Non-empirical methods for ethics research on digital technologies in medicine, health care and public health: a systematic journal review.

Bioethics has developed approaches to address ethical issues in health care, similar to how technology ethics provides guidelines for ethical research on artificial intelligence, big data, and robotic applications. As these digital technologies are increasingly used in medicine, health care and public health, thus, it is plausible that the approaches of technology ethics have influenced bioethical research. Similar to the "empirical turn" in bioethics, which led to intense debates about appropriate moral theories, ethical frameworks and meta-ethics due to the increased use of empirical methodologies from social sciences, the proliferation of health-related subtypes of technology ethics might have a comparable impact on current bioethical research. This systematic journal review analyses the reporting of ethical frameworks and non-empirical methods in argument-based research articles on digital technologies in medicine, health care and public health that have been published in high-impact bioethics journals. We focus on articles reporting non-empirical research in original contributions. Our aim is to describe currently used methods for the ethical analysis of ethical issues regarding the application of digital technologies in medicine, health care and public health. We confine our analysis to non-empirical methods because empirical methods have been well-researched elsewhere. Finally, we discuss our findings against the background of established methods for health technology assessment, the lack of a typology for non-empirical methods as well as conceptual and methodical change in bioethics. Our descriptive results may serve as a starting point for reflecting on whether current ethical frameworks and non-empirical methods are appropriate to research ethical issues deriving from the application of digital technologies in medicine, health care and public health.

The ethics of ChatGPT in medicine and healthcare: a systematic review on Large Language Models (LLMs).

With the introduction of ChatGPT, Large Language Models (LLMs) have received enormous attention in healthcare. Despite potential benefits, researchers have underscored various ethical implications. While individual instances have garnered attention, a systematic and comprehensive overview of practical applications currently researched and ethical issues connected to them is lacking. Against this background, this work maps the ethical landscape surrounding the current deployment of LLMs in medicine and healthcare through a systematic review. Electronic databases and preprint servers were queried using a comprehensive search strategy which generated 796 records. Studies were screened and extracted following a modified rapid review approach. Methodological quality was assessed using a hybrid approach. For 53 records, a meta-aggregative synthesis was performed. Four general fields of applications emerged showcasing a dynamic exploration phase. Advantages of using LLMs are attributed to their capacity in data analysis, information provisioning, support in decision-making or mitigating information loss and enhancing information accessibility. However, our study also identifies recurrent ethical concerns connected to fairness, bias, non-maleficence, transparency, and privacy. A distinctive concern is the tendency to produce harmful or convincing but inaccurate content. Calls for ethical guidance and human oversight are recurrent. We suggest that the ethical guidance debate should be reframed to focus on defining what constitutes acceptable human oversight across the spectrum of applications. This involves considering the diversity of settings, varying potentials for harm, and different acceptable thresholds for performance and certainty in healthcare. Additionally, critical inquiry is needed to evaluate the necessity and justification of LLMs' current experimental use.

'Better see a doctor?' Status quo of symptom checker apps in Germany: A cross-sectional survey with a mixed-methods design (CHECK.APP).

Background: Symptom checker apps (SCAs) offer symptom classification and low-threshold self-triage for laypeople. They are already in use despite their poor accuracy and concerns that they may negatively affect primary care. This study assesses the extent to which SCAs are used by medical laypeople in Germany and which software is most popular. We examined associations between satisfaction with the general practitioner (GP) and SCA use as well as the number of GP visits and SCA use. Furthermore, we assessed the reasons for intentional non-use. Methods: We conducted a survey comprising standardised and open-ended questions. Quantitative data were weighted, and open-ended responses were examined using thematic analysis. Results: This study included 850 participants. The SCA usage rate was 8%, and approximately 50% of SCA non-users were uninterested in trying SCAs. The most commonly used SCAs were NetDoktor and Ada. Surprisingly, SCAs were most frequently used in the age group of 51-55 years. No significant associations were found between SCA usage and satisfaction with the GP or the number of GP visits and SCA usage. Thematic analysis revealed skepticism regarding the results and recommendations of SCAs and discrepancies between users' requirements and the features of apps. Conclusion: SCAs are still widely unknown in the German population and have been sparsely used so far. Many participants were not interested in trying SCAs, and we found no positive or negative associations of SCAs and primary care.

"That's just Future Medicine" - a qualitative study on users' experiences of symptom checker apps.

BACKGROUND: Symptom checker apps (SCAs) are mobile or online applications for lay people that usually have two main functions: symptom analysis and recommendations. SCAs ask users questions about their symptoms via a chatbot, give a list with possible causes, and provide a recommendation, such as seeing a physician. However, it is unclear whether the actual performance of a SCA corresponds to the users' experiences. This qualitative study investigates the subjective perspectives of SCA users to close the empirical gap identified in the literature and answers the following main research question: How do individuals (healthy users and patients) experience the usage of SCA, including their attitudes, expectations, motivations, and concerns regarding their SCA use? METHODS: A qualitative interview study was chosen to clarify the relatively unknown experience of SCA use. Semi-structured qualitative interviews with SCA users were carried out by two researchers in tandem via video call. Qualitative content analysis was selected as methodology for the data analysis. RESULTS: Fifteen interviews with SCA users were conducted and seven main categories identified: (1) Attitudes towards findings and recommendations, (2) Communication, (3) Contact with physicians, (4) Expectations (prior to use), (5) Motivations, (6) Risks, and (7) SCA-use for others. CONCLUSIONS: The aspects identified in the analysis emphasise the specific perspective of SCA users and, at the same time, the immense scope of different experiences. Moreover, the study reveals ethical issues, such as relational aspects, that are often overlooked in debates on mHealth. Both empirical and ethical research is more needed, as the awareness of the subjective experience of those affected is an essential component in the responsible development and implementation of health apps such as SCA. TRIAL REGISTRATION: German Clinical Trials Register (DRKS): DRKS00022465. 07/08/2020.

"ChatGPT, Can You Help Me Save My Child's Life?" - Diagnostic Accuracy and Supportive Capabilities to Lay Rescuers by ChatGPT in Prehospital Basic Life Support and Paediatric Advanced Life Support Cases - An In-silico Analysis.

BACKGROUND: Paediatric emergencies are challenging for healthcare workers, first aiders, and parents waiting for emergency medical services to arrive. With the expected rise of virtual assistants, people will likely seek help from such digital AI tools, especially in regions lacking emergency medical services. Large Language Models like ChatGPT proved effective in providing health-related information and are competent in medical exams but are questioned regarding patient safety. Currently, there is no information on ChatGPT's performance in supporting parents in paediatric emergencies requiring help from emergency medical services. This study aimed to test 20 paediatric and two basic life support case vignettes for ChatGPT and GPT-4 performance and safety in children. METHODS: We provided the cases three times each to two models, ChatGPT and GPT-4, and assessed the diagnostic accuracy, emergency call advice, and the validity of advice given to parents. RESULTS: Both models recognized the emergency in the cases, except for septic shock and pulmonary embolism, and identified the correct diagnosis in 94%. However, ChatGPT/GPT-4 reliably advised to call emergency services only in 12 of 22 cases (54%), gave correct first aid instructions in 9 cases (45%) and incorrectly advised advanced life support techniques to parents in 3 of 22 cases (13.6%). CONCLUSION: Considering these results of the recent ChatGPT versions, the validity, reliability and thus safety of ChatGPT/GPT-4 as an emergency support tool is questionable. However, whether humans would perform better in the same situation is uncertain. Moreover, other studies have shown that human emergency call operators are also inaccurate, partly with worse performance than ChatGPT/GPT-4 in our study. However, one of the main limitations of the study is that we used prototypical cases, and the management may differ from urban to rural areas and between different countries, indicating the need for further evaluation of the context sensitivity and adaptability of the model. Nevertheless, ChatGPT and the new versions under development may be promising tools for assisting lay first responders, operators, and professionals in diagnosing a paediatric emergency. TRIAL REGISTRATION: Not applicable.

Ethical, legal and social aspects of human cerebral organoids and their governance in Germany, the United Kingdom and the United States.

Human cerebral organoids (HCOs) are model systems that enable researchers to investigate the human brain in ways that had previously been impossible. The emergence of HCOs was accompanied by both expert and layperson discussions concerning the possibility of these novel entities developing sentience or consciousness. Such concerns are reflected in deliberations about how to handle and regulate their use. This perspective article resulted from an international and interdisciplinary research retreat "Ethical, Legal and Social Aspects of Human Cerebral Organoids and their Governance in Germany, the United Kingdom and the United States", which took place in Tübingen, Germany, in August 2022. The retreat focused on whether HCO research requires new ethical and regulatory approaches. It addressed epistemic issues around the detection and theorisation of consciousness, ethical concerns around moral status and research conduct, difficulties for legislation and guidelines managing these entities, and public engagement.

Ethical Issues in Cerebral Organoid Research.

About ten years ago, reports of lab-grown "mini brains" or "brains in a dish" appeared in the media, falling somewhere between the curious and the alarming. The trigger of these reports was a new method to grow three-dimensional neural tissue from human stem cells that recapitulates, to some degree, the early development of brain tissue. Despite their relatively small size and other limitations, such model systems capture in part the structure and functions of regions of the human brain and can also be combined to form so-called assembloids.

Artificial Intelligence in Reproductive Medicine - An Ethical Perspective.

Artificial intelligence is steadily being integrated into all areas of medicine. In reproductive medicine, artificial intelligence methods can be utilized to improve the selection and prediction of sperm cells, oocytes, and embryos and to generate better predictive models for in vitro fertilization. The use of artificial intelligence in this field is justified by the suffering of persons or couples who wish to have children but are unable to conceive. However, research into the use of artificial intelligence in reproductive medicine is still in the early experimental stage and furthermore raises complex normative questions. There are ethical research challenges because evidence of the efficacy of certain pertinent systems is often lacking and because of the increased difficulty of ensuring informed consent on the part of the affected persons. Other ethically relevant issues include the potential risks for offspring and the difficulty of providing sufficient information. The opportunity to fulfill the desire to have children affects the welfare of patients and their reproductive autonomy. Ultimately, ensuring more accurate predictions and allowing physicians to devote more time to their patients will have a positive effect. Nevertheless, clinicians must be able to process patient data conscientiously. When using artificial intelligence, numerous actors are involved in making the diagnosis and deciding on the appropriate therapy, raising questions about who is ultimately responsible when mistakes occur. Questions of fairness arise with regard to resource allocation and cost reimbursement. Thus, before implementing artificial intelligence in clinical practice, it is necessary to critically examine the quantity and quality of the data used and to address issues of transparency. In the medium and long term, it would be necessary to confront the undesirable impact and social dynamics that may accompany the use of artificial intelligence in reproductive medicine.

Initial heritable genome editing: mapping a responsible pathway from basic research to the clinic.

Following the Second Summit on Human Gene Editing in Hong Kong in 2018, where the birth of two girls with germline genome editing was revealed, the need for a responsible pathway to the clinical application of human germline genome editing has been repeatedly emphasised. This paper aims to contribute to the ongoing discussion on research ethics issues in germline genome editing by exploring key issues related to the initial applications of CRISPR in reproductive medicine. Following an overview of the current discussion on bringing germline genome editing into clinical practice, we outline the specific challenges associated with such interventions and the features that distinguish them from conventional clinical testing of new medical treatments. We then review proposed ethical requirements for initial heritable genome editing, such as the absence of reasonable alternatives, the existence of sufficient and reliable preclinical data, appropriate informed consent, requirements related to safety, and long-term follow-up.

Ethical, legal, and social aspects of symptom checker applications: a scoping review.

Symptom Checker Applications (SCA) are mobile applications often designed for the end-user to assist with symptom assessment and self-triage. SCA are meant to provide the user with easily accessible information about their own health conditions. However, SCA raise questions regarding ethical, legal, and social aspects (ELSA), for example, regarding fair access to this new technology. The aim of this scoping review is to identify the ELSA of SCA in the scientific literature. A scoping review was conducted to identify the ELSA of SCA. Ten databases (e.g., Web of Science and PubMed) were used. Studies on SCA that address ELSA, written in English or German, were included in the review. The ELSA of SCA were extracted and synthesized using qualitative content analysis. A total of 25,061 references were identified, of which 39 were included in the analysis. The identified aspects were allotted to three main categories: (1) Technology; (2) Individual Level; and (3) Healthcare system. The results show that there are controversial debates in the literature on the ethical and social challenges of SCA usage. Furthermore, the debates are characterised by a lack of a specific legal perspective and empirical data. The review provides an overview on the spectrum of ELSA regarding SCA. It offers guidance to stakeholders in the healthcare system, for example, patients, healthcare professionals, and insurance providers and could be used in future empirical research to investigate the perspectives of those affected, such as users.

Ethical, Legal, and Social Implications of Symptom Checker Apps in Primary Health Care (CHECK.APP): Protocol for an Interdisciplinary Mixed Methods Study.

BACKGROUND: Symptom checker apps (SCAs) are accessible tools that provide early symptom assessment for users. The ethical, legal, and social implications of SCAs and their impact on the patient-physician relationship, the health care providers, and the health care system have sparsely been examined. This study protocol describes an approach to investigate the possible impacts and implications of SCAs on different levels of health care provision. It considers the perspectives of the users, nonusers, general practitioners (GPs), and health care experts. OBJECTIVE: We aim to assess a comprehensive overview of the use of SCAs and address problematic issues, if any. The primary outcomes of this study are empirically informed multi-perspective recommendations for different stakeholders on the ethical, legal, and social implications of SCAs. METHODS: Quantitative and qualitative methods will be used in several overlapping and interconnected study phases. In study phase 1, a comprehensive literature review will be conducted to assess the ethical, legal, social, and systemic impacts of SCAs. Study phase 2 comprises a survey that will be analyzed with a logistic regression. It aims to assess the user degree of SCAs in Germany as well as the predictors for SCA usage. Study phase 3 will investigate self-observational diaries and user interviews, which will be analyzed as integrated cases to assess user perspectives, usage pattern, and arising problems. Study phase 4 will comprise GP interviews to assess their experiences, perspectives, self-image, and concepts and will be analyzed with the basic procedure by Kruse. Moreover, interviews with health care experts will be conducted in study phase 3 and will be analyzed by using the reflexive thematical analysis approach of Braun and Clark. RESULTS: Study phase 1 will be completed in November 2021. We expect the results of study phase 2 in December 2021 and February 2022. In study phase 3, interviews are currently being conducted. The final study endpoint will be in February 2023. CONCLUSIONS: The possible ethical, legal, social, and systemic impacts of a widespread use of SCAs that affect stakeholders and stakeholder groups on different levels of health care will be identified. The proposed methodological approach provides a multifaceted and diverse empirical basis for a broad discussion on these implications. TRIAL REGISTRATION: German Clinical Trials Register (DRKS) DRKS00022465; https://tinyurl.com/yx53er67. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/34026.

The Socio-Political Roles of Neuroethics and the Case of Klotho.

An increasing amount of very diverse scholarship self-identifies as belonging to the field of neuroethics, illuminating a need to provide some reference points for what that field actually entails. We argue that neuroethics is a single field with distinct perspectives, roles, and subspecialties. We propose that-in addition to the three traditional perspectives delineated by Eric Racine-a fourth, socio-political perspective, must be recognized in neuroethics. The socio-political perspective in neuroethics focuses on the interplay between the behavioral as well as the brain sciences and the socio-political system; this interplay includes social regulation in addition to all other realistic elements of social and political neurodiscourses. Thus, defining what-if any-roles the socio-political perspective in neuroethics might have is a pressing issue. Doing so could provide guidance for defining the criteria for prospective ethical evaluations in neuroethics. A promising approach to doing this could be by describing the roles of neuroethics in terms of the more concrete examples of the roles of political philosophy in general, as in the tradition of John Rawls. We take klotho, the supposed "longevity protein," as a modern neuroethics case to exemplify the obstacles faced in securing neuroethics' legitimacy and how the Rawlsian framework we propose may be applied to handle cases such as this. Ultimately, the socio-political perspective in neuroethics should not be swayed by the media hype and ought to offer useful ethical guidance and articulation of genuine ethical concerns to policy makers and the public alike.

[The Tübingen Model "Ethics Consultants on the Ward": a pilot project to establish decentralized structures of clinical ethics consultation at a university hospital]. / Das Tübinger Modell der "Ethikbeauftragten der Station": Ein Pilotprojekt zum Aufbau dezentraler Strukturen der Ethikberatung an einem Universitätsklinikum.

DEFINITION OF THE PROBLEM: Clinical ethics committees form an integral part of ethics management and organizational ethics in clinical healthcare facilities. However, working mostly reactive and not being anchored in the corresponding organizational levels, such instruments are limited in terms of effectiveness. ARGUMENTS: Based on these shortcomings of clinical ethics consultation the multiprofessional working group "Ethics" at the University Hospital Tübingen, Germany has endeavored to design and implement new structures for sustainable ethical decision-making processes on its hospital wards. The Tübingen Model "Ethics Consultants on the Ward" is a pilot project intended to appoint specifically trained nursing staff on all wards as contact partners for ethical issues. Thus, the Tübingen Model represents an extension to established structures of clinical ethics consultation and complements existing top-down strategies. CONCLUSIONS: This article presents the objectives of the Tübingen Model and describes initial experiences in its implementation. After explaining their role within the existing structures of ethics consultation at the hospital, the tasks of the ethics consultants within and across the hospital's wards are presented. Furthermore, the qualification program for ethics consultants (basic and advanced training) as well as a train-the-trainer concept are presented, which support an in-depth development of competencies in nursing as well as medical ethics and provide confidence in the reflection and decision-making processes on the ward.