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2015 ; 3
(ä): e1506
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Establishing the role of honest broker: bridging the gap between protecting
personal health data and clinical research efficiency
#MMPMID26713253
Choi HJ
; Lee MJ
; Choi CM
; Lee J
; Shin SY
; Lyu Y
; Park YR
; Yoo S
PeerJ
2015[]; 3
(ä): e1506
PMID26713253
show ga
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.