Evidence of support for biobanking practices

BMJ 2008; 337 doi: https://doi.org/10.1136/bmj.a337 (Published 10 July 2008) Cite this as: BMJ 2008;337:a337
  1. Graeme Laurie, professor of medical jurisprudence
  1. 1School of Law, University of Edinburgh, Edinburgh EH8 9YL
  1. Graeme.Laurie{at}ed.ac.uk

    Lack of dissent in opt-in mechanisms does not necessarily support a move to opt-out

    In the linked study, Johnsson and colleagues report levels of dissent in Swedish patients who are asked about storage and future research use of samples collected during health care.1 Only 0.14% of patients dissented to either storage or use of their samples, and 0.063% confirmed their decision by completing a dissent form.

    The authors conclude that their survey provides evidence of high levels of trust in the Swedish system, and although this might not translate to other countries or contexts, it may support a move to opt-out systems of regulatory governance. Although the study concerns samples rather than data derived from them, the research value of samples lies in the generalisable data that they can generate, so questions about control of information and access to it are crucial. The suggestion that lack of dissent in an explicit consent system (opt-in) may support a move to presumed consent (opt-out) requires close scrutiny.

    We need to decide what counts as evidence of support for biobanking practices, and more fundamentally, what counts as support for different regulatory mechanisms surrounding those practices. Central to answering these questions is the role and importance we give to consent as the legitimising factor in research …

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