Two GDS expectations may require an exception:
- NIH’s expectation for broad data sharing (i.e., data deposition in an NIH-designated data repository): When consistent with program priorities, NHGRI may accept well-justified data sharing plans that do not include broad data sharing. Researchers are expected to propose an “Alternative Data Sharing Plan.”
Criteria that NHGRI will use to assess requests for an alternative data sharing plan include an Institutional Review Board (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 approved, the study will be registered in the database of Genotypes and Phenotypes (dbGaP) (or other NIH-designated data repository) with information on how to request access to the data and a basic summary of the study. Timelines for data submission and access under alternative data sharing plans should be consistent with NHGRI Guidance for Data Submission and Release.
- NHGRI’s expectation to use samples with explicit consent for future research use and broad data sharing: NHGRI recognizes that not all NHGRI-supported research is able to meet this expectation, and that, in some cases, there are compelling scientific reasons for using human data sources that lack explicit consent for future research use and broad data sharing.
The need for an exception should be documented in the Resource Sharing Plan of the grant application. Requests for exceptions should be submitted via Part VI (“Request for an Exception for Samples Lacking Explicit Consent for Future Research Use and Broad Data Sharing”) of their NHGRI Genomic Data Sharing Plan (GDSP) template (Extramural template / Intramural template).
Last updated: November 16, 2020