NHS Digital Data Release Register - reformatted

Saving Faces - The Facial Surgery Research Foundation projects

85 data files in total were disseminated unsafely (information about files used safely is missing for TRE/"system access" projects).

MR1131 - The Role of Selective Neck Dissection Used Electively in Patients — DARS-NIC-147858-KGYSS

Type of data: information not disclosed for TRE projects

Opt outs honoured: No - consent provided by participants of research study, Identifiable, No (Consent (Reasonable Expectation))

Legal basis: Informed Patient consent to permit the receipt, processing and release of data by the HSCIC, Health and Social Care Act 2012 – s261(2)(c), Informed Patient consent to permit the receipt, processing and release of data by NHS Digital, Health and Social Care Act 2012 – s261(2)(c), Health and Social Care Act 2012 – s261(2)(c); Informed Patient consent to permit the receipt, processing and release of data by NHS Digital

Purposes: No (Charity)

Sensitive: Sensitive, and Non Sensitive

When:DSA runs 2019-10-22 — 2020-02-29 2017.09 — 2024.06.

Access method: Ongoing, One-Off

Data-controller type: SAVING FACES - THE FACIAL SURGERY RESEARCH FOUNDATION

Sublicensing allowed: No

Datasets:

  1. MRIS - Cause of Death Report
  2. MRIS - Cohort Event Notification Report
  3. MRIS - Flagging Current Status Report
  4. MRIS - Members and Postings Report
  5. Civil Registration - Deaths
  6. Demographics
  7. Civil Registrations of Death

Objectives:

The role of selective neck dissection used electively in patients with early oral squamous cell carcinoma (1−3cm primary size) and no clinical evidence of lymph node metastases in the neck (N0)

The trial aims to establish whether selective neck dissection in addition to resection of the primary tumour increases survival when compared with resection of the primary alone, among patients with early oral squamous cell carcinoma who have no clinical or radiological evidence of neck metastases. Additionally the trial aims to determine how SEND and complex reconstruction affect quality of life (QOL) and whether the use of SEND on all patients presenting with tumors measuring 1-3cms and clinically N0 necks represents a cost-effective use of resources.

We will also use the pathology results to try to identify risk factors for metastasis so that in the future elective neck dissection could be reserved for only those patients with an increased risk of neck metastasis based on their primary site pathological markers.

Data access is restricted to those named in section 7 of this agreement. Any changes will be notified to the NHS IC.

Yielded Benefits:

Expected Benefits:

MRIS data was supplied to Saving Faces - The Facial Surgery Research Foundation by the Health and Social Care Information Centre (which has since become NHS Digital) for the purpose of a research study referred to as "MRIS1131 The Role of Selective Neck Dissection Used Effectively in Patients".

This Data Sharing Agreement permits the retention of the data for an interim period but no other processing of the data is permitted.

Permission to retain the data for the interim period is a practical step to enable the study to comply with the necessary legal and ethical requirements.

If, for any reason, it is not possible for the study to meet the necessary requirements, this Agreement will be terminated, and destruction of the data will be required.

Outputs:

This Data Sharing Agreement permits the retention of the data for an interim period but no other processing of the data is permitted.

No further outputs of the data are permitted to be created under this version of the agreement.

Processing:

All organisations party to this agreement must comply with the Data Sharing Framework Contract requirements, including those regarding the use (and purposes of that use) by “Personnel” (as defined within the Data Sharing Framework Contract ie: employees, agents and contractors of the Data Recipient who may have access to that data).

No new or further data will be provided under this version of the agreement. A short term extension is in place as a pragmatic approach to enable legal retention of already disseminated data. This agreement allows retention of data, but not permission to otherwise process it.