The Ethics Blog

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

Tag: biobanks (Page 9 of 9)

Researchers’ opinions about communication of results of biobank research

23 February, 2012 / / 0 Comments

One of the ethical difficulties that confront biobank and genomics research concerns the communication of results to participants.

Should biobank participants be given feedback from research? If so, under what conditions?

A recent article in the European Journal of Human Genetics reports a survey of Dutch biobank researchers’ opinions on the issue.

Here are some findings that struck me:

  1. Most of the respondents held the view that participants have to be informed about findings that are relevant at a group level.
  2. There was less agreement, however, about communication of findings that can be relevant for specific individual participants.
  3. About half of the Dutch biobank investigators found it acceptable to not communicate individual results about genetic variation.
  4. Most of the researchers (74%) answered that participants have to be informed about individual results only if there are implications for treatment or prevention.
  5. The respondents generally agreed that participants should not be informed about individual results in return for their contribution. If results are communicated, then, it is not because participation merits rights to individual feedback.
  6. Some worries among respondents concerning communication of individual results were: personal privacy will be harmed (36%); a therapeutic relation will arise (46%); participants’ insurance premiums might increase (66%); information about individual gene variation can frighten participants (81%).

What I find even more interesting, perhaps, is that the researchers’ opinions (in this study) differ from those of the general public and patients (in a comparable study).

When asked similar questions, the general public and patients want individual feedback regardless of the possibility of prevention or treatment… although they seem to change their minds after they have been recruited by biobanks as participants.

As participants, they are less interested in individual feedback than before recruitment.

This change of opinion among participants in the direction of the researchers’ opinions is fascinating. I cannot resist speculating about its cause. Is there such a thing as a “shared experience” of biobanking that shapes expectations and evaluations?

Nevertheless, according to the authors, the gap between the groups is sufficiently wide to complicate the question of how to communicate results to participants.

Pär Segerdahl

ethics needs empirical input - the ethics blog

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Blood samples to be destroyed in Minnesota

10 February, 2012 / / 0 Comments

Privacy concerns and public health endeavours sometimes clash with each other.

A recent example comes from the state of Minnesota.  After a ruling from the state’s supreme court, one has begun to destroy blood samples taken routinely from newborns in  a screening program. The practice is seen as a violation of privacy, since consent was not obtained first.

Read more in Science, News of the Week.

Pär Segerdahl

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Can infrastructure for biobank research make ethical notions obsolete?

2 January, 2012 / / 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

We challenge habits of thought : the Ethics Blog

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The Swedish Data Inspection Board stops large biobank

20 December, 2011 / / 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:

  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

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Taiwanese researchers forced to destroy biobank samples?

23 November, 2011 / / 0 Comments

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

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Integrity of anonymous donors

7 November, 2011 / / 0 Comments

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

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Does my blood sample make me a research subject?

14 October, 2011 / / 0 Comments

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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