Can infrastructure for biobank research make ethical notions obsolete?

January 2, 2012

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

We challenge habits of thought : the Ethics Blog


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


Research ethics in a new situation

November 15, 2011

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


Does my blood sample make me a research subject?

October 14, 2011

When my blood sample is reused in biobank research, perhaps 5-10 years after I gave it, do I then become a research subject who must be informed about the new research project and give my assent before the sample is used?

The question arises when I read Joanna Forsberg’s article in BMJ on biobank research and the comments it received. She questions assent for each new biobank project in an interview on Nature News Blog. She thinks it is sufficient that the project has taken precautions that guarantee anonymity and is reviewed by an ethical review board.

Contacting people in thousands long after they gave their samples is not only costly, it also means drop out of samples threatening the validity of the results. Joanna thinks we all have an interest in the existence of biobank research even if we do not gain from research on precisely the samples we gave. Today vaccination against cervical cancer can be offered because in a biobank with patient samples from 1969 a connection was found between HPV virus infection and subsequent falling ill. As a reasonable solution Joanna therefore suggests broad consent to the use our samples in future biobank research.

I don’t know if research on my ten-year-old blood sample makes me a research subject today. One thing is obvious: biobank research does not resemble the standard image of medical research where research subjects after consent undergo treatments and regularly are tested.

Pär Segerdahl

We like ethics : www.ethicsblog.crb.uu.se


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