SRTR Data Release Policy
A primary mission of the Scientific Registry of Transplant Recipients (SRTR) is to provide information and data to researchers, clinicians, and members of the general public who have legitimate needs. SRTR will make every attempt to fulfill requests for data. However, providing data can take time and resources away from other important SRTR tasks. Determining which requests should be honored, which should be referred elsewhere, and which should be denied is always a challenge. When making decisions regarding data requests, SRTR considers whether:
- Patient privacy will be maintained.
- The information can be obtained from published sources such as the OPTN/SRTR Annual Data Report.
- The data will likely be used for general benefit rather than personal profit.
Limitations on Data Release
Possible reasons for denying a data request in whole or in part include:
- The data are not collected and/or verified.
- Release of the data violates the Health Insurance Portability and Accountability Act (HIPAA) or applicable federal or state laws regarding confidentiality of patient medical records or trade secrets.
- The purpose of the data use is not sufficiently valuable to warrant a large-scale expenditure of time and effort.
- The data and information are an exception from disclosure under the Freedom of Information Act (FOIA).
Making a Data Request
Please request data from SRTR in writing at firstname.lastname@example.org. In your request, please include the following information:
- Your contact information: name, business/organization name, mailing address, telephone number, and email address.
- Description of data requested.
Once we receive the initial request, we will supply any necessary documentation. All data requests requiring a data use agreement (DUA) will require a signed data release agreement, a data security plan, and a research plan.
Types of Data Requests
The four main types of data requests are:
- Simple Data Requests
Data requests that can be fulfilled with existing data and do not require additional programming or analyses can generally be fulfilled quickly (i.e., in less than 4 hours) and do not require a DUA or the approval of the Health Resources and Services Administration (HRSA), the HRSA SRTR Contracting Officer Representative (COR), or the SRTR Visiting Committee (SVC). Data sets that require a DUA do not fall into the category of simple data requests.
- Data Requests for Standard Analysis Files (SAFs) or Simulated Allocation Models (SAMs)
Data requests that can be fulfilled by releasing a SAF and/or a SAM require a DUA. The release of an SAF or SAM under a DUA requires SRTR's prior approval, but generally does not require prior approval from the SVC. DUAs must be renewed annually throughout the duration of the approved use.
- Data Requests Requiring Linkages
Data requests that require linkage to an external data source or use of personal identifiers to link with other public or private data sources can often be accommodated. To protect the private information of individuals in the transplant registry, SRTR will perform the linkages and analyses that require use of personal identifiers; SRTR will release the resulting data as summary data or as individual data with encrypted identifiers. In exceptional circumstances, identifiers may be released to other government agencies or investigators for linkage. All data requests requiring linkages must be authorized by the SVC and by HRSA. The SVC currently votes through electronic communications. SRTR sends all relevant documentation and background information to the SVC to assist with voting and approval. The SVC is allowed at least 2 weeks to vote on the request, and the SVC may ask that researchers clarify any unclear aspect of their research plan. After SVC approval and receipt of an acceptable finder file, the linkage will take several months to complete.
- Data Request for Additional SRTR Programming
Data requests requiring additional SRTR analyses will be considered depending on resources available, and will be reviewed on a case-by-case basis by SRTR and HRSA.
Standard Analysis Files (SAF) cost $1000; each additional, updated SAF costs $500.
Requests for data that are estimated to require less than 4 hours of SRTR personnel time are generally fulfilled without charge and completed within 30 days.
Requests for data that require more than 4 hours of SRTR personnel time for additional files require payment at an hourly rate, currently $125 per hour. Data sets are associated with a $1000 cost in addition to the hourly rate. The cost of analytical results is based solely on the programming time required to fulfill the request.
All patient linkage requests require more than 4 hours of SRTR personnel time. SRTR will provide an estimate of the cost of the data request. Then, an estimated work-effort and payment agreement must be obtained before the programming proceeds.
A student discount is available for current students using SRTR data to fulfill requirements of a degree program. The student discount is also available for medical doctors currently in residency or fellowship programs. Documentation is required and the student must be named as the principle investigator. For qualifying students, the cost of a SAF is $200. No student discount is available for requests requiring additional SRTR programming.
Please contact SRTR for details regarding adding investigators to a DUA, making an addendum to a current DUA, and other situations not laid out in this document.
Abstracts, manuscripts, or other aggregated data must be submitted to SRTR for review by HRSA, as outlined in the DUA, prior to submission to another party for presentation or publication.
DUAs can be renewed for continued use free of charge by completing a Data Status Confirmation form and a Data Security Plan. Please contact email@example.com or call 612.873.6833 to obtain these documents.
Data sets are sent with a cover letter stating the expiration date of the current DUA. Researchers are responsible for renewing the DUA before that date. After 60 days past the expiration date, the DUA cannot be renewed.
At the time of DUA renewal, researchers may request an updated SAF at a reduced rate. Any additional files will be provided at the standard cost based on programming time required.
Abstracts and Manuscripts Using SRTR Data
All DUAs state:
Before submitting an abstract, manuscript, or other aggregation data to another party for presentation or publication, the recipient must submit it to SRTR and the HRSA SRTR Contracting Officer Representative (COR) for review to ensure compliance with the terms of this agreement regarding confidentiality. The COR shall respond within 30 days. If the abstract, manuscript, or data aggregation does not reflect compliance with the terms of this agreement, the recipient will revise and resubmit to SRTR and COR. Upon publication, the recipient shall provide a copy of the final work and a complete citation to SRTR and COR.
Please submit all abstracts, manuscripts, and other documents to firstname.lastname@example.org for HRSA review. SRTR will notify HRSA as to whether the work was performed under an active DUA and whether the work was performed as described in the research plan. SRTR will submit electronic copies of the documents for HRSA consideration. Allow 30 days for a decision on approval, although decisions are typically rendered in much less time.
Modifying a Research Plan
Altering a research plan or using existing data for a new project requires notifying SRTR before initiating any new work. SRTR will work with researchers to ensure proper documentation for such modifications. To begin this process, contact email@example.com or call 612.873.6833.
Technical Assistance Requests
For technical assistance requests, please visit the designated page.