Post-COVID-19 Lung Transplantation Italian Pivotal Protocol: Some Ethical Considerations.

SARS­CoV­2 mostly affects the respiratory system with clinical patterns ranging from the common cold to fatal pneumonia. During the first wave of the COVID-19 pandemic, owing to the high number of patients who were infected with SARS­CoV­2 and subsequently recovered, it has been shown that some patients with post-COVID-19 terminal respiratory failure need lung transplantation for survival. There is increasing evidence coming from worldwide observations that this procedure can be performed successfully in post-COVID-19 patients. However, owing to the scarcity of organs, there is a need to define the safety and efficacy of lung transplant for post-COVID-19 patients as compared to patients waiting for a lung transplant for other pre-existing conditions, in order to ensure that sound ethical criteria are applied in organ allocation. The Milan's Policlinic Lung Transplant Surgery Unit, with the revision of the National Second Opinion for Infectious Diseases and the contribution of the Italian Lung Transplant Centres and the Italian National Transplant Centre, set up a pivotal observational protocol for the lung transplant of patients infected and successively turned negative for SARS­CoV­2, albeit with lung consequences such as acute respiratory distress syndrome or some chronic interstitial lung disease. The protocol was revised and approved by the Italian National Institute of Health Ethics Committee. Description of the protocol and some ethical considerations are reported in this article.

The ethics of observational/epidemiological research conducted within the Covid-19 pandemic: Implications for informed consent

In observational research we observe what happens in the real world, and particularly in clinical practice. Contrary to what happens in clinical trials, there is no randomization. While clinical trials are governed by a precise and detailed regulatory framework, for observational research there are no specific regulations (except for the protection of personal data), and reference is made only to guidelines, codes and soft law. Consequently, in the absence of specific regulatory references, ethics committees frequently evaluate observational studies by applying the criteria that apply to clinical trials. This leads to inappropriate weighting and stiffness. To counter the Covid-19 pandemic, measures have been adopted to facilitate research, including observational research. Some provisions are also particularly relevant for information and consent, both for clinical practice and for the protection of personal data. These exceptional measures taken during the pandemic deserve attention: limited to some parts, they could be adopted not only in the emergency context of the pandemic, but also in ordinary situations. © 2021

Protection of individual and collective health: ethical-legal issues and opportunities for public health after COVID-19

The Istituto Superiore di Sanita (the National Institute of Health in Italy), as the technical-scientific body of the Italian National Health Service, has a crucial role in the COVID-19 pandemic management in Italy. In this period the ISS Bioethics COVID-19 Working Group has been established to deal with the multiple ethical issues raised by the pandemic. The spread of SARS-CoV-2 has made it necessary to address both clinical ethics questions and public health ethics dilemmas. In the Working Group experts in multiple disciplines - i.e., clinical medicine, public health, epidemiology, paediatrics, palliative care, law, philosophy, biomedical research, nursing sciences and, of course, bioethics - have been debating. This volume contains different Working Group members' contributions and viewpoints, that reflect the multiplicity of disciplines and experiences in an epochal emergency.