Mario Picozzi

The Notion of Neutrality in Clinical Ethics Consultation

Clinical ethics consultation (CEC), as an activity that may be provided by clinical ethics committees and consultants, is nowadays a well-established practice in North America. Although it has been increasingly implemented in Europe and elsewhere, no agreement can be found among scholars and practitioners on the appropriate role or approach the consultant should play when ethically problematic cases involving conflicts and uncertainties come up. In particular, there is no consensus on the acceptability of consultants making recommendations, offering moral advice upon request, and expressing personal opinions. We translate these issues into the question of whether the consultant should be neutral when performing an ethics consultation. We argue that the notion of neutrality 1) functions as a hermeneutical key to review the history of CEC as a whole; 2) may be enlightened by a precise assessment of the nature and goals of CEC; 3) refers to the normative dimension of CEC. Here, we distinguish four different meanings of neutrality: a neutral stance toward the parties involved in clinical decision making, toward the arguments offered to frame the discussion, toward the values and norms involved in the case, and toward the outcome of decision making, that is to say the final decision and action that will be implemented. Lastly, we suggest a non-authoritarian way to intend the term “recommendation” in the context of clinical ethics consultation.

The development of clinical ethics in Italy and the birth of the “Document of Trento”

The Italian debate about the role of clinical ethics and ethics consultation has brought about the need to create a working group of Healthcare Ethics Consultation. The group began to take shape and to be organized in 2010; its activities are largely directed to share experiences, to analyze this field and to develop a professional profile of the clinical ethicist recognized throughout the nation. The working group of Clinical Ethics and Healthcare Ethics Consultation was born from some meetings and the group started to draft a Document about Clinical Ethics Consultation in Healthcare in Rome (June 2013). The Document was approved in Trento at the Kessler Foundation (October 2013) and undersigned by more than 200 people. The newborn document was called “The Document of Trento”: it is the first Italian document regarding clinical ethics consultation.

The Duty to Vaccinate: A Cultural Challenge

ISSN: 1526-5161 (Print) 1536-0075 (Online) Journal homepage: http://www.tandfonline.com/loi/uajb20 The Duty to Vaccinate: A Cultural Challenge Mario Picozzi, Renzo Pegoraro & Andrea Virdis To cite this article: Mario Picozzi, Renzo Pegoraro & Andrea Virdis (2017) The Duty to Vaccinate: A Cultural Challenge, The American Journal of Bioethics, 17:4, 52-53, DOI: 10.1080/15265161.2017.1284927 To link to this article: http://dx.doi.org/10.1080/15265161.2017.1284927

Transparency for each research article. Institutions must also be accountable for research integrity.

Scientific misconduct includes serious breaches of integrity (fabrication, falsification, and plagiarism) and questionable research practices (failure to keep records, mismanagement of data, incomplete acknowledgment, and ghost/guest authorship). The need to ensure that the scientific community and the public have an accurate and complete record of research is increasing.1 The Singapore statement on research integrity, the first international guideline on …

Domestic Use of the Exoskeleton for Gait Training in Patients with Spinal Cord Injuries: Ethical Dilemmas in Clinical Practice

In this paper, as in our previous works1 we evaluate some ethical questions about the domestic use of the robotic exoskeleton (ReWalk Robotics, Marlborough, MA, USA) (Esquenazi et al., 2012; Asselin et al., 2016) for gait assistance in people affected by a Spinal Cord Injury (SCI) (National spinal cord injury statistical center, 2010; Scivoletto et al., 2011). This device is presently FDA and EC market approved and it is now available in two different versions, one for hospital training and one for home-based use. The latter can be provided to the patient when a sufficient level of competence has been reached after special training. This work focuses on this second version of the ReWalk, since it was designed exclusively for domestic use. Ethical concerns may arise because financial coverage of the home ReWalk version is still under debate for most patients; it depends mainly on personal resources in so far as home delivery is not supported by common and shared International Provisional rules. In addition, in SCI patients the long term global consequences for health are marked by an increased risk of cardiovascular and metabolic diseases, while the paretic limbs may have a high risk of osteoporosis, skin lesions and deep venous thrombosis. Bowel constipation and pelvic floor impairment are other negative effects of SCI. Patents with SCI, their relatives, and their health care providers frequently classify the recovery of the ability to walk as a high priority, even where great effort has been made to alleviate the aforementioned consequences (American Spinal Cord Injury Association, 1982; Nene et al., 1996). To counteract these negative effects, Gait Retraining Programs have been operating for many years in order to exploit body-weight-supported gait on a treadmill (Sale et al., 2012), dynamic orthoses based upon passive mechanical hip-knee-ankle-foot orthoses (H-KAFO) which enable patients with SCI to ambulate over ground (Massucci et al., 1998) and/or similar synergic actions of Functional Electrical Stimulation (FES) with synchronized activation according to the different phases of the gait cycle (Nene and Patrick, 1990). Unfortunately, this type of treatment only results in obtaining a very slow gait speed with a high fatigue component.

Medical Involvement in Acts of Torture or Degrading Treatment of Human Beings: Forensic and Medical Reflections

The following chapter condenses the reflections about the legitimacy of torture, a theme that the authors hope to contribute to in the opening of a debate on this important issue for the future of medicine and for the goals that medicine sets for itself in our time. The topic of this article is relevant to the debate exacerbated by the tragic events of 2001. In the case of capture of terrorists in possession of information regarding imminent attacks, is it permissible to subject them to torture? In what situations and under what conditions is it possible? We will report on the requirements of the critics of the international ban and the justifications for their arguments. We will present the criticisms of those who defend the maintenance of the prohibition of torture. Similarly we will discuss the positions of doctors who are favorable and adverse to participation in procedures of torture.

An intriguing Insubria Research Biobank model: Ethical framework and opportunities for a Biobank Ethics Consultation Service (BECS)

T University of Arizona Biorepository is responsible for collecting, storing, tracking, processing, and distributing human tissue, blood, and other bio-specimens. The Biorepository’s mission is to provide high-quality, clinically annotated specimens to the research community at this and other institutions as well as to industry involved in biomedical research. Researchers can use the stored materials for future research studies to learn more about cancer, diabetes, and other health problems. The bank will provide a ready supply of samples, so researchers do not have to look for donors for each new study. The biorepository provides consistent collection, processing, banking and clinical correlative procedures and operates in conjunction with departments of Surgery, Ophthalmology, Pulmonology, Aging, Neurology, Neurosurgery, Biomedical Engineering, OB-GYN, Cardiology and others. Currently the bio-repository has in its possession 1.5 million patient samples obtained through Pathology. The bio-repository utilizes universal electronic consents providing annotated clinical data on each patient through an Honest Broker arrangement. All samples are linked to patient medical identifiers allowing for access to the electronic health record now and at all times in the future in a deidentified fashion. Fresh frozen paraffin blocks, blood, plasma, sera, urine and other biological fluids; as well as biopsies and other tissues/bio-samples are stored. In addition, DNA/RNA/proteins are also banked for all samples. Significantly, we have now developed methodology allowing for genomic and phenotypic sample characterization for approx.

P-123 The psychology and the clinical ethics consultations: Different fields in the palliative care-hospice unit

2/patient sample. As all samples are stored according to industry best practices, in temperature-controlled, monitored, and alarmed environments (in LN2 or other freezers as appropriate) to maximize resource integrity utilizing cGTP practices whenever possible, the biorepository also serves as a source of cells and tissues for projects involving translational and regenerative medicine. To facilitate investigator interactions the biorepository utilizes Tissue Metrix2 as the central database for information on all banked bio-samples. The software has a web-based front-end with an Oracle database which permits access from web browsers across multiple platforms. It employs role based security to permit control over user access to information stored in the database. The i2b2 open source exploration tool is used as a storefront for investigator sample requests in a text based format.T rapid advances made in personalized medicine are compelling the scientific and medical communities to gather an increasing volume of genetic/genomic information from an ever broadening diversity of sources. One of the major issues with this endeavor is the quality of the nucleic acids samples which can be obtained from the source material. Another one has to deal with how the purified nucleic acids are being conserved for future reference, which in itself would be the topic of another presentation. This presentation will focus on two particular cases, whose handling requires some precaution in order to safely obtain usable nucleic acids. The first case deals with the purification of sequence-able nucleic acids from paraffin-embedded tissues (FFPE). An automated protocol will be described, from starting sample to DNA ready to be sequenced. The second case addresses more specifically the purification of DNA samples from large volume, complex and heterogeneous samples, such as in the cases of microbiome and metagenome analysis. The automated protocols which are being developed for these applications will be described as well.T objective of the present study was to evaluate the comparative effects of reduced glutathione (GSH), water soluble Vitamin E analogue Trolox and butylated hydroxytoluene (BHT) on quality of cryopreserved boar spermatozoa. Sixteen sperm-rich fractions of ejaculates, collected from six mature boars were utilized for the study. Using split sample technique three different antioxidants viz., GSH (1 mM), Vitamin E (0.2 mM) and BHT (0.2 mM) were added to the freezing medium of lactose-egg yolkglycerol extender and frozen using controlled freezing rate of 40 ̊C/min from -6 to -140 ̊C in medium straw. Semen samples were evaluated for sperm motility, acrosomal status, plasma membrane integrity, mitochondrial membrane potential (MMP), lipid peroxidation (LPO) and sperm DNA integrity after equilibration and after freezing. Results revealed that GSH, Vitamin E and BHT addition resulted in significantly (p<0.05) higher post thaw motility, live intact acrosome and plasma membrane intact sperm as compared to no supplementation (control). The incidence of post thaw sperm lipid peroxidation was also significantly (p<0.05) reduced after supplementation of antioxidants. However, antioxidants treatment neither significantly (p>0.05) improved MMP of live sperm sub-population nor sperm DNA integrity after freezing. In addition, there was no significant difference of the post thaw sperm characteristics among the three antioxidants. Our findings suggest that the magnitude of protective measure conferred by GSH, Vitamin E and BHT on cryopreserved boar spermatozoa are comparable and thus incorporation of either GSH, Vitamin E or BHT in freezing medium could provide boar semen with better freezability.C of ovarian tissue has been taken at several levels as it helps in maintaining safe genome of female for production of next generation. For this objective, transplantation of the tissue in a model is needed. Marmoset monkey (Callithrix jacchus) has been advocated an alternative model to large size monkeys. However, there are several challenges to shift to the new model. Cryopreservation of ovarian tissues of the marmoset monkey from adult and young animals have been evaluated using dimethyl sulphoxide (DMSO), 1,2-propanediol (PrOH) or ethyl glycol (EG) using slow freezing protocol. After xenografting in nude mice, the follicles were compared in fresh, cryopreserved and xenografted tissues. When compared to fresh, cryopreservation decreased number of follicles to one third in DMSO, one fifth in PrOH and one sixth in EG. After xenografting in nude mice, the survival of follicles in adult tissue was twice in DMSO group than PrOH group. Prepubertal tissue did not show this difference for primordial follicles, but primary follicles were marginally better in DMSO group. Therefore, for adult marmoset monkey DMSO seems better cryoprotectant for ovarian cryopreservation for xenografting of its tissue. Prepubertal ovarian tissues could survive almost to a similar level in all three cryoprotectants (DMSO, PrOH and EG). This is an indication that the prepubertal tissue has greater tolerance to cryo-injuries. Staining with Proliferating Cell Nuclear Antigen indicated survival of the cells in the xenografted tissue. In human both DMSO and PrOH have been reported equally well but DMSO has been superior in certain aspects.

THE DECLARATION OF HELSINKI AND POST‐STUDY ACCESS TO EFFECTIVE DRUG TREATMENTS FOR SUBJECTS PARTICIPATING IN CLINICAL TRIALS

Background To which different questions and needs does the role of the psychologist and the clinical ethicist attempt to reply in a Hospice – Palliative Care clinical setting? This contribution intends to investigate the contact and divergence points between the psychological intervention and the ethical consultation, starting from an analysis of the different competences and evaluating the aspects of a possible convergence, in a Hospice – Palliative Care Unit. Methods A review of the existing literature and a presentation of the clinical cases occurred in a Palliative Care – Hospice Units were performed. Results These two figures can improve the quality of the therapeutic intervention. They can work related in a different and complementary way, responding to different but essential questions and needs for a high quality of care. Discussion The different methods are compared to provide a good answer to specific issues related to the end of life. The psychological intervention is primarily oriented to understand which are the most appropriate actions to create the conditions to control the fear of death. Regarding the ethics consultation, the most relevant aspect concerns the research of a method to analyse the choices in relation to the end of life, crossing the monitored fear of the death. Conclusion The presence of both the professionals is considered necessary during the patient’s care in the Palliative care – Hospice Unit. Moreover, the two disciplines seem to be able to coexist and to complement each other and with other subjects of the healthcare team.