Establishing the role of honest broker: bridging the gap between protecting personal health data and clinical research efficiency.

Background. The objective of this study is to propose the four conditions for the roles of honest brokers through a review of literature published by ten institutions that are successfully utilizing honest brokers. Furthermore, the study aims to examine whether the Asan Medical Center's (AMC) honest brokers satisfy the four conditions, and examine the need to enhance their roles. Methods. We analyzed the roles, tasks, and types of honest brokers at 10 organizations by reviewing the literature. We also established a Task Force (TF) in our institution for setting the roles and processes of the honest broker system and the honest brokers. The findings of the literature search were compared with the existing systems at AMC-which introduced the honest broker system for the first time in Korea. Results. Only one organization employed an honest broker for validating anonymized clinical data and monitoring the anonymity verifications of the honest broker system. Six organizations complied with HIPAA privacy regulations, while four organizations did not disclose compliance. By comparing functions with those of the AMC, the following four main characteristics of honest brokers were determined: (1) de-identification of clinical data; (2) independence; (3) checking that the data are used only for purposes approved by the IRB; and (4) provision of de-identified data to researchers. These roles were then compared with those of honest brokers at the AMC. Discussion. First, guidelines that regulate the definitions, purposes, roles, and requirements for honest brokers are needed, since there are no currently existing regulations. Second, Korean clinical research institutions and national regulatory departments need to reach a consensus on a Korean version of Limited Data Sets (LDS), since there are no lists that describe the use of personal identification information. Lastly, satisfaction surveys on honest brokers by researchers are necessary to improve the quality of honest brokers.