The authorization process of observational studies in Italy: exploring two decades of Ethics Committee approval data.
Although more extensive analyses are necessary, this study suggests that past changes in Italian regulations have affected the evaluation by the Ethics Committee (EC) and have also impacted the conduct of the observational studies. The data generated can be useful for monitoring the future impact of the recently published new AIFA guideline.
Authors
- Alessandra Ori (ORCID: https://orcid.org/0000-0002-0031-5729)
- Barbara Roncari
- Laura Tanzini (ORCID: https://orcid.org/0009-0004-9457-3682)
- Lucia Simoni (ORCID: https://orcid.org/0000-0001-9206-6012)
- Vincenzo Bagnardi (ORCID: https://orcid.org/0000-0002-4938-3482)
- Giovanni Fiori
- Filippo Recenti (ORCID: https://orcid.org/0009-0006-6240-8230)
Institutions
- University of Milano-Bicocca (IT)
- University of Genoa (IT)
Publication Details
- Journal
- PubMed
- Published
- 2025-06-16
- DOI
- https://doi.org/10.4415/ann_25_02_03
- Primary Topic
- Ethics in medical practice
- Type
- article
- Field-Weighted Citation Impact
- 0.00