The NIH does not expect researchers to share all data under this new policy, and acknowledges that ethical, legal or technical factors may limit sharing of data. Researchers must outline their limitations and justification in the Data Management and Sharing Plan.
Potential examples of justifiable limitations (from the NIH FAQ):
Potential examples of unjustifiable limitations:
Researchers must have a clear consent process that informs participants about potential future sharing (and re-use) of their data. If researchers intend to begin data sharing under this policy, they should review their informed consent process to make sure they provide:
When a dataset is too sensitive to share in its entirety, it is necessary to consider: "how can a version that is safe to share be created?". The process of doing so involves de-identification or anonymisation to remove all data that can be used to identify individual participants in a research project, thereby protecting their privacy. This may require hiring a professional statistician, which can be written into a grant.
Controlled access refers to a data sharing model that requires a request for access to all or part of the dataset(s). Some data, e.g. about human participants, remains sensitive even after other measures (de-identification, etc.) have been taken, either because it cannot be sufficiently anonymized or because doing so would make the data less useful. In those cases, planning for controlled access may be necessary.
Controlled access repositories have different models for granting access, including Data Access Request (DAR), Data Use Agreement (DUA), Data Access Condition (DAC), or Data Use Limitation (DUL).
Examples of Controlled access repositories:
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