Human subjects are indispensable for clinical and translational research. Federal and local agencies issue regulations governing the conduct of research involving human subjects in order to properly protect study participants. Institutional Review Boards (IRBs) have the authority to review human subject research to ensure concordance with these regulations. One of the primary goals of the IRB oversight is to protect research participants’ privacy by carefully reviewing the data used and disclosed during a study. However, there are major challenges for IRBs in the typical research process. Due to the information disconnect between the data providers (e.g., a clinical data warehouse) and the IRB, it is often impossible to tell exactly what data has been disclosed to investigators. This causes time-consuming, inefficient, and often ineffective monitoring of clinical studies. This paper proposes an integrated architecture that interconnects a federated healthcare data query platform with an electronic IRB system.
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