Gill Haddow

“Because you’re worth it?” The taking and selling of transplantable organs

In the UK, the legal processes underpinning the procurement system for cadaveric organs for transplantation and research after death are under review. The review originated after media reports of hospitals, such as Alder Hey and Bristol, retaining organs after death without the full, informed consent of relatives. The organ procurement systems for research and transplantation are separate and distinct, but given that legal change will be applicable to both, some have argued now is the time to introduce alternative organ transplant procurement systems such as presumed consent or incentive based schemes (despite inconclusive British and American research on the status of public attitudes). Findings are reported in this paper from qualitative and quantitative research undertaken in Scotland in order to ascertain the public acceptability of different procurement systems. Nineteen in depth interviews carried out with donor families about their experiences of donating the organs of the deceased covered their views of organ retention, presumed consent, and financial incentives. This led onto a representative interview survey of 1009 members of the Scottish public. The originality of the triangulated qualitative and quantitative study offers exploration of alternative organ procurement systems from different “sides of the fence”. The findings suggest that the legal changes taking place are appropriate in clarifying the role of the family but can go further in strengthening the choice of the individual to donate.

Promoting research participation : Why not advertise altruism?

Participation rates have a major impact on the quality, cost and timeliness of health research. There is growing evidence that participation rates may be falling and that new research governance structures and procedures may be increasing the likelihood of recruitment bias. It may be possible to encourage public reflection about research participation and enhance recruitment by providing information about the potential benefits of research to others as well as to research participants and by stimulating debate and influencing social expectations about involvement. Publicly funded and charitable bodies use various forms of advertising to encourage altruistic behaviour and generate social expectations about donating money, blood and organs for the benefit of others. Consideration should be given to the use of similar persuasive communications to promote wider participation in health research generally.

Generation Scotland: consulting publics and specialists at an early stage in a genetic database's development

A preliminary consultation about Scotlands first family-based, population DNA database (Generation Scotland) involved 10 focus groups with diverse publics and a series of 17 interviews with key stakeholders in various locations in Scotland throughout 2003/2004. Unlike similar consultations on genetic databases, this took place at the concept phase of the proposed genetic research. We report on the specific concerns that arose around participation, access, use, feedback and public consultation. Broadly, we find differences between specialists and focus groups are mostly of degree and not of kind, although the specialists were more confident in some areas (e.g. governance). Given the salient and recurring nature of these issues when compared with the UK Biobank consultations, for example, we suggest that the efforts to consult have not been matched with equal effort on policy or institutional response. So, following from this, we offer compelling reasons for introducing more robust legislation and regulation.

Not “human” enough to be human but not “animal” enough to be animal – the case of the HFEA, cybrids and xenotransplantation in the UK

Innovations in scientific and medical technologies, such as xenotransplantation and admixed embryos, invariably become the target of regulatory agencies and often demand new regulatory frameworks. In making decisions associated with these innovations, it is sometimes necessary for regulators to adopt certain positions about the status and significance of the human–animal embryo or body. In the UK, the regulatory and advisory bodies involved in the sphere of human/non-human transfer and exchange of material are: (1) the Human Fertilisation and Embryology Authority (HFEA); (2) the (defunct) UK Xenotransplantation Interm Regulatory Authority; and (3) the Home Offices Animal Procedures Committee (APC). In this article, we critically examine the reasons for the HFEAs involvement in regulating and advising in research which uses admixed embryos, given that the HFEAs remit is the governments fertility watchdog regulating in the area of human embryos. This expansion, we argue, was partly due to pressure from pro-cybrid supporters and the need to fill an institutional void left by the decommissioning of UKXIRA. Ironically, specific institutions such as UKXIRA may have been better placed to deal with animal–human fusions.

Can the governance of a population genetic data bank effect recruitment? Evidence from the public consultation of Generation Scotland

Our objective was to identify an acceptable governance model for population genetic data banks through measuring the importance of different ethical and social concerns and their relationship to reported likelihood to participate. We conducted a face-to-face interview survey of 1,001 members of the general adult Scottish population who were 16 and over, and included a discrete choice experiment. The results showed a quarter of respondents said that they were certain or very likely to take part in genetic database research. However, reported willingness to participate seemed to be unaffected by further information or governance options. We conclude participation is driven by personal and mundane, everyday factors rather than concerns about governance. However, this should not be seen as a reason to relax the transparent and robust governance frameworks currently under development.

3D bioprint me : a socioethical view of bioprinting human organs and tissues

In this article, we review the extant social science and ethical literature on three-dimensional (3D) bioprinting. 3D bioprinting has the potential to be a ‘game-changer’, printing human organs on demand, no longer necessitating the need for living or deceased human donation or animal transplantation. Although the technology is not yet at the level required to bioprint an entire organ, 3D bioprinting may have a variety of other mid-term and short-term benefits that also have positive ethical consequences, for example, creating alternatives to animal testing, filling a therapeutic need for minors and avoiding species boundary crossing. Despite a lack of current socioethical engagement with the consequences of the technology, we outline what we see as some preliminary practical, ethical and regulatory issues that need tackling. These relate to managing public expectations and the continuing reliance on technoscientific solutions to diseases that affect high-income countries. Avoiding prescribing a course of action for the way forward in terms of research agendas, we do briefly outline one possible ethical framework ‘Responsible Research Innovation’ as an oversight model should 3D bioprinting promises are ever realised. 3D bioprinting has a lot to offer in the course of time should it move beyond a conceptual therapy, but is an area that requires ethical oversight and regulation and debate, in the here and now. The purpose of this article is to begin that discussion.

Implantable Smart Technologies (IST): Defining the ‘Sting’ in Data and Device

In a world surrounded by smart objects from sensors to automated medical devices, the ubiquity of ‘smart’ seems matched only by its lack of clarity. In this article, we use our discussions with expert stakeholders working in areas of implantable medical devices such as cochlear implants, implantable cardiac defibrillators, deep brain stimulators and in vivo biosensors to interrogate the difference facets of smart in ‘implantable smart technologies’, considering also whether regulation needs to respond to the autonomy that such artefacts carry within them. We discover that when smart technology is deconstructed it is a slippery and multi-layered concept. A device’s ability to sense and transmit data and automate medicine can be associated with the ‘sting’ of autonomy being disassociated from human control as well as affecting individual, group, and social environments.

New risks inadequately managed: The case of smart implants and medical device regulation

ABSTRACT Many emerging technologies are associated with ‘risk’. While the concept of risk is protean, it is usually conceived of as the potential of something damaging or harmful happening. Thus, risks are a primary target of many regulatory regimes. In this article, after articulating an understanding of risk, we assess the European medical devices regulatory regime from a risk perspective, focusing on its handling of ‘smart’ implantable medical devices. In doing so, we discuss the empirical evidence obtained from expert participants in the Implantable Smart Technologies Project, which evidence is framed around three risk typologies: materiality, geography and modality. We conclude that none of these risks are sufficiently addressed within the existing regime, which falls down not just from a standards perspective, but also from the perspective of transparency and balance.

Banking (on) the Brain: The Neurological in Culture, Law and Science

During the last 50 years, an increasing range of human material has been ‘biobanked’, including blood spots, tissue, and DNA. More recently, the phenomenon of ‘brain banking’ (BBing) – the collection and storage of post-mortem brain tissue to create a research resource for investigation into neurological (especially neurodegenerative) disorders such as Alzheimer’s disease and dementia – has become de rigueur. This is at a time when social and policy concerns abound regarding the problems of an ‘ageing population’. Indeed, the desire to understand and act upon the brain – an object of increasing ‘salience’ and ‘biovalue’ – drives much technoscientific and biomedical innovation, including developments such as brain imaging, scanning, and surgery. Brain research, however, raises a number of concerns which vex not only regulators but also scientists and health-care professionals who are involved in BBing. Key issues include (but are not limited to):