Purpose of this best practice: Data sharing activities should include an “Honest Broker” as intermediary between repositories such as EPIC, MEDITECH, etc., and the project database and also between the project database and external entities. The Honest Broker ensures all outgoing data are appropriate from the perspective of PHI/PII and are in compliance with project requirements.
Positions and Responsibilities
- Principal Investigator (PI): The Principal Investigator must ensure that all PHI required for the study are listed in the HIPAA waiver that is submitted to the IRB/Data Trust.
- Study Coordinator (SC): The Study Coordinator works with the PI, honest broker, and the person preparing the data to ensure data being shared reflects what has been approved for sharing by the IRB/Data Trust.
- Data Manager (DM): The Data Manager should work closely with the honest broker to prepare the data for sharing.
Best Practices
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The honest broker should be a person who has an attention to detail and no stake in the project. Preferably this person should work with the person who is actually preparing the data.
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Prior to finalizing the data extract, the extract headers (age, race, gender, other data fields) should be submitted to the honest broker for review. The honest broker reviews the headers and provides feedback regarding any columns not appropriate/approved for sharing.
Useful Links:
Core for Clinical Data Acquisition