Rosagemma Ciliberti

Regulating the communication of genetic risk information: the Italian legal approach to questions of confidentiality and disclosure

Battistuzzi L, Ciliberti R, Forzano F, De Stefano F. Regulating the communication of genetic risk information: the Italian legal approach to questions of confidentiality and disclosure.

Communication of Clinically Useful Next-Generation Sequencing Results to At-Risk Relatives of Deceased Research Participants: Toward Active Disclosure?

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Conscientious Objection to Animal Experimentation in Italian Universities

Simple Summary This paper examines the trend of Italian academic faculties in complying with the obligation to inform university students of their right to exercise their conscientious objection to scientific or educational activities involving animals, hereafter written as “animal CO”, as established by Law 413/1993, “Norme sull’obiezione di coscienza alla sperimentazione animale” (“Rules on conscientious objection to animal experimentation”), thereafter “Law 413/1993”. Despite an increasing interest in the principles of animal ethics by the international community, this law is still largely disregarded more than 20 years after its enactment. The Ethics Committees, Animal Welfare Committees, as well as the Italian Ministry of Education, University and Research should preside over and monitor the Universities’ compliance with the duty to disclose animal CO. Abstract In Italy, Law 413/1993 states that public and private Italian Institutions, including academic faculties, are obliged to fully inform workers and students about their right to conscientious objection to scientific or educational activities involving animals, hereafter written as “animal CO”. However, little monitoring on the faculties’ compliance with this law has been performed either by the government or other institutional bodies. Based on this premise, the authors have critically reviewed the existing data and compared them with those emerging from their own investigation to discuss limitations and inconsistencies. The results of this investigation revealed that less than half of Italian academic faculties comply with their duty to inform on animal CO. Non-compliance may substantially affect the right of students to make ethical choices in the field of animal ethics and undermines the fundamental right to express their own freedom of thought. The Italian Ministry of Education, Universities and Research, ethics committees and animal welfare bodies should cooperate to make faculties respect this law. Further research is needed to better understand the reasons for the current trend, as well as to promote the enforcement of Law 413/1993 with particular regard to information on animal CO.

Body Image Disorders and Surgical Timing in Patients Affected by Poland Syndrome: Data Analysis of 58 Case Studies.

Background: Poland syndrome is a congenital anomaly of pectoralis muscles, breast, chest, and upper arm. Several studies have reported that patients affected by chest wall deformities often experience body image disorders and decreased quality of life. Cosmetic corrective surgery is generally postponed until physical development is achieved, and latissimus dorsi flap surgery is usually suggested. This study aims to propose a new surgical timing for these patients. Methods: Patients affected by Poland syndrome (n = 58) and control patients (n = 50) were included in the study, and their body-related psychopathology was evaluated through the Body Uneasiness Test, a valuable multidimensional tool for the clinical assessment of body uneasiness. The Global Severity Index and several subscales were considered. Age and surgical status were taken into account. Results: Significant differences were detected between Poland syndrome patients and controls with respect to all Body Uneasiness Test subscales. Among subjects aged younger than 20 years, the group of patients not operated on was the most affected, whereas the group of peers after surgery showed scores similar to those detected in the control group. Conclusions: Surgical planning for patients with Poland syndrome should start in the period of growth to allow proper body image stabilization. Current surgical options allow for reduction of the use of invasive interventions such as the latissimus dorsi flap, in favor of less invasive surgical techniques such as expanders, implants, and autologous fat grafting. This new surgical timing will help to ameliorate problems with physical and mental development. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

3D Bioprinting Technology: Scientific Aspects and Ethical Issues

The scientific development of 3D bioprinting is rapidly advancing. This innovative technology involves many ethical and regulatory issues, including theoretical, source, transplantation and enhancement, animal welfare, economic, safety and information arguments. 3D bioprinting technology requires an adequate bioethical debate in order to develop regulations in the interest both of public health and the development of research. This paper aims to initiate and promote ethical debate. The authors examine scientific aspects of 3D bioprinting technology and explore related ethical issues, with special regard to the protection of individual rights and transparency of research. In common with all new biotechnologies, 3D bioprinting technology involves both opportunities and risks. Consequently, several scientific and ethical issues need to be addressed. A bioethical debate should be carefully increased through a multidisciplinary approach among experts and also among the public.

The Working Alliance in Psychotherapy: Risk, Criticism and Perspectives in the Italian Context

This paper investigates which factors inherent to the various forms of psychotherapy are conducive to success and which are not. Particular emphasis is placed on the role of communication between the therapist and the patient, with specific regard to the outcome of treatment. The habitual practices and main problems facing healthcare professionals with regard to information and consent to psychotherapy are analysed in the context of the results of some recent studies of outcomes and processes which support the notion that the factors most frequently associated with successful psychotherapy are cooperation, proper information and a shared commitment to achieving the objectives of treatment.

Alternative approach to animal testing and cell cultures, according to European laws

ALTEX 34(3), 2017 441 such as skin/eye irritation and partially for skin sensitization. Some non-validated alternative approaches, such as read-across and weight-of-evidence approaches, are also accepted in the EU when sufficiently justified. The OECD launched a program on the development of Adverse Outcome Pathways (AOP) in 2012. AOP is an analytical construct that starts from a mechanistic/ cellular/in vitro sub-profiling to reach the effects observed in populations, and describes sequential events at different levels of biological organization that lead to adverse health or ecotoxicological effects. Dr Stefania Vernazza (LARF-DIMES, University of Genoa) provided an overview on in vitro 3D alternative methods for evaluation of the human risk related to exposure to chemical compounds. International organizations, such as ECVAM and OECD, cooperate on the development of regulations on reducing the use of laboratory animals through the validation of in vitro toxicity tests. Some OECD test guidelines (439, 431 and 492) accept data from in vitro 3D models to classify a substance as irritant/corrosive for skin or eye without the need to perform animal tests. 3D tissues for these applications are commercially available. Prof. Anna Maria Bassi (LARF-DIMES, University of Genoa) explained the concept of a reliable predictive toxicology. Most of the failures in drug discovery are a result of the low predictivity of preclinical animal models for human diseases such as autism syndrome or asthma. There is the pressing need for new toxicity testing models based on human biology. In this regard, Dr Bassi spotlighted the development of a mini-brain by Thomas Hartung’s team (CAAT, Johns Hopkins University) to improve research and drug development for neurodegenerative diseases. Mini-brains derive from patient cells and so can reproduce epigenetic interactions. The second part of the lecture was focused on AOPs, which provide a comprehensive knowledge of human disease and link chemical properties of a toxicant, its macro-molecular interactions, cellular/organ/organism responses and adverse outcomes in the population. This complex of data is critical to identify exposure biomarkers and toxicity pathways. The OECD’s AOP website invites project proposals, offers stakeholder summaries, proposal templates and guidance on developing AOPs. The AOP program foresees a biannual update for new project proposals and new information on ongoing projects. Dr Giorgio Mattei (Research Centre “E. Piaggio”, University of Pisa, Italy) presented an update on innovative technologies for dynamic in vitro 3D models. He explained the characteristics of biomimetic in vitro models resulting from combinations of cell culture systems, advanced materials design, tissue engiOn September 29-30, 2016, the 8th edition of the training course on “Alternative Approach to Animal Testing and Cell Cultures, According to European Laws”, was held in Genoa, chaired by Prof. Anna Maria Bassi and organized and hosted by the team of Laboratory Analysis and Research in Physiopathology (LARF), Department of Experimental Medicine, University of Genoa, Italy. The course was focused on practical work and demonstration/lessons by specialist(s) aiming to supply basic knowledge or improve existing knowledge on alternative methods. Each edition of the course provides an update on innovative in vitro models with a particular emphasis on 3D models. Substantial practical time is included to allow participants to gain hands-on experience. Twenty-four participants, from experts of in vitro methods to undergraduates, from all over Italy took part. The course was opened by Prof. Giovanni Murialdo and Prof. Adriana Voci, coordinators of the degree courses in Medicine and Surgery, and Biological Sciences, respectively, at the University of Genoa. Both stressed the need for such events to ensure that research in Italy for the study of risks to human and animal health following exposure to chemical compounds (drugs, pollutants, food additives, etc.) is in step with new technologies. Prof. Rosagemma Ciliberti (DISSAL, University of Genoa) and Susanna Penco (LARF-DIMES, University of Genoa) highlighted ethical issues of animal-based research. According to Italian Law 413/1993 on “Rules on conscientious objection to animal experimentation”, physicians, researchers, students and healthcare providers can choose not to take part in activities that involve animal experimentation. Conscientious objection to animal experimentation arose from the acknowledgement of animals as conscious beings. Dr Chiara Scanarotti (LARF-DIMES, University of Genoa) gave an update on the development and validation of several well-standardized and reproducible alternative methods for toxicity testing of chemical compounds, underlining how the use of human instead of animal cells improves the accuracy and relevance of the in vitro tests. The lecture highlighted 3D models, spheroids, body-on-a-chip and the latest advancements in stem cell research. Dr Costanza Rovida (CAAT Europe – University of Konstanz, Germany) presented a lecture on the implementation of alternative methods. Full replacement of in vivo tests is a lengthy process as they are mandatory for the registration and risk assessment of chemicals (drugs, additives, etc.) and the use of alternative methods requires formal validation before acceptance. To date, in vitro tests are accepted for some endpoints, Alternative Approach to Animal Testing and Cell Cultures, According to European Laws

Can artificially deforming skulls cause “defects of intelligence”? The observations of a positivist anthropologist on an artificially deformed skull discovered in Naples

We discuss a particular case of an artificially deformed skull discovered in Naples in 1892 and published in the Italian Journal of Natural Sciences by the anthropologist Abele De Blasio. To comprehend the observations of the researcher about the “defects of intelligence” caused by the artificial deformation of the skull, we will also analyze other articles in which De Blasio presented the deformed skulls of ancient Peruvian mummies.

A Survey on the Knowledge and Attitudes of Italian Medical Students toward Body Donation: Ethical and Scientific Considerations

Post mortem body donation (PMBD) for medical training and research plays a key role in medical-surgical education. The aim of this study is to evaluate Italian medical students’ awareness and attitudes regarding this practice. A questionnaire was sent to 1781 Italian medical students (MS). A total of 472 MS responded: 406 (92.91%) had a strongly positive attitude to PMBD, while 31 (7.09%) were not in favor. The majority of subjects were Catholic (56.36%), while 185 and 21 subjects, said that they did not hold any religious beliefs, or were of other religions, respectively. Multivariate analysis showed significant associations (p-values < 0.05) between PMBD and religion, as well as perceptions of PMBD as an act of altruism, a tool for learning surgical practices, body mutilation, and an act contrary to faith. Although Italian MS believed cadaver dissection to be an important part of their education, they did not know much about it and had not received training on this altruistic choice. As future doctors, MS can play an important role in raising public awareness of the importance of PMBD for medical education and research. Specific educational programs to improve knowledge of this topic among MS are needed.

Medical Humanities. Recognition and reorganization within the Italian University

Not available.