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Withdrawal from Biobank Research: Considerations and the Way Forward

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Abstract

The right to withdraw one’s consent after having agreed to participate in research is a fundamental principle in contemporary research ethics. However, it has been questioned whether this right should apply to research conducted on donated biological samples, including stem cells and tissues from which stem cells can be derived. In this article we present some of the concerns that have been expressed related to this question. We then identify five areas that one needs to pay greater attention to before any conclusions can be drawn as to whether donors should be given the right to withdraw, or under what circumstances withdrawal should be allowed.

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Notes

  1. As we shall return to later, it is neither obvious what autonomy means, nor why it should be promoted. One point is worth mentioning here: Increasing a person’s options is not the same thing as promoting that person’s autonomy [12]. Hence, one cannot simply assume that withdrawal promotes autonomy simply because it opens a possible line of action for the donor.

  2. To determine whether the reasons of withdrawal are sufficient and whether waiving the right to withdraw is acceptable, some commentators [6] have suggested a consultation with an Ethical Review Board. This suggestion may introduce variations of evaluation of what can be considered as “sufficient reasons” among different boards and even more so among such boards in different countries. It has been argued that the sense of what constitutes undue influences in withdrawal procedures likely differs among different stakeholders such as researchers, Ethical Review Boards or research participants [17]. It is also far from clear that shifting the problem of determination of what should count as “sufficient reasons” from researchers to Ethical Review Boards would solve the question of when it should be considered acceptable to withdraw from the study.

  3. Minimal risk has been defined as “the probability and magnitude of harms that are normally encountered in the daily lives of the general population” [18].

  4. Actually, it has been argued that it could make sense to speak of a duty not to withdraw without good reasons, a duty that “would potentially conflict with unconditionality, since we normally find it acceptable to ask people to explain or justify their prima facie breaches of moral duties” [7].

  5. This worry has been expressed in the context of clinical trials [27], but could also be of relevance in some studies involving biobank material if withdrawals are frequent enough.

  6. Some have argued that this is a problem for stakeholders such as patients waiting for trial results [28] or research participants remaining in the study who can be disappointed by the loss of information due to withdrawals [16].

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  1. Lund University, Lund, Sweden

    Kristina Hug, Göran Hermerén & Mats Johansson

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Correspondence to Kristina Hug.

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Hug, K., Hermerén, G. & Johansson, M. Withdrawal from Biobank Research: Considerations and the Way Forward. Stem Cell Rev and Rep 8, 1056–1065 (2012). https://doi.org/10.1007/s12015-012-9399-y

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