Funding for this research was provided by:
Agency for Healthcare Research and Quality (1R01HS019908, 1R01HS022956)
Received: 26 May 2016
Accepted: 31 August 2017
First Online: 13 September 2017
Ethics approval and consent to participate
: The work described in this paper describes ETL infrastructure development, testing, and implementation, but does not describe any research using this infrastructure. The ETL tool is implemented behind data owners’ firewalls, or behind firewalls of those with whom data owners have HIPAA Business Associate Agreements (BAAs). Ethical and legal approvals for this work are as follows: 1. The IRB approved an “infrastructure protocol”, indicating that the infrastructure was an approved mechanism for producing and transmitting HIPAA limited data sets for future research. 2. Any data released for research would require separate IRB approval and HIPAA data use agreements with data owners. 3. Data owners signed a legal document (“Master Consortium Agreement”) developed in collaboration with university legal counsel and each organization’ own legal counsel, specifying conditions under which the ETL tool is implemented, maintained, and used to produce research data sets within the research network. 4. For development and testing, several data owners provided fully identified patient data to the software developers, under HIPAA BAAs between the data owners and the university (also covering contractors). These data were not used for research. These data governance processes were discussed in great detail and established as described with legal and regulatory officials from the university and data owners.
: Not applicable.
: The authors declare that they have no competing interests.
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