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

Year: 2011 (Page 1 of 2)

The Swedish Data Inspection Board stops large biobank

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:

  1. Infrastructure for biobank research must not be treated as if it were one of the projects meant to use it.
  2. 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

We challenge habits of thought : the Ethics Blog

Should ethical review boards begin to act like business accountants?

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

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

Debate on changes to the European Data Protection Directive

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

We follow debates : The Ethics Blog

Swedish debate on the protection of animals in research

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

We follow debates : The Ethics Blog

The patentability of inventions requiring destruction of embryos

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

We challenge habits of thought : the Ethics Blog

Taiwanese researchers forced to destroy biobank samples?

Millions of Taiwanese biobank samples might soon be destructed bacause of lack of participant consent. Read more here.

This illustrates the topic I introduced in my previous blog post, Research ethics in a new situation.  The ethical regulation introduced last year in Taiwan was intended to protect human subjects who provided samples to biobanks. But since contacting people in millions long after they provided samples is an expensive and time-consuming process with uncertain result, the actual outcome may be that their samples are destroyed, and thereby also opportunities of future research into common diseases. Ethical regulation and consent procedures clearly create their own ethical problems.

Pär Segerdahl

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

Research ethics in a new situation

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

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

Integrity of anonymous donors

In a comment on our Swedish blog (Etikbloggen), Joanna Forsberg asks if her integrity can be breached if a sample that she donated to a biobank is anonymized (so that it cannot be traced to her) and then is reused in new biobank research. Since the sample is not traceable to her, no one can approach her and ask for consent.

I will probably return to this question. I’m inclined to view an anonymized biological sample as a datum of humankind. A coded sample can become a datum of a specific individual, namely, if the code key is employed so that the donor is traced. The anonymous sample, however, cannot even become sample of “me,” since there is no code key. There is only some tissue and general information, like “male, 48 year old.” It does even not make sense, I want to say, then, to talk about my integrity in relation to anonymous samples.

I notice here that my reasoning is a little bit like that of an experimenter talking about what he or she wants to measure in the laboratory. But is my integrity like an experimental variable? Should bioethicists reason as if ethics was an experimental science?

Pär Segerdahl

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

Have you cited a captive ape?

If you are writing on animal welfare, you may one day cite Savage-Rumbaugh, Wamba, Wamba and Wamba (2007). If you do, you will have cited one human and three captive bonobos.

I cited them last month, presenting a paper at the symposium, “Zoo-ethnographies,” arranged by the Centre for Gender Research in Uppsala. Citing them felt quite natural to me, since I’ve met the authors several times. Although only the human can write, all four understand spoken English and eloquently express their opinions about what you say and do. How do they communicate? Well, to focus on the nonhumans: the first day I visited the bonobos I happened to breach the rule, “just sit and observe,” by chatting with a caretaker just outside Panbanisha’s enclosure. Panbanisha heard when the rule was explained to me, and she looked offended and pointed QUIET on her portable keyboard with several hundred word symbols. I shivered with a combination of shame and metaphysical vertigo. A little later, I could not resist the temptation to touch her son’s hand. He ran to mother who was even more upset than before. She approached me with the keyboard and pointed to another symbol. A researcher asked, “Do you want to communicate with Pär?” She answered with the characteristic short high-pitched vocalization that she, Kanzi and Nyota use to answer questions in the affirmative. Her finger remained firmly on the symbol until I identified it and exclaimed: “She’s calling me a MONSTER!”

Being the first author, Sue Savage-Rumbaugh did the following. She asked the bonobos if they wanted to participate in a conversation about what they see as important for their welfare. They answered in the affirmative. During the tape-recorded conversation she presented a list of welfare items that she guessed might be important to them. It was presented as a series of yes-no questions. If there was uncertainty about a reply, the question was rephrased. Not all suggestions met with the bonobos’ approval. The final list of 12 items was presented in tabular form in the article.

Are Kanzi, Panbanisha and Nyota rightly listed as co-authors? I’ve witnessed the subtlety with which they respond to caretakers’ daily questions about their existence in captive environments. They undoubtedly had more direct verbal input to the article and clearer awareness and approval of their participation than many humans who’ve been listed as co-authors. They certainly were informants who answered questions in conversation with a researcher. But sometimes researchers, especially in ethnography, publish with their informants. I think that choice was particularly apt in this case.

The article concerned the welfare of this group of captive apes. Ever since Kanzi was young, Savage-Rumbaugh treated captivity not as an accidental feature of Kanzi and his family. The fact of captivity cannot be concealed with enrichment items and environments that appear natural for the species (a theme in the article). It is the core of the animal’s existence. If you take captive animals seriously and want to know what their lives can become like, you cannot hide captivity beneath a veneer of “naturalness.” You need to open-mindedly negotiate captivity on a daily basis. Kanzi, Panbanisha and Nyota are experts on their captive existence. Their language developed in negotiation of it. If you cite the article on their welfare as captive language competent apes, you certainly cite them.

Pär Segerdahl

The economisation of the language of medicine

Two American physicians recently wrote in the New England Journal of Medicine about how they were forced back to school again learning another foreign language. In medical school they learned that measles was called rubeola and itching pruritus. Today they learn that patient is called “customer” (or “consumer”) while doctor and nurse both are called “providers.”

The authors guess that spiralling health care costs drive this “economisation” of their professional language. Economists and politicians believe that the solution to the cost problematic lies in the industrialisation and standardisation of health care. Hospitals are to be run as modern businesses and the traditional language of medicine modified with terms that correspond to the professionals’ new factory functions. Above all, the patient relation is updated as a customer relation.

The two doctors see the economisation of their language as reductionist. It neglects the psychological, spiritual, and humanistic aspects of the relation to the patient. Precisely these aspects made medicine a “calling,” they write. The economisation of medicine concerns not only language, however, but also the organization of work. Doctors are less free to make their own decisions based on their clinical judgment. They are forced to follow manuals written by experts, as if they were on the factory floor following the chief engineer’s scheme.

When I read the article I thought that an alternative way of formulating the problem is in terms of means and ends. The authors’ note that clinical care always had a financial aspect, but the treatment of the patient still was in focus as the doctor’s primary goal. When profit took overhand as the goal, it was seen as a betrayal of the doctor’s calling and worth ridiculing, as in Moliere’s plays. The economisation of medicine turns the relation of means and ends inside out. The end of treating the patient is snatched out of the doctor’s hands and become a means towards other, economic ends. The analysis of the alienation this means is old and it is tempting to hear echoes from another century in the article’s finish, which I cannot avoid paraphrasing: “Doctors and nurses of the world, unite! Through off the language that demeans both patient and professional and that threatens the heart of medicine!”

Simultaneously, one must admit that new generations grow up that do not seem alienated in this new world, but act as self-evident consumers of health care.

Pär Segerdahl

We have a clinical perspective : www.ethicsblog.crb.uu.se

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