In general, observational studies that involve human subjects require Institutional Review Board (IRB) approval to ensure that the study is conducted in an ethical manner and that the rights and welfare of study participants are protected. This applies to both clinical trials and observational studies, including those using real-world evidence (RWE).

IRB approval is required because observational studies may involve the collection of personal or sensitive information from study participants, or the implementation of interventions or procedures that may pose risks to participants. IRBs review study protocols to ensure that the study design is scientifically sound, that the risks to participants are minimized, and that the potential benefits of the study outweigh any potential harms.

However, there are some exceptions to this requirement for IRB approval. For example, if the RWE study uses de-identified data and does not involve any interventions or interactions with human subjects, IRB approval may not be required. Additionally, certain types of RWE studies may be exempt from IRB review under certain circumstances, such as studies that use existing data and do not involve the collection of new data from human subjects.

It is important to note that the specific requirements for IRB approval may vary by country or region, and by the specific study design and research question. Therefore, it is important to consult with local regulations and guidelines, as well as with an IRB or ethics committee, to determine whether IRB approval is required for a specific observational study using RWE.