact donors again for renewed consent.

This view is rejected because knowing where research might lead “is not how science works.” And renewed consent would be “confusing, disturbing, and likely expensive.” – I agree.

Ricki Lewis’s own solution is the following:

  • “…informed consent documents should state that the sample might be used in the future to get information unknown today. Participants or patients can agree, or not sign.”

Both solutions seem to operate on a level that strikes me as less relevant to DNA donors.

People who donate DNA to science probably want to contribute to research that can improve prevention, diagnosis and treatment of various diseases. That is the level at which they are concerned about the future use of their DNA: the level of the practical significance of the research.

The exact scientific path that future research takes is less relevant to donors, I believe, as long as the research has the kind of practical significance that motivates their donation. And to ask for consent to do science as science is done – without knowing in advance where it might lead – could be confusing.

I also wonder: could a consent form that emphasizes the open and unpredictable nature of scientific research be misused on the practical level that probably concern donors more?

Pär Segerdahl

Approaching future issues - the Ethics Blog

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“The Route” is taking shape

June 27, 2012

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

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Handling mistaken trust when doctors recruit patients as research participants

June 14, 2012

Patients seem more willing to participate in biobank research than the general public. A possible explanation is the doctor-patient relationship. Patients’ trust in health care professionals might help doctors to recruit them as research participants, perhaps making the task too easy.

That trust in doctors can induce a willingness to participate in research seems threatening to the notion of well-informed autonomous decision making. Can sentiments of trust be allowed to play such a prominent role in these processes?

Rather than dismissing trust as a naïve and irrational sentiment, a new article distinguishes between adequate and mistaken trust, and argues that being trusted implies a duty to compensate for mistaken trust.

The article in Bioethics is written by Linus Johnsson at CRB, together with Gert Helgesson, Mats G. Hansson and Stefan Eriksson.

The article discusses tree forms of mistaken trust:

  1. Misplaced trust: Trusted doctors may lack relevant knowledge of biobank research (for example, about the protection of privacy).
  2. Irrational trust: Patients may be mistaken about why they trust the doctor (the doctor may actually be a form of father or mother figure for the patient).
  3. Inappropriate trust: Patients may inappropriately expect doctors always to play the role of therapists and fail to see that doctors sometimes play the role of research representatives who ask patients to contribute to the common good.

The idea in the paper, if I understand it, is that instead of dismissing trust because it might easily be mistaken in these ways, we need to acknowledge that being trusted implies a duty to handle the potentiality of mistaken trust.

Trust is not a one-sided sentiment: it creates responsibilities in the person who is trusted. If doctors take these responsibilities seriously, the relationship of trust immediately begins to look… well, more trustworthy and rational.

How can mistaken forms of trust be compensated for?

Misplaced trust in doctors can be compensated for by developing the relevant expertise (or by dispelling the illusion that one has it). Irrational trust can be compensated for by supporting the patient’s reasoning and moral agency. Inappropriate trust can be compensated for by nurturing a culture with normative expectations that doctors play more than one role; a culture where patients can expect to be asked by the doctor if they want to contribute to the common good.

If patients’ trust is seen in conjunction with these corresponding moral responsibilities of doctors, the relationship of trust can be understood as supporting the patients’ own decision making rather than undermining it.

That, at least, is how I understood this subtle philosophical treatment of trust and its role when patients are recruited by doctors as participants in biobank research.

Pär Segerdahl

We recommend readings - the Ethics Blog

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Interactive conference seeks the value of biobanking

April 20, 2012

I have the privilege of belonging to a group of ethicists and law scholars that currently discuss how to visualize ethical and legal dimensions of biobanking.

We organize an interactive part of the scientific conference program for HandsOn: Biobanks in September. The conference invites participants to Uppsala to explore the values of biobanking and to take part in its interactive exhibition.

Biobanking is hot in medicine. There are hopes that it will substantially improve diagnosis, treatment and prevention of widespread as well as rare diseases. At the same time, however, the route to such values is difficult to survey, and the goals of large biobank investments are not always entirely transparent.

HandsOn: Biobanks is an ambitious attempt to explore and visualize the values of biobanking and the path towards them.

The conference asks: What are the values sought after? How can they be achieved in practice? There are the ethical, legal, scientific and commercial challenges, but there are also challenges for the industry. How can biobanking affect public trust in medical research and industry?

The conference combines keynote presentations with idea labs and educational sessions. The interactive part of the conference where I participate is called “the Route.” It follows the research process from ethical review, consent, sampling, storage and analysis, to end results that hopefully add value in ethics and trust, in clinical practice, in health economy, and in drug development.

If you want to participate in this interactive conference and help us better understand the values of biobanking, or simply are curious to see how we manage to solve the tricky problem of visualizing ethical and legal aspects – keep these dates in mind:

We are in the midst of brainstorming “the Route.” I hope that future blog posts can share with you some of the ethical and legal issues that we want to visualize and make accessible to participant interaction.

Registration is open – hope to see you in September!

Pär Segerdahl

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