Ethical Considerations In ICU Preparations For Viral Epidemics

"Intensive Care Units (ICUs) admit patients with the most severe forms of the diseases, viral ARDS included. Since the 2009 H1N1 influenza outbreak, ICU preparations and triage have been recommended. The novel COVID-19 clinical picture resembles influenza in terms of organ dysfunction which may start with hypoxemic breathing insufficiency and ultimately, a possibility of evolution towards multiple organ failure. Its current clinical picture is not new for intensivists. However, there are several important differences as far as we know now: there is overall human susceptibility to become infected and nobody can be specifically protected by vaccination. This fact led to large numbers of infected people all over the world, overwhelming medical systems. Almost 10% of COVID-19 infections would be qualified for ICU admittance and ventilatory support. The main ethical issues in ICUs, in time of viral epidemics are: lack of free ICU beds, free ventilator machines, pressures on providing aggressive treatments for people with low chances of survival, dealing with terminally ill patients, high degrees of burnout in the medical team, reporting errors and inadequate behavior of other medical staff, lack of adequate protective equipment, as well as lack of administrative support. All these facts lead to moral distress and high burnout incidences. Administrative preparations, prioritization and triage are important aspects to consider. In conclusion, we all see that the modern world is not prepared enough to face such challenges and from these situations we, all (health care professionals, providers, population and authorities) should learn important personal and professional lessons. "

The Good, the Bad and the Ugly in App Diagnosis: Outcomes and Implications by Example

"The Clinical Decision Support (CDS), a form of artificial intelligence (AI), consider physician expertise and cognitive function along with patient’s data as the input and case-specific medical decision as an output. The improvements in physician’s performances when using a CDS ranges from 13% to 68%. The AI applications are of large interest nowadays, and a lot of effort is also put in the development of IT applications in healthcare. Medical decision support systems for non-medical staff users (MDSS-NMSF) as phone applications are nowadays available on the market. A MDSS-NMSF app is generally not accompanied by a scientific evaluation of the performances, even if they are freely available or not. Two clinical scenarios were created, and Doctor31 retrieved the diagnosis decisions. First scenario: man, 29 years old, and three symptoms: dysphagia, weight loss (normal body mass index), and tiredness. Second scenario: women, 47 years old with L5-S1 disk herniation, abnormal anti-TPO antibodies, lower back pain (burning sensations), constipation, and tiredness. The outcome possible effects and implications, as well as vulnerabilities induced on the used, are highlighted and discussed. "

Ghostwriting and Authorship Practices in Biomedical Research: A Study Protocol

"Background: Scientific paper authorship represents an important form of academic attainment for research professionals and brings specific benefits (e.g., contribution science, recognizing the author’s intellectual efforts). Authors certify their work’s integrity by accepting the responsability of the published content. The principal two important unethical authorship is honorary authors (the criteria of authorship not met) and ghost authors (contributed substantially but not listed as an author). Aim: The current study has two-fold aim: to determine the prevalence of authorship violations in the biomedical journals according to the Web of Science classification and to evaluate its variation by article type (e.g., research, review, or editorial) and presence/absence authors contributions requirements. Materials and Methods: The following steps will be apply: 1) Identification of journal categories of interest – data source: Journal Citation Reports 2020 (JCR2020); 2) Identification of the eligible journal – JCR2020 by selection of journals weighted according to the number of jorunals in a specific category. The selection will be stratified by the Rank by Journal Citation Indicator (JCI); 3) Collection of characteristics of the included journals regarding the year 2020: total number of articles, number of articles and references, number of reviews and associated references; JCI percentile, open access policy and publication fee if applicable; 4) Random selection (simple random method) of authors who published in 2020. The selection will be done weighted according to the number of manuscripts published in 2020; 5) Development and validation of the questionnaire; 6) Invitation of the corresponding author to participate in the study; 7) Online anonymously data collection. The study protocol will be deposited in an international database. "

Supporting Ethical Decision Making – A Tool for Ethical Reflection on Care Technologies

"The tool FreTiP (Fragen zur ethischen Reflexion von digitalen Technologien in der Pflegepraxis – questions on ethical reflection of digital technologies in nursing practice) was developed in 2020 by the Institute Mensch, Ethik und Wissenschaft (IMEW) as part of ELSI research in the PPZ-Berlin project. Our aim was to develop an instrument that stimulates and supports ethical reflection processes in the application of digital care innovation technologies in practice. Ethical considerations are part of everyday (nursing) life, are closely interwoven with other aspects and are therefore difficult to recognise as such. The starting thesis of our work was that actors in care act on the basis of value concepts that they are more or less aware of. An ethics that is consciously integrated into everyday care takes into account all aspects that are relevant for an action or decision. In this respect, it is important to look at ethics in context and not to understand “ethics” as something isolated, coming from outside. Based on this, the development of the instrument should not consist of “breaking down” ethical concepts and theories to practice, but of ethically locating, structuring and making applicable the experiences, questions and needs of the actors working in nursing practice. Thus, FreTiP is not only to be considered practice-oriented, but also to a certain extent practice-based. The instrument was designed to be suitable for everyday care in clinics, care facilities and in the home context. FreTiP was developed as a low-threshold instrument that can be used flexibly and that takes into account the perspective of patients as well as carers. The development of the instrument was preceded by a triangulated study that included a literature review, interviews and (non-)participatory observations. In the paper, experiences with the ethical reflection tool FreTiP will be presented. "

The Digi-Table Method as a Tool for Reflecting on Research Ethics

"concepts and processes by means of a digitable. It is a tool for familiarizing users with complicated and complex issues, learning content, and addressing the more methodical aspects didactically. In this project, we have adapted the DTM for reflecting on research ethics, i.c. research with human beings and its ethical requirements and the review by the medical ethical review committee (MREC). A MREC reviews research proposals based on various (ethical) requirements and requires researchers to understand the ethical consequences and societal impact of their research. Before writing their own proposals, it is important for students to know and understand these ethical requirements and the process through which research proposals are reviewed. In order to train this, we prepared the digitable to simulate the review of a research protocol by an MREC and adapted it into an existing assignment on research ethics for master students. The students were informed of our aim and the use of DTM as an educational tool, and asked for consent. We invited them to critically assess the activity and we ensured participation would not influence their grade. The students reported a better understanding of the medical ethical review and felt it would improve their own work. From the educator’s perspective, the quality of argumentation of the review was much improved compared to previous years. The DTM as an educational tool is now a standard element in different master courses on scientific integrity. "

Artificial Intelligence, Social Media and Depression. ‘Patient’ Autonomy Revisited

"Artificial Intelligence (AI) systems are increasingly being developed and various applications are already used in medical practice. This development promises improvements in prediction, diagnostics and treatment decisions. As one example, in the field of psychiatry, AI systems can already successfully detect markers of mental disorders such as depression. By using data from social media (e.g. Instagram or Twitter), users who are at risk of mental disorders can be identified. This potential of AI-based depression detectors (AIDD) opens chances, such as quick and inexpensive diagnoses, but also leads to ethical challenges especially regarding users’ autonomy. The focus of the presentation is on autonomy-related ethical implications of AI systems using social media data to identify users with a high risk of suffering from depression. First, technical examples and potential usage scenarios of AIDD are introduced. Second, it is demonstrated that the traditional concept of patient autonomy according to Beauchamp and Childress does not fully account for the ethical implications associated with AIDD. Third, an extended concept of “Health-Related Digital Autonomy” (HRDA) is presented. Conceptual aspects and normative criteria of HRDA are discussed. As a result, HRDA covers the elusive area between social media users and patients. "

The Ethics of e-Cigarettes for Smoking Cessation: A Global Challenge

"Tobacco smoking is especially harmful for women because, in addition to its effects on mortality and morbidity, it negatively impacts pregnancy, reproductive, and health of the offspring. Data from our work in Romania revealed that pregnant tobacco smokers are seeking information and clinical advice related to e-cigarette use as a tobacco cessation approach. E-cigarette use increased rapidly in the recent years in the US and in other countries, including LMICs. The tobacco control field is deeply divided on how to respond to the increase in e-cigarette use. Additional evidence on the ethical issues related to e-cigarette use and tobacco cessation will inform our mHealth and other pregnancy tobacco cessation interventions and will guide future tobacco control policy direction. The objective of this study is to identify ethical concerns and associated attitudes and perceptions related to e-cigarette use for tobacco cessation during pregnancy among pregnant smokers, their life partners, medical professionals, and other stakeholders. We will interview (N=20) and conduct two focus groups with women who smoke (one focus group, N=10) and women who quit during pregnancy (one focus group, N=10); interview life partners (N=10) of such women; interview ObGyn physicians (N=10) and nurses (N=10); and interview (N=10) and conduct one focus group (N=10) with perinatal educators. Other relevant stakeholders will be also interviewed including the leadership of 2035 Tobacco Free Romania, the national Stop Smoking program, the Pure Air consortium, the Romanian Pneumology Society, the SAMAS NGO focused on maternal and child health and rights, and others. With respect to expected outcomes, the proposed application is anticipated to advance understanding of the smokers’ and other stakeholders’ ethical concerns and associated attitudes and perceptions related to e-cigarettes use for tobacco smoking cessation. The in-depth new knowledge will have a positive impact on the cessation of prenatal and postnatal tobacco smoking and will inform future tobacco control policy directions. Results will be available and will be presented at the time of the conference. This work is based on research partly funded through six NIH-funded projects (grant no. K01TW009654, R21TW010896, 5R21TW010896-02S1, 5R21TW010896-02S2, 1R21HD103039-0, 1R25TW010518-01A1). "

A Conceptual Framework for the Ethical Evaluation of Supported Decision-Making

"Background: Supported decision-making (SDM) refers to all types of interventions support persons with impaired decision-making capacity (DMC) in making informed treatment decisions. It encompasses a wide range of interventions, such as enhanced consent procedures, elaborated plain language and involvement of family, friends or peers in the informed consent process. Empirical research showed that SDM can enhance DMC. The UN Convention on the Rights of Persons with Disabilities, which has been ratified by 180 states parties to date, pronounces in article 12(3) that “states parties shall take appropriate measures to provide access by persons with disabilities to the support they may require in exercising their legal capacity.” At the same time, medical ethicists and legal scholars have raised the concern that persons with impaired DMC are more likely to become subject to undue influence under SDM arrangements. Objectives: The aim of this presentation is to provide a conceptual framework to facilitate an ethical evaluation of various forms of supported decision-making. Methods: Empirically informed conceptual analysis. Various SDM interventions are analyzed. Findings: It is necessary to distinguish between input, process and output support. Input support involves influencing factors that are negatively correlated with DMC; process support involves interpreting a person’s preferences and carrying out intellectual processing; and output support involves enabling a person to communicate decisions to others. Conclusion: Most forms of input and output support are promising, but ethical issues in relation to framing and interpersonal leverage must be addressed. Forms of process support that involve “outsourcing” decision-making capacities are ethically problematic. "

A “School Of Clinical Ethics”: Clinical Ethics Education for Clinicians and Philosophy Students

"The presentation intends to present and illustrate an experience of teaching clinical ethics realized with a group of clinicians and philosophy students and held at the Philosophy Department of the University of Trento, Italy (Spring 2013 and Spring 2015). The class was intended to train clinicians and students to the main concepts of clinical ethics and to a specific methodology to approach clinical matters with ethical and philosophical tools. The class offered a space and time of listening, confronting, debating and learning. The opportunity to dialogue and to reflect, starting form clinical cases presented by clinicians and to realize an ethical analysis of them, combining languages and competences, resulted extremely relevant for clinicians, for students involved and for the teachers themselves. It represented – as well – a first and previous step to start some action-research in specific clinical units, as the local Intensive Care Unit, the Transplantation Coordination Unit and the Mountain Medicine and Ethics Lab. "

Ethics of First-in-Human Transplantation Trials of Bioartificial Organs

"The most effective treatment for type 1 diabetes is transplantation of either a whole pancreas from a deceased donor or islet cells derived from multiple deceased donors. However, transplantation has several limitations, including shortage of post-mortem donors and the need for post-transplant patients to use life-long immunosuppressive medication. In the last decade, the field of regenerative medicine has combined engineering and biological technologies in the attempt to regenerate organs. The European VANGUARD project aims to develop immune-protected bioartificial pancreases for transplantation into non-immunosuppressed type 1 diabetic patients. This project is creating a ‘combination product’ using cells and tissue from a variety of sources, including placentas and deceased donors. The clinical development of this complex product raises ethical questions for first-in-human (FIH) clinical trials. Under what conditions can bio-artificial organs safely are transplanted in humans for the first time? How can patients be selected, recruited and informed responsibly? In this presentation, we investigate the ethical conditions for clinical trials of bio-engineered organs, focusing inter alia on study design, subject selection, risk-benefit assessment, and informed consent. We present the results of a review of the literature on the ethics of clinical trials in regenerative medicine, cell and gene therapy and transplantation, and specify existing ethical guidance in the context of FIH transplantation trials of bioartificial organs. We conclude that this new and innovative area at the intersection of regenerative medicine, cell and gene therapy and transplantation requires adequate consideration of the ethical issues in order to guide responsible research and clinical implementation. "