The Ethics Blog

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

Does my blood sample make me a research subject?

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

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2 Comments

  1. Mats Hansson

    Verry good I think!

    Mats

  2. Joanna Forsberg

    I would say that there are two different questions to answer here. First, do I become a research subject if my ten year old sample is used for research, and second do I become a research subject that has to be informed and consent?

    Many people would likely give an affirmative reply in both cases. However, I think “no” is a more reasonable answer to the second question. This is because routinely requiring informed consent imposes costs that risk harming me (and all others) more than the research in itself does, by impeding medical advances.

    Provided that there are strict measures to protect confidentiality and that an ethics review board has approved the research, the default postion should be that informed consent is not necessary, regardless of whether I have in fact become a research subject or not.

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