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1.
Ann Ist Super Sanita ; 60(1): 29-36, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38920256

RESUMO

Originally established to evaluate the ethical aspects of clinical trials, Ethics Committees (ECs) are now requested to review different types of projects, including, among others, observational studies and disease registries. In Italy, clinical trials on medicinal products for human use and on medical devices are regulated by EU Regulation 536/2014, EU Regulation 2017/745, and 2017/746 while pharmacological observational studies are regulated by the Italian Medicines Agency guidelines of 2008 and by Ministerial Decree of November 30th, 2021. The other types of studies are not strictly regulated, causing discrepancies in their definition and assessment by the ECs, and slowdowns in the start of projects. The present contribution aims to propose definitions and distinctions between non-pharmacological observational studies and disease registries, which constitute different entities but are often assimilated by ECs, and to formulate suggestions for the evaluation of rare disease registries, which are an expanding research area of interest.


Assuntos
Estudos Observacionais como Assunto , Doenças Raras , Sistema de Registros , Doenças Raras/terapia , Humanos , Estudos Observacionais como Assunto/ética , Itália , Ensaios Clínicos como Assunto/ética , União Europeia
2.
Front Public Health ; 10: 1081150, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36590004

RESUMO

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.


Assuntos
Ensaios Clínicos como Assunto , Humanos , COVID-19 , Atenção à Saúde , Pandemias , Telemedicina , Ensaios Clínicos como Assunto/ética , Ensaios Clínicos como Assunto/métodos
3.
Virchows Arch ; 479(2): 233-246, 2021 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-34255145

RESUMO

The term "biobanking" is often misapplied to any collection of human biological materials (biospecimens) regardless of requirements related to ethical and legal issues or the standardization of different processes involved in tissue collection. A proper definition of biobanks is large collections of biospecimens linked to relevant personal and health information (health records, family history, lifestyle, genetic information) that are held predominantly for use in health and medical research. In addition, the International Organization for Standardization, in illustrating the requirements for biobanking (ISO 20387:2018), stresses the concept of biobanks being legal entities driving the process of acquisition and storage together with some or all of the activities related to collection, preparation, preservation, testing, analysing and distributing defined biological material as well as related information and data. In this review article, we aim to discuss the basic principles of biobanking, spanning from definitions to classification systems, standardization processes and documents, sustainability and ethical and legal requirements. We also deal with emerging specimens that are currently being generated and shaping the so-called next-generation biobanking, and we provide pragmatic examples of cancer-associated biobanking by discussing the process behind the construction of a biobank and the infrastructures supporting the implementation of biobanking in scientific research.


Assuntos
Bancos de Espécimes Biológicos , Pesquisa Biomédica , Medicina de Precisão , Manejo de Espécimes , Acreditação , Bancos de Espécimes Biológicos/classificação , Bancos de Espécimes Biológicos/ética , Bancos de Espécimes Biológicos/legislação & jurisprudência , Bancos de Espécimes Biológicos/normas , Pesquisa Biomédica/classificação , Pesquisa Biomédica/ética , Pesquisa Biomédica/legislação & jurisprudência , Pesquisa Biomédica/normas , Guias como Assunto , Humanos , Formulação de Políticas , Medicina de Precisão/classificação , Medicina de Precisão/ética , Medicina de Precisão/normas , Manejo de Espécimes/classificação , Manejo de Espécimes/ética , Manejo de Espécimes/normas , Participação dos Interessados , Terminologia como Assunto
4.
J Med Ethics ; 46(6): 364-366, 2020 06.
Artigo em Inglês | MEDLINE | ID: mdl-32277018

RESUMO

After initially emerging in China, the coronavirus (COVID-19) outbreak has advanced rapidly. The World Health Organization (WHO) has recently declared it a pandemic, with Europe becoming its new epicentre. Italy has so far been the most severely hit European country and demand for critical care in the northern region currently exceeds its supply. This raises significant ethical concerns, among which is the allocation of scarce resources. Professionals are considering the prioritisation of patients most likely to survive over those with remote chances, and this news has triggered an intense debate about the right of every individual to access healthcare. The proposed analysis suggests that the national emergency framework in which prioritisation criteria are currently enforced should not lead us to perceive scarce resources allocation as something new. From an ethical perspective, the novelty of the current emergency is not grounded in the devastating effects of scarce resources allocation, which is rife in recent and present clinical practice. Rather, it has to do with the extraordinarily high number of people who find themselves personally affected by the implications of scarce resources allocation and who suddenly realise that the principle of 'equals should be treated equally' may no longer be applicable. Along with the need to allocate appropriate additional financial resources to support the healthcare system, and thus to mitigate the scarcity of resources, the analysis insists on the relevance of a medical ethics perspective that does not place the burden of care and choice solely on physicians.


Assuntos
Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/terapia , Alocação de Recursos para a Atenção à Saúde/organização & administração , Pneumonia Viral/epidemiologia , Pneumonia Viral/terapia , Betacoronavirus , COVID-19 , Alocação de Recursos para a Atenção à Saúde/ética , Humanos , Itália/epidemiologia , Pandemias , SARS-CoV-2 , Listas de Espera
5.
Transplant Proc ; 52(5): 1525-1527, 2020 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-32222392

RESUMO

According to Law 91/1999, art. 18, in Italy, health care professionals and administrative staff involved in the process of organ collection and transplantation are required to ensure anonymity of both the donor and the recipient. Against this backdrop, in 2018, the Italian Committee for Bioethics (ICB) released an official opinion titled "Opinion on the preservation of the anonymity of donor and receiver in the transplantation of organs" that offers a new perspective on the topic, effectively opening the possibility of anonymity ending at certain conditions. The relevance of anonymity within the transplant network is a globally recognized principle with a strong ethical value. In this article, based on the experience of one author directly involved in the ICB opinion drafting, we examine the document and discuss how such a proposal could be implemented at the legislative level.


Assuntos
Temas Bioéticos , Anonimização de Dados/ética , Transplante de Órgãos/ética , Doadores de Tecidos/ética , Obtenção de Tecidos e Órgãos/ética , Atitude , Humanos , Itália , Transplante de Órgãos/legislação & jurisprudência , Doadores de Tecidos/legislação & jurisprudência , Obtenção de Tecidos e Órgãos/legislação & jurisprudência , Transplantados/legislação & jurisprudência
6.
J Bioeth Inq ; 16(4): 551-557, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31729685

RESUMO

Cancer is the second leading cause of death in developed countries, making it a global public health problem. In this scenario, early detection is the key to successful treatment. Tissue biopsy, the current gold standard for cancer diagnosis, offers reliable results, but it is feasible only when the mass becomes detectable. On the other hand liquid biopsy, a promising experimental system, not yet implemented within clinical practice, allows early detection as its functioning relies on the analysis of body fluids. Yet, its results are less reliable if compared to those of tissue biopsy as, for instance, false positives and false negatives might occur. Despite technical features, the tradeoff between a reliable diagnosis available at a later time and a potentially less reliable diagnosis available at an early stage poses significant ethical challenges in the clinical scenario which involve, among other aspects, informed consent, communication, and patient-physician encounter.


Assuntos
Biópsia/métodos , Neoplasias/diagnóstico , Neoplasias/patologia , Biópsia/normas , Erros de Diagnóstico , Humanos , Biópsia Líquida/normas , Preferência do Paciente , Sensibilidade e Especificidade , Fatores de Tempo
7.
Mol Cell Endocrinol ; 412: 56-64, 2015 Sep 05.
Artigo em Inglês | MEDLINE | ID: mdl-26027920

RESUMO

Bisphenol A (BPA) and para-Nonylphenol (p-NP) are chemicals of industrial origin which may influence human reproductive health. The effects of these substances in the prenatal life is an important topic that is receiving greater attention in the developed countries. In this study, human trophoblast cells HTR-8/SVneo were exposed to BPA and p-NP (1 × 10(-15), 1 × 10(-13), 1 × 10(-11), 1 × 10(-9) and 1 × 10(-7) M) and incubated for 24, 48 and/or 72 h then, examined for the main physiological processes which characterize the extravillous trophoblast. Cell proliferation showed no changes while the processes of cell migration and invasion were both reduced by BPA and p-NP. For each chemical, the activity was higher at lower concentrations with a maximum activity between 1 × 10(-13) and 1 × 10(-11) M (p < 0.05 for 1 × 10(-9) and p < 0.001 for 1 × 10(-11) M). Co-culture studies with human umbilical cord endothelial cells (HUVEC) revealed that trophoblast/endothelial interaction was significantly reduced by p-NP at 1 × 10(-11) M. Moreover, both chemicals were inducing differentiation of HTR-8/SVneo toward polyploidy by the process of endoreduplication. The estrogen-receptor antagonist ICI significantly reduced p-NP action, while it had no effect on BPA treated cells. In conclusion, p-NP and BPA act on trophoblast cells altering key physiological processes in placenta development. The exact mechanism of action of the chemicals in human trophoblast still needs to be clarified.


Assuntos
Compostos Benzidrílicos/toxicidade , Diferenciação Celular/efeitos dos fármacos , Disruptores Endócrinos/toxicidade , Fenóis/toxicidade , Trofoblastos/fisiologia , Linhagem Celular , Movimento Celular , Proliferação de Células , Forma Celular , Técnicas de Cocultura , Inibidor de Quinase Dependente de Ciclina p57/metabolismo , Células Endoteliais da Veia Umbilical Humana/fisiologia , Humanos , Trofoblastos/efeitos dos fármacos
8.
Reproduction ; 150(2): 115-25, 2015 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-26021997

RESUMO

The human endometrium is a fertility-determining tissue and a target of steroid hormones' action. Endocrine disruptors (EDs) can exert adverse effects on the physiological function of the decidua at the maternal-fetal interface. We examined the potential effects of an ED, bisphenol A (BPA), on endometrial maturation/decidualization, receptivity, and secretion of decidual factors (biomarkers). In vitro decidualized, endometrial stromal cells from six hysterectomy specimens were treated with 1  pM-1  µM of BPA, for 24  h and assessed for cell viability and proliferation. Three non-toxic concentrations of BPA (1  µM, 1  nM, and 1  pM) were selected to study its influence on secretion of cell decidualization biomarkers (IGF-binding protein and decidual prolactin (dPRL)), macrophage migration inhibitory factor (MIF) secretion, and hormone receptors' expression (estrogen receptors (ERα and ERß); progesterone receptors (PRA and PRB); and human chorionic gonadotropin (hCG)/LH receptor (LH-R)). The results showed a decrease in cell viability (P<0.001) in response to BPA at the level of 1  mM. At the non-toxic concentrations used, BPA perturbed the expression of ERα, ERß, PRA, PRB, and hCG/LH-R (P<0.05). Furthermore, 1  µM of BPA reduced the mRNA transcription of dPRL (P<0.05). Secretion of MIF was stimulated by all BPA treatments, the lowest concentration (1  pM) being the most effective (P<0.001). The multi-targeted disruption of BPA on decidual cells, at concentrations commonly detected in the human population, raises great concern about the possible consequences of exposure to BPA on the function of decidua and thus its potential deleterious effect on pregnancy.


Assuntos
Compostos Benzidrílicos/toxicidade , Decídua/citologia , Decídua/efeitos dos fármacos , Disruptores Endócrinos/toxicidade , Poluentes Ambientais/toxicidade , Fenóis/toxicidade , Antimetabólitos/farmacologia , Biomarcadores/análise , Biomarcadores/metabolismo , Bromodesoxiuridina/farmacologia , Sobrevivência Celular/efeitos dos fármacos , Decídua/metabolismo , Endométrio/citologia , Endométrio/efeitos dos fármacos , Endométrio/crescimento & desenvolvimento , Feminino , Regulação da Expressão Gênica/efeitos dos fármacos , Humanos , Técnicas In Vitro , Proteína 1 de Ligação a Fator de Crescimento Semelhante à Insulina/metabolismo , Fatores Inibidores da Migração de Macrófagos/metabolismo , Ciclo Menstrual/efeitos dos fármacos , Gravidez , RNA Mensageiro/biossíntese , RNA Mensageiro/genética
9.
Clin Exp Rheumatol ; 33(4 Suppl 91): S98-105, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-26005773

RESUMO

OBJECTIVES: To investigate serum levels, tissue/cellular expression of macrophage migration inhibitory factor (MIF) in patients with limited (lSSc) and diffuse (dSSc) systemic sclerosis. METHODS: 10 lSSc-patients, 10 dSSc-patients and 10 controls were enrolled. MIF serum levels were assayed by ELISA. MIF and its receptors CD74/CD44 were evaluated by immunohistochemistry on skin biopsies from patients with dSSc, lSSc (affected and not-affected skin) and controls. MIF levels were assessed (ELISA) in supernatants of healthy dermal microvascular endothelial cells (MVECs) and in control (CTR), non-affected SSc (NA) and affected (SSc) fibroblasts treated for 48 h with 10% control serum and 10% SSc-serum. MIF supernatant (ELISA) and mRNA (quantitative real-time PCR) levels were determined in SSc dermal fibroblasts and in control dermal fibroblasts untreated or stimulated at 6 h-24 h-48 h with bleomycin (50 mU/ml). RESULTS: Serum MIF was significantly higher in dSSc (18.7±4.1 ng/ml, p<0.001) and in lSSc (10.4±4.4 ng/ml, p<0.001) patients respect to controls (2.6±1.4 ng/ml). Enhanced MIF immunoreactivity was found in keratinocytes, fibroblasts, endothelium, sebaceous/sweat glands from lSSc/dSSc affected skin. Faint MIF immunoreactivity was found in control skin and not-affected skin of lSSc patients. No differences were found in CD74/CD44 receptors' analysis among control and dSSc/lSSc affected and non-affected skin. MVECs and fibroblasts (CTR, NA and SSc) produced significantly more MIF, when stimulated with SSc serum respect to control-serum (p<0.001). Finally, MIF mRNA levels significantly increased at 6h (p<0.001) and decreased at 48 h (p<0.001) in control fibroblasts treated with bleomycin compared to control untreated. Simultaneously, MIF supernatant protein levels increased after 48 h (p<0.01) in bleomycin-treated fibroblasts respect to untreated ones. CONCLUSIONS: These results suggest that MIF could be implicated in the pathogenesis of SSc, probably acting as protective factor against the SSc stressful conditions.


Assuntos
Fibroblastos/metabolismo , Oxirredutases Intramoleculares/sangue , Fatores Inibidores da Migração de Macrófagos/sangue , Esclerodermia Difusa/sangue , Esclerodermia Limitada/sangue , Pele/metabolismo , Adulto , Antígenos de Diferenciação de Linfócitos B/metabolismo , Biomarcadores/sangue , Biópsia , Bleomicina/farmacologia , Estudos de Casos e Controles , Células Cultivadas , Células Endoteliais/imunologia , Células Endoteliais/metabolismo , Ensaio de Imunoadsorção Enzimática , Feminino , Fibroblastos/efeitos dos fármacos , Fibroblastos/imunologia , Antígenos de Histocompatibilidade Classe II/metabolismo , Humanos , Receptores de Hialuronatos/metabolismo , Imuno-Histoquímica , Oxirredutases Intramoleculares/genética , Fatores Inibidores da Migração de Macrófagos/genética , RNA Mensageiro/metabolismo , Esclerodermia Difusa/diagnóstico , Esclerodermia Difusa/genética , Esclerodermia Difusa/imunologia , Esclerodermia Limitada/diagnóstico , Esclerodermia Limitada/genética , Esclerodermia Limitada/imunologia , Pele/efeitos dos fármacos , Pele/imunologia , Fatores de Tempo
10.
Dose Response ; 13(4): 1559325815611902, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-26740808

RESUMO

The identification of reproductive toxicants is a major scientific challenge for human health. Prenatal life is the most vulnerable and important time span of human development. For obvious ethical reasons, in vivo models cannot be used in human pregnancy, and animal models do not perfectly reflect human physiology. This review describes the in vitro test models representative of the human feto-maternal interface and the effects of environmental chemicals with estrogen-like activity, mainly bisphenol A and para-nonylphenol, with a particular emphasis on the effects at low, nontoxic doses similar to concentrations commonly detected in the population.

11.
Toxicol Lett ; 224(2): 264-71, 2014 Jan 13.
Artigo em Inglês | MEDLINE | ID: mdl-24201001

RESUMO

Human placental trophoblastic cancer BeWo cells can be used as a model of placental trophoblasts. We found that combined exposure to relevant exposure concentrations of ethanol (2‰) and nicotine (15 µM) induces an increase in the amount of reactive oxygen species (ROS). Neither ethanol or nicotine alone, nor their combination affected cell viability. However, nicotine decreased cell proliferation, both alone and combined with ethanol. Nicotine increased the expression of the endoplasmic reticulum (ER)-stress related protein GRP78/BiP, but not another marker of ER-stress, IRE1α. We also studied the effects of nicotine and/or ethanol on phosphorylation and expression of three mitogen-activated protein kinases (MAPKs), i.e. JNK, p38 and ERK1/2. Nicotine decreased the phosphorylation of JNK and also had similar effect on total amount of this protein. Phosphorylation and expression of p38 were increased 1.7- and 1.6-fold, respectively, by nicotine alone, and 1.9- and 2.1-fold by the combined treatment. Some increase (1.8-fold) was also seen in the phosphorylation of ERK2 at 48 h, in cells exposed to both ethanol and nicotine. This study shows that ethanol and nicotine, which harm the development of fetus may induce both oxidative and ER stress responses in human placental trophoblastic cells, implicating these mechanisms in their fetotoxic effects.


Assuntos
Estresse do Retículo Endoplasmático/efeitos dos fármacos , Etanol/toxicidade , Nicotina/toxicidade , Placenta/efeitos dos fármacos , Sobrevivência Celular/efeitos dos fármacos , Células Cultivadas , Chaperona BiP do Retículo Endoplasmático , Estresse do Retículo Endoplasmático/fisiologia , MAP Quinases Reguladas por Sinal Extracelular/metabolismo , Feminino , Proteínas de Choque Térmico/fisiologia , Humanos , Fosforilação , Placenta/metabolismo , Gravidez , Espécies Reativas de Oxigênio/metabolismo
12.
Int J Endocrinol ; 2013: 650984, 2013.
Artigo em Inglês | MEDLINE | ID: mdl-23710176

RESUMO

Phytoestrogens, polyphenolic compounds derived from plants, are more and more common constituents of human and animal diets. In most of the cases, these chemicals are much less potent than endogenous estrogens but exert their biological effects via similar mechanisms of action. The most common source of phytoestrogen exposure to humans as well as ruminants is soybean-derived foods that are rich in the isoflavones genistein and daidzein being metabolized in the digestive tract to even more potent metabolites-para-ethyl-phenol and equol. Phytoestrogens have recently come into considerable interest due to the increasing information on their adverse effects in human and animal reproduction, increasing the number of people substituting animal proteins with plant-derived proteins. Finally, the soybean becomes the main source of protein in animal fodder because of an absolute prohibition of bone meal use for animal feeding in 1995 in Europe. The review describes how exposure of soybean-derived phytoestrogens can have adverse effects on reproductive performance in female adults.

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