There has been extensive discussion in research ethics literature surrounding the appropriate form of informed consent for biobanking, whether with adapted content, or adapted forms such as broad or tiered consent. These discussions presuppose that it is possible to disclose adequate information at the outset to facilitate an informed choice to donate to a biobank. I will argue that informed consent cannot be achieved because in the biobanking context, we are either consenting to an enterprise that is not research or (...) to future research. Nor is the solution to abandon the idea that informed consent ethically requires the disclosure of a certain minimal amount of information to make an informed choice by misleadingly identifying broad, blanket or even tiered consent as forms of ‘informed’ consent. Rather, we should abandon the idea that informed consent for research can be adapted to the type of endeavor that biobanking is, and understand the goal as to develop alternatives not as alternative forms of informed consent, but rather alternatives to informed consent. (shrink)

An ‘Information Centre’ has recently been established by law which has the power to collect, collate and provide access to the medical information forall patients treated by the National Health Service in England, whether in hospitals or by General Practitioners. This so-called ‘care.data’ scheme has given rise to major and ongoing controversies. We will sketch the background of the scheme and look at the responses it has elicited from citizens and medical professionals. In Autumn 2013, NHS England set up a (...) care.data website where citizens could record their concerns regarding the collection of health-related data by the Information Centre. We have reviewed all the comments on this website up until June 2015. We have also analysed the readers’ comments on the coverage of the care.data scheme in one of the main national UK newspapers. When discussing the responses of citizens, we will make a distinction between the problems that citizens detect and the solutions they propose. The solutions that are being perceived as the most relevant ones can be summarized as follows: citizens wish to further the common good without being manipulated into doing it, while at the same time being safeguarded against various abuses. The issue of trust turns out to figure prominently. Our analysis of reactions to the scheme in no way pretends to be exhaustive, yet it provides various relevant insights into the concerns identified by citizens as well as medical professionals. These concerns, moreover, have a more general relevance in relation to other contexts of medical data-mining as well as biobank research. Our analysis also offers important pointers as to how those concerns might be addressed. (shrink)

The UK Chief Medical Officer’s 2016 Annual Report, Generation Genome, focused on a vision to fully integrate genomics into all aspects of the UK’s National Health Service. This process of integration, which has now already begun, raises a wide range of social and ethical concerns, many of which were discussed in the final Chapter of the report. This paper explores how the UK’s 100,000 Genomes Project —the catalyst for Generation Genome, and for bringing genomics into the NHS—is negotiating these ethical (...) concerns. The UK’s 100 kGP, promoted and delivered by Genomics England Limited, is an innovative venture aiming to sequence 100,000 genomes from NHS patients who have a rare disease, cancer, or an infectious disease. GEL has emphasised the importance of ethical governance and decision-making. However, some sociological critique argues that biomedical/technological organisations presenting themselves as ‘ethical’ entities do not necessarily reflect a space within which moral thinking occurs. Rather, the ‘ethical work’ conducted by organisations is more strategic, relating to the politics of the organisation and the need to build public confidence. We set out to explore whether GEL’s ethical framework was reflective of this critique, and what this tells us more broadly about how genomics is being integrated into the NHS in response to the ethical and social concerns raised in Generation Genome. We do this by drawing on a series of 20 interviews with individuals associated with or working at GEL. (shrink)

This paper proposes a refocusing of consent for clinical genetic testing, moving away from an emphasis on autonomy and information provision, towards an emphasis on the virtues of healthcare professionals seeking consent, and the relationships they construct with their patients. We draw on focus groups with UK healthcare professionals working in the field of clinical genetics, as well as in-depth interviews with patients who have sought genetic testing in the UK’s National Health Service. We explore two aspects of consent: first, (...) how healthcare professionals consider the act of ‘consenting’ patients; and second how these professional accounts, along with the accounts of patients, deepen our understanding of the consent process. Our findings suggest that while healthcare professionals working in genetic medicine put much effort into ensuring patients’ understanding about their impending genetic test, they acknowledge, and we show, that patients can still leave genetic consultations relatively uninformed. Moreover, we show how placing emphasis on the informational aspect of genetic testing is not always reflective of, or valuable to, patients’ decision-making. Rather, decision-making is socially contextualised – also based on factors outside of information provision. A more collaborative on-going consent process, grounded in virtue ethics and values of honesty, openness and trustworthiness, is proposed. (shrink)

Objectives: To study the consent process experienced by participants who are enrolled in a molecular genetic research study that aims to find new genetic mutations responsible for an apparently inherited disorder.Design: Semi-structured interviews and analysis/description of main themes.Participants: 78 members of 52 families who had been recruited to a molecular genetic study.Results: People were well informed about the goals, risks and benefits of the genetic research study but could not remember the consent process. They had mostly been recruited to take (...) part by trusted clinicians or their relatives but had little memory of, or concern about signing consent forms. Families appeared to regard the research as a continuation of their, or their relatives’, clinical care.Conclusions: Ethical review should be more flexible in its attitude to consent forms and written information sheets for some sorts of research. For rare genetic disease studies where research has been discussed fully within the clinical setting then the consent obtained at that time could suffice rather than needing extra consent at a later stage. However, clinician-researchers will need to ensure that their duty of care extends for the duration of the research and beyond. (shrink)

Calls are increasing for American health care to be organized as a learning health care system, defined by the Institute of Medicine as a health care system “in which knowledge generation is so embedded into the core of the practice of medicine that it is a natural outgrowth and product of the healthcare delivery process and leads to continual improvement in care.” We applaud this conception, and in this paper, we put forward a new ethics framework for it. No such (...) framework has previously been articulated. The goals of our framework are twofold: to support the transformation to a learning health care system and to help ensure that learning activities carried out within such a system are conducted in an ethically acceptable fashion. (shrink)

Design: Qualitative interview study. Participants: Fifty-nine patients with a family history of cancer who attend a regional cancer genetics clinic in the UK were interviewed about their current and previous research experiences. Findings: Interviewees gave a range of explanations for research participation. These were categorised as social—research participation benefits the wider society by progressing science and improving treatment for everyone; familial—research participation may improve healthcare and benefit current or future generations of the participant’s family; and personal—research participation provides therapeutic or (...) non-therapeutic benefits for oneself. Conclusions: We discuss the distinction drawn between motives for research participation focused upon self and others, and observe that personal, social and familial motives can be seen as interdependent. For example, research participation that is undertaken to benefit others, particularly relatives, may also offer a number of personal benefits for self, such as enabling participants to feel that they have discharged their social or familial obligations. We argue for the need to move away from simple, static, individualised notions of research participation to a more complex, dynamic and inherently social account. (shrink)

Calls are increasing for American health care to be organized as a learning health care system, defined by the Institute of Medicine as a health care system “in which knowledge generation is so embedded into the core of the practice of medicine that it is a natural outgrowth and product of the healthcare delivery process and leads to continual improvement in care.” We applaud this conception, and in this paper, we put forward a new ethics framework for it. No such (...) framework has previously been articulated. The goals of our framework are twofold: to support the transformation to a learning health care system and to help ensure that learning activities carried out within such a system are conducted in an ethically acceptable fashion. (shrink)

This paper reports from an ongoing multidisciplinary, ethnographic study that is exploring the views, values and practices (the ethical frameworks) drawn on by professional staff in assisted conception units and stem cell laboratories in relation to embryo donation for research purposes, particularly human embryonic stem cell (hESC) research, in the UK. We focus here on the connection between possible incidental findings and the circumstances in which embryos are donated for hESC research, and report some of the uncertainties and dilemmas of (...) our staff participants. We explore the views of our study participants in relation to two themes: (1) rights to information and anticipating how donors might be informed about future research findings and (2) occupational work goals and trust. (shrink)

Donors to biobanks are typically asked to give blanket consent, allowing their donation to be used in any research authorized by the biobank. This type of consent ignores the evidence that some donors have moral, religious, or cultural concerns about the future uses of their donations – concerns we call “non-welfare interests”. The nature of non-welfare interests and their effect on willingness to donate to a biobank is not well understood. In order to better undersand the influence of non-welfare interests, (...) we surveyed a national sample of the US population using a probability-based internet panel. Logistic regression models assessed the demographic and attitudinal characteristics associated with participants’ willingness to give consent for unspecified future uses of their donation when presented with 7 research scenarios that raised possible non-welfare interest concerns. Most people had non-welfare interests that significantly affect their willingness to donate to a biobank using blanket consent. Some non-welfare interests are associated with subgroups but others are not. A positive attitude toward biomedical research in general was associated with increased willingness to donate, while concerns about privacy and being African American were associated with decreased willingness. Non-welfare interests matter and can diminish willingness to donate to a biobank. Our data suggest that trust in research promotes willingness to donate. Ignoring non-welfare interests could erode this trust. Donors’ non-welfare interests could be accommodated through greater transparency and easier access to information about the uses of donations. (shrink)