Approval for Data Sharing
To comply with all Federal, State and local regulations, the BDR requires verification of official IRB approval and/or waiver for sharing human subjects’ data with the broader community. The BDR will assist you in this process and provide suggested language to submit to your local institution (see IRB Template).
Data archived in and shared through the BDR will be shared without personal identifiers. That is, local data, including image header files, will be de-identified prior to upload into the BDR. This will include the removal of identifying information such as name, date of birth, date of exam, site of study, and medical record number.
In addition, through standard BDR procedures, shared data will be assigned unique subject ID numbers upon upload or registration to the BDR. Only your local study team will maintain the link table between their internal subject identifiers and the newly generated numbers.
The steps required by your local institution and the result of your request, including additional requirements for sharing, may depend on the nature of the study and how the data were collected.
Once approval has been granted by your local IRB, upload an electronic copy of the signed and/or stamped official approval, together with any related documentation, to the BDR, and the submissions process will move forward.
Please contact us for more information at BDR_info@nbirn.net.