Skip to main content

Data sharing standard 1 - Term of Data Sharing Agreement

This standard is part of a series of guidance documents to support the various stages of a DARS application.

Page contents

Important terminology

'Start Date' - This field is populated before the DSA is issued for signatures from the relevant party.  It is intended to indicate the expected date on which the DSA will become effective and is used to determine the End Date in accordance with this Data Sharing Standard.

The DSA cannot become effective until all named parties have signed the DSA.

'End Date' - The expiry date of the relevant DSA.

'Term' - The duration from the Start Date to the End Date.

Standard description

1.The Data Sharing Agreement (DSA) Start Date should not predate an achievable date by which all named parties can be expected to have signed the DSA – i.e. the Start Date should not be a date prior to the DSA being issued for all parties to sign.

2.The DSA Start Date must not be more than 12 months from the date the DSA is issued for parties to sign.

3. The DSA End Date should take account of:

  1. The data being required for the period of the stated purpose(s)
  2. Any legal requirement to retain data, such as for a clinical trial of an Investigational Medicinal Product (CTIMP)
  3. An end date beyond the period of analysis may be accepted if justified (as documented in the objectives section of the application) by one of the above reasons by a document of requirement of a funder or some other formal requirement, e.g. Research Council Standard

4. After taking into account the factors above, the maximum DSA term from Start Date to DSA End Date is:

Data subjects Purpose for processing  Maximum term
The DSA only covers data of individuals who have given informed consent for their data to be processed in the proposed manner Archiving following processing carried out for academic research purposes. 15 years, or any other such term (longer or shorter) as may be prescribed by regulation or other applicable laws to which the parties to the DSA are subject 1
  Any other purpose(s) excluding archiving Assessed on a case-by-case basis using the criteria in section 5 below
The DSA covers data of individuals who have not given informed consent for their data to be processed in the proposed manner Archiving following processing carried out for academic research purposes 15 years, or any other such term (longer or shorter) as may be prescribed by regulation or other applicable laws to which the parties to the DSA are subject 1
  Sub-licensing  1 year
  Any other purpose(s) excluding archiving or sub-licensing 3 years

1 Subject to Article 89(1), 5(1)(e) and Recital 39 of the GDPR.

5. A Pilot introducing longer term DSA’s is being run within NHS Digitrials and may include a limited number of DARS applications.  Requests for these longer term agreement will be considered on a case by case basis and utilise the criteria below;

The DSA End Date shall not exceed:

a. Any firm or indicative end date for retention communicated to the data subjects

b. The duration for which the requirement for the data is justified within the DSA (as required by section 6 below)

c. The date by which any substantial change is expected to come into effect including but not limited to:

  1. An end date for the processing or retention of the data specified in supporting documentation such as a Protocol, REC approval evidence or HRA CAG approval evidence
  2. Potential changes to the data controllership
  3. Potential changes to the purposes for processing defined within the DSA
  4. Potential changes to the funding or commissioning arrangements which could impact on the purpose(s)/objectives for processing; the duration of processing/retention or on the commercial considerations
  5. Potential changes to the type, level or volume of data required

6. The term of the DSA must be justified within the DARS application form including, if applicable, details of any regulatory and/or procedural requirements for data retention for the duration of the DSA.

7. If the term of the DSA is more than 1 year, the DSA must include Special Conditions requiring the data recipient to submit an Annual Confirmation Report, using the latest DARS template, on or prior to the anniversary of the DSA Start Date.  The purpose of the report is to enable DARS staff to carry out assurance that contractual obligations are met.  The report will include a summary of output and benefits achieved to date which NHS Digital will publish to demonstrate how the data is being used appropriately for public benefit in line with the DSA.

8. NHS Digital may terminate or require amendment to a DSA in the event that an Annual Confirmation Report is unsatisfactory, incomplete and/or not provided by the data recipient.  In accordance with Part 2 Clause 13.3 of the Data Sharing Framework Contract, NHS Digital shall give the Recipient not less than one month’s prior written notice in the event of a decision to terminate or require amendment.

Note: Data Recipients are reminded of the need to adhere to the general responsibilities in relation to the Data specified in Part 2 Clause 4 of the Data Sharing Framework Contract.

Last edited: 12 April 2024 9:05 am