What is the purpose of a "site visit" during the IRB review process?

The purpose of a "site visit" during the IRB review process revolves around ensuring compliance with IRB standards. During a site visit, IRB members or designated representatives assess how a research study is being conducted in practice compared to the initial proposal submitted for review. This may involve evaluating a variety of factors, such as verifying that the informed consent process is being properly implemented, ensuring that participants' rights and welfare are being protected, and confirming that data is being handled in accordance with approved protocols.

The site visit provides an opportunity for the IRB to observe the research environment firsthand, allowing them to identify any potential issues with compliance and address them proactively. This step is essential in safeguarding the integrity of the research process and protecting participants involved in the study.