The COVID-19 Epidemic and the Prison System in Italy.

On March 7 and 8, 2020, revolts erupted in numerous Italian prisons after the announcement of regulations to contain the spread of COVID-19 in prisons. On April 2, 2020, the first prisoner died of COVID-19, and as of April 9, 58 prisoners and 178 penitentiary police officers have tested positive for the virus. The situation in Italy is made all the more dramatic because of endemic overcrowding: As of April 3, 2020, there were 56,830 prisoners in institutions meant for a maximum of 47,000 people, that is, an occupancy level of 121.75%. The Ministry of Justice and that of Health have established two strategies to limit the spread of COVID-19 in prisons: progressive isolation from the external world and adoption of practices to identify possible cases and to treat infected subjects. The legislation has significantly reduced individual rights in order to protect public health, but in the prison context, the limitations imposed do not guarantee the achievement of the goal of the entire legislation, which is to interrupt the chain of transmission of contagion. A prison cannot be entirely cut off, because its operations depend on people who come and go daily, The effects of these strategy are discussed critically.

The State of Play on COVID-19 Vaccination in Pregnant and Breastfeeding Women: Recommendations, Legal Protection, Ethical Issues and Controversies in Italy.

To date, extensive research has been conducted on vaccination against COVID-19 during pregnancy to verify the safety and efficacy of the vaccines, despite the fact that pregnant women were excluded from the initial clinical trials. The ever-increasing number of scientific publications has confirmed the absence of biological mechanisms associating mRNA vaccines with adverse effects in pregnancy and breastfeeding, although few studies have been carried out on their effect on fertility. While the Italian legal system provides for maternity protection measures and indemnity for vaccination damages pursuant to law no. 210/1992, it is not exempt from controversy. This contribution describes the state of play on COVID-19 vaccination in pregnant and lactating women, including: current recommendations for pregnant and lactating women; ethical issues related to vaccination hesitancy among pregnant women; the legislative paradox whereby sanctions may be imposed on women in certain professional categories who refuse vaccination because they are pregnant; and the possible legal consequences in the event of harm to the unborn child due to vaccination. All of this is considered in accordance with the principles of medical ethics, taking into account the national legislation.

The Network of Services for COVID-19 Vaccination in Persons With Mental Disorders: The Italian Social Health System, Its Organization, and Bioethical Issues.

The adoption of restrictive measures aimed at curtailing the spread of SARS-CoV2 has had a harmful impact on socio-affective relationships, while limiting the scope of interventions and activities to promote social inclusion, with considerable negative repercussions for patients with mental disorders. Vaccination has been and will continue to be a valid tool to overcome the barriers of social isolation and to protect the health of this category of patients. In this paper we present an overview of the Italian network of social and healthcare services for COVID-19 vaccination among patients with mental disorders. Some aspects of medical ethics are discussed in order to share good practices for improving the health of this vulnerable group of people. We then consider the measures implemented by the health system in Italy to deal with the phenomenon of vaccine hesitancy before addressing the issue of autonomy and restricted access to vaccination points. Finally, we illustrate some of the perspectives already adopted by the Italian system, which may be useful to the global scientific community.

Informed Consent and Protection of Personal Data in Genetic Research on COVID-19.

The particular characteristics of COVID-19 demand the careful biomedical study of samples from patients who have shown different symptomatology, in order to understand the genetic foundations of its phenotypic expression. Research on genetic material from COVID-19 patients is indispensable for understanding the biological bases for its varied clinical manifestations. The issue of "informed consent" constitutes the crux of the problem in regulating research biobanks, because it concerns the relationship between the person and the parts separated from the body. There are several consensus models that can be adopted, varying from quite restricted models of specific informed consent to forms that allow very broad authorization (open consent). Our current understanding of COVID-19 is incomplete. Thus, we cannot plan, with precision, the research to be conducted on biological samples that have been, or will be, collected from patients infected by the novel coronavirus. Therefore, we suggest utilizing the "participation pact" between researchers and donors, based on a new form of participation in research, which offers a choice based on the principles of solidarity and reciprocity, which represent the communication of "values". In the last part of this paper, the general data protection regulation concerning the matter is discussed. The treatment of personal data must be performed with explicit goals, and donors must be provided with a clear, transparent explanation of the methods, goals and time of storage. The data must not be provided to unauthorized subjects. In conclusion, open informed consent forms will be necessary for research on individual patients and on populations.

Legal and Ethical Issues Regarding Minors in the Italian Coronavirus Flu Emergency.

On February 21, 2020, Italy became one of the countries hit by an epidemic of the new coronavirus that causes "severe acute respiratory syndrome coronavirus 2" (SARS-CoV-2). Even a month before that, however, the Italian government began issuing a series of decrees and ordinances aimed at the containment of the virus in Italy, the first of them on January 25, 2020. The COVID 19 infection has been faced as an epidemic through measures to enforce a high degree of isolation. These regulations hold for minors, as well, with consequent difficulties for this age group. While at the moment young people appear to be the least vulnerable to the severe complications of COVID 19, the psychological problems that may be brought on by pandemic-related restrictions should be taken into serious consideration.

Regulation of Biobanks in Italy.

In Italy, a biobank is "a non-profit organization that must be officially recognized by the appropriate healthcare authority in the member states and must guarantee the treatment, distribution and conservation of biological material according to standards of quality and professionalism," but must not conserve material already regulated by specific laws, as is the case for organs for transplants, blood for transfusions, as well as embryos and gametes for medically assisted reproduction. The concept of biobank includes not only biological samples, but also the related database of clinical and personal information, from which the subject's lifestyle can be deduced. Unfortunately, at the moment, Italian law does not offer specific itineraries for achieving this legal status.

The COVID-19 Epidemic and the Prison System in Italy.

The Italian Ministry of Justice and that of Health have established two strategies to limit the spread of COVID-19 in prisons: progressive isolation from the external world and adoption of practices to identify possible cases and to treat infected subjects. After the announcement of regulations revolts erupted in numerous Italian prisons. The motivations and effects of these strategy are discussed critically into the search for a balance between the right to health and other rights of prisoners in Italian prisons with the problem of an occupancy level of 121.75%.

Histopathology of COVID-19 pneumonia in two non-oncological, non-hospitalised cases as a reliable diagnostic benchmark.

In lung cancer patients infected with COVID-19, pathological features are not easy to distinguish. This report presents detailed histopathological findings in two non-neoplastic subjects whose out-of-hospital deaths were caused by COVID-19 infection. These 'pure' cases differ in the time of presentation of symptoms, the phase of lung anatomopathological patterns (acute lung injury versus diffuse alveolar damage) and the mechanism of death. The results provide a valid diagnostic benchmark for evaluating the evolution of COVID-19 pneumonia.