Author: Pär Segerdahl (Page 43 of 44)

Protecting children: through research or from research?

20 January, 2012 / Pär Segerdahl / 0 Comments

Children pose a dizzyingly difficult problem for research ethics.

One of the most important tasks of research ethics is the protection of human research participants. This significant aim is realized above all through the requirement of proper information and consent procedures.

But children often cannot be protected though these means. They are too young to understand information about research and to give their own autonomous consent.

Children often are excluded from medical research. Since they cannot be protected by the standard ethical precautions, they can be protected only by being excluded from research, so to speak.

The result, however, is that “experimentation” on children in practice moves elsewhere. It moves to the prescription of medical substances to sick children in health care.

We often don’t know the side-effects of medical substances in children; at least not as well as we know them in adults. We often don’t know what dosages are required in children to gain the sought-after effect. We often don’t know when the dosages become toxic.

As a consequence of this, medical prescriptions to children lack the scientific evidence that we have for adult patients. Moreover, when children become sick, they may be “protected” as patients by being denied what could be the most effective medical treatment. Doctors cannot prescribe potent medical substances to children if they don’t know their effects in the body of a child.

The dizzying difficulty can perhaps be simplified thus:

Adults can be ethically protected as research participants. Therefore, scientific knowledge is gained that protects them as patients too.
We cannot protect children as research participants. Therefore, we cannot protect them as patients either (at least not as well as we protect adult patients)

There is growing concern among ethicists about this situation. More knowledge is needed about children’s responses to various medical treatments. Otherwise they cannot be given the best possible treatments when they are patients. That, however, requires more clinical research with children. – But how can we ethically justify such research?

The problem is discussed in the current issue of The American Journal of Bioethics. A target article by David Wendler is followed by seven open peer commentaries.

If you are interested in the problematic, I strongly recommend reading this discussion and considering whether the attempted justifications get to the root of the dizzying problem. One thing is clear, though:

Protecting children ethically by excluding them from research participation is not the unambiguously good deed it may appear to be.

Pär Segerdahl

Trapped in our humanity?

13 January, 2012 / Pär Segerdahl / 5 Comments

Being human, can I think nonhuman thoughts? Can the world I perceive be anything but a human world?

These philosophical questions arise when I read Cora Diamond’s and Bernard Williams’ humanistic portrayals of our relations to animals.

A certain form of “human self-centeredness” is often deemed unavoidable in philosophy. If I talk about a dog as being nervous, for example, I use language. But since this language is my language, and I am human, the dog’s “nervousness” would seem to have its ultimate reference point in my humanity.

When I try these thoughts, they make it look as if we, in some almost occult sense, were trapped in our humanity. The more we reach out toward other bodily beings, the more entrenched we become in our own spirituality. Language may open up an entire world for us. But since language is human, it makes us a solipsistic being that cannot but experience a fundamentally human world.

Believing in an “ineliminable white or male understanding of the world” would be prejudiced, Williams writes. But our humanity cannot, of course, be eliminated as if it were an old prejudice. Therefore: “A concern for nonhuman animals is indeed a proper part of human life, but we can acquire it, cultivate it, and teach it only in terms of our understanding of ourselves.”

Similar thoughts appear in Diamond’s notion that the kind of moral response to animals that can motivate vegetarianism (such as her own) is an “extension to animals of modes of thinking characteristic of our responses to human beings.”

Perhaps I misunderstand them. But the idea seems to be that we become human primarily with other humans, and only thereafter relate to a “nonhuman” world on the basis of the more primordial human one. Humanism, in such philosophical form, could be called: the idea of “humanistic immanence.”

What is valuable in the idea of humanistic immanence is what it has in common with all good philosophy: the self-critical occupation with our own thinking. What I find more questionable is what appears to be an unfounded assumption: that we become human primarily with other humans (a purification of what is human).

One does not have to be a “post-humanist” to make the following observation:

“… in the lives of many people animals occupy a place which is, in certain respects, as central as that occupied by other human beings. In particular, certain animals have a quite fundamental place in the lives of many young children; and a child’s use of the words ‘pain’, ‘fear’ and so on may be acquired as immediately in connection with the pet cat as in connection with human beings.” (David Cockburn)

Consider, in the light of this observation, Diamond’s important idea that, “we learn what a human being is in – among other ways – sitting at a table where WE eat THEM.” Take this notion of human becoming to ape language research, where apes and humans meet daily over food and have conversations that may concern such matters as what to eat, who eats what, and who eats with whom.

What happens when humans share food with apes, sitting down on the ground rather than around a dinner table? What happens to our “humanity” and to their “animality”? What happens to us as men and women when apes communicate attitudes to how humans of different sex and age should behave? What happens to our moral understanding when apes view some visitors as bad and urge their human friends to bite them?

My (human) notion of nervousness may in part have developed through interaction with our sensitive Great Dane when I was a child. What I learned through these interactions may only thereafter have been extended to human nervousness.

I am human and so is my language. But the manner in which I became human (and acquired language) transcends, I want to say, the purified human sphere of “humanistic immanence.”

My ineliminable humanity already is more than human. What are the consequences for philosophy?

Pär Segerdahl

Can infrastructure for biobank research make ethical notions obsolete?

2 January, 2012 / Pär Segerdahl / 0 Comments

In a comment to what I posted earlier about the decision of the Swedish Data Inspection Board to stop LifeGene, Åke Thörn asks what I mean by saying that

“LifeGene represents a new reality in the making.”

Since the question has deep interest, I want to answer it here, in a new post. I will use a simile to explain my intended meaning.

Suppose that rather than discussing biobank ethics, we were playing a form of chess with the strange feature that the chessboard sometimes changes. Squares turn into circles. Or the entire chessboard turns into a rhomb.

These changes of the chessboard make the old rules obsolete. What is “straight” and what is “diagonal” on a chessboard with the shape of a rhomb? The rules need to be reconsidered!

Research ethics and ethical review can be compared to games played on chessboards that sometimes change and require that rules and basic notions are reconsidered. What I meant in my previous post was that LifeGene represents such a basic change of the research ethical chessboard.

How should the “aim” of biobank infrastructure be described, given that infrastructure is not a research project with the aims of individual biobank projects? Do people turn into “research participants” when their ten-year old blood samples are used in new studies?

We cannot always cherish old ethical notions – as if there were no such things as TIME and CHANGE. We sometimes need to rethink rules and basic notions.

I hope these considerations explain my understanding of ethics as sensitive to changing times, and my notion of LifeGene as a “new reality.”

Pär Segerdahl

The Swedish Data Inspection Board stops large biobank

20 December, 2011 / Pär Segerdahl / 0 Comments

Swedish biobank research suffered serious defeat last week. The Swedish Data Inspection Board decided that the ongoing collection of biological samples and health data to the large biobank LifeGene is against the law.

Karolinska Institutet (that runs LifeGene) must now stop collecting further data and is not allowed use already collected data. The reason for the decision is said to be the loosely formulated purpose of LifeGene: “future research.” Participants cannot give consent to anything that vague, the Data Inspection Board argues.

Well, that openness happens to be the point of this new type of biobank!

LifeGene is not a research project, nor is it part of a research project. LifeGene is intended as infrastructure of future biobank projects. Researchers are invited to apply for access to the biobank within specific studies of, for example, genetic and environmental risk factors for widespread diseases.

The more specifically formulated research purposes enter later in the process!

Collecting hundreds of thousands of biological samples and health data anew, each time researchers want to ambitiously study widespread diseases, is unfeasible. Therefore, LifeGene was developed as standing infrastructure of such biobank research in the future.

… And now it has been decided that developing such infrastructure is illegal. Because the purpose cannot be specified as in the research projects that later use the biobank!

This is a category mistake, as philosophers say when what is fundamentally distinct is conflated. In this case, research infrastructure is conflated with research projects.

Other posts about biobanks on this blog are directly related to the risk of the decision that the Swedish Data Inspection Board made:

My views can be summarized in two simple points:

Infrastructure for biobank research must not be treated as if it were one of the projects meant to use it.
My given blood sample does not make me a research participant (who must give consent each time the sample is used).

LifeGene represents a new reality in the making. It remains for the authorities, for legislators, and for all of us to better understand it!

Pär Segerdahl

Should ethical review boards begin to act like business accountants?

16 December, 2011 / Pär Segerdahl / 0 Comments

The company Geron recently decided to stop its unique clinical trial concerning treatment of spinal cord injury with neural cells derived from human embryonic stem cells.

In a previous post on this blog, I used the company’s decision to illustrate a possible consequence of the European ban on stem cell patents requiring the destruction of human embryos. The same day I posted my consideration, Francoise Baylis published a wholly different perspective on Geron’s decision…

Geron claims that the decision to stop the trial was made for business reasons. They wanted to concentrate their limited resources to their oncology drugs. However, the decision left the four research participants that had been enrolled in the trial in a vacuum.

Geron says it will continue to study these participants and report findings. But the trial was originally meant to include ten participants. Will results with only four participants be scientifically valid, Baylis asks. If the results are valid, then using ten participants, as originally planned, would have meant using more patients than required for producing valid results. If results with four participants are not valid, four patients are exposed to risk without any prospects of countervailing new knowledge.

– Which conclusions can be drawn from this example? Should the practices of ethical review be changed for applications from the private sector? Should financial resources and business strategies be included in the issues to consider? That seems to be Baylis’ response to Geron’s decision to quit stem cell research.

For my own part, I think we need more than one example before we consider making ethical review practices even more complex. A more time-consuming process of ethical review has a cost that we need to acknowledge…

As Simon Whitney summarized his views on the expansion of ethical regulation of medical research, “since biomedical research saves lives, it is unsurprising that the regulation of research costs lives.” – It may be unethical to make the process of ethical review even more cumbersome. Patients die when life-saving research is delayed. That cost must be brought into the equation when we consider single examples of ethically problematic conduct that we may wish to regulate against.

Pär Segerdahl

Debate on changes to the European Data Protection Directive

9 December, 2011 / Pär Segerdahl / 0 Comments

In the December issue of the European Journal of Public Health, two groups of researchers present opposed views on planned changes to the European Data Protection Directive.

One group welcomes a harmonization of data protection rules across Europe, provided that new technologies to protect identities are implemented. Their basic idea seems to be that harmonization facilitates data sharing, and thereby research. So go for harmonization, if the required privacy protecting technologies are put in place.

The other group sees the suggested identity protecting technologies as a threat to epidemiological research. Anonymized or pseudonymized data do not allow researchers to trace complex interactions between life-style, preventive interventions, treatments and outcomes. The harmonization may facilitate data sharing, then, but the technical preparation of the data will be cumbersome, and the data become useless for many important research purposes. So avoid harmonization, if it hinders public health research.

The background to the debate – as I understand it – is the double aim of the harmonization: to facilitate data sharing across borders while simultaneously enhancing the protection of privacy. Individuals have a right to abstain from participating in research. Participation requires that they give informed consent.

A harmonization that demands consent for epidemiological research from each sample or data provider each time a new project uses the data is seen by both groups as a threat to much public health research. Thus one group suggests privacy protecting technologies to avoid the requirement of informed consent. The other group suggests that current national exemptions from the principle of consent work well, with no reported breaches of privacy. And it enables the research that the privacy protecting technologies hinder.

Read the two articles and the editorial, and reflect on where the essence of the problem lies. My view is that the relevant ethical question to consider is whether (or in what sense) we are research participants when our already given samples or data are used in epidemiological research.

Pär Segerdahl

Swedish debate on the protection of animals in research

2 December, 2011 / Pär Segerdahl / 0 Comments

A very controversial question was recently debated in a Swedish daily paper, Svenska Dagbladet:

– Has the Swedish protection of animals in research gone too far?

The question was raised by Mats G. Hansson at CRB, Rikard Holmdahl (Professor of Medical Inflammation Research) and Anne Carlsson (President of the Swedish Rheumatism Association). I published a post about the debate on our Swedish blog: Det dubbla ansvaret för djur och människor. In the post, and in its comments, you find links to the three articles in Svenska Dagbladet.

If you don’t read Swedish, here is a summary of the debate:

The basic principle when animal experiments are evaluated ethically is that the scientific merit of the experiment must be greater than the suffering the animals may be exposed to. In the article that started the debate, “scientific merit” was interpreted as an interest for patients. Medical research is done not for its own sake, but to find new treatments for patients. The article thus added a suffering group to the laboratory animals: the patients.

The stage was set, and dramatically so, for intense debate: suffering animals versus suffering patients. The article argued that forgetfulness about the ultimate purpose of medical research has caused an imbalanced emphasis (especially in Sweden) on one of the vulnerable groups: the animals. Ethical committees evaluating animal experiments include representatives of animal welfare organizations, but patient organizations have no representatives in the committees. Moreover, the authority responsible for surveying the Animal Welfare Act has sidestepped the ethics committees by introducing regulations that prohibit certain very common and important experimental procedures with animals, thereby precluding the difficult ethical balancing of expected scientific merit against animal suffering. Researchers can apply for exception from the prohibitions, but the procedure is bureaucratic. The result is that research that could be in the service of patients never gets done. Responsibility for animals is taken in ways that fail patients.

Three representatives of animal rights organizations soon responded that almost all animal experiments are approved by the ethics committees. They also pointed out that the animal welfare representatives in these committees are a minority. Moreover, adding to this disadvantage, only the researchers can appeal against the decision of the committee; no one representing the animals can. The authors expressed concern about suffering patients and the need of high quality science, but questioned that good and useful science required painful animal experiments. There are alternatives to animal experimentation. These may even be scientifically superior.

In the final reply, the authors initiating the debate suggested that the reason that almost all applications for animal experiments are approved by ethics committees is that researchers take ethical questions seriously and write well prepared applications. They also remarked that researchers do consider alternatives to animal experiments, and try to limit the number of animals used. Still, medical science in general is impracticable without experiments with animals. The last new consideration in the final reply was that although interest groups legitimately work to protect animals’ interests, the same one-sided ambition becomes problematic when it occurs on a societal level, in the exercise of public authority.

If I may conclude with a short personal consideration, I’d say that each party repeated its own form of morality, perhaps taking it to a somewhat more eloquent level. One party compared the suffering of two vulnerable groups (animals and patients), and claimed that the other party failed to make the responsible balancing act, one-sidedly favoring the interests of animals. But the other party hardly failed to achieve a responsible comparison, since the legitimacy of comparing animal and human suffering was questioned. Comparing is irresponsible. These two forms of morality are so fundamentally different that I don’t see how they can stop repeating themselves, forever.

Pär Segerdahl

The patentability of inventions requiring destruction of embryos

25 November, 2011 / Pär Segerdahl / 0 Comments

A month ago the European Court of Justice banned patents that require destroying human embryos at and after the blastocyst stage. A month later, the company Geron decided to stop their unique clinical trial concerning a treatment of spinal cord injury with neural cells derived from human embryonic stem cells. The company cited lack of financial resources as their reason. Yet, the termination of their trial illustrates possible consequences of the ruling of the European Court of Justice. Patient groups with, for example, spinal cord injury may less likely hope for efficient treatments.

Bioethics groups, such as the Anscombe Bioethics Centre in Oxford, saw the ruling as a victory of ethics over greed (here is an interview with the director). I want to ask, though: what kind of ethics really won here? And what was defeated?

According to the philosopher Christian Munthe, the argumentation preceding the ruling was unusually bad. Among the many deficiencies he identifies, there is an important missing premise that moreover is false.

I believe that Munthe is right about the missing premise. But perhaps the most important question is WHY the premise began to haunt the argumentation and implicitly steer it towards the ruling. The missing premise contained a comparison of the destruction of human embryos when stem cells are isolated with killings of prisoners in former Yugoslavia to make money on their organs. Obviously, patents for procedures that involve actions that resemble this crime should be banned. But does isolating stem cells from embryos have such resemblances to the brutalities of civil war?

Evidently, the judge working on the issue speculated about established customs and shared moral views in Europe (“ordre public and morality”). People understand the relevant facts of war sufficiently well to react morally to acts of cruelty against prisoners. This moral view is grounded in an unclouded perception of reality. The development of stem cell treatments, however, is unknown to most of us. When we respond to hearing about such procedures, we easily react to IMAGINARY PICTURES of what isolating embryonic stem cells might be like. These pictures often resemble a chamber of horrors with which the new and unknown is compared… like killing victims of war to sell their organs: a “tech noir” image of the future fundamentally stuck in the past.

Notice that we are not dealing with two known procedures and their perceivable similarity. One of the procedures, the isolation of embryonic stem cells, is unknown to most people. When the judge speculated that people in Europe would see a similarity between isolating stem cells and killing prisoners, this meant speculating about how people might speculate about the unknown, using the known as a pattern. As a result of this speculation about speculations about the unknown, treatments of serious conditions like spinal cord injury are now less likely.

Was the ruling a victory of ethics over greed? Or was ethics defeated by speculations about fantasies about the not yet understood?

Instead of being merely a case of bad logical reasoning, the missing premise exemplifies a tremendous moral difficulty in modern societies. Ethics in these rapidly developing societies demand that we are open to learning about NEW notions and facts. If we are not, we risk responding “morally” to imageries rooted in the past rather than to the new realities.

I admit that developments in medicine pose considerable challenges for moral thought today. An example of the efforts that may be required to avoid questionable comparisons and imaginations is an article in Stem Cells, written by Mats G. Hansson at CRB with Gert Helgesson, Richard Wessman and Rudolf Jaenisch. The article is technically advanced and I’m pondering whether the relevant facts could be explained in simpler terms.

While waiting for future posts that may summarize the thoughts less technically, I recommend it as a warning against temptations to compare new facts with a cabinet of old threats.

Pär Segerdahl

Research ethics in a new situation

15 November, 2011 / Pär Segerdahl / 0 Comments

Let me introduce a topic that will be recurrent on this blog! It is the question whether research ethics and the practices of ethical review can give rise to their own ethical problems. Do we create new ethical problems while we handle old ones?

Research ethics developed in a different situation than our present one. The starting-point was inhuman: terrible experiments with prisoners in concentration camps during World War II. Thereafter, a series of research scandals where research subjects were harmed in different parts of the world. Simplifying somewhat, research ethics developed to protect people from being forced into harmful research. One such ethical protection was the demand that people cannot be used as research subjects if they haven’t been properly informed about the project, about its possible risks, and have given their consent. Another protection was a legislated ethical review apparatus that can reject ethically problematic research proposals.

Ethical review and information and consent procedures are integral parts of contemporary medical research. Thereby, however, they change the situation for the research ethics of today. As a result of its success, research ethics may create its own ethical problems! If the previous threat primarily was injustices and acts of cruelty towards research subjects, new threats appear on the ethically regulated horizon. In a number of cases, one can ask if research subjects are overprotected against their own interest.

Pregnant women and children can be vulnerable and are therefore regularly excluded from clinical research. It may seem comforting to know that these groups are safe from possibly harmful research. The result of the well-intentioned protection, however, is that these groups are subjected to possibly harmful medical treatments as patients. We don’t know how treatments that are effective on non-pregnant adults work on children and pregnant women, nor the dosage. Vulnerable groups are protected as research subjects, but as a result of that protection they are put to risk as patients. Clearly, new ethical problems arise here because of the way we handle the old ones!

I’m not claiming that the old problems have disappeared. Just read The Independent (Monday, 14 November 2011): “Without consent: how drug companies exploit Indian guinea pigs.” But perhaps we have become a little too habituated to the rhetoric of victimizing research, if we fail to see and address the questions that arise as a result of the present ethical regulation and practice. If research ethics is not open to unforeseen ethical problems related to its own role in contemporary research, I believe it risks becoming self-sufficient and ideological.

We discussed these self-critical ethical questions last year at the conference, “Is Medical Ethics Really in the Best Interest of the Patient?” Conference articles were published in the April issue of JIM, 2011. I can inform you that several related articles from CRB are in the pipeline. I’ll reflect on them as they are published.

Pär Segerdahl

Author: Pär Segerdahl (Page 43 of 44)

Trapped in our humanity?

Can infrastructure for biobank research make ethical notions obsolete?

Should ethical review boards begin to act like business accountants?

Swedish debate on the protection of animals in research

The patentability of inventions requiring destruction of embryos

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