Use of Honest Broker Creation of a Data Set
An honest broker is an individual who has access to the desired data by virtue of his or her Hospital responsibilities and who is not involved as a listed researcher on the respective research study.
- The honest broker accesses the desired medical record information and provides the researcher with de-identified data or a limited data set.
- If the honest broker is providing the researcher with a limited data set, the broker must present an internal data use agreement to the researcher prior to receiving the data set.
- The honest broker can assign a code to the data, provided that the researcher does not have access to the information linking the code to the identities of the research subjects. Using the code, the researcher can request, through the honest broker, additional medical information corresponding to a given research subject.
- If the honest broker provides coded data to the research but not the method to de-code the data, then the information provided will be considered de-identified or a limited data set depending upon the data elements included in the data set.
An honest broker can provide a firewall between the investigator and subjects' identifiable information. For example, an honest broker could generate or receive a dataset and then strip out subject identifiers so that the data was no longer readily identifiable. They could either create a de-identified data set or a limited data set.
The CHOP Research Institute policy Use and Disclosure of Protected Health Information for Research defines an honest broker and their role in research.
What can an honest broker do?
Additional protections for confidential information:
The honest broker can add a layer of protection to enhance the confidentiality of subjects' data and specimens. This typically involves prospectively collected data and specimens. For example, an honest broker could encrypt data and specimens so that the researchers are no longer able to identify the individuals from whom they were obtained.
However, employing an honest broker is a decision that should be made with great care; it can prevent an investigator from being able to re-identify individual subject's data/specimens. There have been many studies where the use of an honest broker has prevented the investigator from going back to the subject or their records for additional data or to recruit subjects to participate in a new study.
An honest broker is often best used to code data specimens that are provided by an investigator or a registry/repository to recipients. By removing all links to individually identifiable data, the honest broker can facilitate secondary uses of data/specimens.
Converting identifiable data into data/specimens that are not readily identifiable:
When the research involves existing specimens - from clinical care or prior research - using an honest broker can alter the regulatory category of the research by providing the investigator with data and biospecimens that are not readily identifiable. This makes the secondary use of the data/specimens not human subjects research and therefore, without requirements for prior IRB review and approval. If an investigator strips out the identifiers themselves, the research would require a determination of exemption.
If the data provided by the honest broker contains dates or zip codes then the data set is considered a limited data set/biospecimens. The data provider and the data recipient must enter into a data use agreement before the data/specimens are shared. At CHOP, this does not require IRB review or approval. However, there are institutions whose requirements exceed those put forth in regulation.