Department of Biological Sciences and Chemistry, College of Arts and Sciences, University of Nizwa, Nizwa, Oman.
Department of Pharmaceutical Sciences, University of Perugia, Perugia, Italy.
Acta Biomed. 2020 Nov 9;91(13-S):e2020016. doi: 10.23750/abm.v91i13-S.10643.
Guiding legislation and associated bureaucracy for the ethical review of clinical trials observational studies and food related research play an important role in the competitiveness of a nation in the face of tough global competition to attract sponsors and investigators. This is of particular relevance in the case of multicentre trials and multidisciplinary research. Accordingly, in this report we tried to gather in-depth knowledge of the current role and practices of ethics committees nationwide in both clinical and research settings. This mini-review aims to describe the formulation and organization of ethical committees in Italy in order to provide a focus for deliberations on ethical issues in medical and scientific research in line with human rights, as set out in the European Union charter. Furthermore, we evaluated the impact of an institution's ethical committee intervention on reducing the time required to obtain an opinion from Research Ethics Committees by guiding investigators in addressing ethical issues in their proposed studies.
指导临床试验、观察性研究和与食品相关研究的伦理审查的立法和相关机构在面对全球竞争激烈的赞助商和研究者招募时,对一个国家的竞争力起着重要作用。在多中心试验和多学科研究的情况下,这一点尤为重要。因此,在本报告中,我们试图深入了解全国临床和研究环境中伦理委员会的当前作用和实践。本次迷你综述旨在描述意大利伦理委员会的组成和组织方式,以便为审议符合欧盟宪章规定的人权原则的医学和科学研究中的伦理问题提供重点。此外,我们还评估了机构伦理委员会干预对减少研究伦理委员会意见所需时间的影响,方法是指导研究者解决其拟议研究中的伦理问题。