Element 5: Protecting Privacy, Rights, and Confidentiality of Research Participants


Question

If scientific data derived from human research participants will be shared, will privacy, rights, and confidentiality of participants be protected as outlined in NOT-OD-22-213?

Guidance for Response

A response of "Yes" is expected. If your data is not derived from humans, "Not Applicable" can be checked, unless the project involves a combination of data from both human and non-human sources.

A "Yes" response implies at least the following (per NOT-OD-22-213, a Supplemental NIH guidance document on protecting research participant privacy):

  • The investigator's commitment to NOT deposit or share data that contains personal identifiers, or that can be re-identified based on triangulation or other methods. If you plan to share a subset of data that originally contained PII (personally identifiable information), a plan to de-identify the data in a way that completely prevents its re-identification is needed before proceeding with any type of data sharing
  • All Data Use Agreements entered into with partner and/or data-providing institutions are respected
  • All legal, regulatory, and policy protections that may apply to the data have been checked and are respected
  • The investigator has carefully considered whether the data can only be shared as Controlled Access Data. (This type of data CANNOT be shared in Zenodo, and instead can only be shared through a repository on the list of NIH-controlled or -approved Controlled Access Data Repositories (CADRs).
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