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1.
BioLaw Journal ; 2021(SpecialIssue 2):17-33, 2021.
Artigo em Inglês | Scopus | ID: covidwho-1341975

RESUMO

Focusing on clinical trials in the time of a pandemic, the contribution offers a comprehensive overview of the main challenges for investigators-physicians and patient-participants, discussing their ethical implications for the informed consent. Namely, adaptive and pragmatic trial designs can balance the rapidly changing standards of care with speed and agility, but these are designs which encompass specific implications for the informed consent process;the move towards the use of off-label drugs and compassionate pharmaceuticals in pandemics, which has been unavoidable due to the urgency of treating patients and the lack of knowledge on the virus, on the other hand raises many ethical questions that should be carefully addressed;the impact of the pandemic on ongoing clinical trials and on new trials, due to Covid-19 restrictions, needs proper consideration as well. Moreover, the contribution discusses the ethical conditions for deferred consent and key elements of re-consent alongside with ethical issues related to an electronic-digital consent in the case of tele-medicine and remote information-monitoring. Finally, the article encompasses a focus on patients’ vulnerabilities, including specific vulnerabilities (age, gender and ethnicity) that should be protected in conducting clinical research. © 2021

2.
BioLaw Journal ; 2021(SpecialIssue 2):3-15, 2021.
Artigo em Inglês | Scopus | ID: covidwho-1341973

RESUMO

The article examines the transformations of informed consent in the context of the Covid-19 pandemic, analysing the bioethical discussion and in particular the national and international documents relevant to bioethical and biolegal issues, in both institutional bodies and bioethics committees. Informed consent is analysed in the context of experimentation with treatments and vaccines, the use of biological samples and the processing of personal data. © 2021

3.
BioLaw Journal ; 2021(SpecialIssue 2):1-2, 2021.
Artigo em Inglês | Scopus | ID: covidwho-1339958
4.
BioLaw Journal ; 2021(2):137-150, 2021.
Artigo em Inglês, Italiano | Scopus | ID: covidwho-1292226

RESUMO

The need to vaccinate large numbers of individuals to obtain heard immunity and the scarcity of available vaccines opens up the problem of ethical criteria for defining the priority of distribution both at the macro-allocation and micro-allocation level. There are several theories in the pluralistic context (libertarian, utilitarian, egalitarian, personalist, communitarian theory) applying different concepts of justice and equity between the market and the common good, with concrete implications in the identification of the priority of phases and categories. Vaccine distribution inevitably calls into question also the global dimension of distribution (global justice), as we will never fully emerge from the pandemic if we do not all come out of the pandemic. The voice of ethics plays an essential role in this area both through the recommendations of experts and interdisciplinary committees and through the possible consultation of the citizens. © 2021. All Rights Reserved.

5.
BioLaw Journal ; - (3):323-335, 2020.
Artigo em Inglês | Scopus | ID: covidwho-1107127

RESUMO

The article examines the transformations and declinations of informed consent in the context of the Covid-19 pandemic, analyzing the bioethical discussion and in particular international and national documents with bioethical and biolegal relevance, both of institutional bodies and bioethics committees. In particular, informed consent is analyzed in the context of experimentation with treatments and vaccines, the use of biological samples and the processing of personal data. © 2020. All Rights Reserved.

6.
Medicina e Morale ; 69(4):431-434, 2020.
Artigo em Italiano | Scopus | ID: covidwho-1050662
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