Per the NIH GDS Policy, NHGRI will consider requests for exceptions to standard data sharing plan expectations. When consistent with program priorities, NHGRI may accept well-justified data sharing plans that do not include broad data sharing or that include more narrow data use limitations for future research.
Basic criteria that NHGRI will use to assess exception requests include an IRB or equivalent determination that informed consent materials preclude broad data sharing, or an IRB assessment that there are additional participant protection concerns related to the nature or character of the study population (e.g., geographical location or small study designs focused on a rare disease).
Investigators may also submit a justification within a data sharing plan demonstrating that data sharing costs (e.g., financial or personnel resources) outweigh the potential for broad scientific value of access to the data.
In all cases where alternative data sharing plans are determined to be appropriate, information on how to request access to the data and a basic summary of the study and study data will be listed in dbGaP (or other appropriate NIH-designated data repository). Timelines for data submission and access under alternative data sharing plans should be consistent with those for standard data sharing under the NIH GDS Policy.
Information about any additional elements to consider in requesting exceptions from data deposition in NIH-designated data repositories will be added to this page as they are developed.
Last updated: July 11, 2019