Co-Chairs: Jeff Brown, Lesley Curtis
Advisor: Richard Platt
NIH Representative: Barbara Wells
Members: Nick Anderson, Alan Bauck, Pedro Gozalo, Katherine Haffenreffer, Gene Hart, Susan Huang, Brett Moran, Jon Puro, Erik Van Eaton, Ferdinand Velasco, Wolfgang Winkelmayer
Project Manager: Beth Syat
The ability to harness electronic health data is transforming the way clinical research is conducted. The Electronic Health Records (EHR) Core’s goal is to facilitate multisite research collaborations between investigators and data stewards by creating secure networking capabilities and analysis tools. The Core also develops policies and practices to govern the responsible use of these resources.
The EHR Core has established the NIH Collaboratory Distributed Research Network (DRN), which will allow investigators to collaborate in the use of clinical data while safeguarding protected health information and proprietary data. The DRN will enable authorized researchers to send queries to collaborators. In some cases, queries are computer programs that a data partner can execute on a pre-existing dataset. The data partner can return the query result, rather than the actual data. This form of remote querying reduces legal, regulatory, privacy, proprietary, and technical barriers associated with data sharing for research.
By facilitating knowledge exchange without requiring a massive data warehousing effort, the DRN combines local control and security with the power that can be achieved from large datasets. All data queries are opt-in; in other words, data partners can choose whether to accept a query and execute it.
The DRN uses the PopMedNet software application and complies with the standards for distributed querying supported by the Office of the National Coordinator for Health Information Technology’s Query Health Initiative and adopted by other research collaborations, including Mini-Sentinel. The DRN supports both single-site and multisite research projects.
Its capabilities include the following:
Assessing disease burden and outcomes
- Estimate the frequency of conditions or patterns of care
- Example: determine frequency and duration of insulin pump use and characterize the individuals who use them
|Pragmatic clinical trial design
- Assess baseline rate of events of interest
- Identify organizations with enough potential study participants
- Identify potential study participants within an organization
|Pragmatic clinical trial follow-up
- Scan electronic data of study participants for outcomes of interest
- Examples: prescription medications dispensed, inpatient and ambulatory medical encounters
- Information may include medications, dates, diagnoses, procedures, etc.
|Allowing reuse of research data
- An investigator who has created a clinically rich research dataset can authorize an investigator at another organization to submit analytic programs
- Depending on the analysis, the output need not contain patient identifiers
|Establishing a private network for a multicenter study
- The Collaboratory Coordinating Center can establish a private distributed network to send out programs that create separate analysis files at each site
- Analysis files are securely transferred to the analyst
The NIH Collaboratory DRN Coordinating Center (CC) will facilitate identification of topic-appropriate data resources available within the NIH Collaboratory DRN, aid in developing requests, and support feasible queries and implementation of approved research protocols. The NIH Collaboratory DRN operates under an “opt in” model. That is, no participating Data Partners are expected to participate in research activities without explicit prior approval and involvement of a Data Partner investigator. Data Partner organizations and requestors are not mutually exclusive; Data Partners can also be requestors and can collaborate with other Data Partners/requestors on specific projects.
All data requests must be submitted to the NIH Collaboratory DRN CC using the NIH Collaboratory DRN request form. The NIH Collaboratory DRN CC will conduct an administrative review to determine appropriateness of the query/request. This may involve clarification of the request with the requestor, and determination of appropriateness with relevant Data Partner Site PIs. Once a request is approved by the NIH Collaboratory DRN CC, the CC will initiate the request, manage the request process, and provide the results to the requestor. In addition, the NIH Collaboratory DRN CC tracks all network activities and ensures network functionality.
Distributed querying is typically accomplished through the following steps:
- The requestor completes the NIH Collaboratory DRN request form and sends it to the NIH Collaboratory DRN CC;
- The NIH Collaboratory DRN CC reviews the request, asks for any necessary clarification, determines best query mechanism, and determines whether the request is appropriate for the DRN;
- The NIH Collaboratory DRN CC works with requester to develop the specific query to be distributed to the Data Partners and distributes the query to the Data Partners using the NIH DRN Query Tool;
- Each Data Partner determines whether or not to answer the request and whether or not an agreement with the requestor is needed;
- Data Partners use their local datasets to obtain results;
- Data Partners securely send results to the NIH Collaboratory DRN CC using the NIH Collaboratory DRN Query Tool;
- The NIH Collaboratory DRN CC reviews the results and submits the response to the requestor. Results are often aggregate counts, without confidential or proprietary data. The level of data sharing is determined, in advance, as part of the collaboration agreement, and all query responses can be reviewed by the Data Partner before they are released.
Authorized requestors include NIH Collaboratory leadership and the Data Partners, and other individuals/organizations designated by NIH Collaboratory leadership. All requestors must adhere to the responsibilities and expectations outlined below.
Requestors are responsible for:
- Completing request forms
- Clearly describing the nature of the request and the intended use of the findings, including grant or other funding applications
- Responding to requests for clarification from the NIH DRN CC and the EHR Core
- Obtaining necessary approvals by IRBs and HIPAA privacy boards
- Working with NIH DRN CC and Data Partners to execute necessary agreements/contracts
Requestors are expected to:
- Use results provided only for the stated and approved purpose. This may include a requirement to keep results confidential.
- Abide by any other limitations on use, issued by the EHR Core, the NIH Collaboratory DRN CC, and/or the Data Partner providing and reporting data