Value Sharing Framework

1. Summary
Here, we provide a summary of the UK National Neonatal Research Database (NNRD) Value Sharing Framework. We developed the Framework through discussions with the NHS England Transformation Directorate and Health Data Research UK (HDR-UK). The Value Sharing Framework is a set of guiding  principles to inform agreements between the Neonatal Data Analysis Unit at Imperial College London and academic or industry users who wish to access NNRD data. The purpose is to ensure agreements are consistent, fair, and robust, while recognising that these involve complex issues, and will evolve over time.

2. What is the NNRD?
The NNRD is a National Information Asset, a dynamic relational database containing around 450 defined variables many recorded daily, that flow from the real-time electronic patient records of all admissions to NHS neonatal units. NNRD data include demographics, diagnoses, outcomes, treatments and care processes, many recorded daily during the neonatal in-patient stay. We update NNRD data quarterly. The NNRD was established in 2007 jointly at Imperial College London and Chelsea and Westminster NHS Foundation Trust, led by Professor Modi and her team in collaboration with a wide range of stakeholders (British Association of Perinatal Medicine; Bliss, the national newborn charity; neonatal nurses; neonatal managers; trainees, parents; NHS Trusts; devolved nations representatives). 

The purpose of the NNRD is to provide a source of high-quality data for diverse secondary purposes to improve care and outcomes across the neonatal patient benefit pathway e.g. audit and quality improvement, surveillance, health services research, epidemiological studies, surveillance, clinical trials, and policy development. NNRD data are mapped to national codes, SNOMED-CT, and the Observational Medical Outcomes Partnership Common Data Model, an open data standard designed to ensure consistency of structure and content of observational data. The data extract held in the NNRD are The Neonatal Data Set, DAPB1595, which is an NHS Information Standard for England. To-date the NNRD contains detailed clinical information on over 1.3 million infants. We add data on around 100,000 new infants each year. Prior to incorporation into the NNRD, we quality-assure data and notify contributing neonatal units of potentially erroneous or missing entries. A version curated for artificial intelligence and other data science applications (NNRD-AI), is also available.

The NNRD represents collaborative effort across the UK neonatal healthcare community as all 181 NHS neonatal units in England, Wales and Scotland submit data under approval by the Caldicott Guardian of each NHS Trust. Northern Ireland neonatal units are currently working through regulatory requirements to join as soon as possible. The UK Health Research Authority and Scottish Public Benefit and Privacy Panel have approved the NNRD as a research database. Although not a regulatory requirement, we ask every contributing NHS Trust if they agree to the inclusion of data from their neonatal unit in studies that utilise the NNRD.

Parents have been involved in the development of the NNRD since inception. Parents/patients and their organisations are members of the NNRD Steering Board. Over 1000 parents involved in a NNRD NIHR Research Programme showed they trusted healthcare professionals with their baby’s data and want these used to improve care. Parents can opt-out of the inclusion of their baby’s data in the NNRD through their neonatal unit, and for England, additionally through the NHS opt-out system, but less than 1% have done so.

The NNRD receives no core funding from the UK government, Imperial College London, Chelsea and Westminster NHS Foundation Trust, or any other source, and is therefore obligated to be self-sustaining. We resource development and maintenance through project grants awarded to Professor Modi and her team, donations, and cost recovery from external research that utilises the NNRD. The resourcing model includes enhanced cost recovery for commercial use.

3. The four NHSE principles governing commercial terms for data partnerships 
Together with a wide range of stakeholders, NHS England has developed four principles to govern the terms for data partnerships:

Principle 1 The cost of access should not prevent good use of data 
Principle 2 The NHS will always charge a fee for accessing health data
Principle 3 The cost of access should depend on how data will be used
Principle 4 The NHS should share in the value created by the data

4. The NNRD Value Sharing Framework
Based on the principles above, consultation with NHSE, discussion during the Health Data Research Alliance Pan-UK Data Governance Steering Group meeting, and our prior work, we have developed the following NNRD Value Sharing Framework:

Principle 1 The NNRD will adopt a consistent, efficient approach that aligns incentives for all parties and does not prevent good use of data.

Principle 2 The cost of access to NNRD data includes elements that reflect the cost of maintaining and developing the NNRD, and elements specific to the work required to support the individual access request (see Principle 3).

Principle 3 The NNRD will identify requirements associated with the access request and charge for them appropriately. This includes data volume, and services such as data preparation and transformation, clinical or analytical expertise, and administrative requirements. Routes to access data will change as the NNRD moves to a Secure Data Environment thus minimising transfer of data. At this point, the NNRD will factor in costs for data access through the Secure Data Environment.

Principle 4 Neonatal units should as a community, collectively benefit from any use of NNRD data for commercially funded/sponsored studies. If we receive data access requests from or on behalf of commercial entities, we will seek appropriate value that is proportionate to the NNRD contribution, which will vary by project. Value shares may be agreed upfront using a range of approaches including upfront, subscription, or milestone payments, or revenue royalties. We will use income from commercial studies to support the development of further tools and web-based resources for neonatal units building on the work initiated through an MRC award. We will consult stakeholder representatives on the NNRD Steering Board to identify tools and resources that neonatal units would find most useful.

For partnerships with non-commercial uses of data, we may use ‘consent to commercialise’ clauses in initial agreements to allow for the negotiation of financial value sharing in the future. 

National Neonatal Research Database
November 2023

We gratefully acknowledge that this work was supported by

• Health Data Research UK, an initiative funded by UK Research and Innovation, Department of Health and Social Care (England) and the devolved administrations, and leading medical research charities
• The Innovation Business Development team who are part of NHSE England Innovation, Research, Life Sciences & Strategy Team