The Ethics Blog

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

Category: Musings (Page 19 of 19)

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

Research ethics in a new situation

15 November, 2011 / / 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

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

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

Have you cited a captive ape?

4 November, 2011 / / 0 Comments

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

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