The term RWE stands for Real-World Evidence, which is evidence derived from real-world data (RWD). RWD are data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources.
 
Ethical approval is needed for the publication of RWE studies in international peer-reviewed journals for several key reasons:
 
[1] Participant Protection: Ethical approval ensures that the rights, safety, and well-being of the study participants are protected. It guarantees that the study has been designed to minimize harm and discomfort to the participants.
 
[2] Informed Consent: Ethical review boards (RECs/IRBs) ensure that participants have given informed consent. This means participants are made aware of the nature of the study, its purpose, the procedures involved, the potential risks and benefits, and their rights, including the right to withdraw from the study at any time without penalty.
 
[3] Privacy and Confidentiality: Ethical approval also ensures that the researchers have a plan in place to protect participant’s privacy and confidentiality. This is particularly important in RWE studies, where the data may come from various sensitive sources such as electronic health records, insurance claims databases, patient registries, and more.
 
[4] Avoidance of Bias: Ethics committees help ensure that the study is designed in a way that will minimize bias, increasing the validity of the results.
 
[5] Trustworthiness of the Research: By requiring ethical approval, journals are able to guarantee a certain level of quality control. Ethical approval can indicate that the research has been conducted appropriately and that the results are trustworthy.
 
[6] Compliance with International Standards: Ethical approval ensures that research is conducted in line with the globally recognized ethical guidelines and principles such as the Declaration of Helsinki e.g., the International Committee of Medical Journal Editors “Recommendations” (Link: https://lnkd.in/er-Sj5py). Also, according to the National Health Commission of China, when academic journals publish the results of human life science and medical research, they shall confirm that the research has been approved by the ethics review committee. Researchers should provide relevant proof (Article 29 of the 2023 Ethical Review Measures).
 
By requiring ethical approval, peer-reviewed journals ensure that the research they publish is ethical, credible, and respectful of participant rights. This is crucial in maintaining trust in the research community and the broader public who may ultimately benefit from the research findings.