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Centralised, compliance-focused approaches to research ethics have been normalised in practice. In this paper, we argue that the dominance of such systems has been driven by neoliberal approaches to governance, where the focus on controlling and individualising risk has led to an overemphasis of decontextualised ethical principles and the conflation of ethical requirements with the documentation of ‘informed consent’. Using a UK-based case study, involving a point-of-care-genetic test as an illustration, we argue that rather than ensuring ethical practice such compliance-focused (...) approaches may obstruct valuable research. We call for an approach that encourages researchers and research communities—including regulators, ethics committees, funders and publishers of academic research—to acquire skills to make morally appropriate decisions, and not base decision-making solely on compliance with prescriptive regulations. We call this ‘ethical preparedness’ and outline how a research ethics system might make space for this approach. (shrink)

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Much has been published about the ethical issues encountered by clinicians in genetics/genomics, but those experienced by clinical laboratory scientists are less well described. Clinical laboratory scientists now frequently face navigating ethical problems in their work, but how they should be best supported to do this is underexplored. This lack of attention is also reflected in the ethics tools available to clinical laboratory scientists such as guidance and deliberative ethics forums, developed primarily to manage issues arising within the clinic.We explore (...) what ethical issues are being experienced by clinical scientists, how they think such issues could be best analysed and managed, and whether their practice might be enhanced by more situated approaches to ethics deliberation and practice such as ethical preparedness. From thematic analysis of cases presented by clinical scientists at a specially convened meeting of the UK Genethics Forum, we derived three main ethical themes: (1) the redistribution of labour and responsibilities resulting from the practice of genomic medicine; (2) the interpretation and certainty of results and (3) the proposal that better standardisation and consistency of ethical approaches (for example, more guidelines and policy) could resolve some of the challenges arising.We argue that although standardisation is important for promoting shared understandings of good (including ethical) practice, supplementary approaches to enhance and sustain ethical preparedness will be important to help clinical scientists and others in the recently expanded genetic/genomic medicine environment foster quality ethical thinking. (shrink)

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Our ability to generate genomic data is currently well ahead of our ability to understand what they mean, raising challenges about how best to engage with them. This article considers ethical aspects of work with such data, focussing on research contexts that are intertwined with clinical care. We discuss the identifying nature of genomic data, the medical information intrinsic within them, and their linking of people within a biological family. We go on to consider what this means for consent, the (...) importance of thoughtful sharing of genomic data, the challenge of constructing meaningful findings, and the legacy of unequal representation in genomic datasets. We argue that the ongoing success of genomic data research relies on public trust in the enterprise: to justify this trust, we need to ensure robust stewarding, and wide engagement about the ethical issues inherent in such practices. (shrink)

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Gils-Schmidt and Salloch recognise that human and climate health are inextricably linked, and that mitigating healthcare-associated climate harms is essential for protecting human health.1 They argue that physicians have a duty to consider how their own practices contribute to climate change, including during their interactions with patients. Acknowledging the potential for conflicts between this duty and the provision of individual patient care, they propose the application of Korsgaard’s neo-Kantian account of practical identities to help navigate such scenarios. In this commentary, (...) we argue that by focusing attention on this physician–patient level, the authors overlook the complexity of climate change, both within the healthcare sector and beyond. We recognise the importance of individual agency in tackling this issue, and we also recognise that the authors do briefly acknowledge the importance of considering these broader complexities; however, we emphasise the need for climate and health discussions/action to be situated in a wider framework of systemic change. Our concern is that overemphasis on patient-level interactions risks normalising the prioritisation of individual-level approaches to addressing climate change, detracting from such a broader approach. Physician training emphasises the need for trust, confidentiality and shared decision-making in the doctor–patient relationship. …. (shrink)

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Considerations of the notion of preparedness have come to the fore in the recent pandemic, highlighting a need to be better prepared to deal with sudden, unexpected and unwanted events. However, the concept of preparedness is also important in relation to planned for and desired interventions resulting from healthcare innovations. We describe ethical preparedness as a necessary component for the successful delivery of novel healthcare innovations, and use recent advances in genomic healthcare as an example. We suggest that practitioners and (...) organisations charged with delivering innovative and ambitious healthcare programmes can only succeed if they are able to exhibit the attribute of ethical preparedness. (shrink)

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This article investigates a high-profile and ongoing dilemma for healthcare professionals (HCPs), namely whether the existence of a (legal) duty of care to genetic relatives of a patient is a help or a hindrance in deciding what to do in cases where a patient’s genetic information may have relevance to the health of the patient’s family members. The English caseABC v St George’s Healthcare NHS Trust and othersconsidered if a duty of confidentiality owed to the patient and a putative duty (...) of care to the patient’s close relatives could coexist in this context. This article examines whether embracing the concept of coexisting duties could enable HCPs to respect duties in line with their clinical judgement, thereby providing legal support and clarity to professionals to allow them to provide the best possible genetics service to both the patient and their family. We argue that these dual duties, framed as a novel, composite duty to consider the interests of genetic relatives, could allow HCPs to exercise and act on their professional judgements about the relative value of information to family members, without fears of liability for negligence or breach of confidence. (shrink)

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We discuss a case where medically optimal investigations of health problems in a donor-conceived child would require their egg donor to participate in genetic testing. We argue that it would be justified to contact the egg donor to ask whether she would consider this, despite her indicating on a historical consent form that she did not wish to take part in future research and that she did not wish to be informed if she was found to be a carrier of (...) a ‘harmful inherited condition’. We suggest that we cannot conjecture what her current answer might be if, by participating in clinical genetic testing, she might help reach a diagnosis for the donor-conceived child. At the point that she made choices regarding future contact, it was not yet evident that the interests of the donor-conceived child might be compromised by her answers, as it was not foreseen that the egg donor’s genome might one day have the potential to enable diagnosis for this child. Fertility consent forms tend to be conceptualised as representing incontrovertible historical boundaries, but we argue that rapid evolution in genomic practice means that consent in such cases is better seen as an ongoing and dynamic process. It cannot be possible to compel the donor to aid in the diagnosis of the donor-conceived child, but she should be given the opportunity to do so. (shrink)

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In this round table response, we discuss some of the problems inherent in insisting on specific consent for an activity that needs to happen rapidly as part of a package of care. The Human Tissue Authority (the UK regulator for human tissue and organs) consider that specific consent is mandatory to assess which antibiotics are appropriate on the neonatal unit, but this insistence may actually limit the autonomy which consent aims to promote. While genetic testing to determine which child will (...) react adversely to particular antibiotics has been available clinically for several years, the research proposed here is to assess whether improving the speed of testing allows decisions to be made before treatment starts. Insisting on specific consent before this activity can take place is likely to delay appropriate care in some cases. On admission to the neonatal unit, the unwell infant is routinely subjected to a range of investigations and treatments. A person with parental responsibility will usually be asked to provide consent to undertake treatments for children who do not have capacity to give consent themselves.1 For the acutely unwell child, consent will usually be sought for a package of care: the urgent nature of neonatal medicine often requires clinicians to make many decisions without explicit consent. Doctors must always act in a child’s best interests: their decisions need to protect the health and well-being of a child and hold the child’s welfare paramount in accordance with the Children Act (1989) and General Medical Council (GMC) guidelines.1 2 Thus, for example, ventilation might be initiated, sedation provided, antibiotics commenced or diagnostic investigations requested without separate consent conversations or …. (shrink)

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Gyngell and colleagues consider that the recent Nuffield Council report does not go far enough: heritable genome editing is not just justifiable in a few rare cases; instead, there is a moral imperative to undertake it. We agree that there is a moral argument for this, but in the real world it is mitigated by the fact that it is not usually possible to ensure a better life. We suggest that a moral imperative for HGE can currently only be concluded (...) if one first buys into an overly deterministic view of a genome sequence, and the role of variation within in it, in the aetiology of the disease: most diseases cannot simply be attributed to specific genetic variants that we could edit away. Multiple, poorly understood genetic and environmental factors interact to influence the expression of diseases with a genetic component, even well understood ‘monogenic’ disorders. Population-level genome analyses are now demonstrating that many genetic ’mutations' are much less predictive than previously thought 1. Furthermore, HGE might introduce new risks just as it reduces old ones; or remove protections not yet clearly delineated. (shrink)

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The aim of this study is to assess patients' recall of their previous research participation. Recall was established during interviews and compared with entries from clinical notes. Participants were 49 patients who had previously participated in different types of research. Of the 49 patients, 45 (92%) interviewees recalled 69 of 109 (63%) study participations. Level of recall varied according to the type of research, some participants clearly recalled the details of research aims, giving consent and research procedures. Others recalled procedures (...) (e.g. DNA testing) but were unclear about their purpose. There was no significant effect of time on recall. Some types of research participation (e.g. DNA testing) may be recalled as clinical care. We argue that such misunderstandings may have the potential to undermine participants' ongoing consent, particularly in ongoing/longitudinal studies. Valid consent may be best achieved by re-assessing the scope of consent and relating it to the nature of the interventions themselves rather than the reasons for undertaking them. (shrink)

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The objective of this study is to describe researchers', health-care providers' and other stakeholders' views of ethical review and research governance procedures. The study design involved qualitative semi-structured interviews. Participants included 60 individuals who either undertook research in the subspecialty of cancer genetics (n = 40) or were involved in biomedical research in other capacities (n = 20), e.g. research governance and oversight, patient support groups or research funding. While all interviewees observed that oversight is necessary to protect research participants, (...) ethical review and research governance (ERG) arrangements were described negatively throughout these interviews. Interviewees identified a number of problems with ERG, including: over-bureaucratization, over-standardization of information requirements for different types of research, a lack of standardization in the types of information required by different committees for the same research and a lack of consistency in different committees' responses. A number of solutions were proposed including streamlining application procedures and harmonizing committees' responses and information requirements. Recent reports suggest that ethical review procedures and research governance arrangements threaten the possibility of undertaking clinical research in the UK, hence the introduction of the Integrated Research Application System (IRAS) is long overdue. However, while IRAS may solve some of the problems identified by interviewees, it remains to be seen to what extent it will impact upon the very negative perceptions of ethics and research governance procedures reported here. (shrink)

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Discussion of a “duty to recontact” emerged as technological advances left professionals considering getting back in touch with patients they had seen in the past. While there has been much discussion of the duty to recontact as a matter of theory and ethics, there has been rather little empirically based analysis of what this “duty” consists of. Drawing on interviews with 34 professionals working in, or closely with, genetics services, this paper explores what the “duty to recontact” means for healthcare (...) professionals involved in genetics. Using a discourse analytic framework, the paper identifies three system generated discourses on recontact (governance, legal and responsibilizing discourses) and three lifeworld discourses (situating recontact as a formal duty; more loosely as an obligation; and as a personal sense of responsibility). In summary, the paper shows that the “duty” to recontact involves a complex interplay of system responsibilities with professional duties, responsibilities and obligations. (shrink)

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The UK Genethics Club was established in November 2001 in order to provide a national forum of ethics support for the profession of clinical genetics in the UK. The forum brings together health professionals, medical ethicists and lawyers and support is provided through detailed discussion of cases and sharing of good practice. Clinical genetics professionals had previously voiced concerns about making extremely difficult ethical decisions, with profound implications, in something of a vacuum. Professionals saw a lack of guidance in the (...) area and lack of time for discussion of difficult cases as reasons for this. This paper describes the origins of the group and gives (anonymized) examples of some of the types of issues discussed. (shrink)

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In her paper, Galasso contends that transitioning precision medicine from its current emphasis on healthcare benefits, to a focus on precision public health, may help address the equity concerns th...

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We discuss a case where clinical genomic investigation of muscle weakness unexpectedly found a genetic variant that might (or might not) predispose to kidney cancer. We argue that despite its off-target and uncertain nature, this variant should be discussed with the man who had the test, not because it is medical information, but because this discussion would allow the further clinical evaluation that might lead it to becoming so. We argue that while prominent ethical debates around genomics often take ‘results’ (...) as a starting point and ask questions as to whether to look for and how to react to them, the construction of genomic results is fraught with ethical complexity, although often couched as a primarily technical problem. We highlight the need for greater focus on, and appreciation of, the ethical work undertaken daily by scientists and clinicians working in genomic medicine and discuss how public conversations around genomics need to adapt to prepare future patients for potentially uncertain and unexpected outcomes from clinical genomic tests. (shrink)

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We thank Lucy Frith for her thought-provoking response1 to our paper, where we argued that it would be ethically acceptable to contact an anonymous egg donor to help facilitate diagnostic genetic testing for a donor-conceived child.2 While we read Frith’s commentary with interest, we still think that the egg donor should be contacted in the case that we describe. Frith raises concerns as to whether contact would constitute ‘ overriding consent ’, thus ’ potentially set(ting) a dangerous precedent ’ for (...) existing gamete donors and donor-conceived children. In contrast, we consider that contacting the egg donor would not override her consent, as her views on contact in the instance that has now arisen were never sought. Our view is that given we do not currently know what she might want, contacting her is a more legitimate way of respecting her autonomy than trying to anticipate her likely answer. We strongly agree with Frith’s suggestion that future consent discussions around gamete donation should make explicit ‘ the possibility of being contacted in the future if there is a relevant reason for doing so ’. Frith expresses a concern that contact would constitute ‘ overriding [the egg donor’s] consent ’, meaning that we have to ‘ justify contacting the egg donor against her previously stated wishes not to be contacted ’. However, our argument is that the egg donor was never asked whether or not she was happy to be contacted in the circumstances that have now arisen. Thus, there is no consent to be overridden, given that she never gave or withheld it in the first place. Frith rightly acknowledges that her arguments therefore ‘ [do] not fully address [our] main worry that the donor’s wishes are essentially unknown, as she was not asked about this specific situation and …. (shrink)

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We thank Parker and Wright for engaging in this roundtable debate in such a spirited way. The ‘Pharmacogenetic [test] to Avoid Loss of Hearing’ (PALOH) Trial is the first time a genetic point of care test has been applied in the acute neonatal setting; therefore, it is not surprising that questions have been raised which require debate, discussion and clarification. Parker and Wright misattribute several assumptions to the roundtable authors, which we would like to clarify here. Since they raise wider (...) questions about the PALOH trial itself, several of the roundtable discussants have made a joint response. (shrink)

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The past few decades have seen patient autonomy ascend to a prime position in health care. Patient consent is seen as a key component to expression of autonomy. Yet, interventions may also be justified without consent because they are deemed to be in the public interest. We observe some subtle shifts in balance in these justifications in health care and illustrate these with a range of examples. We hope thereby to stimulate a more explicit debate so that health-care professionals can (...) manage these competing interests. (shrink)

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Clinical 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 codependent. The 100 000 genomes project is a hybrid venture where a person can obtain a clinical investigation only if he or she agrees 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. To address the tensions identified, we explore the appropriateness of Faden et al.’s framework of ethical obligations for when research and clinical care are completely integrated. We also argue that enabling ongoing transparent and trustworthy communication between patients/families and professionals around the kinds of research that should be permitted in 100kGP will help to understand and ensure that 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. (shrink)

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This excellent compilation of essays covers a broad range of genetic topics and is a must for anyone interested in the ethical, social, legal, and historical perspectives of human genetics. This is not a new edition but a paperback version of the 1996 edition. The book begins with a section on “the voices of family members whose lives have been deeply touched by genetic disease”. There are ten very moving accounts of individuals' experiences of a range of different ….

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