Volume 6, Issue 1 - ELSI in Biobanks - Guest editors: C. Corradetti and D. Mascalzoni

On 12 March 2009 Time dedicated an entire issue indicating the top ten world-changing ideas for the next future and among these a special attention was dedicated to biobanks. The article asks a very important and challenging question: are there benefits that can be reasonably expected from very costly biomaterial storage and — if yes — which kind of benefits are these? What is insisted upon is the identification of the following burning ethical issue: privacy and security of data.The need of deepening these social and ethical aspects related to the biobank enterprise lead to the organization of the conference on “patientcentricity”. The conference took place in Rome on 28-29 September 2011 and it was organized by the Center of Biomedicine of the European Academy of Bolzano thanks to the financial support of the Italian Ministry of University and Research.This special issue introduces that conference, and this editorial introduces our motivations for this work.The wish and hope of the guest editors is that such discussions will contribute to opening new research and policy agendas by addressing new challenges and helping out in thinking new solutions.

«The voluntary consent of the human subject is absolutely necessary». The first sentence of the Nuremberg Code still builds the fundamental bulwark of the Ethics of Biomedical Research. Nonetheless, later declarations, codes and guidelines have deepened and widened this imperative of respect for autonomy and self-determination, either pointing at the conditions required for an actually free and informed consent or linking it to the more comprehensive scope of human rights. This short paper explores these concepts.

The involvement of the public in the governance of genomics has become a topic of growing interest among scholars, practitioners and policy-makers. The implementation of public involvement programmes may be expensive, and the design and evaluation of public participation is a matter of controversy. Thus, this paper examines the justifications for public participation in the governance of genomics to help understand whether public involvement is worthwhile and to provide a guide to the design of public participation.I identify four primary justifications in support of public involvement. I argue that three of them have serious flaws: neither an increase in the stability of institutions, nor the positive effects on individual virtues, nor the epistemic merits of participatory activities provide a solid ground for the engagement of the public in the governance of genomics. However, the ideal of legitimacy in the exercise of coercive power appears to lend strong support to public involvement programmes. Given that the reasons why public involvement is sought shape the design of the participatory activities, restricting the range of valid justifications promises to simplify the task of designing and evaluating public involvement.

Collection, storage, and use of biological specimens and clinical data is a historically contentious practice, especially among certain populations. It is therefore believed that public perceptions and opinions should be considered in the exploration of ethical issues associated with biobanking. It is hoped that this research will both help to illuminate the nature and depth of the social issues and inform the development of policy responses. We collected original research articles that dealt with public perceptions of biobanking initiatives, including both quantitative and qualitative findings. The intent was to elucidate public opinion on persistent key issues, including willingness to participate, consent, incidental findings and return of results, privacy, withdrawal, and ownership and control of provided material. While a wide range of issues and perspectives were explored in the research articles, the focus of this review is on the above list of key issues. With few exceptions (e.g., return of results and withdrawal), what is disclosed by this review of survey work is a lack of consensus on key issues, especially in the context of the nature of consent required.

There is an international discussion to transform the collection of dried blood spot (DBS) card collections resulting from neonatal public health screening programs into a kind of biobank through the formalization of their (prolonged) retention and by expanding their use in medical research and development (R&D) practices. Given the scale of neonatal heel prick screening, these blood samples are increasingly being considered as a wealth of biological data for medical R&D. Due to the fact that donors are newborns and that the primary purpose of DBS is health care, the card collection is not a conventional biobank. However, it may be treated as such if there could be societal support and if a management body could be developed to deal with prolonged retention and use policies. One strategy to gain support for biomedical research is to involve citizens, donors, patients and their representatives and advocates at various stages and levels of the R&D process. This article explores the feasibility of existing notions of patient participation in the governance of medical R&D (in particular biobanking) in relation to the possible transformation of the Dutch DBS collection into a more formal biobank. In doing so we describe some of the current challenges of using of DBS cards for medical R&D, and explore what role patients have played in research processes in general and specifically in biobanking as well as the management of DBS collections. We focus on the current management structure of the Dutch DBS collection, and explore what role for patients and publics is needed to address the current proposal for changes to their storage, management, and use. We conclude by exploring a model of ‘adaptive governance’ in which a Participant Association is created to elect a Participant Board to operate alongside and within the biobank’s management structure (O’Doherty et al. 2011), which could work to increase transparency and trust of R&D decisions on DBS collection. This would neither preclude patient involvement, nor positions such involvement as a kind of panoptic answer to challenges in governance.

Large-scale biobanking, or what Camben-Thomsen (2003) calls – ‘Biobank-omics’, has become a marked trend within the biomedical field. Biobanks have achieved great popularity within epidemiological studies, due to their temporal framework, which is longitudinal and prospective in nature. The purpose of this is to examine gene-disease correlations with the environment, through the inspection of medical and lifestyle information with biological data. However, the inclusion of children within epidemiological studies has raised, Ethical, Legal and Social Issues (ELSI), particularly concerning their competency to consent to participation. This article explores such issues when viewed from the perspective of children, whilst drawing attention to the social constructiveness of concepts central to the child’s decisional power.