Finland has aimed to make itself an international leader in genomic research and related business and, in working towards that goal, has enacted biobank legislation. The Biobank Act requires biobanks to gain approval, be supervised, and register at the national level. Numerous other laws may also apply in any given research setting, such as the Personal Data Act, the Medical Research Act, and the Act on Medical Use of Human Organs and Tissues. In terms of privacy protection, anonymization is generally (...) not permitted under Finnish law and therefore most biobanks pseudonomize data and samples. However, the broad understanding of what is identifiable data in Finland has created difficulties in sharing with non-EU countries. Furthermore, consent to biobank research is only applicable to the sample and related data, not to data stored in other health-related registries, and consent is only to the field of research for that particular biobank. These restrictions impede the sharing of samples and data for research. (shrink)

Biobanks that are run on an opt-in basis depend on people having the motivation to give and to trust in those who control their samples. Yet in the UK trust in the healthcare system has been in decline and there have been a number of health-related scandals that have received widespread media and public attention. Given this background, and the previous public consultations on UK Biobank, the paper explores the way people express their trust and mistrust in the area of (...) medical and genetic information through discussions in six focus groups held in different areas of Britain. The themes that emerged in the discussion were the special character of genetic data; the ease with which information spreads; the public/private divide in genetic research; the potential of genetic information to harm people; choice, consent and lack of control; and the difficulty of establishing trustworthy governing arrangements. The expert agenda of policy-makers and medical ethics does not address the broader concerns expressed by participants. It seems that public consultation and the language of openness and transparency may not be sufficient to establish trust in the governance of genetic databases. Donors will be asked to give freely without any return but the participants' perception of those using the samples is that they are motivated by success and profit rather than healthcare priorities. In this context altruism seems naive and even dangerous. In order to place their trust well people need evidence of a relationship with obligations and expectations on both sides. (shrink)

The term research subject has traditionally been the preferred term in professional guidelines and academic literature to describe a patient or an individual taking part in biomedical research. In recent years, however, there has been a steady shift away from the use of the term 'research subject' in favour of 'research participant' when referring to individuals who take part by providing data to various kinds of biomedical and epidemiological research. This article critically examines this shift, reflecting on the different meanings (...) evoked by the terms 'subject' and 'participant', as well as examining recent examples of patient activism in research. It concludes by suggesting that the wholesale unreflective adoption of the term 'participant' is inappropriate and provides instead a guide on how to determine the circumstances in which the terms subject, participant and activist should legitimately be used. (shrink)

Modern biobanks typically rely on the public to freely donate genetic data, undergo physical measurements and tests, allow access to medical records and give other personal information by questionnaire or interview. Given the demands on participants it is not surprising that there has been extensive public consultation even before biobanks in the UK and elsewhere began to recruit. This paper considers the different ways in which biobanks have attempted to engage and appeal to their publics and the reaction of potential (...) and actual donors. Whilst those organising biobanks presumably want to be as close to their publics as they need to be in order to successfully recruit and sustain participation in sufficient numbers, the closer the relationship the more obligations and expectations there are on both sides. (shrink)

This article poses the question of whether biobanking practices and standards are giving rise to the construction of populations from which various biobanking initiatives increasingly draw on for legitimacy? We argue that although recent biobanking policies encourage various forms of engagement with publics to ensure legitimacy, different biobanks conceptualize their engagement strategies very differently. We suggest that biobanks undertake a broad range of different strategies with regard to engagement. We argue that these different approaches to engagement strategies are contributing to (...) the construction of populations, whereby specific nationalities, communities, societies, patient groups and political systems become imbued or bio-objectified with particular characteristics, such as compliant, distant, positive, commercialized or authoritarian. This bio-objectification process is problematic in relation to policy aspirations ascribed to biobanking engagement since it gives rise to reified notions of different populations. (shrink)