Ethics committees for clinical experimentation at international level with a focus on Italy

Zakira Naureen, Tommaso Beccari, Robert S. Marks, Richard Brown, Lorenzo Lorusso, Derek Pheby, Stanislav Miertus, Karen L. Herbst, Liborio Stuppia, Gary Henehan, Benedetto Falsini, Ludovica Lumer, Munis Dundar, Matteo Bertelli, Peter Sykora, Donald Martin, Michele Samaja, Mykhaylo Kapustin, Stephanie S.G. Sullivan, Paul SievingAriola Bacu, Assunta Morresi, Natale Capodicasa

Research output: Contribution to journalReview articlepeer-review

Abstract

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. (www.actabiomedica.it).

Original languageEnglish (US)
Article numbere2020016
Pages (from-to)1-15
Number of pages15
JournalActa Biomedica de l'Ateneo Parmense
Volume91
DOIs
StatePublished - 2020
Externally publishedYes

Keywords

  • Clinical trials
  • Ethics
  • Ethics Committee
  • Food related research
  • Italy
  • Observational study
  • Risks

ASJC Scopus subject areas

  • Medicine(all)

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