1,721,034 research outputs found
Expert report to the infected blood inquiry: Medical ethics
No full textThis report has been written by a medical ethics expert group appointed by Sir Brian Langstaff in 2019 on behalf of the Infected Blood Inquiry (‘the Inquiry’). In the Letter of Instruction from the Inquiry, we were asked to respond to a series of specific questions grouped into six sections, together with supplemental questions added at a later date. This report is organised into those six sections and we respond to each of the questions, numbered as per the letters of instruction. Our report discusses the ethical principles that should govern and inform clinical decisionmaking. We are instructed to express our opinion on the matters set out from today’s perspective and, where we identify changes or developments, to make reference to them. With regard to legal variations between the devolved administrations, we focus on English law simply because that corresponds to our expertise. With regard to terminology, we use ‘child’ as a shorthand for any person under the age of 18 and ‘doctor’/‘clinician’ as a shorthand for healthcare professional. Anyone reading the report from start to finish will notice a degree of repetition. Having tested for consistency, we felt it was important to answer each question as fully as necessary, even where similar points were being made. In some cases, we have cross referenced between questions to indicate the relevance of material covered in more detail elsewhere in the report
Towards a national genomics medicine service: the challenges facing clinical-research hybrid practices and the case of the 100,000 genomes project
No full textClinical practice and research are governed by distinct rules and regulations and have different approaches to, for example, consent and providing results. However, genomics is an example of where research and clinical practice have become co-dependent. The 100,000 genomes project (100kGP) is a hybrid venture where a person can obtain a clinical investigation only if they agree to also participate in ongoing research—including research by industry and commercial companies. In this paper, which draws on 20 interviews with professional stakeholders involved in 100kGP, we investigate the ethical issues raised by this project’s hybrid nature. While some interviewees thought the hybrid nature of 100kGP was its vanguard, interviewees identified several tensions around hybrid practice: how to decide who should be able to participate; how to determine whether offering results might unduly influence participation into wide-ranging but often as yet unknown, research; and how to ensure that patients/families do not develop false expectations about receiving results. These areas require further debate as 100kGP moves into routine healthcare in the form of the national genomic medicine service. We explore the appropriateness of Faden et al.’s framework of ethical obligations for when research and clinical care are completely integrated, for addressing the tensions identified. We also argue that enabling on-going transparent and trustworthy communication between patients/families and professionals around the kinds of research that should be permitted in 100kGP will help understanding and ensure expectations remain realistic. Our paper aims to encourage a focused discussion about these issues and to inform a new ‘social contract’ for research and clinical care in the health service
Healthcare professionals’ and patients’ perspectives on consent to clinical genetic testing: moving towards a more relational approach
No full textBackgroundThis 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.MethodsWe 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 (data collected 2013–2015). 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.ResultsOur 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.ConclusionsA more collaborative on-going consent process, grounded in virtue ethics and values of honesty, openness and trustworthiness, is proposed
Public trust and ‘ethics review’ as a commodity: the case of Genomics England Limited and the UK’s 100,000 genomes project
Full text linkThe UK Chief Medical Officer’s 2016 AnnualReport, Generation Genome, focused on a vision to fullyintegrate genomics into all aspects of the UK’s NationalHealth Service (NHS). This process of integration, whichhas now already begun, raises a wide range of social andethical concerns, many of which were discussed in thefinal Chapter of the report. This paper explores how theUK’s 100,000 Genomes Project (100 kGP)—the catalystfor Generation Genome, and for bringing genomics intothe NHS—is negotiating these ethical concerns. The UK’s100 kGP, promoted and delivered by Genomics EnglandLimited (GEL), is an innovative venture aiming to sequence100,000 genomes from NHS patients who have a rare disease,cancer, or an infectious disease. GEL has emphasisedthe 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 whichmoral thinking occurs. Rather, the ‘ethical work’ conducted(and displayed) by organisations is more strategic, relating tothe politics of the organisation and the need to build publicconfidence. We set out to explore whether GEL’s ethicalframework was reflective of this critique, and what this tellsus more broadly about how genomics is being integratedinto the NHS in response to the ethical and social concernsraised in Generation Genome. We do this by drawing on aseries of 20 interviews with individuals associated with orworking at GEL
Genomics England’s implementation of its public engagement strategy: Blurred boundaries between engagement for the United Kingdom’s 100,000 Genomes project and the need for public support
Full text link The United Kingdom’s 100,000 Genomes Project has the aim of sequencing 100,000 genomes from National Health Service patients such that whole genome sequencing becomes routine clinical practice. It also has a research-focused goal to provide data for scientific discovery. Genomics England is the limited company established by the Department of Health to deliver the project. As an innovative scientific/clinical venture, it is interesting to consider how Genomics England positions itself in relation to public engagement activities. We set out to explore how individuals working at, or associated with, Genomics England enacted public engagement in practice. Our findings show that individuals offered a narrative in which public engagement performed more than one function. On one side, public engagement was seen as ‘good practice’. On the other, public engagement was presented as core to the project’s success – needed to encourage involvement and ultimately recruitment. We discuss the implications of this in this article. </jats:p
Expert Witness Report to Justice Gage in the case of AB and Others vs Leeds Teaching Hospital NHS Trust and Cardiff Vale NHS Trust (Nationwide Organ Group Litigation)
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