Translational or translationable? A call for ethno-immersion in (empirical) bioethics research.

The shift towards "empirical bioethics" was largely triggered by a recognition that stakeholders' views and experiences are vital in ethical analysis where one hopes to produce practicable recommendations. Such perspectives can provide a rich resource in bioethics scholarship, perhaps challenging the researcher's perspective. However, overreliance on a picture painted by a group of research participants-or on pre-existing literature in that field-can lead to a biased view of a given context, as the subjectivity of data generated in these ways cannot (and should not wholly) be escaped. In response, we propose the implementation of a complementary approach of ethno-immersion in bioethics research. By positioning oneself in the context being researched, the researcher can better understand the realities of that context. The researcher's understanding will, naturally, be subjective too. However, it will act as a better developed and more informed outsider view, when considering the picture painted by participants and previous studies, thus enabling the researcher to introduce more nuance when analysing data. We introduce this approach after examining what we call the context detachment problem, whereby some bioethics scholarship-empirical or otherwise-fails to reflect the reality of the healthcare setting it concerns. Our proposed ethno-immersion (which differs from formal ethnography) is then explored as a response, highlighting its benefits, and answering the question of timing within a research project. Finally, we reflect on the applicability of our proposal to non-empirical bioethics scholarship, concluding that it remains important but may require some adjustments.

Improvidence, Precaution, and the Logical-Empirical Disconnect in UK Health Policy.

The last decade has seen significant developments in UK health policy, with are largely claimed to be evidence based. However, such a characterisation ought, in many cases, to be questioned. Policies can be broadly understood as based primarily on either a logical or empirical case. In the absence of relevant empirical evidence, policymakers understandably appeal to logical cases. Once such evidence is available, however, it can inform policy and enable the logical case to be set aside. Such a linear policy process is not always the reality, and logical cases often continue to guide policy decisions in direct opposition to empirical evidence. In this paper, I discuss two recent examples of this disconnect between logical and empirical cases in UK health policy. The first-organ donation-illustrates an example of a significant policy change being made in opposition to the evidence. I refer to this as the improvidence approach. The second-abortion-provides an example of policymakers not making a change that has extensive supporting data. I refer to this using the more recognisable language of the precautionary approach. Ultimately, I argue that both the improvidence and precautionary approaches are examples of problematic public policy where policymakers provide no explicit justification for going against the evidence.

Directed and conditional uterus donation.

Uterus transplantation (UTx) is highly anticipated for the benefits that it might bring to individuals wanting to carry a pregnancy in order to reproduce who do not have a functioning uterus. The surgery-now having been performed successfully in several countries around the world-remains experimental. However, UTx is at some point expected to become a routine treatment for people without a uterus and considering themselves in need of one: women with absolute uterine factor infertility; transgender women; and even cisgender men who wish to gestate. Given the unique benefits UTx offers, uteri are likely to be 'in demand', and such demand, we suggest, will feasibly outstrip supply. Therefore, allocation of those uteri available for transplant may become a pressing issue. In this paper, we consider one aspect of organ allocation-the preferences of donors in making a directed or conditional donation of their uterus. To what extent, in the context of uterus donation, would such donations be ethically permissible?

From proband to provider: is there an obligation to inform genetic relatives of actionable risks discovered through direct-to-consumer genetic testing?

Direct-to-consumer genetic testing is a growing phenomenon, fuelled by the notion that knowledge equals control. One ethical question that arises concerns the proband's duty to share information indicating genetic risks in their relatives. However, such duties are unenforceable and may result in the realisation of anticipated harm to relatives. We argue for a shift in responsibility from proband to provider, placing a duty on test providers in the event of identified actionable risks to relatives. Starting from Parker and Lucassen's (2004) 'joint account model', we adapt Kilbride's (2018) application of the rule of rescue and balance it against the relative's right not to know, placing responsibility on the providers of direct-to-consumer genetic testing. Where the risk of disease to a relative is actionable, we argue providers ought to share results even in the face of the proband's objections. Confidentiality issues are navigated by a pre-emptive consent model, whereby consumers agree to the sharing of certain information with their relatives ahead of testing and as a condition of testing. When a relative is informed, the proband's privacy is protected by maximal deidentification, and the rights of the relative are met by a stepwise approach to informing that allows them to decide how much information they receive.

In defence of the bioethics scoping review: Largely systematic literature reviewing with broad utility.

There is growing interest in the possible role of systematic methods of reviewing literature in bioethics. This has arisen alongside the growth of empirical bioethics and a general push towards introducing some level of rigour and reproducibility into scholarship in the field. However, there remain a range of approaches to reviewing literature utilized in bioethics, which vary significantly in their 'systematicness' and suitability for different purposes. In this article, we first detail a taxonomy of various existing reviews used in bioethics and how scholars have defended and critiqued them, presenting them relationally along axes of 'systematic' and 'critical'. Considering the suitability of these reviews, we then explore the inherent differences between normative and empirical literature in relation to how they can be reviewed. In particular, we highlight the challenges in reviewing both normative and empirical literature in a single review. As something of an answer to these challenges, we introduce and defend the scoping review as, in many ways, a method of reviewing literature with wide-ranging utility in bioethics. Demonstrating the many benefits of the scoping review, we then position it within the existing taxonomy of reviews, ultimately arguing that its combination of systematic and critical, inclusive of a reasonable degree of flexibility, makes it deserving of increased attention and use in bioethics.

The Case for Telemedical Early Medical Abortion in England: Dispelling Adult Safeguarding Concerns.

Access to abortion care has been hugely affected by the COVID-19 pandemic. This has prompted several governments to permit the use of telemedicine for fully remote care pathways, thereby ensuring pregnant people are still able to access services. One such government is that of England, where these new care pathways have been publicly scrutinised. Those opposed to telemedical early medical abortion care have raised myriad concerns, though they largely centre on matters of patient safeguarding. It is argued that healthcare professionals cannot adequately carry out their safeguarding duties if the patient is not in the room with them. These concerns lack empirical support. Emerging evidence suggests that safeguarding processes may, in fact, be more effective within telemedical abortion care pathways. In this article, we address two specific safeguarding concerns: (1) that a remote consultation prevents a healthcare professional from identifying instances of abuse, and (2) that healthcare professionals cannot reliably confirm the absence of coercion during a remote consultation. We demonstrate that such concerns are misplaced, and that safeguarding may actually be improved in telemedical care pathways as victims of abuse may find it easier to engage with services. It is inevitable that some individuals will fall through the net, but this is unavoidable even with in-person care and thus does not constitute a strong critique of the use of telemedicine in abortion care. These safeguarding concerns set aside, then, we argue that the current approval that enables telemedical early medical abortion should be afforded permanence.

The Excessive Regulation of Early Abortion Medication in the UK: The Case for Reform.

Early medical abortion (EMA) involves the administration of two medications-mifepristone and misoprostol-24-48 hours apart. These routinely used medications are recognised as safe and effective by the World Health Organization which recommends this combination of medications as a safe form of abortion until nine weeks' gestation. Despite the safety and effectiveness of this drug regimen, there exists excessive regulation around EMA. This is despite new regulations introduced in Northern Ireland in 2020 and (temporary) changes made in 2020 to allow at-home administration of mifepristone in Great Britain (following earlier changes to permit home use of misoprostol). We argue that the excessive regulation of EMA is inappropriate because it fails to recognise that abortion is essential healthcare. Further, the regulation constitutes disproportionate interference with clinical discretion and service organisation because it is medically unnecessary and prevents abortion providers in the UK from adapting their service provision in line with emerging evidence of best practice.

The telemedical imperative.

Technology presents a means of improving health outcomes for vast numbers of individuals. It has historically been deployed to streamline healthcare delivery and reach those who would previously have faced obstacles to accessing services. It has also enabled improved health education and management. Telemedicine can be employed in everything from primary care consultations to the monitoring of chronic diseases. Despite recommendation by the World Health Organization, countries have been slow to embrace such technology in the health sector. Nonetheless, it is expected to become more prevalent with increased digitization. Further, amidst the COVID-19 pandemic, there was a rush to implement forms of telemedicine where possible to prevent patients breaking social distancing rules. In this paper, I present and defend what I term the 'telemedical imperative'. The telemedical imperative represents a duty for healthcare systems to implement remote access to services where possible, thereby furthering the mission of equity in access to healthcare. It is intended as an addition to in-person services rather than a replacement. After highlighting the benefits of telemedicine, I provide four criteria that must be met for the telemedical imperative to arise. The first three-safety, effectiveness, and acceptability-are consistent and essential. The fourth adapts to the service in question and requires that there be no other obstacles specific to that service that cannot reasonably be overcome. Finally, I address several potential objections to the telemedical imperative based on more general concerns around the implementation of telemedicine.

Dialysis decisions concerning cognitively impaired adults: a scoping literature review.

BACKGROUND: Chronic kidney disease is a significant cause of global deaths. Those who progress to end-stage kidney disease often commence dialysis as a life-extending treatment. For cognitively impaired patients, the decision as to whether they commence dialysis will fall to someone else. This scoping review was conducted to map existing literature pertaining to how decisions about dialysis are and should be made with, for, and on behalf of adult patients who lack decision-making capacity. In doing so, it forms the basis of a larger body of work that is exploring how these decisions ought to be made. METHODS: To identify relevant papers, searches were conducted on Ovid MEDLINE(R), Embase, PsychINFO, The Cochrane Library, and Web of Science. Inclusion criteria were then applied, requiring that papers: report on empirical studies about how decisions about dialysis are made and/or discuss how decisions about dialysis should be made with, for, and on behalf of adult patients who lack decision-making capacity; be published from 1961 onwards; and be published in English. This resulted in 27 papers eligible for inclusion. RESULTS: Of note, the majority of papers originated in the United States. There was wide variation across the included papers. Extracted data were grouped under the following themes: involving various parties (patient involvement, family dominance, and wider communication); objectivity about care options (including difficulties with family detachment); cultural sensitivity; medical versus non-medical factors; managing nonadherent patients; and the role and prevalence of substituted judgement. The literature shows that there is inconsistency in the principles and processes surrounding decisions made about dialysis with, for, and on behalf of adult patients who lack decision-making capacity. CONCLUSIONS: This scoping review demonstrates that there is significant variation in both the practice and theory of dialysis decision making with, for, and on behalf of cognitively impaired adult patients. Complexity arises in considering who should get a say, how influential their say should be in a decision, and what factors are most relevant to the decision. A lack of up-to-date literature exploring this issue is highlighted, with this scoping review providing a useful groundwork from which further research can be undertaken.

Ethics of kidney care in the era of COVID-19.

The coronavirus disease 2019 pandemic presents significant challenges for health systems globally, including substantive ethical dilemmas that may pose specific concerns in the context of care for people with kidney disease. Ethical concerns may arise as changes in policy and practice affect the ability of all health professionals to fulfill their ethical duties toward their patients in providing best practice care. In this article, we briefly describe such concerns and elaborate on issues of particular ethical complexity in kidney care: equitable access to dialysis during pandemic surges; balancing the risks and benefits of different kidney failure treatments, specifically with regard to suspending kidney transplantation programs and prioritizing home dialysis, and barriers to shared decision-making; and ensuring ethical practice when using unproven interventions. We present preliminary advice on how to approach these issues and recommend urgent efforts to develop resources that will support health professionals and patients in managing them.

Best interests versus resource allocation: could COVID-19 cloud decision-making for the cognitively impaired?

The COVID-19 pandemic is putting the NHS under unprecedented pressure, requiring clinicians to make uncomfortable decisions they would not ordinarily face. These decisions revolve primarily around intensive care and whether a patient should undergo invasive ventilation. Certain vulnerable populations have featured in the media as falling victim to an increasingly utilitarian response to the pandemic-primarily those of advanced years or with serious existing health conditions. Another vulnerable population potentially at risk is those who lack the capacity to make their own care decisions. Owing to the pandemic, there are increased practical and normative challenges to following the requirements of the Mental Capacity Act 2005. Both capacity assessments and best interests decisions may prove more difficult in the current situation. This may create a more paternalistic situation in decisions about the care of the cognitively impaired which is at risk of taking on a utilitarian focus. We look to these issues and consider whether there is a risk of patients who lack capacity to make their own care decisions being short-changed.

"All hands on deck": a qualitative study of safeguarding and the transition to telemedical abortion care in England and Wales.

The COVID-19 pandemic raised significant challenges for in-person healthcare provision, leading healthcare providers to embrace digital health like never before. Whilst changes were made as part of a public health response, many have now become permanent fixtures of the healthcare landscape, significantly altering the way care is provided not only for patients, but also for the healthcare professionals that provide care. In abortion care in England and Wales, previously stringent regulations on in-person care provision were relaxed to permit the use of telemedicine and self-administration of medications at home. These changes have since been made permanent. However, there remains opposition to remote abortion care pathways on the basis of safeguarding. Opponents argue that it is not feasible to effectively safeguard patients accessing abortion care remotely. We conducted a qualitative study using semi-structured interviews with abortion care providers in England and Wales. Participants were asked about their views and experiences of the transition to remote care provision, with a particular focus on how they adapted their safeguarding practice. In this article, we present three themes that highlight the changing roles of healthcare professionals in abortion care: (1) a challenging backdrop and resulting apprehension, (2) adaptive practices, and (3) the continued importance of professional curiosity. Across all three themes, participants reflected significantly on how changes were made and what they experienced in the period of transition to telemedicine. In particular, they discussed the changing nature of their professional roles amidst digitalisation. Our findings provide a basis for reflection on the increasing introduction of digital approaches to healthcare provision, highlighting points for caution and emphasising the need to involve professionals in the transition process to ensure vital buy-in. Through this, we articulate two novel understandings of digitalisation: (1) the impact of speed-associated pressures on professional adaptation during digitalisation, and (2) off-proforma safeguarding through telemedicine as a form of invisible non-routine work.

Early telemedical abortion, safeguarding, and under 18s: a qualitative study with care providers in England and Wales.

BACKGROUND: Telemedical early medical abortion (TEMA) was introduced in England and Wales as a temporary measure in 2020 and was made permanent in 2022. While there are considerable data showing the safety, efficacy, and acceptability of TEMA for patients, there have been objections raised to TEMA based on safeguarding-particularly for people under 18 years of age. Little is known about abortion care providers' views and experiences of carrying out their safeguarding duties with people aged under 18 in the shift to TEMA. METHODS: This is a qualitative study involving online semi-structured interviews and reflexive thematic analysis. Audio-recorded, semi-structured interviews with abortion providers in England and Wales (n=20) generated data about their views and experiences of safeguarding in telemedical abortion care. Recordings were transcribed verbatim and then subject to reflexive thematic analysis to construct themes. RESULTS: While the study was designed with adult safeguarding in mind, the safeguarding of under 18s became a key area of discussion. Three major themes were constructed in relation to under 18s: (1) age as a risk factor in safeguarding; (2) telemedicine as improving access to care; and (3) telemedicine as enhancing communication. CONCLUSION: Care providers believe TEMA has benefitted the under 18s. There was a strong feeling both that TEMA had improved access (which, in turn, improved safeguarding) and that under 18s were comfortable communicating using remote means. Providers believe safeguarding proformas must account for the different nature of risks where service users are under 18, but that it is disproportionate to assume that TEMA is unsuitable for all under 18s or groups of under 18s.

Deemed consent for organ donation in Northern Ireland.

Shortages of organs for transplantation have led many countries to introduce systems of deemed consent for organ donation, whereby donation is the default upon death and an individual must provide express opposition to donation to prevent it. Despite a lack of clear supporting evidence, it is often suggested that deemed consent will contribute significantly to addressing the organ shortage. Northern Ireland appears set to be one of the next countries to pursue this route, with the Organ and Tissue Donation (Deemed Consent) Bill currently making its way through the Northern Ireland Assembly. If passed, this Bill will see Northern Ireland follow in the footsteps of the rest of the UK. In this viewpoint, we provide an overview of Northern Ireland's progress towards introducing deemed consent and argue two related points. First, that public awareness of the policy (if introduced) is vital to both its defensibility and longevity, and that this must be recognised through the imposition of a ministerial duty to focus on such awareness. Second, that policymakers in Northern Ireland ought to support the policy to ensure consistency across the UK in organ procurement, thereby preventing Northern Ireland from disproportionately benefitting from the UK-wide organ allocation system.

Deemed consent for organ donation: a comparison of the English and Scottish approaches.

Deemed consent for organ donation has long been discussed as a potential solution to the shortage of organs for transplantation, with several countries having implemented it. In Great Britain, Wales was the first nation to introduce such a system, having done so in 2015. Now, the other two nations are following suit. In this paper, I compare the approaches of England and Scotland in moving to systems of deemed consent for organ donation. After outlining both sets of legislation, I focus on three points on which the two nations differ. First, the role of those close to the deceased in the consent process and the extent to which clinicians are required to consult them ahead of consent being deemed. Second, the role of government ministers in ensuring widespread public awareness. Third, the ways in which the two nations responded to the challenge of the COVID-19 pandemic in relation to the implementation of deemed consent. I conclude that on all three points, the Scottish approach is preferable.

2020 developments in the provision of early medical abortion by telemedicine in the UK.

The COVID-19 pandemic has necessitated the rapid implementation of telemedical health services. In the United Kingdom, one service that has benefitted from this response is the provision of early medical abortion. England, Wales, and Scotland have all issued approval orders to this effect. These orders allow women to terminate pregnancies up to certain gestational limits, removing the need for them to contravene social distancing measures to access care. However, they are intended only as temporary measures for the duration of the pandemic response. In this paper, we chart these developments and further demonstrate the already acknowledged politicisation of abortion care. We focus on two key elements of the orders: (1) the addition of updated clinical guidance in the Scottish order that suggests an extended gestational limit, and (2) sunset clauses in the English and Welsh orders, as well as an indication of similar intentions in Scotland. In discussing these two issues, we suggest that the refusal of UK governments to introduce telemedical provision of early medical abortion previously has not been based on health concerns. Further, we question whether it would be appropriate for the approval orders to be lifted following the pandemic, suggesting that to do so would represent regressive and harmful policy.