The Ethics Blog

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

Tag: consent (Page 6 of 6)

Debate on changes to the European Data Protection Directive

9 December, 2011 / / 0 Comments

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

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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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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

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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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