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Section 251 Annual Reviews

It is a condition of approval that all approved applications are reviewed annually to ensure that identifiable data is still required for the purpose and the conditions of approval are being met. An annual review report has to be submitted to confirm that the data is being processed and stored securely and confidentially and that it is only being used for the agreed purposes. The annual review is also used to check that steps are being taken to reduce the need to rely on section 251. Applicants should contact the NIGB Office to obtain the necessary documentation and ensure this is received before the approval expires. It is the applicants’ responsibility to provide the documents for the annual review.

Download the section 251 annual review template (Word, 40Kb)

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If you no longer require section 251 support:

If your study is complete, you no longer require patient identifiable information or you have obtained consent from your cohort and therefore no longer require section 251 support then please provide a final letter confirming:

  •   All identifiable data has been anonymised/pseudonymised or deleted in line with your approved security arrangements.
  •  What information has been retained about your cohort.
  • Confirmation that dissent has been respected and the information has been processed in line with the dissenting individual’s expectations.
  •  Confirmation that information continues to be processed in line with your approved security arrangements.

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