Data Access Policy
Electronic Health Record data access for secondary use facilitated by ICBI
Georgetown Innovation Center for Biomedical Informatics (ICBI) acts in the role of an honest broker to provide electronic medical records, registry and other patient data collected during clinical care and operations for research purposes. Our primary goal is to protect the privacy of patients while safely allowing use of clinical data for novel hypothesis generation and research use. ICBI follows data governance policies that align with its clinical partners for Access to Protected Health Information for Research Purposes. All data requests strictly adhere to the clinical partner and Institutional Review Board (IRB) policies and applicable state and federal regulatory requirements, including all privacy regulations. A written and signed consent and an Authorization (or waiver of Authorization) for disclosure of protected health information are required for all human subjects research, and any modifications to these requirements must be granted by the IRB or per regulations.
Process to request electronic health record and other clinical datasets through ICBI:
The Principal Investigator (PI) submits a ‘Patient Data Request form for Research’ through REDCap to the ICBI Shared Resources team (SR).
- An ICBI data coordinator gets in touch with the PI about their request within 72H to discuss and clarify any details and to further refine the data request that can fall into 3 data request categories:
- Access or use PHI for research purposes (requires IRB Approval & Consent forms)
- Access to limited Data Sets (requires IRB Approval & Consent forms)
- Cohort Discovery (aggregate numbers) or De-Identified data (requires approval of Department Chair or designee for preparatory to research).
- Following a clear definition of the data request, an honest broker with access to patient databases is assigned to the project.
- If the research has been reviewed and approved (or declared exempt from the need for prospective approval) by a Georgetown University IRB or another IRB at the clinical partner or a central IRB, proof of this is requested from the PI to grant access to the PHI, provided all HIPAA and other legal requirements have been met.
- The honest broker proceeds to identify the relevant data sources across the clinical enterprise systems to assess the number of patient records that meet the data request criteria
- For cohort discovery projects, the honest broker provides the final counts to PI
- For PHI and LDS:
- If not enough subjects in the systems, PI will be provided with the query results and options to change the query or stop the search.
- If enough subjects meet the recruitment criteria, the honest broker will process the request, query different relevant data sources, and extract all requested data.
- Honest Broker receives final approval from the clinical partner (typically, the Chief Scientific Officer, Chief Data Governance Officer or equivalent)
- Honest securely provides data to PI (via approved methods such as sftp, secure shared drive).
- After completion of tasks the honest broker informs the data coordinator and the data coordinator will close the request ticket with any additional notes for future use.
Please see the section on Curated and Standardized Research Datasets for descriptions of additional curated, research datasets that are maintained by ICBI. You can contact the investigators listed to initiate collaboration using a dataset of interest.