Ethical considerations for real-world evidence studies

Abstract

Real-world evidence (RWE) studies are conducted on patient’s data primarily collected for monitoring of health status of patients. The use of real-world data to generate evidence in academic research or for regulatory submission raises a variety of ethical issues such as privacy, confidentiality, data protection, data de-identification, data sharing, scientific design of study, and informed consent requirements. The investigators–researchers and sponsors should adhere to current standards of ethics whilst planning and conduct of RWE studies. The ethics committees should consider ethical issues specific to RWE studies before approval.