The tissue biobanking of specific biological residual materials, which constitutes a useful resource for medical/scientific research, has raised some ethical issues, such as the need to define which kind of consent is applicable for biological residual materials biobanks.
This article focuses on three scenarios in which residual biological materials are turned into research collections during the procedure of procuring these materials for diagnostic, therapeutic or other non-research purposes. These three scenarios differ from each other primarily because they employ different models of consent: (a) precautionary consent, which may be secured during the collecting procedure; (b) the presumed consent model, which may be applied during the collection of materials; and (c) consent for research use of identifiable human biological materials, (...) which may be skipped entirely. These scenarios offer additional sources of biological samples for research purposes and at the same time seem to offer even more flexibility in terms of stringency of consent as compared with the more traditional models of broad consent in prospective research collections and the waiver of consent in retrospective research. Our discussion leads us to think that precautionary consent is preferable to presumed consent and no consent when handling issues of consent in the use of residual human biological materials for research. However, such precautionary consent should not be construed as blanket, unrestricted consent for any future use. (shrink)
Biobanks are an important resource for medical research. Genetic research on biological material from minors can yield valuable information that can improve our understanding of genetic–environmental interactions and the genesis and development of early onset genetic disorders. The major ethical concerns relating to biobanks concern consent, privacy, confidentiality, commercialisation, and the right to know or not to know. However, research on paediatric data raises specific governance and ethical questions with regard to consent and privacy. We have considered the Italian normative (...) context focusing on what is mentioned in each document on the ethical and legal requirements that guarantee the rights of minors. We found out that there is no systematic reflection on the ethical and policy issues arising from the participation of minors in biobank research. Moreover, we have focused on the same aspects for the new Italian Law on the National Forensic Biobank. (shrink)
Esta pesquisa tem como objetivo discutir, com fundamentação teórica na Psicologia Analítica de C. G. Jung, as concepções de médicos e psicólogos sobre o processo saúde-doença e a formação do profissional para atuar em contexto hospitalar. A partir de uma pesquisa em campo qualitativa-descritiva, est..
Clinical ethics has developed significantly in Europe over the past 15 years and remains an evolving process. While sharing our experiences in different European settings, we were surprised to discover marked differences in our practice, especially regarding the position and role of patients. In this paper, we describe these differences, such as patient access to and participation or representation in ethics consults. We propose reasons to explain these differences, hypothesizing that they relate to the historic and sociocultural context of implementation (...) of clinical ethics consultation services (Cecs), as well as the initial aims for which each structure was established. Then, we analyse those differences with common ethical arguments arising in patient involvement. We conclude that there is no unique model of best practice for patient involvement in clinical ethics, as far as Cecs reflect on how to deal with the challenging ethical issues raised by patient role and position. (shrink)
Clinical ethics support services are developing in Europe. They will be most useful if they are designed to match the ethical concerns of clinicians. We conducted a cross-sectional mailed survey on random samples of general physicians in Norway, Switzerland, Italy, and the UK, to assess their access to different types of ethics support services, and to describe what makes them more likely to have used available ethics support. Respondents reported access to formal ethics support services such as clinical ethics committees (...) (23%), consultation in individual cases (17.6%), and individual ethicists (8.8%), but also to other kinds of less formal ethics support (23.6%). Access to formal ethics support services was associated with work in urban hospitals. Informal ethics resources were more evenly distributed. Although most respondents (81%) reported that they would find help useful in facing ethical difficulties, they reported having used the available services infrequently (14%). Physicians with greater confidence in their knowledge of ethics (P = 0.001), or who had had ethics courses in medical school (P = 0.006), were more likely to have used available services. Access to help in facing ethical difficulties among general physicians in the surveyed countries is provided by a mix of official ethics support services and other resources. Developing ethics support services may benefit from integration of informal services. Development of ethics education in medical school curricula could lead to improved physicians sensititity to ethical difficulties and greater use of ethics support services. Such support services may also need to be more proactive in making their help available. (shrink)
While much work has been done on improving undergraduate education in bioethics, particularly in medicine, less has been said about continuing education of health care workers, particularly non-medical and nursing personnel. Hospitals bring together a variety of professional and non-professional groups in the place where clinical dilemmas are daily events, and would seem ideal places to conduct an ongoing bioethics dialogue. Yet evidence that this is being achieved is sparse.The European Hospital (-Based) Bioethics Program (EHBP) brings together both current and (...) aspirant members of the EU as partners in a project that aims to assess the current situation with regard to bioethics education in hospitals, identify shortfalls, and address these. In order to achieve the first objective of the EHBP a survey of the current training activities (focused on activities in hospitals) in clinical bioethics in Europe was carried out. The results are presented in this paper, along with a discussion about the implications for the EHBP to address these issues. (shrink)
In 2001 the Italian Government defined Essential Assistance Levels (LEA), which can be considered as an important step forward in the health care system. The Italian health care system would provide payment of essential and uniform aid services in order to safeguard many values such as human dignity, personal health, equal assistance and good health practices. The Ministry of Health has worked to rationalize the National Formulary and to define evaluation methods for drugs in order to choose what to reimburse (...) without penalizing the rights of the individual and society.This paper describes how this job of rationalization was done and tries to illustrate the choices made in Italy by the use of two meaningful examples (statins and rivastigmine). (shrink)