UK Early Life Cohort Feasibility Study (ELC-FS)
University College London (UCL) · Academic
Expired The latest version ended on 27 December 2025. The September 2026 register still lists the agreement, but its term has passed.
- Reference
- DARS-NIC-482185-K8G0F
- Latest version
- v2.3
- Term of latest version
- 28 March 2025 to 27 December 2025
- Start date
- 8 May 2023
- Data controller
- Sole Data Controller
- Commercial purposes
- No
- Sublicensing
- No
- Files released to date
- 10
Why the data was released
Objective for processing
University College London (UCL) requires access to NHS England data for the purpose of the following research project: The Early Life Cohort Feasibility Study (ELC-FS).
The following is a summary of the aims of the research project provided by University College London:
“The ELC-FS will test proof of concept for a new national birth cohort study for the UK. It will collect rich data on babies born across the UK during two consecutive months of 2022 or 2023, capturing the economic and social environments into which these babies are born, and their health, well-being and development in their first 6-10 months. The study will provide data of substantive value in itself, providing vital evidence on new lives across the UK at a critical time, particularly with regards to the shock to health and the economy induced by the COVID-19 pandemic, as well as the as yet unknown impacts of Brexit on our economy and society. It will highlight major sources of early developmental inequalities and family stressors, and identify potential foci for early intervention and support.
NHS England data will be used for the recruitment and sampling elements of the study, including sampling participants in England and Wales for the study from birth registrations linked to birth notifications and using an opt-out approach to taking part in the study following first contact with the sample.
The primary scientific aim of the study will be to understand how variability, and particularly inequalities, in the central domains of early child development emerge over time and to determine the social and biological factors influencing their trajectories. The study will use the ethnicity fields to boost the England sample. Although for this study it is unlikely to be practicable to include boost samples based on the other fields, securing access to these variables is important to demonstrating the future feasibility of this, including for Wales (and Scotland and Northern Ireland under separate applications to relevant controllers). The study also proposes to use additional fields for targeted fieldwork approaches to maximise engagement and inclusivity. Access to the individual-level characteristics by the Centre for Longitudinal Studies (CLS) also provides possibilities for wider use of records for methodological research, including non-response analysis to assess population representivity, weighting and adjustment.
NHS England will draw a sample of registrations of births linked to NHS birth notifications for the two selected birth months. The initial source of the sampling fields would be (i) the mother who has registered a birth (ii) informant, where father/other parent, is not at same address as mother. Before contacting the sample, NHS England would provide the study with up-to-date address details, embarkations and death notifications from its Personal Demographics Service. The study requires access to names and addresses including baby name and address (from birth notifications), mother name and address (from birth registrations), father/other parent name and address (from birth registrations).
For assessing feasibility of using the birth registrations linked to NHS birth notifications as a sample frame, for over-sampling on ethnicity, for targeted fieldwork materials and also for methodological and research purposes the study also requires additional fields from the birth notification and birth registration records. These include fields such as age of mother, multiple birth, birthweight, ethnicity baby, ethnicity mother, gestational age from birth notification records; and fields such as age of mother, multiple birth, birth weight, socioeconomic status, occupation, registration type (sole/joint), name and address mother, name and address father (if registered), country of birth mother, country of birth father (if registered), previous births from birth registration records. Variables which are in both the birth notifications and birth registrations are requested for verification/validation purposes and to fill in missing data.
The study team also require de-identified sampling fields for all patients who are sampled for the study for non-response analysis and adjustment. Non-response analysis, carried out on data from the whole sample, forms a vital part of the feasibility study since it is needed for the project to understand response rates among different population groups, what the biases are in who decides to take part, and whether or not the sample achieved is sufficiently representative of the national population. This analysis will be used for non-response adjustment (in particular to generate non-response weights, as well as other statistical methods). These weights and guidance on non-response adjustment will be provided to data users and are essential to the study in order that any substantive scientific analyses that are undertaken using the feasibility study data (and in due course, the main study) can be adjusted for any to biases due to selection into the sample, and to ensure the study findings are robust and valid.”
Phase I: Data for Sampling
The following NHS England data will be accessed:
• Birth Notifications – necessary because this dataset will be used to identify all births in the selected two-month period and will contain the dates of birth and each baby’s ethnicity;
• Civil Registration Births – necessary because this dataset will contain the mother’s postcode which will be converted to Lower Super Output Area (LSOA)
The level of the data will be:
• Pseudonymised
The data will be minimised as follows:
• Limited to all babies born in England and Wales during two consecutive months in either 2022 or 2023;
• Limited to four non-identifying variables:
- Unique person ID
- Baby’s ethnicity
- Baby’s month of birth
- Lower Super Output Area of mother’s place of residence
Phase II: Data for Fieldwork and Recruitment
The following NHS England data will be accessed:
• Birth Notifications – necessary because this dataset provides universal coverage of the population of babies, contains key characteristics of the baby, mother and father, including where they live, and may allow own-household fathers (OHFs, defined as fathers resident at a different address to the baby at the time of the interview) to be recruited in their own right;
• Civil Registration Births – necessary because this dataset contains additional variables which could be used for sampling, including the ethnic group of the baby and because it facilitates timely access to updated addresses for any post-birth moves and provides notifications of early infant deaths, as well as providing possibilities for wider use of health records for substantive and methodological research.
• Demographics – necessary to facilitate timely access for address updates, any post-birth moves and provides notifications of deaths.
The level of the data will be:
• Identifiable – necessary in order to be able to make contact with the selected sample to let them know they have been chosen to take part in a study and to give them the option to opt out.
The data will be minimised as follows:
• Limited to approximately 2,970 ‘families’ selected for recruitment by Ipsos and meeting the inclusion criteria (~2,376 ‘families’ in England and ~594 in Wales) – ‘families’ in this context is defined as the baby, their mother and their father or other parent;
• NHS England will screen for deaths and/or possible adoption cases and will apply National Data Opt-Outs and ‘families’ will be excluded from the data disseminated if:
- either the baby or mother are identified as deceased;
- either the baby or mother are identified as having de-registered from the NHS for the reason of moving abroad ('embarkation');
- the baby’s record is marked as sensitive or is not traced;
- any of the baby, mother or father has registered a National Data Opt-Out
Sample sizes have been calculated taking into account estimated recruitment rates and to ensure a representative sample. The fields being requested from the data sources are those that are necessary to draw the sample and contact people, to be able to assess the feasibility of using them in the sampling frame, to oversample on particular characteristics such as ethnicity, for targeted engagement (e.g. including leaflets aimed at teen mums), responsive design (e.g. during fieldwork checking to see if certain groups are not taking part and putting more effort into recruiting from those groups) and for important methodological purposes, including non-response analysis to assess population representivity, weighting and adjustment.
University College London is the research sponsor and the controller as the organisation responsible for ensuring that the data will only be processed for the purpose described above.
The lawful basis for processing personal data under the UK GDPR is:
Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller;
The lawful basis for processing special category data under the UK GDPR is:
Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.
This processing is in the public interest because it adheres to the UK Policy Framework for Health and Social Care Research, which protects and promotes the interests of patients, service users and the public, and aims to produce generalisable and publicly available information to inform future decisions over patients’ treatments or care.
The funding is provided by the Economic and Social Research Council (ESRC). The funding is specifically for the feasibility study described. Funding is in place until June 2024.
Ipsos is a processor acting under the instructions of University College London. Ipsos is a fieldwork agency which will undertake the sampling and recruitment tasks.
Amazon Web Services (AWS) is a processor acting under the instructions of UCL. UCL stores data on the Cloud provided by Amazon Web Services.
The project is led by three Co-Directors employed by UCL. These Co-Directors are supported by a team of Co-Investigators, including experts in each of the four nations of the UK, including from UCL, Swansea University, University of Edinburgh, University of Ulster, and the Fatherhood Institute.
A number of highly experienced senior collaborators are supporting the project by providing input into the study design from Bryson Purdon Social Research, Public Health Scotland, University of Edinburgh, University of Belfast, Manchester Metropolitan University, ScotCen. These senior collaborators are not Controllers or Processors for the study. These contributions are all funded by an ESRC grant.
The study also has project partners who are providing non-financial support to the project, not directly funded. Project partners also bringing extensive networks and experience to the project are the Nuffield Family Justice Observatory, First 1001 Days Movement, and the National Children’s Bureau (NCB).
Public and Patient Involvement and Engagement helped refine the purpose of the research.
During September-November 2021, two waves of public dialogue workshops for the ELC-FS were hosted by Kantar Public, with the approach carefully modified in each UK nation to reflect the different legal frameworks in place across the UK. These involved 62 participants, all parents with young children across five locations (two in England and one each in Wales, Scotland and Northern Ireland). Kantar explored the attitudes of parents of young children to the proposed uses of administrative data in the ELC-FS through the public dialogue workshops. This included exploring views about the use of linked birth registration data and NHS maternity records as the sample frame for this project, and the proposed recruitment process. Overall, parents were accepting and supportive of the proposed uses of identifiable administrative data and recruitment processes proposed, as they saw them as necessary to draw the sample and to ensure sufficient representativeness of the study. The public engagement suggested that parents of young children understood the rationale and public benefit for this proposed use of their data and its importance to building an inclusive cohort.
UCL has used existing parent and young person advisory groups, recruited from across England and Northern Ireland, run by NCB as representatives of potential study participants. The Young Research Advisors (YRAs) are a diverse group of approximately 40 children and young people aged from 7-18. The Family Research Advisory Group (FRAG) comprises approximately 25 parents and carers, some of whom are parents of young people with additional support needs. Workshops have been conducted with each of these groups focusing on co-production of the scientific content, ethics and participant engagement. In addition to work with the NCB, UCL commissioned Ipsos to conduct qualitative research with own household fathers (OHFs) and low-income families to understand how best to engage these groups in the ELC-FS. In both the NCB and qualitative research projects, the participants had useful suggestions about how to build trust with study participants through our communication strategies and interviewer training.
Processing activities
Phase I: Data for Sampling
NHS England data will provide the relevant records from the Civil Registration Births and Birth Notifications datasets to Ipsos (the ‘full population de-identified sampling file’). The data will contain no direct identifying data items but will contain a unique person ID which can be used by NHS England to link the data with other record level data it holds.
The data will be stored on servers at Ipsos. Access is restricted to employees or agents of Ipsos.
Analysts from Ipsos will process the data for the purpose of selecting a random sample of families selected for recruitment to the study.
Ipsos will transfer data to NHS England. The data will consist of the unique person ID (as originally supplied by NHSE) for the ~2,970 babies selected for recruitment.
NHSE will extract the relevant data from the Civil Registration Births and Birth Notifications datasets for each baby, their mother and, where known, their father. NHSE will match the details of each ‘family’ member with the latest Demographics data to identify any deaths, embarkations or no traces. and will apply National Data Opt-Outs to the output. NHSE will then remove any ‘family’ where any member has applied the National Data Opt-Out or where either the baby or mother is deceased or where the baby is not traced.
Ipsos will also transfer the data, including any derived fields such as an Index of Multiple Deprivation (derived by Ipsos from LSOA) to UCL for the purposes of non-response analysis.
Phase II: Data for Fieldwork and Recruitment
NHS England data will provide the relevant records from the Civil Registration Births, Birth Notifications and Demographics datasets to Ipsos. The data will contain directly identifying data items including Names, NHS Number, Date of Birth, Address and Postcode which are required to facilitate contact with the parents and also to enable Ipsos to screen for deaths and obtain latest address information from NHSE ahead of each contact attempt.
The data will be stored on servers at Ipsos.
Ipsos fieldworkers will use the name and contact details to send an initial letter to the relevant mothers and fathers giving them information about the study and giving an opportunity for respondents to remove themselves from the sample. Additionally, analysts from Ipsos will process the data for the purpose of real time analyses of response rates.
Prior to mailing out further correspondence to potential recruits, Ipsos will upload the details of the cohort, excluding those who opt-out, to NHS England’s Cohort Management System (CMS) and will download reports containing latest vital status and addresses.
Ipsos will extract a pseudonymised subset of the data containing variables necessary for non-response analysis and securely transfer this to UCL. The data will be stored in UCL’s Data Safe Haven.
UCL uses offsite back-up services provided by VIRTUS Data Centres.
UCL stores data on the Cloud provided by Amazon Web Services.
The data will be accessed by authorised personnel via remote access. The data will remain on the servers at UCL at all times. There will be no requirement and no attempt to reidentify individuals when using this data.
Once the fieldwork has concluded, Ipsos will transfer the details, including direct identifiers, of all people who consented to participate to UCL along with the deidentified data for non-respondents and those who declined to participate or opted out of taking part.
Ipsos will retain the data until instructed by UCL to destroy it or contractually required to destroy it. UCL will undertake verification checks on receipt of the data from Ipsos and will instruct deletion when ready. Ipsos are contractually required to delete the data within 28 calendar days from the end of their contract with UCL.
The data will not leave England and Wales at any time.
All personnel accessing the data have been appropriately trained in data protection and confidentiality.
Expected output
The expected outputs of the processing will be:
• A Research resource deposited with the UK Data Archive late 2024, available to bona fide researchers for the purposes of statistical data analysis comprised of information collected from the consented participants. The information provided by NHS England will have facilitated the collection of this information. The deposited data will not include the sampling field data provided by NHS England.
• A Number of recommendations for funders and stakeholders around the design for a future main early life cohort study. These will include a set of high-quality, open-access outputs (including reports, working papers and journal articles) to enable a thorough assessment of the feasibility of the main ELC and to inform its design and implementation. Outputs from the feasibility study will include an evaluation of recruitment rates and biases, and of data quality (including item non-response), the suitability and scalability of data collection innovations that have been tested, and an evaluation of experimental components (targeted incentives and bio-samples).
• An assessment of the quality of data fields on the achieved sample frames, and their suitability for use for over-sampling or targeted recruitment strategies, a report on record linkages (lessons learned), recommended next steps in developing a national study of ‘children in need’, reports from the public dialogue, parent and young person groups, including qualitative work with fathers.
• A set of design protocols for the main study including for the sample design, participant contact, and scientific content (including data collection instruments, bio-samples and record linkages) and a public engagement policy.
The outputs will not contain NHS England data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived.
The outputs will be communicated to relevant recipients through the following dissemination channels:
• Reports to funders and stakeholders;
• The CLS website https://cls.ucl.ac.uk/cls-studies/
• A participant facing ELC-FS website with its own branding (to be commissioned).
The target date for production and dissemination of the above outputs is throughout 2024.
Expected measurable benefits
While the primary aim of the study is to provide evidence on the potential for successful recruitment into a new national birth cohort study, and to inform on the best approach to design and measurement, the data from ELC-FS will be of substantive value in itself, providing vital evidence on new lives across the UK at a critical time, highlighting major sources of early developmental inequalities and family stressors, and identifying potential foci for early intervention and support.
Circumstances can hardly be more different to those facing previous generations of newborns, as families, and the services supporting them, grapple with the tumultuous effects of a severe economic recession, widespread social distress, and the shock to health and the economy induced by the Covid-19 pandemic, as well as the as yet unknown impacts of Brexit on our economy and society. The need to understand the challenges facing babies, their development as children, and long-term prospects is pressing. At the time of writing, evidence was emerging of an alarming rise in babies being killed or harmed during the first lockdown, due - according to Ofsted - to a "toxic mix” of isolation, poverty, stress and mental illness, all of which will be important themes for our data collection.
Given the earliest stages of life are vital for healthy development, the primary scientific aim of the feasibility study will be to understand how inequalities in the central domains of early child development, and the social and biological factors influencing their trajectories are evolving over time. Its scientific themes will include:
● Inequality, disadvantage, and diversity
● Cognitive, social, and emotional development of infants, infant-parent relationships, and the early home environment
● Infant health, including growth, nutrition and sleep
● Mental health of parents and the developing child
● Social, environmental and neighbourhood influences on infant and family
● Early adversity and biological embedding of stress
The new study will collect rich data on babies born across the UK, capturing the economic and social environments into which these babies are born, and their health, well-being and development in their first 6 – 10 months. The study is a feasibility study, aiming to test the feasibility of a major new study- or ‘main study’, which would be commissioned once the feasibility study has reported. Since the feasibility study is designed to provide evidence to enable a main study to be commissioned, their public benefits are very closely aligned.
The scientific aim of the study, which drives its public benefits, is to enable a rich understanding of how environmental and genetic influences interact to shape infant and child development over time, and to inform policy on effective interventions to improve lives. The study will therefore capture multiple dimensions of infant and child development including in key domains of cognitive, social and emotional development, and health, and multi-layered environmental influences including infant-parent relationships and the home environment, parental health and mental health, poverty, disadvantage and social mobility, and social environmental and neighbourhood influences. The study also aims to collect genetic data to capture genetic influences. The study sample design will include sample boosts among ethnic minority and low-income families enabling powered subgroup analyses within these groups, and has a strong focus on engagement of both mothers and fathers built into its study design.
The data will enable a range of important scientific questions to be addressed, leading to strong public benefits. This includes for example, addressing new questions about the relative influence of different home environments and infant-child interactions on infant development, for different sub-groups of families; the role of non-primary caregivers, especially fathers, whether they are co-resident with the baby or in their own households, in supporting infant development and later outcomes, and the factors influencing infant health, weight and growth in the early years.
The study will provide such evidence at a critical time, providing vital data on new lives across the UK, given the ongoing social, health and economic upheavals caused by the Covid-19 pandemic on families. As a study initiated over a period of time, both during and after the pandemic, it will capture the unequal circumstances of families, including inequalities in individual, family and community stressors, and the impact of these on infants and children, identifying potential foci for early intervention and support. It is also likely to provide a rich source of natural experiments, since its window of births chosen for sampling and data collection both take place over periods of time when many, often unexpected changes are likely to be happening, providing comparators across place as well as time (e.g. the rise and decline of new covid variants, renewed and lifted lockdown-type restrictions, changes to economic-support policies, varying stretch on NHS hospital services) that will be used for rich analysis in the years to come.
It is hoped that research from the study would:
- add to the existing body of evidence supporting various scientific publications;
- provide research evidence used for government briefing papers;
- attract media coverage to the wider issues surrounding the research.
The requested datasets will allow the study to draw an appropriate sampling frame, to assess the feasibility of using requested variables for the sampling frame, and also to be able to tailor and target letters and leaflets for certain groups. Access to ethnicity, together with other individual-level characteristics, allows for important methodological purposes, including non-response analysis to assess population representivity, weighting and adjustment. The primary scientific aim of the study will be to understand how variability, and particularly inequalities, in the central domains of early child development emerge over time and to determine the social and biological factors influencing their trajectories.
At its conclusion, this study will provide a series of recommendations for a potential main study, drawing on the results of this feasibility study. These recommendations will cover all aspects of the feasibility study including sample design, sampling frame, survey design and implementation, questionnaires, novel measure, bio-samples, public and participant engagement, ethics, information governance and data protection and record linkages. The recommendations from the feasibility study will help funders to determine whether to fund a larger scale main study and how that study should be designed and implemented.
The study is a major high-profile investment for the ESRC and will pave the way for the first new UK-wide birth cohort study for twenty years. It is also ground breaking in its use of birth registrations as the sampling frame and could therefore set an important precedent for their use.
Benefits reported so far
3,960 addresses (3,422 birth events) were issued with opt-out letters. Of those, 3,230 were issued to interviewers and the study is currently in the field. Interviews have been conducted with over half of the addresses issued to interviewers. Around 98% of addresses have had some work started. Ipsos provides regular fieldwork monitoring reports to UCL. Ipsos have also started to deliver collected survey data to UCL and will soon deliver pseudonymised sampling frame fields to UCL, to enable UCL to begin work on non-response analysis. The fieldwork is expected to conclude towards the end of April 2024.
A participant facing ‘Generation New Era’ website has been published. Reports from public dialogue work have been published on the Centre for Longitudinal Studies website.
Some initial deliverables have been written and submitted to the funder around the effectiveness of the agreement, the sampling frame performance, and the possibility of recruiting parents with younger babies in a future study. These deliverables will help inform the commissioning and design of a future larger study. Reports from public dialogue work are due to be published on the Centre for Longitudinal Studies website.
While the primary aim of the study is to provide evidence on the potential for successful recruitment into a new national birth cohort study, and to inform on the best approach to design and measurement, the data from ELC-FS will be of substantive value in itself, providing vital evidence on new lives across the UK at a critical time, highlighting major sources of early developmental inequalities and family stressors, and identifying potential foci for early intervention and support. The study still aims to deposit a research dataset with the UK Data Service by the end of 2024.
Datasets on the latest version
Legal basis for provision: National Health Service Act 2006 - s251 - 'Control of patient information'.
| Dataset | Type of data | Sensitivity | Frequency | Confidential data |
|---|---|---|---|---|
| Birth Notification Data | Identifiable | Sensitive | One-Off | Section 251 NHS Act 2006 |
| Civil Registration - Births | Identifiable | Sensitive | One-Off | Section 251 NHS Act 2006 |
| Demographics | Identifiable | Sensitive | Ongoing | Section 251 NHS Act 2006 |
Files released
Files released counts only files released externally by DARS. Access granted in NHS England's own systems, such as its Secure Data Environment, is not included.
Patient opt-outs were applied to all 10 files released under this agreement, across every version. About opt-outs
No files recorded as released under the latest version. 10 were released under earlier versions, shown in the version history.
Version history
The register lists each renewal of this agreement as a separate row. This site has 3 versions.
DARS-NIC-482185-K8G0F-v2.3 28 March 2025 to 27 December 2025
- Title
- UK Early Life Cohort Feasibility Study (ELC-FS)
- Commercial
- No
- Sublicensing
- No
- Datasets
- 3
- Files released
- 0
Datasets: Birth Notification Data; Civil Registration - Births; Demographics
What changed from DARS-NIC-482185-K8G0F-v1.3
Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.
| Field | Was | Became |
|---|---|---|
| Start date | 2025-03-28 | |
| End date | 2025-12-27 |
Objective for processing
[3 paragraphs unchanged]
“NHS
NHS
England data will be used for the recruitment and sampling elements of
[24 words unchanged]
to taking part in the study following first contact with the sample.
“The
The
primary scientific aim of the study will be to understand how variability,
[122 words unchanged]
methodological research, including non-response analysis to assess population representivity, weighting and adjustment.
“NHS
NHS
England will draw a sample of registrations of births linked to NHS
[79 words unchanged]
address (from birth registrations), father/other parent name and address (from birth registrations).
“For
For
assessing feasibility of using the birth registrations linked to NHS birth notifications
[107 words unchanged]
registrations are requested for verification/validation purposes and to fill in missing data.
“The
The
study team also require de-identified sampling fields for all patients who are
[138 words unchanged]
the sample, and to ensure the study findings are robust and valid.”
[36 paragraphs unchanged]
*Update under v1:
Formara is responsible for printing the mailing materials. Ipsos share the relevant data required for the mailings with Formara. Formara is sub-contracted by Ipsos. UCL does not have a direct contract with Formara for this specific project, but the UCL contract with Ipsos includes a sub-contracting clause affording UCL inspection rights for any sub-contractor.*
[7 paragraphs unchanged]
Processing activities
[1 paragraph unchanged]
NHS England data will provide the relevant records from the Civil Registration Births and Birth Notifications datasets to
Ipsos.
Ipsos (the ‘full population de-identified sampling file’).
The data will contain no direct identifying data items but will contain
[10 words unchanged]
England to link the data with other record level data it holds.
[4 paragraphs unchanged]
Ipsos will also transfer the data, including any derived fields such as an Index of Multiple Deprivation (derived by Ipsos from LSOA) to UCL for the purposes of non-response analysis.
[6 paragraphs unchanged]
*Update under v1:
Ipsos will share the data required for the mailings with Formara using a SFTP. Formara holds the data in an encrypted environment on their servers with access controls in place only for users who require access. The data is held for one complete month after the end of the project at which point it will be destroyed.*
[7 paragraphs unchanged]
Benefits reported
3960
3,960
addresses
(3422
(3,422
birth events) were issued with opt-out letters. Of those, 3,230 were issued
[70 words unchanged]
The fieldwork is expected to conclude towards the end of April 2024.
[1 paragraph unchanged]
Some initial deliverables have been written and submitted to the funder around
[40 words unchanged]
work are due to be published on the Centre for Longitudinal Studies
web site.
website.
[1 paragraph unchanged]
Unchanged: Expected output, Expected measurable benefits.
DARS-NIC-482185-K8G0F-v1.3 11 April 2024 to 10 April 2025
- Title
- UK Early Life Cohort Feasibility Study (ELC-FS)
- Commercial
- No
- Sublicensing
- No
- Datasets
- 3
- Files released
- 0
Datasets: Birth Notification Data; Civil Registration - Births; Demographics
What changed from DARS-NIC-482185-K8G0F-v0.19
Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.
| Field | Was | Became |
|---|---|---|
| Start date | 2024-04-11 | |
| End date | 2025-04-10 | |
| Birth Notification Data: legal basis | National Health Service Act 2006 - s251 - 'Control of patient information'. | |
| Civil Registration - Births: legal basis | National Health Service Act 2006 - s251 - 'Control of patient information'. | |
| Demographics: legal basis | National Health Service Act 2006 - s251 - 'Control of patient information'. |
Objective for processing
University College London
(UCL)
requires access to NHS England data for the purpose of the following research project: The Early Life Cohort Feasibility Study (ELC-FS).
[16 paragraphs unchanged]
o
-
Unique person ID
o
-
Baby’s ethnicity
o
-
Baby’s month of birth
o
-
Lower Super Output Area of mother’s place of residence
[10 paragraphs unchanged]
o
-
either the baby or mother are identified as deceased;
o
-
either the baby or mother are identified as having de-registered from the NHS for the reason of moving abroad ('embarkation');
o
-
the baby’s record is marked as sensitive or is not traced;
o
-
any of the baby, mother or father has registered a National Data Opt-Out
[9 paragraphs unchanged]
*Update under v1:
Formara is responsible for printing the mailing materials. Ipsos share the relevant data required for the mailings with Formara. Formara is sub-contracted by Ipsos. UCL does not have a direct contract with Formara for this specific project, but the UCL contract with Ipsos includes a sub-contracting clause affording UCL inspection rights for any sub-contractor.*
[7 paragraphs unchanged]
Processing activities
[12 paragraphs unchanged] *Update under v1: Ipsos will share the data required for the mailings with Formara using a SFTP. Formara holds the data in an encrypted environment on their servers with access controls in place only for users who require access. The data is held for one complete month after the end of the project at which point it will be destroyed.* [7 paragraphs unchanged]
Expected output
[10 paragraphs unchanged]
The target date for production and dissemination of the above outputs is
2023/2024.
throughout 2024.
Benefits reported
Yielded Benefits is not a requirement for new applications.
3960 addresses (3422 birth events) were issued with opt-out letters. Of those, 3,230 were issued to interviewers and the study is currently in the field. Interviews have been conducted with over half of the addresses issued to interviewers. Around 98% of addresses have had some work started. Ipsos provides regular fieldwork monitoring reports to UCL. Ipsos have also started to deliver collected survey data to UCL and will soon deliver pseudonymised sampling frame fields to UCL, to enable UCL to begin work on non-response analysis. The fieldwork is expected to conclude towards the end of April 2024.
A participant facing ‘Generation New Era’ website has been published. Reports from public dialogue work have been published on the Centre for Longitudinal Studies website.
Some initial deliverables have been written and submitted to the funder around the effectiveness of the agreement, the sampling frame performance, and the possibility of recruiting parents with younger babies in a future study. These deliverables will help inform the commissioning and design of a future larger study. Reports from public dialogue work are due to be published on the Centre for Longitudinal Studies web site.
While the primary aim of the study is to provide evidence on the potential for successful recruitment into a new national birth cohort study, and to inform on the best approach to design and measurement, the data from ELC-FS will be of substantive value in itself, providing vital evidence on new lives across the UK at a critical time, highlighting major sources of early developmental inequalities and family stressors, and identifying potential foci for early intervention and support. The study still aims to deposit a research dataset with the UK Data Service by the end of 2024.
Changed only in punctuation, spacing or capitalisation: Expected measurable benefits.
Objective for processing
University College London (UCL) requires access to NHS England data for the purpose of the following research project: The Early Life Cohort Feasibility Study (ELC-FS).
The following is a summary of the aims of the research project provided by University College London:
“The ELC-FS will test proof of concept for a new national birth cohort study for the UK. It will collect rich data on babies born across the UK during two consecutive months of 2022 or 2023, capturing the economic and social environments into which these babies are born, and their health, well-being and development in their first 6-10 months. The study will provide data of substantive value in itself, providing vital evidence on new lives across the UK at a critical time, particularly with regards to the shock to health and the economy induced by the COVID-19 pandemic, as well as the as yet unknown impacts of Brexit on our economy and society. It will highlight major sources of early developmental inequalities and family stressors, and identify potential foci for early intervention and support.
“NHS England data will be used for the recruitment and sampling elements of the study, including sampling participants in England and Wales for the study from birth registrations linked to birth notifications and using an opt-out approach to taking part in the study following first contact with the sample.
“The primary scientific aim of the study will be to understand how variability, and particularly inequalities, in the central domains of early child development emerge over time and to determine the social and biological factors influencing their trajectories. The study will use the ethnicity fields to boost the England sample. Although for this study it is unlikely to be practicable to include boost samples based on the other fields, securing access to these variables is important to demonstrating the future feasibility of this, including for Wales (and Scotland and Northern Ireland under separate applications to relevant controllers). The study also proposes to use additional fields for targeted fieldwork approaches to maximise engagement and inclusivity. Access to the individual-level characteristics by the Centre for Longitudinal Studies (CLS) also provides possibilities for wider use of records for methodological research, including non-response analysis to assess population representivity, weighting and adjustment.
“NHS England will draw a sample of registrations of births linked to NHS birth notifications for the two selected birth months. The initial source of the sampling fields would be (i) the mother who has registered a birth (ii) informant, where father/other parent, is not at same address as mother. Before contacting the sample, NHS England would provide the study with up-to-date address details, embarkations and death notifications from its Personal Demographics Service. The study requires access to names and addresses including baby name and address (from birth notifications), mother name and address (from birth registrations), father/other parent name and address (from birth registrations).
“For assessing feasibility of using the birth registrations linked to NHS birth notifications as a sample frame, for over-sampling on ethnicity, for targeted fieldwork materials and also for methodological and research purposes the study also requires additional fields from the birth notification and birth registration records. These include fields such as age of mother, multiple birth, birthweight, ethnicity baby, ethnicity mother, gestational age from birth notification records; and fields such as age of mother, multiple birth, birth weight, socioeconomic status, occupation, registration type (sole/joint), name and address mother, name and address father (if registered), country of birth mother, country of birth father (if registered), previous births from birth registration records. Variables which are in both the birth notifications and birth registrations are requested for verification/validation purposes and to fill in missing data.
“The study team also require de-identified sampling fields for all patients who are sampled for the study for non-response analysis and adjustment. Non-response analysis, carried out on data from the whole sample, forms a vital part of the feasibility study since it is needed for the project to understand response rates among different population groups, what the biases are in who decides to take part, and whether or not the sample achieved is sufficiently representative of the national population. This analysis will be used for non-response adjustment (in particular to generate non-response weights, as well as other statistical methods). These weights and guidance on non-response adjustment will be provided to data users and are essential to the study in order that any substantive scientific analyses that are undertaken using the feasibility study data (and in due course, the main study) can be adjusted for any to biases due to selection into the sample, and to ensure the study findings are robust and valid.”
Phase I: Data for Sampling
The following NHS England data will be accessed:
• Birth Notifications – necessary because this dataset will be used to identify all births in the selected two-month period and will contain the dates of birth and each baby’s ethnicity;
• Civil Registration Births – necessary because this dataset will contain the mother’s postcode which will be converted to Lower Super Output Area (LSOA)
The level of the data will be:
• Pseudonymised
The data will be minimised as follows:
• Limited to all babies born in England and Wales during two consecutive months in either 2022 or 2023;
• Limited to four non-identifying variables:
- Unique person ID
- Baby’s ethnicity
- Baby’s month of birth
- Lower Super Output Area of mother’s place of residence
Phase II: Data for Fieldwork and Recruitment
The following NHS England data will be accessed:
• Birth Notifications – necessary because this dataset provides universal coverage of the population of babies, contains key characteristics of the baby, mother and father, including where they live, and may allow own-household fathers (OHFs, defined as fathers resident at a different address to the baby at the time of the interview) to be recruited in their own right;
• Civil Registration Births – necessary because this dataset contains additional variables which could be used for sampling, including the ethnic group of the baby and because it facilitates timely access to updated addresses for any post-birth moves and provides notifications of early infant deaths, as well as providing possibilities for wider use of health records for substantive and methodological research.
• Demographics – necessary to facilitate timely access for address updates, any post-birth moves and provides notifications of deaths.
The level of the data will be:
• Identifiable – necessary in order to be able to make contact with the selected sample to let them know they have been chosen to take part in a study and to give them the option to opt out.
The data will be minimised as follows:
• Limited to approximately 2,970 ‘families’ selected for recruitment by Ipsos and meeting the inclusion criteria (~2,376 ‘families’ in England and ~594 in Wales) – ‘families’ in this context is defined as the baby, their mother and their father or other parent;
• NHS England will screen for deaths and/or possible adoption cases and will apply National Data Opt-Outs and ‘families’ will be excluded from the data disseminated if:
- either the baby or mother are identified as deceased;
- either the baby or mother are identified as having de-registered from the NHS for the reason of moving abroad ('embarkation');
- the baby’s record is marked as sensitive or is not traced;
- any of the baby, mother or father has registered a National Data Opt-Out
Sample sizes have been calculated taking into account estimated recruitment rates and to ensure a representative sample. The fields being requested from the data sources are those that are necessary to draw the sample and contact people, to be able to assess the feasibility of using them in the sampling frame, to oversample on particular characteristics such as ethnicity, for targeted engagement (e.g. including leaflets aimed at teen mums), responsive design (e.g. during fieldwork checking to see if certain groups are not taking part and putting more effort into recruiting from those groups) and for important methodological purposes, including non-response analysis to assess population representivity, weighting and adjustment.
University College London is the research sponsor and the controller as the organisation responsible for ensuring that the data will only be processed for the purpose described above.
The lawful basis for processing personal data under the UK GDPR is:
Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller;
The lawful basis for processing special category data under the UK GDPR is:
Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.
This processing is in the public interest because it adheres to the UK Policy Framework for Health and Social Care Research, which protects and promotes the interests of patients, service users and the public, and aims to produce generalisable and publicly available information to inform future decisions over patients’ treatments or care.
The funding is provided by the Economic and Social Research Council (ESRC). The funding is specifically for the feasibility study described. Funding is in place until June 2024.
Ipsos is a processor acting under the instructions of University College London. Ipsos is a fieldwork agency which will undertake the sampling and recruitment tasks.
*Update under v1:
Formara is responsible for printing the mailing materials. Ipsos share the relevant data required for the mailings with Formara. Formara is sub-contracted by Ipsos. UCL does not have a direct contract with Formara for this specific project, but the UCL contract with Ipsos includes a sub-contracting clause affording UCL inspection rights for any sub-contractor.*
Amazon Web Services (AWS) is a processor acting under the instructions of UCL. UCL stores data on the Cloud provided by Amazon Web Services.
The project is led by three Co-Directors employed by UCL. These Co-Directors are supported by a team of Co-Investigators, including experts in each of the four nations of the UK, including from UCL, Swansea University, University of Edinburgh, University of Ulster, and the Fatherhood Institute.
A number of highly experienced senior collaborators are supporting the project by providing input into the study design from Bryson Purdon Social Research, Public Health Scotland, University of Edinburgh, University of Belfast, Manchester Metropolitan University, ScotCen. These senior collaborators are not Controllers or Processors for the study. These contributions are all funded by an ESRC grant.
The study also has project partners who are providing non-financial support to the project, not directly funded. Project partners also bringing extensive networks and experience to the project are the Nuffield Family Justice Observatory, First 1001 Days Movement, and the National Children’s Bureau (NCB).
Public and Patient Involvement and Engagement helped refine the purpose of the research.
During September-November 2021, two waves of public dialogue workshops for the ELC-FS were hosted by Kantar Public, with the approach carefully modified in each UK nation to reflect the different legal frameworks in place across the UK. These involved 62 participants, all parents with young children across five locations (two in England and one each in Wales, Scotland and Northern Ireland). Kantar explored the attitudes of parents of young children to the proposed uses of administrative data in the ELC-FS through the public dialogue workshops. This included exploring views about the use of linked birth registration data and NHS maternity records as the sample frame for this project, and the proposed recruitment process. Overall, parents were accepting and supportive of the proposed uses of identifiable administrative data and recruitment processes proposed, as they saw them as necessary to draw the sample and to ensure sufficient representativeness of the study. The public engagement suggested that parents of young children understood the rationale and public benefit for this proposed use of their data and its importance to building an inclusive cohort.
UCL has used existing parent and young person advisory groups, recruited from across England and Northern Ireland, run by NCB as representatives of potential study participants. The Young Research Advisors (YRAs) are a diverse group of approximately 40 children and young people aged from 7-18. The Family Research Advisory Group (FRAG) comprises approximately 25 parents and carers, some of whom are parents of young people with additional support needs. Workshops have been conducted with each of these groups focusing on co-production of the scientific content, ethics and participant engagement. In addition to work with the NCB, UCL commissioned Ipsos to conduct qualitative research with own household fathers (OHFs) and low-income families to understand how best to engage these groups in the ELC-FS. In both the NCB and qualitative research projects, the participants had useful suggestions about how to build trust with study participants through our communication strategies and interviewer training.
Expected output
The expected outputs of the processing will be:
• A Research resource deposited with the UK Data Archive late 2024, available to bona fide researchers for the purposes of statistical data analysis comprised of information collected from the consented participants. The information provided by NHS England will have facilitated the collection of this information. The deposited data will not include the sampling field data provided by NHS England.
• A Number of recommendations for funders and stakeholders around the design for a future main early life cohort study. These will include a set of high-quality, open-access outputs (including reports, working papers and journal articles) to enable a thorough assessment of the feasibility of the main ELC and to inform its design and implementation. Outputs from the feasibility study will include an evaluation of recruitment rates and biases, and of data quality (including item non-response), the suitability and scalability of data collection innovations that have been tested, and an evaluation of experimental components (targeted incentives and bio-samples).
• An assessment of the quality of data fields on the achieved sample frames, and their suitability for use for over-sampling or targeted recruitment strategies, a report on record linkages (lessons learned), recommended next steps in developing a national study of ‘children in need’, reports from the public dialogue, parent and young person groups, including qualitative work with fathers.
• A set of design protocols for the main study including for the sample design, participant contact, and scientific content (including data collection instruments, bio-samples and record linkages) and a public engagement policy.
The outputs will not contain NHS England data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived.
The outputs will be communicated to relevant recipients through the following dissemination channels:
• Reports to funders and stakeholders;
• The CLS website https://cls.ucl.ac.uk/cls-studies/
• A participant facing ELC-FS website with its own branding (to be commissioned).
The target date for production and dissemination of the above outputs is throughout 2024.
Benefits reported
3960 addresses (3422 birth events) were issued with opt-out letters. Of those, 3,230 were issued to interviewers and the study is currently in the field. Interviews have been conducted with over half of the addresses issued to interviewers. Around 98% of addresses have had some work started. Ipsos provides regular fieldwork monitoring reports to UCL. Ipsos have also started to deliver collected survey data to UCL and will soon deliver pseudonymised sampling frame fields to UCL, to enable UCL to begin work on non-response analysis. The fieldwork is expected to conclude towards the end of April 2024.
A participant facing ‘Generation New Era’ website has been published. Reports from public dialogue work have been published on the Centre for Longitudinal Studies website.
Some initial deliverables have been written and submitted to the funder around the effectiveness of the agreement, the sampling frame performance, and the possibility of recruiting parents with younger babies in a future study. These deliverables will help inform the commissioning and design of a future larger study. Reports from public dialogue work are due to be published on the Centre for Longitudinal Studies web site.
While the primary aim of the study is to provide evidence on the potential for successful recruitment into a new national birth cohort study, and to inform on the best approach to design and measurement, the data from ELC-FS will be of substantive value in itself, providing vital evidence on new lives across the UK at a critical time, highlighting major sources of early developmental inequalities and family stressors, and identifying potential foci for early intervention and support. The study still aims to deposit a research dataset with the UK Data Service by the end of 2024.
DARS-NIC-482185-K8G0F-v0.19 8 May 2023 to 30 April 2024
- Title
- UK Early Life Cohort Feasibility Study (ELC-FS)
- Commercial
- No
- Sublicensing
- No
- Datasets
- 3
- Files released
- 10
Datasets: Birth Notification Data; Civil Registration - Births; Demographics
Objective for processing
University College London requires access to NHS England data for the purpose of the following research project: The Early Life Cohort Feasibility Study (ELC-FS).
The following is a summary of the aims of the research project provided by University College London:
“The ELC-FS will test proof of concept for a new national birth cohort study for the UK. It will collect rich data on babies born across the UK during two consecutive months of 2022 or 2023, capturing the economic and social environments into which these babies are born, and their health, well-being and development in their first 6-10 months. The study will provide data of substantive value in itself, providing vital evidence on new lives across the UK at a critical time, particularly with regards to the shock to health and the economy induced by the COVID-19 pandemic, as well as the as yet unknown impacts of Brexit on our economy and society. It will highlight major sources of early developmental inequalities and family stressors, and identify potential foci for early intervention and support.
“NHS England data will be used for the recruitment and sampling elements of the study, including sampling participants in England and Wales for the study from birth registrations linked to birth notifications and using an opt-out approach to taking part in the study following first contact with the sample.
“The primary scientific aim of the study will be to understand how variability, and particularly inequalities, in the central domains of early child development emerge over time and to determine the social and biological factors influencing their trajectories. The study will use the ethnicity fields to boost the England sample. Although for this study it is unlikely to be practicable to include boost samples based on the other fields, securing access to these variables is important to demonstrating the future feasibility of this, including for Wales (and Scotland and Northern Ireland under separate applications to relevant controllers). The study also proposes to use additional fields for targeted fieldwork approaches to maximise engagement and inclusivity. Access to the individual-level characteristics by the Centre for Longitudinal Studies (CLS) also provides possibilities for wider use of records for methodological research, including non-response analysis to assess population representivity, weighting and adjustment.
“NHS England will draw a sample of registrations of births linked to NHS birth notifications for the two selected birth months. The initial source of the sampling fields would be (i) the mother who has registered a birth (ii) informant, where father/other parent, is not at same address as mother. Before contacting the sample, NHS England would provide the study with up-to-date address details, embarkations and death notifications from its Personal Demographics Service. The study requires access to names and addresses including baby name and address (from birth notifications), mother name and address (from birth registrations), father/other parent name and address (from birth registrations).
“For assessing feasibility of using the birth registrations linked to NHS birth notifications as a sample frame, for over-sampling on ethnicity, for targeted fieldwork materials and also for methodological and research purposes the study also requires additional fields from the birth notification and birth registration records. These include fields such as age of mother, multiple birth, birthweight, ethnicity baby, ethnicity mother, gestational age from birth notification records; and fields such as age of mother, multiple birth, birth weight, socioeconomic status, occupation, registration type (sole/joint), name and address mother, name and address father (if registered), country of birth mother, country of birth father (if registered), previous births from birth registration records. Variables which are in both the birth notifications and birth registrations are requested for verification/validation purposes and to fill in missing data.
“The study team also require de-identified sampling fields for all patients who are sampled for the study for non-response analysis and adjustment. Non-response analysis, carried out on data from the whole sample, forms a vital part of the feasibility study since it is needed for the project to understand response rates among different population groups, what the biases are in who decides to take part, and whether or not the sample achieved is sufficiently representative of the national population. This analysis will be used for non-response adjustment (in particular to generate non-response weights, as well as other statistical methods). These weights and guidance on non-response adjustment will be provided to data users and are essential to the study in order that any substantive scientific analyses that are undertaken using the feasibility study data (and in due course, the main study) can be adjusted for any to biases due to selection into the sample, and to ensure the study findings are robust and valid.”
Phase I: Data for Sampling
The following NHS England data will be accessed:
• Birth Notifications – necessary because this dataset will be used to identify all births in the selected two-month period and will contain the dates of birth and each baby’s ethnicity;
• Civil Registration Births – necessary because this dataset will contain the mother’s postcode which will be converted to Lower Super Output Area (LSOA)
The level of the data will be:
• Pseudonymised
The data will be minimised as follows:
• Limited to all babies born in England and Wales during two consecutive months in either 2022 or 2023;
• Limited to four non-identifying variables:
o Unique person ID
o Baby’s ethnicity
o Baby’s month of birth
o Lower Super Output Area of mother’s place of residence
Phase II: Data for Fieldwork and Recruitment
The following NHS England data will be accessed:
• Birth Notifications – necessary because this dataset provides universal coverage of the population of babies, contains key characteristics of the baby, mother and father, including where they live, and may allow own-household fathers (OHFs, defined as fathers resident at a different address to the baby at the time of the interview) to be recruited in their own right;
• Civil Registration Births – necessary because this dataset contains additional variables which could be used for sampling, including the ethnic group of the baby and because it facilitates timely access to updated addresses for any post-birth moves and provides notifications of early infant deaths, as well as providing possibilities for wider use of health records for substantive and methodological research.
• Demographics – necessary to facilitate timely access for address updates, any post-birth moves and provides notifications of deaths.
The level of the data will be:
• Identifiable – necessary in order to be able to make contact with the selected sample to let them know they have been chosen to take part in a study and to give them the option to opt out.
The data will be minimised as follows:
• Limited to approximately 2,970 ‘families’ selected for recruitment by Ipsos and meeting the inclusion criteria (~2,376 ‘families’ in England and ~594 in Wales) – ‘families’ in this context is defined as the baby, their mother and their father or other parent;
• NHS England will screen for deaths and/or possible adoption cases and will apply National Data Opt-Outs and ‘families’ will be excluded from the data disseminated if:
o either the baby or mother are identified as deceased;
o either the baby or mother are identified as having de-registered from the NHS for the reason of moving abroad ('embarkation');
o the baby’s record is marked as sensitive or is not traced;
o any of the baby, mother or father has registered a National Data Opt-Out
Sample sizes have been calculated taking into account estimated recruitment rates and to ensure a representative sample. The fields being requested from the data sources are those that are necessary to draw the sample and contact people, to be able to assess the feasibility of using them in the sampling frame, to oversample on particular characteristics such as ethnicity, for targeted engagement (e.g. including leaflets aimed at teen mums), responsive design (e.g. during fieldwork checking to see if certain groups are not taking part and putting more effort into recruiting from those groups) and for important methodological purposes, including non-response analysis to assess population representivity, weighting and adjustment.
University College London is the research sponsor and the controller as the organisation responsible for ensuring that the data will only be processed for the purpose described above.
The lawful basis for processing personal data under the UK GDPR is:
Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller;
The lawful basis for processing special category data under the UK GDPR is:
Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.
This processing is in the public interest because it adheres to the UK Policy Framework for Health and Social Care Research, which protects and promotes the interests of patients, service users and the public, and aims to produce generalisable and publicly available information to inform future decisions over patients’ treatments or care.
The funding is provided by the Economic and Social Research Council (ESRC). The funding is specifically for the feasibility study described. Funding is in place until June 2024.
Ipsos is a processor acting under the instructions of University College London. Ipsos is a fieldwork agency which will undertake the sampling and recruitment tasks.
Amazon Web Services (AWS) is a processor acting under the instructions of UCL. UCL stores data on the Cloud provided by Amazon Web Services.
The project is led by three Co-Directors employed by UCL. These Co-Directors are supported by a team of Co-Investigators, including experts in each of the four nations of the UK, including from UCL, Swansea University, University of Edinburgh, University of Ulster, and the Fatherhood Institute.
A number of highly experienced senior collaborators are supporting the project by providing input into the study design from Bryson Purdon Social Research, Public Health Scotland, University of Edinburgh, University of Belfast, Manchester Metropolitan University, ScotCen. These senior collaborators are not Controllers or Processors for the study. These contributions are all funded by an ESRC grant.
The study also has project partners who are providing non-financial support to the project, not directly funded. Project partners also bringing extensive networks and experience to the project are the Nuffield Family Justice Observatory, First 1001 Days Movement, and the National Children’s Bureau (NCB).
Public and Patient Involvement and Engagement helped refine the purpose of the research.
During September-November 2021, two waves of public dialogue workshops for the ELC-FS were hosted by Kantar Public, with the approach carefully modified in each UK nation to reflect the different legal frameworks in place across the UK. These involved 62 participants, all parents with young children across five locations (two in England and one each in Wales, Scotland and Northern Ireland). Kantar explored the attitudes of parents of young children to the proposed uses of administrative data in the ELC-FS through the public dialogue workshops. This included exploring views about the use of linked birth registration data and NHS maternity records as the sample frame for this project, and the proposed recruitment process. Overall, parents were accepting and supportive of the proposed uses of identifiable administrative data and recruitment processes proposed, as they saw them as necessary to draw the sample and to ensure sufficient representativeness of the study. The public engagement suggested that parents of young children understood the rationale and public benefit for this proposed use of their data and its importance to building an inclusive cohort.
UCL has used existing parent and young person advisory groups, recruited from across England and Northern Ireland, run by NCB as representatives of potential study participants. The Young Research Advisors (YRAs) are a diverse group of approximately 40 children and young people aged from 7-18. The Family Research Advisory Group (FRAG) comprises approximately 25 parents and carers, some of whom are parents of young people with additional support needs. Workshops have been conducted with each of these groups focusing on co-production of the scientific content, ethics and participant engagement. In addition to work with the NCB, UCL commissioned Ipsos to conduct qualitative research with own household fathers (OHFs) and low-income families to understand how best to engage these groups in the ELC-FS. In both the NCB and qualitative research projects, the participants had useful suggestions about how to build trust with study participants through our communication strategies and interviewer training.
Expected output
The expected outputs of the processing will be:
• A Research resource deposited with the UK Data Archive late 2024, available to bona fide researchers for the purposes of statistical data analysis comprised of information collected from the consented participants. The information provided by NHS England will have facilitated the collection of this information. The deposited data will not include the sampling field data provided by NHS England.
• A Number of recommendations for funders and stakeholders around the design for a future main early life cohort study. These will include a set of high-quality, open-access outputs (including reports, working papers and journal articles) to enable a thorough assessment of the feasibility of the main ELC and to inform its design and implementation. Outputs from the feasibility study will include an evaluation of recruitment rates and biases, and of data quality (including item non-response), the suitability and scalability of data collection innovations that have been tested, and an evaluation of experimental components (targeted incentives and bio-samples).
• An assessment of the quality of data fields on the achieved sample frames, and their suitability for use for over-sampling or targeted recruitment strategies, a report on record linkages (lessons learned), recommended next steps in developing a national study of ‘children in need’, reports from the public dialogue, parent and young person groups, including qualitative work with fathers.
• A set of design protocols for the main study including for the sample design, participant contact, and scientific content (including data collection instruments, bio-samples and record linkages) and a public engagement policy.
The outputs will not contain NHS England data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived.
The outputs will be communicated to relevant recipients through the following dissemination channels:
• Reports to funders and stakeholders;
• The CLS website https://cls.ucl.ac.uk/cls-studies/
• A participant facing ELC-FS website with its own branding (to be commissioned).
The target date for production and dissemination of the above outputs is 2023/2024.
Benefits reported
Yielded Benefits is not a requirement for new applications.
Register history
When this agreement appeared in, or was edited in, each monthly edition of the register. Built by comparing every edition this site holds.
-
June 2023 —
first listed. 1 version: DARS-NIC-482185-K8G0F-v0.19
-
May 2024
1 version added: DARS-NIC-482185-K8G0F-v1.3
-
April 2025
1 version added: DARS-NIC-482185-K8G0F-v2.3
Cite this page
NHS England (2026) Data Uses Register, September 2026 edition, agreement DARS-NIC-482185-K8G0F, “UK Early Life Cohort Feasibility Study (ELC-FS)”. Read via NHS Data Access Explorer (unofficial), https://healthdatauses.uk/agreements/dars-nic-482185-k8g0f/ (accessed [date]).
This address stays the same, but the page is rebuilt with each monthly edition, so the citation names the edition it shows. Every edition's data is kept in the facts store.
Source: datausesregister_september2026.xlsx, September 2026 edition of the NHS England Data Uses Register. Search that workbook for DARS-NIC-482185-K8G0F to see the original rows.