Medical Ethics

This paper combines considerations from ethics, medicine and public health policy to articulate and defend a systematic case for mask wearing mandates. The paper argues for two main claims of general interest in favour of these mandates. First, mask wearing mandates provide a more effective, just and fair way to tackle the ongoing COVID-19 pandemic than policy alternatives such as laissez-faire approaches, mask wearing recommendations and physical distancing measures. And second, the proffered objections against mask wearing mandates may justify some (...) exemptions for specific categories of individuals, but do not cast doubt on the justifiability of these mandates. Hence, unless some novel decisive objections are put forward against mask wearing mandates, governments should adopt such mandates. (shrink)

Commitment devices (CDs) can help people overcome self-control problems to act on their plans and preferences. In these arrangements, people willingly make one of their options worse in order to change their own future behaviour, often by setting aside a sum of money that they will forfeit it if they fail to complete the planned action. Such applications of behavioural science have been used to help people stick to healthier lifestyle choices, overcome addictions and adhere to medication; they are acceptable (...) to many patients and even relatively small sums can be effective. Some authors have objected to the use of nudges in healthcare. Engelen has listed nine potential objections to nudges in relation to means (why nudge rather than persuade?), ends (what action is being promoted?) and agents (who is nudging whom?). These objections are shown to lack force in the context of CDs. Instead, an analysis specific to the ethical issues in CDs is employed. CDs exclude certain groups including so-called ‘naifs’ and risk increasing health inequality. CDs may promote the wrong behaviour and people might legitimately change their minds. Intermediaries might encounter perverse incentives. Approaches to overcoming these problems are described and eight key ethical considerations for those considering implementing CDs in the future are described. Altogether this paper illustrates the advantages of appraising the ethics of behavioural science in medicine on a case-by-case basis. (shrink)

BackgroundCurrent advances in biomedical research have introduced new ethical challenges in obtaining informed consent in low and middle-income settings. For example, there are controversies about the use of broad consent in the collection of biological samples for use in future biomedical research. However, few studies have explored preferred informed consent models for future use of biological samples in Malawi and South Africa. Therefore, we conducted an empirical study to understand preferred consent models among key stakeholders in biomedical studies that involve (...) collection of biological samples in Malawi and South Africa. The main objective of the study was to explore views of key stakeholders on current policies on informed consent in Malawi and South Africa. MethodsThis was a qualitative study involving in-depth interviews and focus group discussions. Thirty-four in-depth interviews and 6 focus group discussions were conducted with REC members, Funders, Policymakers, CAB members and Research Participants in Malawi and South Africa to gather their views on models of informed consent. The study was conducted in Cape Town, South Africa, and Blantyre and Lilongwe in Malawi.ResultsMost key stakeholders preferred broad consent and tiered consent to specific consent. Some participants expressed a strong preference for specific consent to other models of informed consent in biomedical research. Few participants did not have any preference for a consent model, opting for any consent model which provides adequate information about the proposed research and what their national consent regulations require. Finally, very few participants preferred blanket consent to other informed consent models.ConclusionsThis study aimed to help fill the gap in the scientific literature on key stakeholder views on consent models for future use of biological samples in Malawi and South Africa. The findings of the study have provided some evidence that may support policies on permissible consent models for future use of biological samples in sub-Saharan Africa considering the differences in informed consent regulations and guidelines. Finally, the findings can inform ongoing discussions on permissible consent models to be used for future use of biological samples. (shrink)

BackgroundThe informed consent process in clinical trials has been extensively studied to inform the development processes which protect research participants and encourage their autonomy. However, ensuring a meaningful informed consent process is still of great concern in many research settings due to its complexity in practice and interwined socio-cultural factors.ObjectivesThis study explored the practices and meaning of the informed consent process in two clinial trials conducted by Oxford University Clinical Research Unit in collaboration with the Hospital for Tropical Diseases in (...) Ho Chi Minh City, Vietnam.MethodsWe used multiple data collection methods including direct observervations, in-depth interviews with study physicians and trial participants, review of informed consent documents from 2009 to 2018, and participant observation with patients’ family members. We recruited seven physicians and twenty-five trial participants into the study, of whom five physicians and thirteen trial participants completed in-depth interviews, and we held twenty-two direct observation sessions.ResultsWe use the concept “fragmented understanding” to describe the nuances of understanding about the consent process and unpack underlying reasons for differing understandings.ConclusionsOur findings show how practices of informed consent and different understanding of the trial information are shaped by trial participants’ characteristics and the socio-cultural context in which the trials take place. (shrink)

The paper offers the concept of reversing the medical humanities. In agreement with the call from Kristeva et al. to recognise the bidirectionality of the medical humanities, I propose moving beyond debates of attitude and aptitude in the application and engagement (either friendly or critical) of humanities to/in medicine, by considering a reversal of the directions of epistemic movement (a reversal of the flow of knowledge). I situate my proposal within existing articulations of the field found in the medical humanities (...) meta-literature, pointing to a gap in the current terrain. I then develop the proposal by unfolding three reasons why we might gain something from exploring a reversed knowledge flow. First, a reversed knowledge flow seems to be an inherent—but still to be articulated—possibility in medical humanities and thus provides an opportunity for more knowledge. Second, the current unidirectionality of the field is founded on an inconsistency in the depiction of the connection between medicine and humanities, which risks creating the very divide that medical humanities set out to bridge. Practising a reversal may help avoid this divide. And third, a reversal might help rebalance the internal epistemic power, so as to motivate less external scepticism and in turn displace more external epistemic power towards medical humanities. I end the paper with a remark on precursors for a reversal, and ideas for where to go from here. (shrink)

BackgroundEmpirical research can become relevant for bioethics in at least two ways. First, by informing the development or refinement of ethical recommendations. Second, by evaluating how ethical recommendations are translated into practice. This study aims to investigate the scope and objectives of empirical studies evaluating how ethical recommendations are translated into practice. MethodsA sample of the latest 400 publications from four bioethics journals was created and screened. All publications were included if they met one of the following three criteria: (1) (...) evaluative empirical research, (2) non-evaluative empirical research and (3) borderline cases. For all publications categorized as evaluative empirical research we analyzed which objects (norms and recommendations) had been evaluated.Results234 studies were included of which 54% (n = 126) were categorized as non-evaluative empirical studies, 36% (n = 84) as evaluative empirical studies, and 10% (n = 24) as borderline cases. The object of evaluation were aspirational norms in 5 of the 84 included evaluative empirical studies, more specific norms in 14 (16%) studies and concrete best practices in 65 (77%) studies. The specific best practices can be grouped under five broader categories: ethical procedures, ethical institutions, clinical or research practices, educational programs, and legal regulations.ConclusionsThis mapping study shows that empirical evaluative studies can be found at all stages in the translational process from theory to best practices. Our study suggests two intertwined dimensions for structuring the field of evaluative/translational empirical studies in bioethics: First, three broader categories of evaluation objects and second five categories for types of best practices.Trial registration: The methodology used was described in a study protocol that was registered publicly on the Open Science Framework (https://osf.io/r6h4y/). (shrink)

BackgroundVascular surgery offers a range of treatments to relieve pain and ulcerations, and to prevent sudden death by rupture of blood vessels. The surgical procedures involve risk of injury and harm, which increases with age and frailty leading to complex decision-making processes that raise ethical questions. However, how vascular surgeons negotiate these questions is scarcely studied. The aim was therefore to explore vascular surgeons’ moral reasoning of what ought to be done for the patient.MethodsQualitative, semi-structured interviews were conducted with 19 (...) vascular surgeons working at three Swedish university hospitals. Data were analysed according to systematic text condensation.ResultsThe surgeons’ moral reasoning about what ought to be done comprised a quest to relieve suffering and avoid harm by exploring what is reasonable to do for the patient. Exploring reasonableness included to shift one´s perspective from the vessels to the whole person, to balance patient’s conflicting needs and to place responsibility for right decision on one´s shoulders. The shift from blood vessels to the whole person implied gaining holistic knowledge in pondering of what is best, struggling with one´s authority for surgery through dialogue, and building relationship for mutual security. To balance patient’s conflicting needs implied weighing the patient’s independence and a sense of being whole against ease of suffering, respecting the patient’s will against protecting life and well-being, and weighing longer life against protecting the present well-being. Finally, to place responsibility on one´s shoulders was conveyed as an urge to remind oneself of the risk of complications, withholding one’s power of proficiency, and managing time during the illness course.ConclusionsThis study contributes to uncovering how moral reasoning is embodied in the vascular surgeons’ everyday clinical discourse as a tangible part of their patient care. The results underpin the significance of moral considerations in the assemblage of medical knowledge and technical skills to further understand vascular surgeons’ clinical practice. The clinical application of these results is the need of forums with sufficient possibilities for articulating these important moral considerations in everyday care. (shrink)

Ageing populations and rising rates of chronic disease globally have shifted key elements of disease management to ideas of integrated care and self-management. The associated policies and programmes often focus on intervention and support beyond the sites of the hospital and clinic. These shifts have significantly impacted the delivery and practice of nursing for both nurses and the clients with whom they work. This article argues that Foucault's comments on space, place and heterotopia (1986) are useful in exploring these changes (...) from a philosophical perspective, to draw out the complexity of these programmes and add texture to discussions on the ways these shifts to localisation and the dominant discourses of self-management and responsibility have reconfigured nursing practices. The theoretical discussion is augmented with illustrations from an Australian integrated health care programme. (shrink)

Background In China, informal payments in the medical profession, which workers in the public health care system receive from patients in the course of performing profession-related activities, are usually referred to as “red packets” (Hongbao 红包). The phenomenon of red packets is widespread and has become one of the most negative factors affecting the doctor-patient relationship in China. Our study aims to explore the situation concerning the phenomenon of red packets in China after the “Red Packet Ban”. Methods A questionnaire (...) was developed including general demographic characteristics, asking whether they had ever been offered red packets, whether they had ever accepted red packets, their reasons for accepting the first red packet and so on. We recruited a total of 413 doctors to complete this questionnaire and conducted in-depth telephone interviews with 18 doctors from the initial group. Results Our data shows that 73 doctors claimed to have accepted red packets, accounting for 17.7% (73/413) of all respondents and 27.8% (73/263) of doctors who had been provided with red packets. 23.2% of red packets were offered after the operation and 67.1% of the doctors declared that the main reason for accepting the red packet was that they “refused the red packets more than once, but the patients/family members were sincere and it was difficult to refuse.” The total amount of the red packets they received each month accounted for no more than 5% of their income. Conclusions (1) The acceptance of red packets does exist among young doctors in China, but shows a significant decrease compared to previous studies. (2) There has been a sharp rise in the proportion of gratitude red packets. (3) Patients should also be educated regarding their behaviour in providing red packets. (shrink)

Background In Saudi clinical settings, cultural influences can give a patient’s family authority to override the patient’s autonomous right to make informed health-related decisions. Cultural values should not prevent patients from exercising their genuine preferences when making medical decisions in their own best interests. Discussion This article discusses the moral implications of family-centred medical decisions for autonomous patients who are competent and capable of making decisions. The author argues that socio-cultural values do not justify the decision to override patient autonomy (...) when patients express a preference for making their own choices. Conclusion The author recommends the use of a model of shared decision-making that accounts for both individual and relational conceptions of autonomy, approaching patients’ preferences in all medical encounters with the aim of minimising the potential for socio-cultural values to undermine patient autonomy. Although this approach is a safeguard against both family and medical paternalism, allowance is made for clinicians to act in weakly paternalistic ways when patients at high risk of exacerbating existing medical conditions are likely to benefit from delaying or limiting the disclosure of potentially distressing but non-fatal diagnoses and prognoses. Thus, the author argues that even in a culture that supports family involvement in management decisions, physicians should respect patient autonomy by asking patients for their preferences in the disclosure of their medical diagnoses, prognoses and management options and verifying patients’ preferences about the roles they wish their families to play (if any) in health-related decisions. (shrink)

Calum Miller recently argued that a commitment to a very modest form of egalitarianism—equality between non-disabled human adults—implies fetal personhood. Miller claims that the most plausible basis for human equality is in being human—an attribute which fetuses have—therefore, abortion is likely to be morally wrong. In this paper, I offer a plausible defence for the view that equality between non-disabled human adults does not imply fetal personhood. I also offer a challenge for Miller’s view.

It is common to think of medical and ethical modes of thought as different in kind. In such terms, some clinical situations are made more complicated by an additional ethical component. Against this picture, we propose that medical and ethical modes of thought are not different in kind, but merely different aspects of what it means to be human. We further propose that clinicians are uniquely positioned to synthesise these two aspects without prior knowledge of philosophical ethics.

“Wicked” problems are characterized by intractable complexity, uncertainty, and conflict between individuals or institutions, and they inhabit almost every corner of medical ethics. Despite wide acceptance of the same ethical principles, we nevertheless disagree about how to formulate such problems, how to solve them, what would _count_ as solving them, or even what the possible solutions _are_. That is, we don’t always know how best to implement ethical ideals in messy real-world contexts. I sketch an implementation framework for medical ethics (...) that can help clarify wicked problems and organize further ethics research toward their resolutions. This framework describes the procedural variables that work alongside substantive ethical ideals to deliver ethical decisions in complex real-world situations. Using controversial GM mosquito research as an example, I illustrate how the generalizable relationships between the variables clarify emerging ethical guidelines of research governance and provide a pathway to extend these guidelines in a way consistent with our ethical intuitions across a wide range of research and public health ethics. (shrink)

Medical artificial intelligence (AI) is considered to be one of the most important assets for the future of innovative individual and public health care. To develop innovative medical AI, it is necessary to repurpose data that are primarily generated in and for the health care context. Usually, health data can only be put to a secondary use if data subjects provide their informed consent (IC). This regulation, however, is believed to slow down or even prevent vital medical research, including AI (...) development. For this reason, a number of scholars advocate a moral civic duty to share electronic health records (EHRs) that overrides IC requirements in certain contexts. In the medical AI context, the common arguments for such a duty have not been subjected to a comprehensive challenge. This article sheds light on the correlation between two normative discourses concerning informed consent for secondary health record use and the development and use of medical AI. There are three main arguments in favour of a civic duty to support certain developments in medical AI by sharing EHRs: the ‘rule to rescue argument’, the ‘low risks, high benefits argument’, and the ‘property rights argument’. This article critiques all three arguments because they either derive a civic duty from premises that do not apply to the medical AI context, or they rely on inappropriate analogies, or they ignore significant risks entailed by the EHR sharing process and the use of medical AI. Given this result, the article proposes an alternative civic responsibility approach that can attribute different responsibilities to different social groups and individuals and that can contextualise those responsibilities for the purpose of medical AI development. (shrink)

In his paper, ‘What moral work can Nussbaum’s account of human dignity do in the context of dementia care?’, Soofi seeks to modify Nussbaum’s conception of dignity to deal with four key objections that arise when appeals to dignity are made in the context of dementia care. We will not discuss the first of these, the redundancy of dignity talk, since this issue has already been much discussed in the literature. Instead, we will focus on the remaining three issues raised, (...) that of the exclusion of persons with advanced dementia from having dignity, unjustified speciesism as a ground of human dignity, and the unclear practical implications that follow from having dignity. (shrink)

On 24 July 2022, the landmark decision Roe v. Wade (1973), that secured a right to abortion for decades, was overruled by the US Supreme Court. The Court decision in Dobbs v. Jackson Women’s Health Organisation severely restricts access to legal abortion care in the USA, since it will give the states the power to ban abortion. It has been claimed that overruling Roe will have disproportionate impacts on women of color and that restricting access to abortion contributes to or (...) amounts to structural racism. In this paper, we consider whether restricting abortion access as a consequence of overruling Roe could be understood as discrimination against women of color (and women in general). We argue that banning abortion is indirectly discriminatory against women of color and directly (but neither indirectly, nor structurally) discriminatory against women in general. (shrink)

Definition of the problem Feminist approaches to medical ethics are well established in international discourses. By contrast, in the German-speaking medical ethical discourse, they still seem to be rather marginal. In this article, we analyze which feminist perspectives are prominent in German medical ethics and suggest new approaches. Arguments We present our results from a systematized review of the literature, in which we identify existing feminist approaches within the German-speaking medical ethics discourse as well as research gaps. Based on the (...) review, our preliminary research and discussions in the working group “Feminist perspectives in bio and medical ethics”, we defend three hypotheses aimed at advancing the German feminist medical ethical discourse. We posit that (1) feminist medical ethics aim at (epistemic) justice, (2) feminist medical ethics are critical and context-sensitive, and (3) intersectional and postcolonial approaches within feminist medical ethics may contribute to epistemically just, critical, and context-sensitive medical ethics. Conclusion We argue that feminist perspectives should be implemented as a fundamental perspective in medical ethics because they can bring together key dimensions such as epistemically just, critical, context-sensitive, intersectional, and postcolonial thinking. (shrink)

Research involving human participants requires their consent, and it is common practice to capture consent information on paper and store those hard copies, presenting issues such as long-term storage requirements, inefficient retrieval of consent forms for reference or future use, and the potential for transcription errors when transcribing captured informed consent. There have been calls to move to electronic capture of the consent provided by research participants (e-consent) as a way of addressing these issues. A tiered framework for e-consent was (...) designed using the freely available features in the inbuilt REDCap e-consent module. We implemented ‘branching logic’, ‘wet signature’ and ‘auto-archiver’ features to the main informed consent and withdrawal of consent documents. The branching logic feature streamlines the consent process by making follow-up information available depending on participant response, the ‘wet signature’ feature enables a timestamped electronic signature to be appended to the e-consent documents and the ‘auto-archiver’ allows for PDF copies of the e-consent documents to be stored in the database. When designing the content layout, we provided example participant information text which can be modified as required. Emphasis was placed on the flow of information to optimise participant understanding and this was achieved by merging the consent and participant information into one document where the consent questions were asked immediately after the corresponding participant information. In addition, we have provided example text for a generic human genomic research study, which can be easily edited and modified according to specific requirements. Building informed consent protocols and forms without prior experience can be daunting, so we have provided researchers with a REDCap template that can be directly incorporated into REDCap databases. It prompts researchers about the types of consent they can request for genomics studies and assists them with suggestions for the language they might use for participant information and consent questions. The use of this tiered e-consent module can ensure the accurate and efficient electronic capture and storage of the consents given by participants in a format that can be easily queried and can thus facilitate ethical and effective onward sharing of data and samples whilst upholding individual participant preferences. (shrink)

Background Clinical ethics consultation (CEC) is not sufficiently widespread in Japan. A possible reason is that a practical training system for CEC has not been established. Hence, we have developed “immersive role-play (IR)” as a practical training program that applies a new theatrical technique, immersive theater, to role-play learning. Its characteristics include high fidelity in the use of a studio and actors and dynamic realism in the progression of the scenario to immerse learners in role-play learning. Methods We offered an (...) intensive course on CEC for healthcare professionals from 2016 to 2019, with IR as part of the course curriculum. A questionnaire survey was administered to the participants regarding the educational effectiveness of IR. The questionnaire was anonymous, and participants responded on a 4-point Likert scale regarding their satisfaction with IR and their perception of its learning effects. An open-ended section at the end of the questionnaire asked about the effectiveness and areas for improvement of IR. Results The questionnaire survey showed good results in all categories: usefulness, satisfaction, understanding, and interest. In the questions that compared the learning to traditional role-play learning, the participants gave significantly high ratings, specifically for “realism,“ “seriousness,“ “understanding the importance of communication skills,“ and “understanding the diversity of the narratives.“ In the free-text responses, the most frequent response was that they learned a lot about the practical procedures for participation. Conclusion IR is sufficiently effective as a practical educational program, but not for everyone. It is suitable for those who are or will soon work as consultants. Conversely, beginners and intermediates who have not fully mastered the CEC theory and skills will need a stage-specific educational program separate from the IR. (shrink)

Like the ‘thoughts and prayers’ so commonly offered by politicians in the aftermath of disaster, it is incredibly common to hear ‘autonomy and dignity’ invoked together in response to some threat to human wellbeing. As such, it seems natural to assume they must bear some kind of relation to one another. But are they merely two core human interests, that happen to be vulnerable to the same kinds of threat? Or are they interrelated in a deeper way? What I aim (...) to do in this chapter is draw on the philosophical literature on both concepts to consider how they might be connected, and explore whether certain ways of connecting them are more fruitful than others. I argue that the two most prominent connections drawn in the philosophical literature – that dignity is grounded in autonomy, and that respect for dignity is synonymous with respect for autonomy – are both highly problematic. Instead, I suggest we see autonomy and dignity as mutually supportive. Doing so has both practical and theoretical benefits: it can help us identify threats to both autonomy and dignity; and it exposes theoretical lacunae, especially within the autonomy literature. (shrink)

Blumenthal-Barby et al. (2022) present a nuanced and convincing case for the continued presence of moral and political philosophers in bioethics. We agree with the authors that philosophers should have a role in bioethical inquiry. However, we partly disagree on what that role should be. We assess the case taking our clues from a concern the authors mention – and another one that they do not directly address.

Since March of 2020, the world has been brought to its knees by unscientific and unethical mandates. These mandates have destroyed the world economy and the lives of countless innocent individuals. The “cure” that has been offered by medical bureaucrats and politicians has been more deadly than the disease (COVID-19). The imposition of ludicrous lockdowns, mask-wearing, coerced vaccination, and vaccine passports have not only proved to be ineffective, but also much more harmful than SARS-CoV-2 and all its variants. COVID-19 has (...) a recovery rate of close to 99% for most of the world’s population, however, despite this, institutions and power-hungry individuals have trampled upon our civil liberties and ignored our inalienable human rights. It is precisely as Thomas Paine famously stated: “The greatest tyrannies are always perpetrated in the name of the noblest causes.” -/- Many lives have been gratuitously lost because of the administration of deadly medical treatments, and the rejection of effective treatments that follow genuine science. In the process, informed consent has been disparaged and desecrated. For over two years, we were instructed to “trust the science,” but the “science” advocated by medical bureaucrats and greedy politicians was the reason why the world was turned upside-down. In the face of these crimes against humanity, justice will only be brought by real courts and real judges, but this will require the awakening of a critical mass. This book serves as an instrument for this awakening. (shrink)

Background Bioethics can play an important role in addressing diversity both in and outside of academia, setting precedents for meaningful contributions to public discourse, research, teaching, training, and policy development. However, in order to do so, these conversations also need to reflect on the issue of diversity within the field of bioethics across the globe. This study aims to examine current gender representation and diversity at medical ethics and humanities institutes in Germany, the German-speaking areas of Switzerland, and Austria. Methods (...) A total of forty-nine medical ethics and humanities institutes from Germany (n=42), the German-speaking areas of Switzerland (n=5), and Austria (n=2) were included in the study. Institutes websites were reviewed in the first week of March 2021 and the details of each staff member listed on the website recorded. Results Overall, a total of 964 staff members were identified at the forty-nine German-speaking medical ethics and humanities institutes. Just over half (530/964; 55%) of all staff were female. There were significant differences between gender in some staff positions: 64.6 per cent (31/48) of directors were male (χ 2 (1) =4.1, _P=_.04); 62.7 per cent (84/134) of student assistants were female (χ 2 (1) =8.6, _P=_.003); and 83.7 per cent (77/92) of administrative staff were female (χ 2 (1) =41.8, _P_ 2 (1) =8.8, _P=_.003). When comparing the institute director’s gender presentation with staff gender presentation, it was found that male-led institutes had 53.4 per cent (286/536) female staff overall but had 52.7 per cent (136/258) male researchers and lecturers. However, the difference between genders were not found to be significant. On the other hand, female-led institutes had significantly more female staff overall (59.9% (223/372); χ 2 (1) =14.7, _P_ 2 (1) =6.4, _P=_.01). Conclusions There has been a significant push to address gender diversity in German-speaking academia, and this study finds overall good gender parity in medical ethics and humanities institutes. However, there has not been a similar openness to discussing issues of systemic racism or how other forms of inequality affect academic diversity. Taking diversity seriously requires opening up conversations around intersectionality, including difficult conversations around race and cultural background that have long been taboo in German-speaking countries. (shrink)

This article surveys and analyses the reflections on medical ethics teaching by colleagues teaching in United Kingdom (UK) medical schools in the early 2020s. Participants were recruited mainly by using the worldwide web to identify 64 people from 41 UK medical schools who were thought to contribute to teaching medical ethics based on their internet profiles. Twenty-three people responded. The survey data reveals that many staff are happy with the provision of medical ethics teaching, but also that some are concerned (...) about the quality of provision due to concerns with staff expertise and teaching time. In spite of the fact that the General Medical Council (GMC) and other organisations are perceived to have contributed to raising the profile of medical ethics, there is significant concern with how it is embedded within local UK medical curricula. Some participants contributed hardly or not at all to research in medical ethics, where one attributed this decline in research to the pandemic. Future work will need to address what can be done to improve the provision of medical ethics teaching to address some of these findings and to survey and analyse how perceptions might have changed in light of recent challenges and developments. (shrink)

Background Seeking assent from children for participation in medical research is an ethical imperative of numerous institutions globally. However, none of these organizations provide specific guidance on the criteria or process to be used when obtaining assent. The primary objective of this scoping review was to determine the descriptions of assent discussed in the literature and the reported criteria used for seeking assent for research participation in pre-adolescent children. Methods Medline and Embase databases were searched until November 2020 using the (...) term “assent” in the title or abstract. Inclusion criteria were studies enrolling children which specifically described operationalization of the assent process and studies of the assent process which provided a description of assent. Data collected included participant information, patient criteria for seeking assent, guidelines referenced, description of assent reported, how assent was obtained and assent information presented, and reported assent rate. For qualitative articles focusing on the assent process, important themes were identified. Results A total of 116 articles were included of which 79 operationalized assent and 57 studies described the assent process. The most commonly reported criterion used to determine the ability of a child to assent was age. The reported minimal age for obtaining pediatric assent varied considerably across and within jurisdictions. Cognitive ability was reported as a criterion for obtaining assent in 5.1% of studies. Assent rates were only reported in 17.7% of citations and ranged from 32.0 to 100%. Analysis of the 57 studies describing the assent process identified several themes, including age thresholds, assessment of capacity, variable knowledge of pediatric assent and parental roles. Conclusion We found significant variation in criteria used for assessment of patient capacity, delivery of information used to obtain assent and documentation of the assent process. While we acknowledge that individual children, settings and jurisdictions may require different approaches to obtaining assent, there should be agreement on important principles to be followed with resulting common guidance on assessing capacity, delivering information and documentation of the assent process for publication. (shrink)

Background While healthcare professionals’ right to invoke the conscience clause has been recognised as a fundamental human right, it continues to provoke a heated debate in Polish society. Although public discourse is filled with ethical and legal considerations on the conscience clause, much less is known about the attitudes of healthcare professionals regarding that matter. The aim of this study was therefore to describe the attitudes of Polish physicians, nurses and pharmacists towards the ethical and legal aspects of the conscience (...) clause. Methods We analysed a group of three hundred healthcare professionals: physicians, nurses and pharmacists in Poznan, Poland, using a standard questionnaire comprising of 29 questions about various ethical and legal aspects of the conscience clause and participants’ personal experiences with the conscience clause. The study was conducted between January and March 2020. Results This research shows that although most Polish healthcare workers support the right to invoke the conscience clause they differ significantly in their opinions on to whom and to what medical procedures the conscience clause should apply to. It also demonstrated that while the conscience clause is rarely invoked in Poland, most healthcare professionals declare that the current legal regulations in that sphere are unclear and inaccurate. Conclusions While there is an urgent need to raise the awareness regarding the conscience clause among medical students and healthcare professionals and educate them about such issues, it is even more important to improve the legal system in regard to the CC so that it protects both HCPs’ right to the CC and safeguards patients’ rights to medical services. (shrink)

Background Residual dried blood spots from newborn screening programmes represent a valuable resource for medical research, from basic sciences, through clinical to public health. In Hong Kong, there is no legislation for biobanking. Parents’ view on the retention and use of residual newborn blood samples could be cultural-specific and is important to consider for biobanking of rDBS. Objective To study the views and concerns on long-term storage and secondary use of rDBS from newborn screening programmes among Hong Kong Chinese parents. (...) Methods A mixed-method approach was used to study the views and concerns on long-term storage and secondary use of rDBS from newborn screening programmes among Hong Kong Chinese parents of children 0–3 years or expecting parents through focus groups and a survey designed with insights obtained from the focus groups. We used framework analysis to summarise the themes as supportive factors, concerns and critical arguments for retention and secondary use of rDBS from focus group discussion. We used multiple logistic regression to assess factors associated with support for retention and secondary use of rDBS in the survey. Results Both in focus groups and survey, majority of parents were not aware of the potential secondary use of rDBS. Overall secondary use of rDBS in medical research was well accepted by a large proportion of Hong Kong parents, even if all potential future research could not be specified in a broad consent. However parents were concerned about potential risks of biobanking rDBS including leaking of data and mis-use of genetic information. Parents wanted to be asked for permission before rDBS are stored and mainly did not accept an “opt-out” approach. The survey showed that parents born in mainland China, compared to Hong Kong born parents, had lower awareness of newborn screening but higher support in biobanking rDBS. Higher education was associated with support in rDBS biobanking only among fathers. Conclusion Long-term storage and secondary use of rDBS from newborn screening for biomedical research and a broad consent for biobanking of rDBS are generally acceptable to Hong Kong parents given their autonomy is respected and their privacy is protected, highlighting the importance of an accountable governance and a transparent access policy for rDBS biobanks. (shrink)

Background The ownership status of individual-level health data affects the manner in which it is used. In this paper we analyze two competing models of the ownership status of the data discussed in the literature recently: private ownership and public ownership. Main body In this paper we describe the limitations of these two models of data ownership with respect to individual-level health data, in particular in terms of ethical principles of justice and autonomy, risk mitigation, as well as technological, economic, (...) and conceptual issues. We argue that undifferentiated application of neither private ownership nor public ownership will allow us to resolve all the problems associated with effective, equitable, and ethical use of data. We suggest that, instead of focusing on data ownership, we should focus on the institutional and procedural aspects of data governance, such as using Data Access Committees or equivalent managed access processes, which can balance the elements of these two ownership frameworks. Conclusion Undifferentiated application of the ownership concept is not helpful in resolving problems associated with sharing individual-level health data. DACs or equivalent managed access processes should be an integral part of data governance. They can approve or disapprove data access requests after considering the potential benefits and harms to data subjects, their communities, primary researchers, and the wider society. (shrink)

Background Informed consent is a process in which a healthcare provider obtains permission from an individual prior to surgery. Patient satisfaction with the informed consent process is one of the main indicators of healthcare service quality. This study aimed to assess patient satisfaction with surgical informed consent at Jimma Medical Center, Ethiopia, in 2020. Methods A facility-based cross-sectional study was conducted from April 1 to June 30, 2020, at Jimma Medical Center. Face-to-face interviews were conducted using structured questionnaires. A systematic (...) sampling technique was used to select the study participants. The collected data were coded, entered into Epi data version 3.1, and analyzed using SPSS version 25. Bivariate and multivariate regression analyses were performed to determine the association between patient satisfaction and socio-demographic and facility-related factors. In multivariate regression, predictors with a P-value of < 0.05 were considered statistically significant. Results Totally 372 study participants were interviewed with a response rate of 97.8%. Nearly two-fifths of patients were satisfied with surgical informed consent. Living in an urban area, having current referred history, consent form version, time spent on the provision of informed consent and having better patient-health providers relationship predictors were positively associated with patient satisfaction. Conclusion Patient satisfaction with the surgical informed consent process was relatively low. Therefore, Health care professionals need to emphasize a way of delivering informed consent, patients' needs and obey a standard informed consent to improve patient satisfaction. (shrink)

A practical approach to ethics -- The doctor-patient relationship -- Consent, choice, and refusal : adults with capacity -- Treating adults who lack capacity -- Treating children and young people -- Confidentiality -- Management of health records --Prescribing and administering medication.

Intersubjectivity is the proposition that human experience occurs in a world of shared and embodied understandings, mediated by culture and language. Nursing is fundamentally relational, and nursing research stems from an exchange between participants and researchers and indeed around the transaction of the patient and the nurse in the intersubjective space of clinical settings. Through the philosophical standpoints of Husserl, Merleau-Ponty, Heidegger, and Gadamer we examine these differing philosophical constructs of intersubjectivity and the contribution of these positions to phenomenological nursing (...) inquiry. Particular framings of intersubjectivity should influence the way researchers interact with their participants and data so that the chosen philosophy sits coherently within a research plan and methodology. This exploration of philosophical standpoints is extended through examples of, and reflections upon, the authors' experiences of intersubjectivity in our published phenomenological nursing studies and through dynamic interactions that characterise interpretive activities within a research team. (shrink)