Anna Sierawska

Despite the physical proximity between Poland and Germany, there are differences between the two countries in terms of language, customs, healthcare systems, legal frameworks, and socio-economic conditions. These differences and the membership of both countries in the European Union make cross-border healthcare a complex bioethical field. This paper examines the key areas of healthcare provision that are influenced by the political and geographical circumstances between Poland and Germany. This work employs an exploratory approach to map ethical risks and challenges using literature reviews and diverse sources (policy documents, local media reports, etc.). Ethical analysis is rooted in various established frameworks. We outline six areas where patient and healthcare staff mobility may raise ethical issues: (1) access to termination of pregnancy, (2) implications of differing regulations on artificial reproductive technologies, (3) dental care, (4) patient mobility for planned treatments under Directive 2011/24/EU, (5) healthcare challenges in border regions, and (6) migration of healthcare staff. The German and Polish healthcare systems, rooted in principles of solidarity, aim to provide equal access to healthcare services. European Union regulations allow patients to receive treatment abroad, but this can strain state budgets, particularly in less affluent countries. Language barriers might also impact doctor–patient interactions and the process of gaining informed consent. Political and economic differences further complicate ethical dilemmas, affecting healthcare migration and treatment availability. Asymmetric resources might contribute to the growth of private healthcare, affecting integrated public services locally and internationally.

Integrating artificial intelligence (AI) into critical domains such as healthcare holds immense promise. Nevertheless, significant challenges must be addressed to avoid harm, promote the well-being of individuals and societies, and ensure ethically sound and socially just technology development. Innovative approaches like Embedded Ethics, which refers to integrating ethics and social science into technology development based on interdisciplinary collaboration, are emerging to address issues of bias, transparency, misrepresentation, and more. This paper aims to develop this approach further to enable future projects to effectively deploy it. Based on the practical experience of using ethics and social science methodology in interdisciplinary AI-related healthcare consortia, this paper presents several methods that have proven helpful for embedding ethical and social science analysis and inquiry. They include (1) stakeholder analyses, (2) literature reviews, (3) ethnographic approaches, (4) peer-to-peer interviews, (5) focus groups, (6) interviews with affected groups and external stakeholders, (7) bias analyses, (8) workshops, and (9) interdisciplinary results dissemination. We believe that applying Embedded Ethics offers a pathway to stimulate reflexivity, proactively anticipate social and ethical concerns, and foster interdisciplinary inquiry into such concerns at every stage of technology development. This approach can help shape responsible, inclusive, and ethically aware technology innovation in healthcare and beyond.

Background Transcranial direct current stimulation (tDCS) is a brain stimulation technique currently being researched as an alternative or complimentary treatment for various neurological disorders. There is little knowledge about experiences of the participants of tDCS clinical research, especially from pediatric studies. Methods An interview study with typically developing minors (n = 19, mean age 13,66 years) participating in a tDCS study, and their parents (n = 18) was conducted to explore their views and experiences and inform the ethical analysis. Results Children (10–13 years old) and adolescents (14–18 years old) reported good experiences with the stimulation. Next to financial incentives, main motives to participate in the study were curiosity and the possibility to help develop treatments for children affected by neurological disorders. They could also see a potential of using tDCS in a non-medical setting, especially regarding the provision of equal opportunity, e.g. in education. Parents also presented a positive attitude towards tDCS and their children participation in the basic research study. Nevertheless, their understanding of tDCS was rather poor. Even though many of them understood the techniques, they often did not see the link between the (current) lack of side effects and an absence of longitudinal studies. Parents were also cautious about using tDCS for non-medical/enhancement purposes. Conclusions The study findings show a need for more transparent information about the state of the art of tDCS, its function and what it might be able to offer, especially considering the good acceptability of tDCS.

Background In the course of the COVID-19 pandemic, the biomedical research community’s attempt to focus the attention on fighting COVID-19, led to several challenges within the field of research ethics. However, we know little about the practical relevance of these challenges for Research Ethics Committees. Methods We conducted a qualitative survey across all 52 German RECs on the challenges and potential solutions with reviewing proposals for COVID-19 studies. We de-identified the answers and applied thematic text analysis for the extraction and synthesis of challenges and potential solutions that we grouped under established principles for clinical research ethics. Results We received an overall response rate of 42%. The 22 responding RECs reported that they had assessed a total of 441 study proposals on COVID-19 until 21 April 2020. For the review of these proposals the RECs indicated a broad spectrum of challenges regarding social value, scientific validity, favourable risk–benefit ratio, informed consent, independent review, fair selection of trial participants, and respect for study participants. Mentioned solutions ranged from improved local/national coordination, over guidance on modified consent procedures, to priority setting across clinical studies. Conclusions RECs are facing a broad spectrum of pressing challenges in reviewing COVID-19 studies. Some challenges for consent procedures are well known from research in intensive care settings but are further aggravated by infection measures. Other challenges such as reviewing several clinical studies at the same time that potentially compete for the recruitment of in-house COVID-19 patients are unique to the current situation. For some of the challenges the proposed solutions in our survey could relatively easy be translated into practice. Others need further conceptual and empirical research. Our findings together with the increasing body of literature on COVID-19 research ethics, and further stakeholder engagement should inform the development of hands-on guidance for researchers, funders, RECs, and further oversight bodies.

Prenatal diagnosis challenges the issue of parental autonomy. Two ethical aspects of the parental decision making process with reference to PND have been taken into consideration: the duty to know and the right not to know. Whilst the first approach has been widely discussed in literature, the latter seems to be overlooked. In order to find good moral reasons supporting the right not to know, firstly the duty to know approach was critically analysed. Subsequently, the emphasis was put on the unconditional parental love and the issue of child’s best interests as the features supporting parental right not to know. The clarification of what is good parenthood was presented as the best normative approach supporting the parental right not to know in case of PND. Apart from parental autonomy, raising the question of the right not to know is important in the debate about the place and role of people with disabilities in society.

We discuss an epileptic incident in an undiagnosed 13-year old girl participating in a clinical study investigating the effects of transcranial direct current stimulation in healthy children and adolescents. This incident poses important research ethics questions with regard to study design, especially pertaining to screening and gaining informed consent. Potential benefits and problems of the incident also need to be considered. The ethical analysis of the case presented in this paper has been informed by an in-depth interview conducted after the incident with the child and the accompanying parent. We discuss the ethical implications of the epileptic incident, the need for improving screening procedures for studies with minors and for providing more effective communication. This case also underscores the problem of undetected teenage epilepsy in neuropsychological clinical studies and the necessity of raising more awareness of this issue. Since research in tDCS is an active and expanding field, we conclude with providing some recommendation that could ensure that future research on tDCS, or other therapies and neuro-interventions where there is a risk of triggering an epileptic seizure, take into account the specifics of teenage epilepsy and the need for more thorough provision of information during the process of gaining informed consent.