'Dirty pigs' and the xenotransplantation paradox.

For almost the last 300 years human beings have sought to use organs from non-human animals to repair or replace their own failing organs. This procedure of intraspecies transplant is called xenotransplantation, and despite the continued attempts by researchers, it is yet to be successful. Experiments in xenotransplantation persist, however, partly based on the perceived biological similarities that exist between humans and non-human animals despite the success of xenotransplantation being hampered by the ability of the human body's immune system to attack and therefore reject foreign material. In this article, I explore the sociocultural reactions to xenotransplantation which demonstrates that it is based on a paradox; although non-human animals and humans are thought to be biologically compatible or similar, many assume and emphasise just how different we are from non-human animals. These two positions of 'same but different' are arguably incompatible. I begin by reviewing social science research that demonstrates, despite some variation, a range of persistent concerns towards xenotransplantation including the consequences for personal identity should a person receive a non-human animal organ. I add to this body of work, findings from a mixed-method study involving focus groups and a representative survey with young adults to show that most people prefer to have their organs replaced by materials from their own body and non-human animals the least. These reactions sit within a broader context of a 'wisdom of repugnance' that is brought into existence when our classifications of what is thought to be natural or not is threatened.

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.

Biomedicine, self and society: An agenda for collaboration and engagement.

The commitment of massive resources - financial, social, organisational, and human - drives developments in biomedicine. Fundamental transformations in the generation and application of knowledge are challenging our understandings and experiences of health, illness, and disease as well as the organisation of research and care. Coupled with the accelerated pace of change, it is pressing that we build authentic collaborations across and between the biomedical sciences, humanities and social sciences, and wider society. It is only in this way that we can ask and answer the penetrating questions that will shape improvements in human health now and in the decades ahead. We delineate the need for such commitments across five key areas of human and societal experience that impact on and are impacted by developments in biomedicine: disease; bodies; global movements and institutions; law; and, science-society engagements. Interactions between ideas, researchers, and communities across and within these domains can provide a way into creating the new knowledges, methods, and partnerships we believe are essential if the promises of biomedicine are to be realised.

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.

Horizon scanning implanted biosensors in personalising breast cancer management: First pilot study of breast cancer patients views.

AIMS: This study aimed to explore breast cancer patients' understanding and acceptability of implanted biosensors (BS) within the primary tumour to personalise adjuvant radiotherapy, and to determine optimal design and number of BS, and evaluate potential clinical benefits as well as concerns about tolerance, toxicity, dwell time, and confidentiality of data. PATIENTS AND METHODS: A total of 32 patients treated by surgery (29 breast conserving, 3 mastectomy), postoperative radiotherapy and systemic therapy for early breast cancer, were recruited from a posttreatment radiotherapy clinic at a cancer centre. Patients participated in semistructured interviews. Interview transcripts were analysed using qualitative methods. RESULTS: Participants were aged 39 to 87 years, with a median age of 62 years. Most (N = 23[72%]) were unfamiliar with biosensors. The majority (N = 29[90.6%]) were supportive of the technology's potential use in future breast cancer treatment and were willing to accept biosensors (N = 28[88%]) if they were endorsed by their breast cancer consultant. Only 3 patients expressed concerns, predominantly about uncertainties on their role in the diagnostic and treatment pathway. Patients were flexible about the size and shape of BS, but had a preference for small size (N = 28 [87.5%]). Most (N = 22[69%]) would accept implantation of more than 5 BS and were flexible (N = 22[69%]) about indefinite dwell time. Patients had a strong preference for wireless powering of the BS (N = 28[87.5%]). Few had concerns about loss of confidentiality of data collected. All patients considered biosensors to be potentially of important clinical benefit. CONCLUSIONS: While knowledge of biosensors was limited, patients were generally supportive of biosensors implanted within the primary tumour to collect data that might personalise and improve breast cancer radiotherapy in future.

Stakeholder perspectives on new ways of delivering unscheduled health care: the role of ownership and organizational identity.

RATIONALE, AIMS AND OBJECTIVES: To explore stakeholder perspectives of the implementation of a new, national integrated nurse-led telephone advice and consultation service [National Health Service 24 (NHS 24)], comparing the views of stakeholders from different health care organizations. METHODS: Semi-structured interviews with 26 stakeholders including partner organizations located in primary and secondary unscheduled care settings [general practitioner (GP) out-of-hours cooperative; accident and emergency department; national ambulance service, members of NHS 24 and national policy makers. Attendance at key meetings, documentary review and email implementation diaries provided a contextual history of events with which interview data could be compared. RESULTS: The contextual history of events highlighted a fast-paced implementation process, with little time for reflection. Key areas of partner concern were increasing workload, the clinical safety of nurse triage and the lack of communication across the organizations. Concerns were most apparent within the GP out-of-hours cooperative, leading to calls for the dissolution of the partnership. Accident and emergency and ambulance service responses were more conciliatory, suggesting that such problems were to be expected within the developmental phase of a new organization. Further exploration of these responses highlighted the sense of ownership within the GP cooperative, with GPs having both financial and philosophical ownership of the cooperative. This was not apparent within the other two partner organizations, in particular the ambulance service, which operated on a regional model very similar to that of NHS 24. CONCLUSIONS: As the delivery of unscheduled primary health care crosses professional boundaries and locations, different organizations and professional groups must develop new ways of partnership working, developing trust and confidence in each other. The results of this study highlight, for the first time, the key importance of understanding the professional ownership and identity of individual organizations, in order to facilitate the most effective mechanisms to enable that partnership working.

Cyborgs in the Everyday: Masculinity and Biosensing Prostate Cancer.

An in vivo biosensor is a technology in development that will assess the biological activity of cancers to individualise external beam radiotherapy. Inserting such technology into the human body creates cybernetic organisms; a cyborg that is a human-machine hybrid. There is a gap in knowledge relating to patient willingness to allow automated technology to be embedded and to become cyborg. There is little agreement around what makes a cyborg and less understanding of the variation in the cyborgisation process. Understanding the viewpoint of possible beneficiaries addresses such gaps. There are currently three versions of 'cyborg' in the literature (i) a critical feminist STS concept to destabilise power inherent in dualisms, (ii) an extreme version of the human/machine in science-fiction that emphasises the 'man' in human and (iii) a prediction of internal physiological adaptation required for future space exploration. Interview study findings with 12 men in remission from prostate cancer show a fourth version can be used to describe current and future sub-groups of the population; 'everyday cyborgs'. For the everyday cyborg the masculine cyborg status found in the fictionalised human-machine related to issues of control of the cancer. This was preferred to the felt stigmatisation of being a 'leaker and bleeder'. The willingness to become cyborg was matched with a having to get used to the everyday cyborg's technological adaptations and risks. It is crucial to explore the everyday cyborg's sometimes ambivalent viewpoint. The everyday cyborg thus adds the dimension of participant voice currently missing in existing cyborg literatures and imaginations.

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

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.

'Nothing is really safe': a focus group study on the processes of anonymizing and sharing of health data for research purposes.

RATIONALE AND OBJECTIVES: The availability of anonymized data is a keystone of medical research, yet little is known about lay views towards the process of anonymization or on the way that anonymized medical data are transferred to researchers. METHODS: During May and June 2009, as part of a wider consultation on methods for releasing data to researchers, three focus groups (n = 19) were conducted exploring lay attitudes towards the traditional 'warehouse' model commonly used in medical research for delivering anonymized National Health Service (NHS) data to researchers. The focus groups explored different processes such as the copying of data, use of programmers for linkage and anonymization, the transfer of data and governance. RESULTS: The recognition of the positive aspects of medical research and desire to support it formed the context for discussions. Nonetheless, individuals varied in their attitudes to the use of anonymized data extracts for research from their health records (without consent); although some appeared positive wanted to be asked to consent for this use. Furthermore, participants were acutely aware of security breaches of NHS information nevertheless, they continued to display a high level of trust in NHS staff. Participants were concerned about the practicalities of the warehouse model and relied on their own life experiences to make sense of the model (using analogies with 'banks' or 'libraries'). The general attitude towards the processes underlying the warehouse model might best be captured by the term 'ambivalence'. CONCLUSIONS: This research (1) offers unique insights into views of anonymization of health data extracts, how it is undertaken and data are transferred and (2) adds to an increasing body of work that demonstrates that a minority of individuals are concerned about consent, even when data are anonymized although (3) those concerned about anonymization do not necessarily seek resolution through gaining consent.