Ethics and consent in randomized clinical trial integrity: A scoping systematic review.
Uložené v:
| Názov: | Ethics and consent in randomized clinical trial integrity: A scoping systematic review. |
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| Autori: | AlaaEldein Elsuity M; Department of Dermatology, Venereology and Andrology, Sohag University, Egypt; IbnSina (Sohag), Banon (Asyut), Qena (Qena), Amshaj (Sohag) IVF Centres, Egypt., Butt FA; Department of Preventive Medicine and Public Health, University of Granada , Granada, Spain. Electronic address: furqanab.phd@gmail.com., Saeed Khan K; Department of Preventive Medicine and Public Health, University of Granada , Granada, Spain; Epidemiology and Public Health Networking Biomedical Research Centre (CIBERESP), Madrid, Spain., Fawzy M; IbnSina (Sohag), Banon (Asyut), Qena (Qena), Amshaj (Sohag) IVF Centres, Egypt., Martín-Díaz M; General Surgery Department, Hospital Santa Ana, Motril, Granada, Spain., Chien PFW; Department of Obstetrics & Gynecology, RCSI & UCD Malaysia Campus, Penang, Malaysia., Perez de Rojas J; Department of Preventive Medicine and Public Health, University of Granada , Granada, Spain., Núñez-Núñez M; Epidemiology and Public Health Networking Biomedical Research Centre (CIBERESP), Madrid, Spain; Department of Pharmacy, San Cecilio University Hospital, Granada, Spain., Rashwan MM; IbnSina (Sohag), Banon (Asyut), Qena (Qena), Amshaj (Sohag) IVF Centres, Egypt; Department of Forensic Medicine and Clinical Toxicology, Faculty of Medicine, Sohag University, Sohag, Egypt., Bueno-Cavanillas A; Department of Preventive Medicine and Public Health, University of Granada , Granada, Spain; Epidemiology and Public Health Networking Biomedical Research Centre (CIBERESP), Madrid, Spain; Instituto de Investigación Biosanitaria de Granada (ibs.GRANADA), Granada, Spain. |
| Zdroj: | Semergen [Semergen] 2025 Dec; Vol. 51 (9), pp. 102579. Date of Electronic Publication: 2025 Oct 22. |
| Spôsob vydávania: | Journal Article; Scoping Review |
| Jazyk: | English |
| Informácie o časopise: | Publisher: Saned, S.A Country of Publication: Spain NLM ID: 9610769 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1578-8865 (Electronic) Linking ISSN: 11383593 NLM ISO Abbreviation: Semergen Subsets: MEDLINE |
| Imprint Name(s): | Publication: <2000->: Madrid : Elsever España, : Saned, S.A. Original Publication: Madrid : Saned, S.A., [1996- |
| Výrazy zo slovníka MeSH: | Informed Consent*/ethics , Informed Consent*/standards , Randomized Controlled Trials as Topic*/ethics , Randomized Controlled Trials as Topic*/standards , Ethics, Research*, Humans ; Research Design/standards |
| Abstrakt: | Objectives: This scoping systematic review aimed to collate and synthesize available evidence on research ethics and consent aspects related to research integrity standards in RCTs. Prospective registration (https://osf.io/gxryb). Materials and Methods: We searched PubMed and Scopus databases from January 2018 to August 2023, using combinations of terms related to research ethics, approval, and informed consent. We included full academic articles relevant to the scope of the review without language restriction, including primary research articles, systematic reviews, scoping reviews, and narrative reviews. Two teams of four reviewers independently assessed the full text to select articles and extract data, performing the tasks independently and any disagreements were resolved through arbitration. A descriptive synthesis of the included articles main characteristics and findings were performed. Results: Sixty-nine articles were selected, covering RCT-related ethics and consent issues in 141 countries, including 89 (63%) low or middle-income ones. The extracted data fell into nine domains: general issues (30 articles; 43%), journals' instructions and policies (one article; 1.4%), research institutions and funders' policies (three articles; 4.3%), ethics committee regulations (five articles; 7.2%), ethics committee evaluation and approval (12 articles; 17%), informed consent and related procedures (six articles; 8.7%), monitoring of trials for compliance (three articles; 4.3%), post-publication concerns on ethics and consent (five articles; 7.2%), and recommendations for future research (four articles; 5.8%). Conclusions: The key areas include standardization of ethics committee approval processes and enhancement of informed consent procedures. There were notable deficiencies in trial registration and reporting concerning ethics and consent. The observed variability in ethics and consent practices across RCTs globally needs to be addressed through an international expert consensus. (Copyright © 2025 Sociedad Española de Médicos de Atención Primaria (SEMERGEN). Publicado por Elsevier España, S.L.U. All rights reserved.) |
| Contributed Indexing: | Keywords: Consent; Consentimiento; Integridad de la investigación; Research ethics; Research integrity; Revisión de alcance; Revisión sistemática; Scoping review; Systematic review; Ética de la investigación |
| Entry Date(s): | Date Created: 20251023 Date Completed: 20251206 Latest Revision: 20251206 |
| Update Code: | 20251207 |
| DOI: | 10.1016/j.semerg.2025.102579 |
| PMID: | 41129936 |
| Databáza: | MEDLINE |
Nájsť tento článok vo Web of Science | Abstrakt: | Objectives: This scoping systematic review aimed to collate and synthesize available evidence on research ethics and consent aspects related to research integrity standards in RCTs. Prospective registration (https://osf.io/gxryb).<br />Materials and Methods: We searched PubMed and Scopus databases from January 2018 to August 2023, using combinations of terms related to research ethics, approval, and informed consent. We included full academic articles relevant to the scope of the review without language restriction, including primary research articles, systematic reviews, scoping reviews, and narrative reviews. Two teams of four reviewers independently assessed the full text to select articles and extract data, performing the tasks independently and any disagreements were resolved through arbitration. A descriptive synthesis of the included articles main characteristics and findings were performed.<br />Results: Sixty-nine articles were selected, covering RCT-related ethics and consent issues in 141 countries, including 89 (63%) low or middle-income ones. The extracted data fell into nine domains: general issues (30 articles; 43%), journals' instructions and policies (one article; 1.4%), research institutions and funders' policies (three articles; 4.3%), ethics committee regulations (five articles; 7.2%), ethics committee evaluation and approval (12 articles; 17%), informed consent and related procedures (six articles; 8.7%), monitoring of trials for compliance (three articles; 4.3%), post-publication concerns on ethics and consent (five articles; 7.2%), and recommendations for future research (four articles; 5.8%).<br />Conclusions: The key areas include standardization of ethics committee approval processes and enhancement of informed consent procedures. There were notable deficiencies in trial registration and reporting concerning ethics and consent. The observed variability in ethics and consent practices across RCTs globally needs to be addressed through an international expert consensus.<br /> (Copyright © 2025 Sociedad Española de Médicos de Atención Primaria (SEMERGEN). Publicado por Elsevier España, S.L.U. All rights reserved.) |
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| ISSN: | 1578-8865 |
| DOI: | 10.1016/j.semerg.2025.102579 |