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Current international legal instruments recognise the use of advance directives to carry on the will of the dementing research participant beyond the boundaries of her present legal capacity. Advance directives are gaining greater recognition in patient care than in medical research, where their legal status is still somewhat unclear. In particular, the three major international documents on medical research – the Council of Europe Convention on Biomedicine and Human Rights (ETS 164), its Additional Protocol on Biomedicai Research (ETS 195), and Directive 2001/20/EC on Clinical Trials on Medicinal Products – give conflicting messages on the legal status of advance directives in medical research. This article examines the provisions in these documents and their national applications in Finland and the United Kingdom.

Austerity, by its very nature, imposes constraints by limiting the options for action available to us because certain courses of action are too costly or insufficiently cost effective. In the context of healthcare, the constraints imposed by austerity come in various forms; ranging from the availability of certain treatments being reduced or withdrawn completely, to reductions in staffing that mean healthcare professionals must ration the time they make available to each patient. As austerity has taken hold, across the United Kingdom and Europe, it is important to consider the wider effects of the constraints that it imposes in healthcare. Within this paper, we focus specifically on one theorised effect—moral distress. We differentiate between avoidable and unavoidable ethical challenges within healthcare and argue that austerity creates additional avoidable ethical problems that exacerbate clinicians’ moral distress. We suggest that moral resilience is a suitable response to clinician moral distress caused by unavoidable ethical challenges but additional responses are required to address those that are created due to austerity. We encourage clinicians to engage in critical resilience and activism to address problems created by austerity and we highlight the responsibility of institutions to support healthcare professionals in such challenging times.

Background National Ethics Committees (NECs) offer important oversight and guidance functions and facilitate public debate on bioethical issues. In an increasingly globalized world where technological advances, multi-national research collaborations, and pandemics are creating ethical dilemmas that transcend national borders, coordination and the joining of efforts among NECs are key. The purpose of this study is to take stock of the current NEC landscape, their varying roles and missions, and the range of bioethical topics on which they deliberated since their inception. Methods Data on the availability, functions, and ethical deliberations (publications) of NECs globally were gathered through a systematic search of NEC websites and through contacts known to the authors. The search was conducted in English, French, and Spanish. The data abstraction was done in Excel and included the NEC’s country, region, functions, and deliberations on bioethical issues. Deliberation topics were classified into thematic categories through an iterative process of regrouping to arrive at the main set of themes. Results 124 NECs in 100 countries were identified. 44% of the NECs are in Europe and 47% are in high-income countries. Out of the 1108 retrieved publications, 40% were on bioethics in the context of research, followed by the clinic (28%) and public health issues (22%). The top five topics of these publications were: research ethics (124; 9%), genetics and genomics (62; 6%), organ transplantation (58; 5%), assisted reproductive technology (49; 4%), and end of life (36; 3%). Conclusion Our study makes an important contribution to understanding the current interests and functions of NECs and the range of their bioethics deliberations. By making the data publicly available through this publication, it allows users to conduct tailored analyses and queries based on their interests, and to seek and strengthen collaboration and exchange. It also makes the case for the fruitfulness of developing and maintaining a global repository of current and new deliberations to more effectively advance this field for the greater good of humanity, research, and public health.

Calls for solidarity have been an ubiquitous feature in the response to the COVID-19 pandemic. However, we know little about how people have thought of and practised solidarity in their everyday lives since the beginning of the pandemic. What role does solidarity play in people’s lives, how does it relate to COVID-19 public health measures and how has it changed in different phases of the pandemic? Situated within the medical humanities at the intersection of philosophy, bioethics, social sciences and policy studies, this article explores how the practice-based understanding of solidarity formulated by Prainsack and Buyx helps shed light on these questions. Drawing on 643 qualitative interviews carried out in two phases (April–May 2020 and October 2020) in nine European countries (Austria, Belgium, France, Germany, Ireland, Italy, The Netherlands, German-speaking Switzerland and the UK), the data show that interpersonal acts of solidarity are important, but that they are not sustainable without consistent support at the institutional level. As the pandemic progressed, respondents expressed a longing for more institutionalised forms of solidarity. We argue that the medical humanities have much to gain from directing their attention to individual health issues, and to collective experiences of health or illness. The analysis of experiences through a collective lens such as solidarity offers unique insights to understandings of the individual and the collective. We propose three essential advances for research in the medical humanities that can help uncover collective experiences of disease and health crises: (1) an empirical and practice-oriented approach alongside more normative approaches; (2) the confidence to make recommendations for practice and policymaking and (3) the pursuit of cross-national and multidisciplinary research collaborations.

Rare diseases (RD) patient registries are powerful instruments that help develop clinical research, facilitate the planning of appropriate clinical trials, improve patient care, and support healthcare management. They constitute a key information system that supports the activities of European Reference Networks (ERNs) on rare diseases. A rapid proliferation of RD registries has occurred during the last years and there is a need to develop guidance for the minimum requirements, recommendations and standards necessary to maintain a high-quality registry. In response to these heterogeneities, in the framework of RD-Connect, a European platform connecting databases, registries, biobanks and clinical bioinformatics for rare disease research, we report on a list of recommendations, developed by a group of experts, including members of patient organizations, to be used as a framework for improving the quality of RD registries. This list includes aspects of governance, Findable, Accessible, Interoperable and Reusable (FAIR) data and information, infrastructure, documentation, training, and quality audit. The list is intended to be used by established as well as new RD registries. Further work includes the development of a toolkit to enable continuous assessment and improvement of their organizational and data quality.

Background The underrepresentation of scholarly works from low- and middle-income countries (LMICs) in academic literature is a documented concern, attributed partly to editorial biases. This trend, prevalent across various disciplines, has been less explored in the context of medical ethics journals. This study aimed to examine the composition of editorial board members (EBM) in high-impact medical ethics journals and to evaluate the extent of international diversity within these editorial teams. Methods This study incorporated an analysis of 16 high-impact medical ethics journals. Information regarding the EBM of these journals was systematically gathered and categorized based on the World Bank’s country income classifications. An in-depth examination of the editorial board compositions was then conducted. Results The study identified 669 EBM across the selected journals. A predominant 89.84% (601) of these members were from high-income countries (HICs), with upper-middle-income countries contributing 7.47% (50) and lower-middle-income countries 2.69% (18). No EBM were associated with low-income countries. A regional breakdown indicated that North America was the most represented area, accounting for 48.88% (327), followed by Europe & Central Asia (27.50%, 184), East Asia & Pacific (13.45%, 90), Latin America & Caribbean (4.63%, 31), Sub-Saharan Africa (4.19%, 28), Middle East & North Africa (0.75%, 5), and South Asia (0.60%, 4). In total, these EBMs hailed from 46 different countries, with the United States representing the largest proportion (43.80%, 293), followed by the United Kingdom (13.15%, 88), Australia (7.92%, 53), Germany (6.73%, 45), and Canada (5.08%, 34). Conclusions There is a significant lack of international representation within the EBM of high-impact medical ethics journals. The majority of editors in this field are affiliated with HICs, leading to a severe underrepresentation of LMICs within the editorial boards.

Background During recent decades, providing patients with access to their electronic health records (EHRs) has advanced in healthcare. In the European Union (EU), the General Data Protection Regulation provides individuals with the right to check their data in registries such as EHRs. A proposal for a European Health Data Space has been launched, which will further strengthen patients’ right to have online access to their EHRs throughout Europe. Against these policy changes, scant attention has been paid to the ethical question about whether adolescents and parents should access the adolescent’s EHR, and if so, under what conditions. Methods In this paper, we apply biomedical ethical principles to explore key questions about adolescents’ and parents’ access to adolescents’ EHRs, with the aim of informing future discussions about the development of ethical and policy practice guidelines. Results Drawing on current empirical research, we find preliminary evidence that in some contexts, patient online record access (ORA) could help to facilitate autonomy for adolescents and parents as well as offering support in managing appointments and medications. Notably, however, we find contrasting perspectives between adolescents’ and parents’ experienced benefits and healthcare professionals’ (HCPs) perceived potential harm, with the latter worried about decreased documentation quality after access. Concerns about capacity to understand their health information, and increased anxiety among adolescents obstruct the support of adolescent autonomy among parents and HCPs. Still, research is limited, particularly with respect to adolescents’ experiences of reading their EHRs, and differences across settings have not been closely examined. Conclusions To advance more comprehensive understanding of the effects of ORA, and to inspire greater attention to, and development of, evidence-informed ethical guidance in this domain of clinical practice, we outline a range of empirical questions regarding adolescents’ and parents’ experiences that now warrant further study.

There is a growing international agreement on the need to provide greater access to research data and bio-specimen collections to optimize their long-term value and exploit their potential for health discovery and validation. This is especially evident for rare disease research. Currently, the rising value of data and bio-specimen collections does not correspond with an equal increase in data/sample-sharing and data/sample access. Contradictory legal and ethical frameworks across national borders are obstacles to effective sharing: more specifically, the absence of an integrated model proves to be a major logistical obstruction. The Charter intends to amend the obstacle by providing both the ethical foundations on which data sharing should be based, as well as a general Material and Data Transfer Agreement (MTA/DTA). This Charter is the result of a careful negotiation of different stakeholders' interest and is built on earlier consensus documents and position statements, which provided the general international legal framework. Further to this, the Charter provides tools that may help accelerate sharing. The Charter has been formulated to serve as an enabling tool for effective and transparent data and bio-specimen sharing and the general MTA/DTA constitutes a mechanism to ensure uniformity of access across projects and countries, and may be regarded as a consistent basic agreement for addressing data and material sharing globally. The Charter is forward looking in terms of emerging issues from the perspective of a multi-stakeholder group, and where possible, provides strategies that may address these issues.

Background Freedom of conscience is a core element of human rights respected by most European countries. It allows abortion through the inclusion of a conscience clause, which permits opting out of providing such services. However, the grounds for invoking conscientious objection lack clarity. Our aim in this paper is to take a step in this direction by carrying out a systematic review of reasons by midwives and nurses for declining, on conscience grounds, to participate in abortion. Method We conducted a systematic review of ethical arguments asking, “What reasons have been reported in the argument based literature for or against conscientious objection to abortion provision by nurses or midwives?” We particularly wanted to identify any discussion of the responsibilities of midwives and nurses in this area. Search terms were conscientious objection and abortion or termination and nurse or midwife or midwives or physicians or doctors or medics within the dates 2000–2016 on: HEIN legal, Medline, CINAHL, Psychinfo, Academic Search Complete, Web of Science including publications in English, German and Dutch. Final articles were subjected to a rigorous analysis, coding and classifying each line into reason mentions, narrow and broad reasons for or against conscientious objection. Results Of an initial 1085 articles, 10 were included. We identified 23 broad reasons, containing 116narrow reasons and 269 reason mentions. Eighty one (81) narrow reasons argued in favour of and 35 against conscientious objection. Using predetermined categories of moral, practical, religious or legal reasons, “moral reasons” contained the largest number of narrow reasons ( n  =  58). The reasons and their associated mentions in this category outnumber those in the sum of the other three categories. Conclusions We identified no absolute argument either for or against conscientious objection by midwives or nurses. An invisibility of midwives and nurses exists in the whole debate concerning conscientious objection reflecting a gap between literature and practice, as it is they whom WHO recommend as providers of this service. While the arguments in the literature emphasize the need for provision of conscientious objection, a balanced debate is necessary in this field, which includes all relevant health professionals.

Background Health examination surveys (HESs), carried out in Europe since the 1950’s, provide valuable information about the general population’s health for health monitoring, policy making, and research. Survey participation rates, important for representativeness, have been falling. International comparisons are hampered by differing exclusion criteria and definitions for non-response. Method Information was collected about seven national HESs in Europe conducted in 2007–2012. These surveys can be classified into household and individual-based surveys, depending on the sampling frames used. Participation rates of randomly selected adult samples were calculated for four survey modules using standardised definitions and compared by sex, age-group, geographical areas within countries, and over time, where possible. Results All surveys covered residents not just citizens; three countries excluded those in institutions. In two surveys, physical examinations and blood sample collection were conducted at the participants’ home; the others occurred at examination clinics. Recruitment processes varied considerably between surveys. Monetary incentives were used in four surveys. Initial participation rates aged 35–64 were 45 % in the Netherlands (phase II), 54 % in Germany (new and previous participants combined), 55 % in Italy, and 65 % in Finland. In Ireland, England and Scotland, household participation rates were 66 %, 66 % and 63 % respectively. Participation rates were generally higher in women and increased with age. Almost all participants attending an examination centre agreed to all modules but surveys conducted in the participants’ home had falling responses to each stage. Participation rates in most primate cities were substantially lower than the national average. Age-standardized response rates to blood pressure measurement among those aged 35–64 in Finland, Germany and England fell by 0.7-1.5 percentage points p.a. between 1998–2002 and 2010–2012. Longer trends in some countries show a more marked fall. Conclusions The coverage of the general population in these seven national HESs was good, based on the sampling frames used and the sample sizes. Pre-notification and reminders were used effectively in those with highest participation rates. Participation rates varied by age, sex, geographical area, and survey design. They have fallen in most countries; the Netherlands data shows that they can be maintained at higher levels but at much higher cost.