title: Establishing the role of honest broker: bridging the gap between protecting personal health data and clinical research efficiency.
abstract: 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.
authors.affiliation: Office of Clinical Research Information, Asan Institute of Life Sciences, Asan Medical Center, Seoul, Korea.
authors.forename: Hyo Joung
authors.initials: HJ
authors.lastname: Choi
authors.affiliation: Office of Clinical Research Information, Asan Institute of Life Sciences, Asan Medical Center, Seoul, Korea.
authors.forename: Min Joung
authors.initials: MJ
authors.lastname: Lee
authors.affiliation: Office of Clinical Research Information, Asan Institute of Life Sciences, Asan Medical Center, Seoul, Korea.|Department of Pulmonology and Critical Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.|Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
authors.forename: Chang-Min
authors.initials: CM
authors.lastname: Choi
authors.affiliation: Office of Clinical Research Information, Asan Institute of Life Sciences, Asan Medical Center, Seoul, Korea.|Department of Biomedical Informatics, Asan Medical Center, Seoul, Korea.|Department of Emergency Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
authors.forename: JaeHo
authors.initials: J
authors.lastname: Lee
authors.affiliation: Office of Clinical Research Information, Asan Institute of Life Sciences, Asan Medical Center, Seoul, Korea.|Department of Biomedical Informatics, Asan Medical Center, Seoul, Korea.
authors.forename: Soo-Yong
authors.initials: SY
authors.lastname: Shin
authors.affiliation: Office of Clinical Research Information, Asan Institute of Life Sciences, Asan Medical Center, Seoul, Korea.
authors.forename: Yungman
authors.initials: Y
authors.lastname: Lyu
authors.affiliation: Department of Biomedical Informatics, Asan Medical Center, Seoul, Korea.|Clinical Research Center, Asan Institute of Life Sciences, Asan Medical Center, Seoul, Korea.
authors.forename: Yu Rang
authors.initials: YR
authors.lastname: Park
authors.affiliation: Human Research Protection Center, Asan Institute of Life Sciences, Asan Medical Center, Seoul, Korea.
authors.forename: Soyoung
authors.initials: S
authors.lastname: Yoo
keywords: Honest broker; Patient health information protection; Research efficiency; Secondary use of clinical data