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‚Mirroring‘ the Ethics of Biobanking: What Analysis of Consent Documents Can Tell Us?

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An Erratum to this article was published on 07 January 2014

Abstract

Biobanks have been recognized as a key research infrastructure and how to approach ethical questions has been a topic of discussion for at least a decade by now. This article explores the characteristics of donors’ participation in European biobanks as reflected in the consent documents of a selection of different biobanks from various European countries. The primary aim of this study is to understand how donors are informed about their participation in biobanking. Also the paper discusses what the most important thematic issues of information are to be given to the biobank participants and how this information should be presented in the consent documents. For these purposes, we analyse consent documents from 14 biobanks in 11 countries for six ethically relevant issues: (1) model of consent, (2) scope of future research, (3) access to medical data, (4) feedback to the participants, (5) consent withdrawal, and (6) role of research ethics committee. In order to compare different trends of informing donors of human biological material and medical data, we interpret the six analysed issues in the context of respect to donor’s autonomy paradigm. Although the results of the paper reflect the heterogeneity of biobank consent document policies applied in different European countries, we uncovered some trends and suggested several examples of good practices to balance the interests of the donors with those of the researchers and future patients.

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Notes

  1. Swiss Academy of Medical Sciences, German Ethics Council (two opinions), Austrian Bioethics Commission at the Federal Chancellery (two opinions), UK Medical Research Council, Cyprus National Bioethics Committee, Federation of Medical Scientific Societies, Belgian Advisory Committee on Bioethics, French National Consultative Ethics Committee for Health and Life Sciences, Irish Council for Bioethics, National Bioethics Commission of Greece, Organisation of European Cancer Institutes (Milano), Nuffield Council.

  2. A population biobank primarily aims to obtain biomarkers of susceptibility and population identity, and their operational substrate is germinal-line DNA from a huge number of healthy donors, representative of a concrete country/region or ethnic cohort (Riegman et al. 2008).

  3. A disease biobank‘s (i.e. tumour banks) aims correspond to biomarkers of disease through prospective and/or retrospective collections of tumour and non-tumour samples and their derivates (DNA/RNA/proteins), usually associated with clinical data and sometimes associated with clinical trials. Those data are usually not collected for a concrete research project, except the case of clinical trials, but from the healthcare clinical records. The amount of clinical data linked to the sample determines the availability and biological value of the sample (Riegman et al. 2008).

  4. See the note 1.

  5. See the note 1.

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Acknowledgments

This project was supported in part by Grant Number R25 TW007085 from the US National Institutes of Health (NIH) Fogarty International Center. Its contents are solely the responsibility of the authors and do not necessarily represent the official view of the Fogarty International Center or the NIH. We would like to thank the following people from the field of biobanking for sharing their informed consent documents and replying to our questions, without this work would not have been possible: Maria Grazia Diadone (Istituto dei Nazionale Tumori, Milan), Luciana Caenazzo (University Hospital of Padova), Peter Riegman (Erasmus MC, Rotterdam), Wenche Reed (Oslo University Hospital, Oslo), Peter Collins (University of Cambridge, Addenbrooks Hospital, Cambridge), Roberto Salgado (Institute Jules Bordet, Brussels), Manfred Schmitt (Frauenklinik MRI TU München, Munich), Fatima Carneiro (Serviço de Anatomia Patológica do H.S. João, Porto), Dominic Allen (Integrated Biobank of Luxemburg, Luxemburg), Signe Mezinska (University of Latvia), Aime Keis (University of Tartu). For valuable comments and suggestions we would also like to thank Jacqueline Hall (EORTC).

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Correspondence to Serepkaite Jurate.

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Jurate, S., Zivile, V. & Eugenijus, G. ‚Mirroring‘ the Ethics of Biobanking: What Analysis of Consent Documents Can Tell Us?. Sci Eng Ethics 20, 1079–1093 (2014). https://doi.org/10.1007/s11948-013-9481-0

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  • DOI: https://doi.org/10.1007/s11948-013-9481-0

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