ICMJE Data Sharing Statement Guidance
Guidance on ICMJE Data Sharing Statements for Investigator-Initiated Research
Effective July 1, 2018 manuscripts submitted to ICMJE journal members must contain a data sharing statement. In connection with this requirement, a related field exists within ClinicalTrials.gov records (i.e., “IPD Sharing Statement”) wherein the applicable sharing plan should be indicated. Note that the ICMJE does not consider “Undecided” to be a valid response although it currently remains as a possible pull-down selection. If you are truly unsure about your plans, then indicate “No.”
The data sharing statement needs to indicate:
- Whether individual deidentified data will be shared;
- What data will be shared;
- Availability of related documents (e.g., study protocol, statistical analysis plan);
- When the data will be available and for how long;
- Criteria for obtaining the data.
UNC recommends the following data sharing statement:
Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
When data sharing is permitted, a Data Use Agreement (DUA) specifying the uses of such data to be shared must be in place before any data is shared. Requests can be submitted to the Office of Industry Contracting for processing. The Principal Investigator must confirm that the DUA has been fully executed and IRB, IEC, or REB approval has been granted before sharing data. For further information on DUAs, please refer to the the Data Use Agreement Guidance.
Those studies initiated after January 2019 require an IPD Sharing Statement in the designated section (i.e., “IPD Sharing Statement”) of the ClinicalTrials.gov registration record.