The rapid development of Artificial Intelligence (AI) has raised concerns regarding the potential risks it may pose to humans, society, and the environment. Recent advancements have intensified these concerns, emphasizing the need for a deeper understanding of the technical, societal, and ethical aspects that could lead to adverse or harmful failures in decisions made by autonomous and intelligent systems (AIS). This paper aims to examine the ethical dimensions of risk management in AIS. Its objective is to highlight the significance of (...) ethical considerations in mitigating risks associated with the development, deployment, and use of AIS. The paper provides an overview of various types of AI risks and risk management procedures aimed at mitigating the negative impacts of those risks. We employ a comprehensive risk management approach that combines technical expertise with ethical analysis to ensure alignment with human values and societal objectives. Through the analysis of AI risks and risk management procedures, we advocate for establishing effective mechanisms for ethical oversight and legal control to promote ethical and trustworthy AIS. The findings reveal key risks associated with transparency, accountability, privacy infringement, algorithmic bias, and unintended consequences. To address these challenges, we consider integrating ethical principles into risk management practices, transparent risk communication, continuous engagement with all stakeholders, establishing robust accountability mechanisms, and regular ethical oversight as imperative in ethically designing and operating AI systems. Given the diminished effectiveness of internal audits compared to external audits, we also recommend the implementation of regular monitoring mechanisms through independent external audits when evaluating risk management practices. (shrink)

Over the past decade, significant progress in artificial intelligence (AI) has spurred the adoption of its algorithms, addressing previously daunting challenges. Alongside these remarkable strides, there has been a simultaneous increase in model complexity and reliance on opaque AI models, lacking transparency. In numerous scenarios, the systems themselves may necessitate making decisions entailing ethical dimensions. Consequently, it has become imperative to devise solutions to integrate ethical considerations into AI system development practices, facilitating broader utilization of AI systems across various domains. (...) Research endeavors should explore innovative approaches to enhance ethical principles in AI systems, fostering greater transparency, accountability, and trustworthiness. Upholding fundamental individual rights, human dignity, autonomy, privacy, equality, and fairness, while mitigating potential harm, remains paramount. Considering ethical values and ensuring compliance with ethical requirements throughout the development lifecycle of autonomous and intelligent systems nurture trust and reliability in their utilization. Ethical considerations should be ingrained within organizational procedures guiding AI research activities, establishing robust frameworks that address ethical concerns and reflect the ethical implications of AI-based systems. This paper presents an overview of ethical approaches and processes aimed at integrating ethical considerations into AI system development practices. It underscores the significance of ethical frameworks in fostering ethical AI implementation and ensuring the ethical integrity of AI technologies. (shrink)

The current coronavirus disease 2019 pandemic has led to essential adjustments in clinical research involving human subjects. The pandemic is substantially affecting most procedures of ongoing, as well as new clinical trials related to diseases other than COVID-19. Procedural changes and study protocol modifications may significantly impact ethically salient fundamentals, such as the risk-benefit profile and safety of clinical trial participants, which raise key ethical challenges the subject-matter experts must face. This article aims to acquaint a wide audience of clinical (...) research professionals, ethicists, as well as the general public interested in this topic with the legal, ethical and practical considerations in the field of clinical trials during the COVID-19 pandemic and to support the clinical researchers and study sponsors to fulfil their responsibilities in conducting clinical trials in a professional way that does not conflict with any legal or ethical obligations. (shrink)

The COVID-19 pandemic led to significant changes of the usual procedures in the clinical trials conduct, as well as to modifications of the relevant study documentation, which also affected regular quality assurance activities ensuring the safety of clinical trial participants, compliance with good clinical practice, and the integrity and validity of the clinical trial data collected during the COVID-19 pandemic. The paper deals with the ethical guidelines and legal regulations that govern the conduct of clinical trials and discusses the ethical (...) implications that arose from the forced adjustments of routine processes and procedures in the clinical trial conduct during the COVID-19 public health emergency. The paper also reflects on the ethical consequences of conducting clinical trials during the public health emergency, as well as on means of performing quality assurance activities and a regular oversight of clinical research. (shrink)