Decentralized clinical trials (DCTs): A few ethical considerations.

Decentralized clinical trials (DCTs) are studies in which the need for patients to physically access hospital-based trial sites is reduced or eliminated. The CoViD-19 pandemic has caused a significant increase in DCT: a survey shows that 76% of pharmaceutical companies, device manufacturers, and Contract Research Organizations adopted decentralized techniques during the early phase of the pandemic. The implementation of DCTs relies on the use of digital tools such as e-consent, apps, wearable devices, Electronic Patient-Reported Outcomes (ePRO), telemedicine, as well as on moving trial activities to the patient's home (e.g., drug delivery) or to local healthcare settings (i.e., community-based diagnosis and care facilities). DCTs adapt to patients' routines, allow patients to participate regardless of where they live by removing logistical barriers, offer better access to the study and the investigational product, and permit the inclusion of more diverse and more representative populations. The feasibility and quality of DCTs depends on several requirements including dedicated infrastructures and staff, an adequate regulatory framework, and partnerships between research sites, patients and sponsors. The evaluation of Ethics Committees (ECs) is crucial to the process of innovating and digitalizing clinical trials: adequate assessment tools and a suitable regulatory framework are needed for evaluation by ECs. DCTs also raise issues, many of which are of considerable ethical significance. These include the implications for the relationship between patients and healthcare staff, for the social dimension of the patient, for data integrity (at the source, during transmission, in the analysis phase), for personal data protection, and for the possible risks to health and safety. Despite their considerable growth, DCTs have only received little attention from bioethicists. This paper offers a review on some ethical implications and requirements of DCTs in order to encourage further ethical reflection on this rapidly emerging field.

Criteria for allocation of life-saving resources during the SARS-COV-2 pandemic: ethical implications and aspects of legal liability.

The issue of political, institutional and professional liability in the context of the SARS-COV-2 pandemic is currently widely debated and involves several levels of investigation. One crucial aspect relates to the allocation of life-saving resources in situations where there is an imbalance between need and availability and the associated questions of ethical and legal liability. This work looks at the implications of the criteria applied to rationing under extraordinary conditions and the issue of their legitimacy. Considering the European scenario, we describe the approach taken by Italy in proposing criteria for pandemic triage of intensive treatment and highlight certain problems and critical issues. We emphasise that the decision, based on a comparative assessment, to deny treatment to a patient in critical condition, compromising that patient's right to care, exceeds the scope of decision-making autonomy of the professional concerned and requires a theoretical and procedural definition shared at multiple levels of society.

Ethics of triage for intensive-care interventions during the COVID-19 pandemic: Age or disability related cut-off policies are not justifiable

Public health emergencies such as pandemics can put health systems in a position where they need to ration medical equipment and interventions because the resources available are not sufficient to meet demand. In public health management, the fair allocation of resources is a permanent and cross-sector issue since resources, and especially economic resources, are not infinite. During the COVID-19 pandemic resources need to be allocated under conditions of extreme urgency and uncertainty. One very problematic aspect has concerned intensive care medicine and age discrimination has been among the most hotly discussed issues, as age has been touted as a probable criterion for selection. In this paper we analyse some documents originating from scientific societies and medical associations, mainly related to EU sphere and available in English, French, Spanish and Italian (Switzerland, Spain, Belgium, France, England and Italy), concerning the criteria for admission to the intensive care units. We highlights how, in most of these documents, it is explicitly stated that ?age itself? is not a criterion for patient selection. Our conclusion is that these criteria should be defined in advance of a crisis situation and be grounded in clinical indicators. Establishing ?cut-off? policies with regard to criteria such as age or chronic disability is definitely an unjustifiable form of discrimination even in the context of a public health emergency.