Regulatory, scientific, and ethical issues arising from institutional activity in one of the 90 Italian Research Ethics Committees
Autor: | Benfatto, G, Drago, Filippo, Longo, Laura, Mansueto, Silvana, Gozzo, Lucia, Vitale, Daniela C., Amato, Salvatore, Basile, Francesco, Blanco, Adele, Borzì, Vito, Cavallaro, Patrizia, Cilia, Sonia, Malatino, L. |
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Jazyk: | angličtina |
Rok vydání: | 2021 |
Předmět: |
Health (social science)
Adolescent Harmonization 03 medical and health sciences 0302 clinical medicine Documentation Clinical trials Informed consent 030225 pediatrics Humans 030212 general & internal medicine Child Placebo Retrospective Studies Protocol (science) Ethics Committees Research ethics Medical education lcsh:R723-726 Research Health Policy Clinical trials Placebo Minors/Parental consent Research Ethics Committees/consultation Minors/Parental consent Europe Clinical trial Issues ethics and legal aspects Italy Internal audit Philosophy of medicine Research Ethics Committees/consultation Psychology lcsh:Medical philosophy. Medical ethics Ethics Committees Research Research Article |
Zdroj: | BMC Medical Ethics, Vol 22, Iss 1, Pp 1-9 (2021) BMC Medical Ethics |
Popis: | Background 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 subject from Italy and the rest of Europe are limited; encouraging constructive debate can improve RECs’ service to the subject of the clinical trial. Methods We retrospectively reviewed a cohort of 822 clinical trial protocols, initially reviewed by REC, from June 2014 to December 2018. Data collected for each protocol were type of trial, sample size, use of placebo, number and kind of revisions requested by the REC before approval, and time taken for approval. Data for each protocol were collected by a trained clinical research assistant using the REC’s files and electronic archives. Results Almost 45% of the reviewed studies (374/822) required clarifications, significant changes to the documentation, or minor changes before final approval. Conclusions Preventive measures are needed to reduce the number of requested corrections and thus also the time required for approval, while maintaining review quality. All critical points and proposals presented in this paper require harmonization through updates to European regulations, as regulatory harmonization produces better compliance with rules and reduces the number of changes required before the trials’ final approval. Such updates include the development of standardized formats for informed consent, the verification of any evidence in favor of using off-label treatments over placebo as comparators, using multidisciplinary staff in clinical trials with children and adolescents, improving the legal definition of RECs to assign responsibilities and ensure independence, and providing guidance for RECs to engage clinical research assistants in internal audits. |
Databáze: | OpenAIRE |
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