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.
Highlights
Prior to the age of big data, privacy was protected by individuals who maintained control over their own personal information
Review of the literature on honest brokers Ten organizations were selected from our literature review to evaluate the commonalities and differences in honest broker systems that are currently used in biomedical research (Table 1)
The University of Pittsburgh operates an honest broker certification process that is composed of institutional review boards (IRBs)-mandated education modules, such as Research Integrity, Human Subjects Research in Biomedical Sciences, and HIPAA Researchers Privacy Requirements (Dhir et al, 2008)
Summary
Prior to the age of big data, privacy was protected by individuals who maintained control over their own personal information. In the current age of big data, “informed consent” may no longer be a realistic and efficient method for protecting privacy (Solove, 2012; Tene & Polonetsky, 2014) This is because there is an immense need for data sharing and interlinking of data for secondary research purposes, and this secondary use, in most cases, has not been planned when the data were originally collected and stored. Even if the researchers obtain consent from the subjects who are not representative of the original population, the study may turn out to be statistically skewed or underpowered (El Emam, Jonker & Fineberg, 2011; Kho et al, 2009; Macleod & Watt, 2008; Willison et al, 2008) These issues are not about obtaining consent from all subjects for secondary use or discarding all clinical data for which permission has not been given for secondary use. Guidelines that regulate the definitions, purposes, roles, and requirements for honest brokers are needed, since there are no currently existing
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