Ethical review of real-world study

Abstract

This article is devoted to an ethical review of planned real-world studies. The legal basis of such examinations has also been considered. Most real-world studies are non-interventional, so the ethical review of such studies is similar to that of observational studies.

Keywords

• real-world study
• real-world data
• ethical review
• ethical committee
• non-interventional study
• interventional study
• confidentiality
• personal data
• confounding