Regulatory, scientific, and ethical issues arising from institutional activity in one of the 90 Italian Research Ethics Committees

• Published in: BMC medical ethics Vol. 22; no. 1; pp. 40 - 9
• Main Authors: Benfatto, G., Longo, Laura, Mansueto, Silvana, Gozzo, Lucia, Vitale, Daniela C., Amato, Salvatore, Basile, Francesco, Blanco, Adele, Borzì, Vito, Cavallaro, Patrizia, Cilia, Sonia, Conti, Mario, Cristaudo, Concetto, Daidone, Letterio D., Di Fazzio, Salvatore, Di Mauro, Maurizio, Garozzo, Rosaria, Giardina, Gaetano, Gulino, Antonio, Iachelli, Liliana, La Bella, Maria L., La Rosa, Agata, Lazzara, Antonio, Leonardi, Francesco, Monaco, Francesca Lo, Malatino, Lorenzo, Mattina, Teresa, Negro, Matteo, Palermo, Filippo, Puleo, Stefano, Raciti, Rosa, Ruggieri, Martino, Sapuppo, Antonio, Scillieri, Renato, Squatrito, Sebastiano, Tanasi, Francesco, Drago, F.
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 07.04.2021; BioMed Central; BMC
• Subjects: Administrative support; Analysis; Annual reports; Archives & records; Bioethics; Biomedical research; Clinical trials; Data processing; Documentation; Drugs; Ethical aspects; Ethics; Food products; Human subjects; Medical equipment; Medical protocols; Medical research; Medicine, Experimental; Minors/Parental consent; Placebo; Quality standards; Regulatory agencies; Research ethics; Research Ethics Committees/consultation; Revisions; Italy; Clinical trials; Minors/Parental consent; Placebo; Research Ethics Committees/consultation

This paper highlights the issues that one of the 90 Italian Research Ethics Committees (RECs) might encounter during the approval phase of a clinical trial to identify corrective and preventive actions for promoting a more efficient review process and ensuring review quality. Publications on the sub...