The Swedish Data Inspection Board stops large biobank

December 20, 2011

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?

December 16, 2011

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

December 9, 2011

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

December 2, 2011

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


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