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1.  Research involving subjects with Alzheimer’s disease in Italy: the possible role of family members 
BMC Medical Ethics  2015;16:12.
Alzheimer’s disease is a very common, progressive and still incurable disease. Future possibilities for its cure lie in the promotion of research that will increase our knowledge of the disorder’s causes and lead to the discovery of effective remedies. Such research will necessarily involve individuals suffering from Alzheimer’s disease. This raises the controversial issue of whether patients with Alzheimer’s disease are competent to give their consent for research participation.
We discuss the case of subjects with Alzheimer’s disease who may have impaired decision-making capacity and who could be involved in research protocols, taking into consideration aspects of the Italian normative framework, which requires a court-appointed legal representative for patients who are not able to give consent and does not recognise the legal value of advance directives. We show that this normative framework risks preventing individuals with Alzheimer’s disease from taking part in research and that a new policy that favours research while promoting respect for patients’ well-being and rights needs to be implemented.
We believe that concerns about the difficulty of obtaining fully valid consent of patients with Alzheimer’s disease should not prevent them from participating in clinical trials and benefiting from scientific progress. Therefore, we argue that the requirement for patients to have a legal representative may not be the best solution in all countries and clinical situations, and suggest promoting the role of patients’ family members in the decision-making process. In addition, we outline the possible role of advance directives and ethics committees.
PMCID: PMC4357192  PMID: 25888878
Alzheimer’s disease; Clinical trials; Competence; Legal representative; Family members
2.  Umbilical cord blood banking: from personal donation to international public registries to global bioeconomy 
The procedures for collecting voluntarily and freely donated umbilical cord blood (UCB) units and processing them for use in transplants are extremely costly, and the capital flows thus generated form part of an increasingly pervasive global bioeconomy. To place the issue in perspective, this article first examines the different types of UCB biobank, the organization of international registries of public UCB biobanks, the optimal size of national inventories, and the possibility of obtaining commercial products from donated units. The fees generally applied for the acquisition of UCB units for transplantation are then discussed, and some considerations are proposed regarding the social and ethical implications raised by the international network for the importation and exportation of UCB, with a particular emphasis on the globalized bioeconomy of UCB and its commerciality or lack thereof.
PMCID: PMC4069132  PMID: 24971040
cord blood banking; economy; ethics; stem cells; transplantation
3.  Blood and blood-associated symbols: some ethical and legal considerations 
Blood Transfusion  2014;12(1):10-13.
PMCID: PMC3926708  PMID: 24333067
4.  Ethical and legal aspects of refusal of blood transfusions by Jehovah’s Witnesses, with particular reference to Italy 
Blood Transfusion  2014;12(Suppl 1):s395-s401.
PMCID: PMC3934270  PMID: 23736931
autonomy; bioethics; blood transfusion; informed consent; responsibility
5.  Production of plasma-derived medicinal products: ethical implications for blood donation and donors 
Blood Transfusion  2014;12(Suppl 1):s389-s394.
PMCID: PMC3934296  PMID: 23522886
bioethics; blood; plasma-derived medicinal products
6.  Is my blood mine? Some comments on the Convention on Human Rights and Biomedicine 
Blood Transfusion  2013;11(3):321-323.
PMCID: PMC3729117  PMID: 23058862
8.  Ethical and legal considerations regarding the ownership and commercial use of human biological materials and their derivatives 
This article considers some of the ethical and legal issues relating to the ownership and use – including for commercial purposes – of biological material and products derived from humans. The discussion is divided into three parts: after first examining the general notion of ownership, it moves to the particular case of possible commercial use, and finally reflects on the case in point in the light of the preceding considerations. Units of cord blood donated altruistically for transplantation and which are found unsuitable for storage and transplantation, or which become unsuitable while stored in biobanks, are taken as an example. These cord-blood units can be discarded together with other biological waste, or they can be used for research or the development of blood-derived products such as platelet gel. Several ethical questions (eg, informed consent, property, distribution of profits, and others) arise from these circumstances. In this regard, some criteria and limits to use are proposed.
PMCID: PMC3440234  PMID: 22977316
bioethics; biological specimen banks; cord-blood stem cell transplantation; ethics; informed consent; legislation
9.  A comparative analysis of the opinions from European national and international ethics committees regarding the collection, storage and use of umbilical cord blood 
Blood Transfusion  2012;10(3):279-289.
PMCID: PMC3417726  PMID: 22337278
bioethics; cord blood bank; ethics committees; stem cell transplant; umbilical cord blood
10.  Risk Assessment and Management for Medically Complex Potential Living Kidney Donors: A Few Deontological Criteria and Ethical Values 
Journal of Transplantation  2011;2011:307130.
A sound evaluation of every bioethical problem should be predicated on a careful analysis of at least two basic elements: (i) reliable scientific information and (ii) the ethical principles and values at stake. A thorough evaluation of both elements also calls for a careful examination of statements by authoritative institutions. Unfortunately, in the case of medically complex living donors neither element gives clear-cut answers to the ethical problems raised. Likewise, institutionary documents frequently offer only general criteria, which are not very helpful when making practical choices. This paper first introduces a brief overview of scientific information, ethical values, and institutionary documents; the notions of “acceptable risk” and “minimal risk” are then briefly examined, with reference to the problem of medically complex living donors. The so-called precautionary principle and the value of solidarity are then discussed as offering a possible approach to the ethical problem of medically complex living donors.
PMCID: PMC3235912  PMID: 22174982
11.  Informed consent for cord blood donation. A theoretical and empirical study 
Blood Transfusion  2011;9(3):292-300.
Background and objectives
Umbilical cord blood (CB) banking and therapeutic use raise several ethical issues: medical indications, legal framework, public versus private biobanks, autologous versus allogeneic use, ownership, commercialisation, quality assurance and many others. Surrogate informed consent is one of the most notable controversial ethical issues. The aim of this study was to analyse and compare informed consent forms for CB collection, storage and use in the 18 accredited biobanks of the Italian Network.
Material and methods
The first part of the article gives a brief overview of the scientific framework, the comparison of allogeneic and autologous use and Italian regulations. In the second part the contents of the consent forms from the 18 Italian biobanks are compared with the “NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration”.
Most of the Italian consent forms differ significantly from the NetCord-FACT Standards, with regards both to formal and substantial aspects.
Italian forms for CB collection, storage and use need standardisation to meet international criteria.
PMCID: PMC3136597  PMID: 21251456
cord blood; informed consent; biological specimens banks; transplantation
13.  Umbilical cord blood collection, storage and use: ethical issues 
Blood Transfusion  2010;8(3):139-148.
PMCID: PMC2906192  PMID: 20671872
Ethics; cord blood; biobank; informed consent
14.  How Are the Interests of Incapacitated Research Participants Protected through Legislation? An Italian Study on Legal Agency for Dementia Patients 
PLoS ONE  2010;5(6):e11150.
Patients with dementia may have limited capacity to give informed consent to participate in clinical research. One possible way to safeguard the patients' interests in research is the involvement of a proxy in the recruitment process. In Italy, the system of proxy is determined by the courts. In this study we evaluate the timing for appointment of a legal proxy in Italy and identify predictive variables of appointment.
Methodology/Principal Findings
Subjects were recruited among the outpatients seeking medical advice for cognitive complaints at the Centre for Research and Treatment of Cognitive Dysfunctions, University of Milan, “Luigi Sacco” Hospital.
The Centre was participating to the AdCare Study, a no-profit randomised clinical trial coordinated by the Italian National Institute of Health. The requirement that informed consent be given by a legal representative dramatically slowed down the recruitment process in AdCare, which was prematurely interrupted. The Centre for Research and Treatment of Cognitive Dysfunctions collected data on the timing required to appoint the legal representatives. Patients diagnosed with dementia and their caregivers were provided information on the Italian law on legal agency (law 6/2004). At each scheduled check-up the caregiver was asked whether she/he had applied to appoint a legal proxy for the patient and the time interval between the presentation of the law, the registration of the application at the law court chancellery and the sentence of appointment was registered. The study involved 169 demented patients. Seventy-eight patients (46.2%) applied to appoint a legal proxy. These subjects were usually younger, had been suffering from dementia for a longer time, had less than two children and made more use of memantine. The mean interval time between the presentation of the law and the patients' application to the law court chancellery was two months. The mean interval time between the patient's application to the law court chancellery and the sentence of appointment was four months.
In Italy the requirement that legal representatives be appointed by the courts slows down subjects' participation in research. Other procedures for legal agency of the incapacitated patients may be adopted, taking as examples other EU countries' systems.
PMCID: PMC2886844  PMID: 20585400
15.  Theoretical Models and Operational Frameworks in Public Health Ethics 
The article is divided into three sections: (i) an overview of the main ethical models in public health (theoretical foundations); (ii) a summary of several published frameworks for public health ethics (practical frameworks); and (iii) a few general remarks. Rather than maintaining the superiority of one position over the others, the main aim of the article is to summarize the basic approaches proposed thus far concerning the development of public health ethics by describing and comparing the various ideas in the literature. With this in mind, an extensive list of references is provided.
PMCID: PMC2819784  PMID: 20195441
ethics; public health; utilitarianism; personalism; foundations; models; frameworks

Results 1-15 (15)