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

Year: 2012 (Page 2 of 5)

Biobanks and alternative energy resources

Last week I participated in HandsOn: Biobanks, an interactive conference exploring the values of biobanking. The warm and collaborative atmosphere made the conference a both moving and encouraging experience.

Here is how the conference made me think about the value of biobanks:

New techniques of fundamental importance to humanity tend to appear in proportion to our needs for them. Efforts to develop efficient uses of alternative energy resources, for example, were not seriously supported until we became truly aware of how the world’s oil finds were running dry.

My impression at the conference was that biobanks could be compared to a new and much needed global energy resource. Biobanks are presently being set up all over the world as part of a new infrastructure not only for medical research, but also for health care and the pharmaceutical industry.

And the point is that efficient uses of this alternative resource of biological material appear urgently needed in our current situation.

Health care costs run amok, and so does the industry’s costs for developing new drugs. An efficient infrastructure of biobank resources would very likely help us come to terms with the problems that accumulate in the old framework.

The industry wastes billions on medical hypotheses that after years of hard work turn out to be unfeasible. Translating research results into safe and efficient drugs often is more complex and time-consuming than the research itself. Using biobanks could speed up the translation of research into drugs and make the process more predictable.

The health care sector too has problems and needs to make its practices more efficient, for example, through personalized medicine. Increasingly clever uses of biobank resources allow researchers to begin answering questions like:

  • Who is in the risk category for developing prostate cancer?
  • Who responds to which treatment?
  • Who will experience side effects?
  • Who can be given a clean bill of health after cancer treatment?

Answering such questions is revolutionary in medicine. So revolutionary in fact, that the intelligent use of biobank resources promises to generate new definitions of health and disease; new notions of diagnosis, treatment, and preventive medicine.

Developing a global infrastructure of biobank resources is a challenge for biobankers. Two challenges that were discussed at the conference were harmonization and evidence-based sampling and storing techniques. I got the impression that these challenges were manageable.

However, seeing the real significance of the biological resources that are being collected in biobanks is a challenge also for politicians, legislators and ethicists. To approach the political, legal and ethical issues in the right spirit, I believe we need a bigger picture of our situation.

Perhaps the comparison to our present need to develop intelligent uses of alternative energy resources can provide such a picture.

Pär Segerdahl

Approaching future issues - the Ethics Blog

No consent for maintaining high-quality health care?

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

We recommend readings - the Ethics Blog

How unspecific is broad consent?

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

Research for the sake of the patient

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

Genetic exceptionalism and unforgivingness

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

We want to be just - the Ethics Blog

Ethics before the event

It is easy to be wise after the event. This easily accessible form of wisdom is also a painful accusation: you should have been wise before the event.

If you are extremely sensitive to the pain of these attacks, you might want to become someone who always is “wise before the event.” If you let your life be governed by such an ideal, you’ll become an ethical perfectionist.

Ethical perfectionism may seem like the most demanding form of ethical attitude. If it derives from oversensitivity to the pain of being wise after the event, however, which is ridiculously easy, I’m more doubtful about the value of this attitude.

The ethical perfectionist runs the risk of avoiding life altogether, until even the slightest chance of moral complexity has been eliminated. “Postpone life; I’ve discovered another possible ethical problem!”

My reason for bringing up this subject is that research ethics seems to be in continual danger of succumbing to problematic forms of ethical perfectionism. The dependence on research scandals in the past and the demand to avoid them in the future makes it especially vulnerable to this strange ideal.

Don’t for a moment believe that I recommend living without reflection. But ethical problems must be confronted while we live and develop our activities: “as we go along.” We cannot postpone life until all ethical complexity has been eliminated.

The risk is that we fancy ethical problems without reality and postpone urgent research initiatives on the basis of derailed demands, while we fail to face the real ethical challenges.

Pär Segerdahl

We think about bioethics : www.ethicsblog.crb.uu.se

What is philosophy?

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

We challenge habits of thought : the Ethics Blog

Interesting conferences

The Ethics Blog recommends three important conferences this autumn:

1.      Genomics for Healthcare and Socio-Economic Progress

This conference is organized by the Wales Gene Park. It discusses the economic potential of genomics in, for example, healthcare, agriculture and bio-energy.

  • When? 13-14 September 2012
  • Where? Radisson Blu Hotel, Cardiff
  • Website? Here

2.      HandsOn: Biobanks

This interactive conference is organized by BBMRI.se. It dicusses biobanking and the value of biobank research.

  • When? 20-21 September 2012
  • Where? Uppsala, Sweden
  • Website? Here

3.      Children’s Participation and Decision-Making in Medical Matters

This conference is organized by the Nordic Committee on Bioethics. It discusses the ethics of children’s participation in medical research.

  • When? 11-12 October 2012
  • Where? Lund, Sweden
  • Website? Here

Visit the websites to find out more about these interesting events!

Pär Segerdahl

We recommend conferences - the ethics blog

Who, or what, becomes human?

Our long childhood and dependence on parental care seem to leave no doubt about it: we are not born as humans, we become human.

I want to highlight a particularly tempting metaphor for this process of “becoming human” – the metaphor of:

  • “Order out of chaos.”

According to this metaphor, human infancy is abundantly rich in possibilities; so abundant, in fact, that it is a formless chaos – a “blooming, buzzing confusion,” as William James characterized the infant’s experience of being alive.

To acquire recognizable human form, the child’s inner chaos must be tamed through the disciplining efforts of parents and society at large (the metaphor suggests). The child’s formlessly rich inner life must me narrowed down, hardened, made boring… until, finally, it becomes another obedient member of society.

Society does not acknowledge a real human subject until the norms of “being human” are confidently repeated: as if the child easily would slip back into its more original state of blooming, buzzing confusion, the moment the reiteration of the social norms of humanity terminates.

The “order out of chaos” metaphor makes life and growth look like death and atrophy. To become human means aborting limitless possibilities and gradually turning into that tragic effect of social forces that we know as “the mature adult.”

Perhaps the intriguing topic of the “deconstruction of the subject” is nothing but rigorous faithfulness to the logic of this tempting metaphor? If becoming human is anything like what the metaphor presents it as, then “no one” becomes human, strictly speaking, for before the disciplined human is formed, there is nameless chaos and no recognizable human subject.

But how can the proto-human chaos – I mean, the child – be so responsive to its non-chaotic parents that it reduces its inner chaos and becomes… human? Isn’t that responsiveness already a form of life, a way of being human?

Dare we entertain the hypothesis that the newborn already is active, and that her metamorphoses throughout life require her own creative participation?

I believe we need another understanding of human becoming than that of “order out of chaos.” – Or is human life really a form of colonization of the child?

Pär Segerdahl

We challenge habits of thought : the Ethics Blog

What do donors need to know about future research?

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

« Older posts Newer posts »