TRUSTED CONSENT AND RESEARCH BIOBANKS: TOWARDS A ‘NEW ALLIANCE’ BETWEEN RESEARCHERS AND DONORS GIOVANNI BONIOLO, PIER PAOLO DI FIORE AND SALVATORE PECE Keywords biobank, consent, trust, new alliance ABSTRACT We argue that, in the case of research biobanks, there is a need to replace the currently used informed consent with trusted consent. Accordingly, we introduce a proposal for the structure of the latter. Further, we discuss some of the issues that can be addressed effectively through our proposal. In particular, we illustrate: i) which research should be authorized by donors; ii) how to regulate access to information; iii) the fundamental role played by a Third Party Authority in assuring compliance with the reciprocal expec- tations and obligations of donors and scientists. Finally, we briefly analyse two issues that might represent important elements of a ‘new alliance’ between researchers and donors to which the trusted consent could pave the way: i) the correlations between needs and rights of the two parties, and ii) possible economic transactions. INTRODUCTION The increasing number of publications reporting advances in post-genomics and biobanking has been par- alleled, over the past few years, by an increasing number of studies dealing with the numerous related ethical aspects. 1 The ensuing debate has highlighted several of the problems to be faced, and has addressed topics (such as consent, withdrawal and privacy) common to the dif- ferent types of biorepositories for human samples. There are, however, specificities that apply to different types of biobanks and in this paper we will explore the issue of consent in a specific setting, i.e. that of a research biobank. We intend, by this term, a repository of human biospecimens collected for basic science and clinical research, rather than for the purpose of transplant or for use as medical material. 2 We believe that this particular type of biorepository is associated with specificities that justify a dedicated analysis of the problem of consent. There is a point that deserves a short remark. Scientific progress is regarded as inevitable; however, less consid- eration is given to the idea of parallel progress in the ethical analysis of scientific progress. Others have already discussed this point, 3 but its importance is such that we feel it necessary to re-emphasize it. New frontiers in the field of post-genomic biomedicine require a specific ethical analysis and present a unique opportunity to rethink ethical categories and approaches. It is with this idea in mind that we propose a new view of consent. We will argue that, at least for research biobanks, traditional informed consent is unsuitable and we should adopt what we have named trusted consent, which implies a higher order of ethical mediation among: 1) the autonomy of donors; 2) the competence, expertise and moral integrity of scientists; and 3) the biobank governance. We will discuss the structure of trusted consent and examine how it forces us to rethink: i) what should be authorized; ii) how to deal with access to present and future informa- tion; iii) the fundamental role played by a Third Party Authority in assuring that donors and scientists comply with their reciprocal expectations and obligations. 1 A. Cambon-Thomsen. The Social and Ethical Issues of Post-Genomic Human Biobanks. Nat Rev Genet 2004; 5: 866–873; A. Cambon- Thomsen, E. Rial-Sebbag & B.M. Knoppers. Trends in Ethical and Legal Framework for the Use of Human Biobanks. Eur Respir J 2007; 3: 373–382; E. Salvaterra, L. Lecchi, S. Giovanelli et al. Banking Together. A Unified Model of Informed Consent for Biobanking. EMBO Rep 2008; 9: 307–313. 2 The definition that we propose is taken, with slight modifications, from that indicated in www.biobankcentral.org, a portal to connect all the constituencies in the biobank community. 3 B.M. Knoppers & R.K. Chadwick. Human Genetic Research: Emerging Trends in Ethics. Nat Rev Genet 2005; 6: 75–79. Address for correspondence: Prof. Giovanni Boniolo, IFOM, Via Adamello, 16 Milano 20139, Italy. Email: giovanni.boniolo@ifom-ieo-campus.it Bioethics ISSN 0269-9702 (print); 1467-8519 (online) doi:10.1111/j.1467-8519.2010.01823.x Volume 26 Number 2 2012 pp 93–100 © 2010 Blackwell Publishing Ltd., 9600 Garsington Road, Oxford OX4 2DQ, UK and 350 Main Street, Malden, MA 02148, USA.