BackgroundInnovations in technology have contributed to rapid changes in the way that modern biomedical research is carried out. Researchers are increasingly required to endorse adaptive and flexible approaches to accommodate these innovations and comply with ethical, legal and regulatory requirements. This paper explores how Dynamic Consent may provide solutions to address challenges encountered when researchers invite individuals to participate in research and follow them up over time in a continuously changing environment.MethodsAn interdisciplinary workshop jointly organised by the University of Oxford and the COST Action CHIP ME gathered clinicians, researchers, ethicists, lawyers, research participants and patient representatives to discuss experiences of using Dynamic Consent, and how such use may facilitate the conduct of specific research tasks. The data collected during the workshop were analysed using a content analysis approach.ResultsDynamic Consent can provide practical, sustainable and future-proof solutions to challenges related to participant recruitment, the attainment of informed consent, participant retention and consent management, and may bring economic efficiencies.ConclusionsDynamic Consent offers opportunities for ongoing communication between researchers and research participants that can positively impact research. Dynamic Consent supports inter-sector, cross-border approaches and large scale data-sharing. Whilst it is relatively easy to set up and maintain, its implementation will require that researchers re-consider their relationship with research participants and adopt new procedures.

Crigler-Najjar syndrome type 1 (CN1) is an inherited disorder characterized by the absence of hepatic uridine diphosphoglucuronate glucuronosyltransferase (UDPGT), the enzyme responsible for the conjugation and excretion of bilirubin. We performed allogenic hepatocyte transplantation (AHT) in a child with CN1, aiming to improve bilirubin glucuronidation in this condition. A 9-year-old boy with CN1 was prepared with plasmapheresis and immunosuppression with prednisolone and tacrolimus. When a graft was made available, 7.5 x 10(9) hepatocytes were isolated and infused into the portal vein percutaneously. After 2 weeks phenobarbitone was added to promote the enzymatic activity of UDPGT of the transplanted hepatocytes. Nocturnal phototherapy was continued throughout the studied period. Total bilirubin was considered a reliable marker of allogenic cell function. There was no significant variation of vital signs nor complications during the infusion. Mean +/- SD bilirubin level was 530 +/- 38 micromol/L before and 359 +/- 46 micromol/L after AHT (t-test, p < 0.001). However, the introduction of phenobarbitone was followed by a drop of tacrolimus level with increase of alanine aminotransferase (ALT) and increase of bilirubin. After standard treatment of cellular rejection bilirubin fell again but from then on it was maintained at a greater level. After discharge the patient experienced a further increase of bilirubin that returned to predischarge levels after readmission to the hospital. This was interpreted as poor compliance with phototherapy. Only partial correction of clinical jaundice and the poor tolerability to nocturnal phototherapy led the parents to refuse further hepatocyte infusions and request an orthotopic liver transplant. After 24 months the child is well, with good liver function on tacrolimus and prednisolone-based immunosuppression. Isolated AHT, though effective and safe, is not sufficient to correct CN1. Maintenance of adequate immunosuppression and family compliance are the main factors hampering the success of this procedure.

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Treatment with hAFS cells has a reparative potential through active involvement of cells in alveolarization and angiogenesis. A downstream paracrine action was also taken into account, in order to understand the immunodulatory response.

Current policy approaches to social and ethical issues surrounding biobanks manifest lack of public information given by researchers and government, despite the evidence that Italian citizens are well informed about technical and other public perspectives of biotechnologies. For this reason, the focus of our survey was to interview our University’s students on these aspects. The sample consisted of Padua University students (N = 959), who were administered a questionnaire comprising eight questions covering their knowledge about biobanks, their perception of the related benefits and risks, their willingness to donate samples to a biobank for research purposes, their attitude to having their own DNA profile included in a forensic DNA database, and the reasons behind their answers. The vast majority of the students invited to take part in the survey completed the questionnaire, and the number of participants sufficed to be considered representative of the target population. Despite the respondents’ unfamiliarity with the topics explored, suggested by the huge group of respondents answering “I don’t know” to the questions regarding Itaian regulation and reality, their answers demonstrate a general agreement to participate in a biobanking scheme for research purposes, as expressed by the 91% of respondents who were reportedly willing to donate their samples. As for the idea of a forensic DNA database, 35% of respondents said they would agree to having their profile included in such a database, even if they were not fully aware of the benefits and risks of such action.This study shows that Italian people with a higher education take a generally positive attitude to the idea of donating biological samples. It contributes to empirical evidence of what Italy’s citizens understand about biobanking, and of their willingness to donate samples for research purposes, and also to have their genetic profiles included in a national forensic DNA database. Our findings may have clear implications for the policy discussion on biobanks in Italy, in particular it is important to take into account the Italian population’s poor consciousness of forensic DNA database, in order to ensure a better interaction between policy makers and citizens and to make them more aware of the need to balance the individual’s rights and the security of society.

In Western countries, a social trend toward delaying childbearing has been observed in women of reproductive age for the last two decades. This delay is due to different factors related to lifestyle, such as the development of a professional career or the absence of the right partner. As a consequence, women who defer childbearing may find themselves affected by age-related infertility when they decide to conceive. Fertility preservation techniques are, therefore, proposed as a solution for these women. Among all possible solutions, social freezing is an alternative strongly discussed from a scientific, social and ethical point of view. A survey among 930 female students at the University of Padova (Italy) investigated their knowledge and attitudes on social egg freezing and their potential intentions regarding this procedure. To our knowledge, this is the first study to examine the level of awareness of age-related infertility in Italian young women and their attitudes regarding acceptable indications for elective oocyte freezing, their potential personal use, the circumstances in which they would then decide to use cryopreserved eggs, and their attitudes towards cost coverage and oocyte donation. Data collected in this study revealed some important points about young women and their knowledge about social oocyte freezing in Italy as compared to other European countries and the United States. Overall, 34.3% of the students reported having heard about the possibility of oocyte cryopreservation for non-medical reasons and being aware of the meaning of this procedure; only 19.5% were in favour of social egg freezing and 48.4% thought that the cost for this procedure should be borne entirely by the woman herself. Regarding egg donation, the majority of students (64.9%) would not accept donating their eggs to a known woman or couple and 42.5% would instead accept donating to a biobank. Our study shows that young Italian women are significantly less aware of age-related decline in fertility and the possibility of using social egg freezing compared to their similarly situated counterparts in other Western countries.

IL12, formed from p35 and p40 subunits encoded by\ud IL12A and IL12B genes, favours T helper 1 (Th1)\ud differentiation. Th1 lymphocytes prevail over Th2 in\ud H pylori associated chronic gastritis, the first step in\ud H pylori associated gastric carcinogenesis. In this\ud study, 110 patients with non-cardia gastric cancer\ud were compared with 251 patients with benign gastroduodenal\ud diseases to see whether there was any\ud correlation between IL12 gene polymorphisms and\ud H pylori associated gastric adenocarcinoma.\ud N Two single nucleotide polymorphisms were identified\ud on IL12A (2504 T/G and +6686 A/G) and one on\ud IL12B (+15485 A/G). Eleven and six alleles were\ud found for CT and TG-TA dinucleotide repeats (VNTR) of\ud IL12A intron 6 and IL12B intron 4, respectively.\ud N The frequency of non-cardia gastric cancer was higher\ud in patients with the IL12A 2504 T/T (odds ratio\ud (OR) = 2.38) or with the IL12B VNTR (TG-TA)9/(TGTA)\ud 11 genotype (OR = 1.36).\ud N No IL12 gene polymorphisms were correlated with\ud intestinal metaplasia.\ud N These findings suggest that IL12A and IL12B gene\ud polymorphisms may affect the final steps in gastric\ud carcinogenesis in H pylori infected subjects

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