Element 4: If "No" was Responded to any of the First Three Questions, Provide Explanation


Question

If you answered "No" to elements 1, 2, or 3, or if you anticipate that sharing will be limited in some other way, please describe these limitations and the ethical, legal, or technical factors for them. Your response should specify a particular reason(s) for limiting sharing.

Guidance for Response

To address the time-based questions (Elements 2 and 3) first, use your response to this Element to explain any reasons why data sharing may need to take place later than the recommended deadlines (e.g., student involvement in a project, patents/licenses, data use agreements, etc.)

Also use this space to explain why data may not be made available for as long as any required or expected retention periods, as outlined by a journal, etc.

If a limitation to the maximum amount of data sharing must be explained (e.g., a "No" response to Element 1), consult NIH's FAQ on What are justifiable reasons for limiting sharing of data.

Justifiable reasons to limit data sharing include:

  • The project's informed consents limit the scope of data sharing
  • Existing consent (e.g., for previously collected biospecimens) prohibits sharing or limits the scope or extent of sharing
  • A dataset is impossible to de-identify sufficiently to guarantee that the privacy and safety of the research participants can be protected (and Certificates of Confidentiality would also be insufficient)
  • Datasets cannot be digitized with reasonable efforts.
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