Ethics and consent in randomized clinical trial integrity: A scoping systematic review

Ethics and consent in randomized clinical trial integrity: A scoping systematic review
Authorea, 6 May 2025
Mohamad Alaa Elsuity, Furqan Ahmad Butt, Khalid Saeed Khan, Mohamed Fawzy, Manuel Martín-Díaz, Javier Perez Rojas, Patrick FW Chien, María Núñez-Núñez, Mosab M Rashwan, Aurora Bueno-Cavanillas
Abstract
Background
Research ethics committee approval and informed consent are fundamental to the integrity of randomized clinical trials (RCTs), the strongest possible evidence source for informing clinical decision-making.
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).
Search Strategy and selection criteria
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.
Data collection and analysis
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
69 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.