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

Tag: research participant (Page 6 of 6)

Introspective genomics and the significance of one

As a philosopher, I am familiar with the image of the solitary thinker who studies the human mind though introspective study of his own. A recent article in the journal Cell reminds me of that image, but in unexpected “genomic” guise.

To achieve statistical significance, medical researchers typically engage large numbers of research subjects. The paper in Cell, however, has only one research subject: the lead author of the paper, Michael Snyder.

Snyder and colleagues studied how his body functioned molecularly and genetically over a 14-month period. Samples from Snyder were taken on 20 separate occasions. A personal “omics profile” was made by integrating information about his genomic sequence with other molecular patterns gathered from the samples, as these patterns changed over time.

Early results indicated that Snyder was genetically disposed to type 2 diabetes. Strangely enough, the disease began to develop during the course of the study. Snyder could follow in detail how two virus infections and the diabetes developed molecularly and genetically in his body.

Snyder changed his life style to handle his diabetes. When he informed his life-insurance company about the disease, however, his premiums became dramatically more expensive.

The introspective paper illustrates the potential usefulness, as well as the risks, of what has been dubbed “personalized medicine.” Here I want speculate, though, on how this new paradigm in medicine challenges scientific and intellectual ideals.

When philosophers introspectively studied the human mind, they took for granted that what they found within themselves was shared by all humans. The general could be found completely instantiated in the particular.

The particular was for philosophers no more than a mirror of the general. What they saw in the mirror was not the individual mirror (it was intellectually invisible). What they saw in the mirror was a reflection of the general (and only the general was intellectually visible).

That simple image of the relation between the particular and the general was discarded with Darwin’s theory of the origin of species. A species has no essence shared by all individuals. Therefore, to achieve scientific generality about what is human, you cannot rely on one human subject only. You need many subjects, and statistics, to achieve intellectual vison of general facts.

A noteworthy feature of the paper under discussion is that we seem partly to have returned to the era of introspective research. We return to it, however, without the discarded notion of the particular as mirror of the general.

New molecular techniques seem to open up for study of what previously were simply individual cases without significance in themselves. For personalized medicine, each subject unfolds as a universe; as a world full of significant processes.

By studying the “genomic universe” of one person and following it over a period of time time, Snyder and colleagues could discern processes that would have been invisible if they had superimposed data from several distinct research subjects.

This new significance of the particular is fascinating and novel from an intellectual perspective. Has the traditional contempt for the particular case been overcome in personalized medicine?

Speaking personally as a philosopher, I cannot avoid seeing this aspect of personalized medicine as congenial with certain philosophical tendencies.

I am thinking of tendencies to investigate (and compare) particular cases without magnifying them on a wall of philosophical abstraction, as if only the general was intellectually visible. I am thinking of serious attempts to overcome the traditional contempt for the particular case.

We seem to have arrived at a new conception of one and many; at a new conception of the particular case as visible and worthy of study.

Pär Segerdahl

We challenge habits of thought : the Ethics Blog

The Swedish government announced new rules for research registers

Will new Swedish rules for research registers enable LifeGene to continue?

In December 2011, the Swedish Data Inspection Board (DI) decided that the large biobank investment LifeGene is against the law.

In its motivation, DI focused on the purpose of the data collection and the information to participants about this purpose. According to DI, LifeGene’s purpose – “future research” – is too unspecific to be in accordance with the Personal Data Act.

Yesterday (February 28), the Swedish government announced new rules for research registers. These rules are supposed to enable LifeGene to continue. If you read Swedish, you might want to study the government’s press release.

I am not a legal expert, but it seems to me that even if the government’s new rules can make LifeGene lawful as a research register, other laws become relevant when the register is being used in research… for example, the Personal Data Act, surveyed by DI.

I happen to believe that LifeGene’s purpose can be interpreted as being sufficiently specific even for the demands of the Personal Data Act. LifeGene does not bluntly state “future research” as its purpose, but specifies the kind of diseases that will be studied, as well as the goal of creating new tools to prevent, diagnose, and treat these diseases.

Karolinska Institutet (that administers LifeGene) has appealed against DI’s decision to stop LifeGene. If DI does not withdraw its decision, my uncertain layman guess is that the result of this legal process might still be relevant for the possibility of continuing LifeGene as planned.

Pär Segerdahl

Following the news - the ethics blog

Researchers’ opinions about communication of results of biobank research

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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