Continuation of AVON LONGITUDINAL STUDY OF PARENTS AND CHILDREN (ALSPAC): section 251

The Data will be used for the purpose of the following research programme: The Avon Longitudinal Study of Parents and Children (ALSPAC)

ALSPAC, popularly known as “Children of the 90s”, is a transgenerational prospective birth cohort study that recruited women during pregnancy in the early 1990s. ALSPAC is designed to investigate influences on health, wellbeing and development across the life course. To inform these investigations, ALSPAC collects information on genetic, epigenetic, biological, psychological, social and environmental exposures and a similar range of health, social and developmental outcomes. ALSPACs primary objective is to manage a long-term relationship with the study families and through this to build a DataBank resource that can be used to inform the investigation of diverse health and social hypotheses across the life course. To achieve this objective, data are collected through postal questionnaires, study clinical assessments, the collection of biological samples and through linkage to routinely collected health and social administrative records (including those held by the NHS England).

The Data will be incorporated into a research database containing data from multiple sources on ALSPAC participants.

Approved researchers are permitted to request access to the data in the database to answer questions about health, education, social and other issues amongst the different generations - young adults, their parents and their children. These include questions relating to the impact of parental health, environmental exposures and behaviour on their children’s health and wellbeing.

ALSPAC will also work with local NHS partners to improve their services and with local communities/local authorities to help with policy and planning.

The University of Bristol must ensure that there remains a legal basis in place for the collection of education and Ministry of Justice data, and for this data to be linked to NHS England data, throughout the lifetime of this Agreement.

Sublicensing:

Data requests will be from internal University of Bristol researchers or approved sublicensees. Sublicensees will be from UK-based bona fide research organisations. This may include commercial organisations, but ALSPAC does not permit ‘for profit’ research.

Researchers are required to pass the Medical Research Council’s (MRC) GDPR training and provide a certificate to ALSPAC, or to be an ONS Accredited Researcher.

The proposal must benefit healthcare. Researchers approaching ALSPAC to use health (NHS) data in the database are doing so for a medical purpose, which includes medical researchers requesting NHS data from ALSPAC, as per the DSA in place between the parties. Data access requesters are asked ‘How will the outputs from using this data generate benefits for the Health and Social Care system?’ as part of their proposal and are required to explain why they need each dataset.

The Data will not be used for:

- Purposes that will not benefit healthcare

- Marketing, sales or insurance purposes

The ALSPAC Executive team, its members employed by the University of Bristol, approves requests for the use of data.

The ALSPAC Executive team will assess projects against the following criteria:

- Only relevant data is (securely) shared with approved researchers.

- The NHS data request is appropriate and proportionate.

- The proposal will benefit healthcare. Researchers approaching ALSPAC to use health (NHS) data in the database are doing so for a medical purpose, which includes medical researchers requesting NHS data from ALSPAC, as per the DSA in place between the parties.

- The applying researcher(s) are UK-based

- A lay summary of the project has been provided, which is required for the ALSPAC webpages.

All requests to use the data will proceed according to the following process:

(1) Application Stage: Researchers apply to ALSPAC through the Online Proposal System (OPS). They must provide details of who the researchers are, where they are based, funding, the research project and the data they will need. ALSPAC considers the project using the ‘five safes’ framework.

(2) Triage: Initial checks are made to confirm the researchers, and their organisation are bona fide. The project and data requests are reviewed by Senior Management of the relevant teams – data linkage, clinical, genetics, bio-samples, questionnaires, or if they want new data collected specifically.

Focusing on NHS data requests:

(3) Request Review: The Data Access Team at ALSPAC handle most requests for data received by ALSPAC. The Data Access Team will perform the initial triage of the people and places involved in the project. Proposals are reviewed as they come in and it is determined which can be approved, which require specialist review, and which require further information from the applicants. The team is well versed in Information Security. Strict processes are followed to ensure that:

- Only relevant data is (securely) shared with approved researchers

- The NHS data request is appropriate and proportionate.

- The proposal will benefit healthcare. Researchers approaching ALSPAC to use health (NHS) data in the database are doing so for a medical purpose, which includes medical researchers requesting NHS data from ALSPAC, as per the DSA in place between the parties. Data access requesters are asked ‘How will the outputs from using this data generate benefits for the Health and Social Care system?’ as part of their proposal, and are required to explain why they need each dataset.

- They are UK based

- A lay summary of the project has been provided, which is required for the ALSPAC webpages.

(4) Ethics Notification: ALEC (ALSPAC Legal & Ethics Committee) are notified of NHS projects.

(5) PPIE Consultation: APPAP (ALSPAC Participant and Public Advisory Panel) and ALEC are consulted if new data collection is also involved.

(6) Approval Decision: The Executive Team take in the advice and make a final decision to approve. The Board may be involved with large or controversial projects.

(7) Agreements Signed: If the request is approved, organisations are required to sign DAAs (Data Access Agreements) and Researchers must sign DURAs (Data User Responsibilities Agreement). If the request has come from an external organisation, organisations are also required to sign a Sublicensing Agreement. Funding is confirmed and the request is invoiced.

(8) Training: Researchers must do an approved training course to access the linked data, sending in a certificate.

(9) Data Access Granted: Approved researchers are granted access to the data. NHS data is only accessible within the ALSPAC Secure Data Environment in UKSeRP) and the specific data required is built within a secure project workspace. Only de-identified data is made available to researchers for analysis. This includes such precautions as removing names, addresses, truncating dates of birth and postcodes, removal of free text fields which may inadvertently contain disclosive information and any other details that might directly identify our participants. An unprocessed ‘raw’ copy will be held by the University of Bristol on a secure server for backup but will not be available, or even visible, to researchers. Neither the raw version nor the researcher accessed version are kept on the same infrastructure as participant identifiers.

(10) Outputs Exported: As researchers cannot take data out of the UKSeRP once they’ve completed their work, they need the ALSPAC Linkage team to check their results and send them outputs they can use. To ensure that the outputs, tables and charts produced cannot identify the data-subjects they are checked to ensure that they meet ALSPAC’s confidentiality standards, including small cell count suppression and review of any text. Only aggregated outputs are allowed. The reviewed results are sent to the researcher, who can then write and publish their report.

There are several advisory committees involved in the ALSPAC approvals process. The functions and responsibilities of these are outlined below.

ALSPAC Participant and Public Advisory Panel (APPAP):

The APPAP is comprised of study participants and members of the public, with a diverse range of backgrounds and experiences. APPAP provides advice, guidance, and feedback to researchers on new proposed studies and general advice to the ALSPAC study team. It meets bi-monthly. The views of study participants and the public are central to the success of ALSPAC. Patient and Public Involvement (PPI) in research is vital to make studies more relevant, more effective and improve the quality of the research it conducts. APPAP are periodically asked for their views on data linkage as a whole, and occasionally on particular data linkage projects if new data collection is also involved.

ALSPAC Law and Ethics committee (ALEC):

The ALEC is comprised of clinicians, researchers, lawyers and study participants. It provides ethical oversight of ALSPAC as a whole and, where relevant, reviews individual proposals for new data collection. It meets bi-monthly.

ALSPAC Executive Team:

The ALSPAC executive is comprised of the CI Professor, Chief Operating Officer (COO), Executive Director (data) (EDD), Executive Director (bioresource) (EDB) and Executive Director (collection) (EDC). The CI has overall responsibility for all areas of activity in ALSPAC and is supported by the executive team in the execution of ALSPAC activities. The role of the executive is to provide effective management of ALSPAC, and it meets weekly and reports to the board.

ALSPAC Senior Management Team (SMT):

The SMT manages operational activity in ALSPAC within the following areas: administration, clinic, data, and bio samples. The SMT is led by the COO and reports to the executive. It meets weekly

ALSPAC maintains a release register which records data sharing for research, which is part of their annual NHS DSPT review. Once sublicensing is granted and projects begin to be approved under sub licencing, the ALSPAC website will be updated with this release register.

The University of Bristol will transfer data to NHS England. The data will consist of identifying details (specifically NHS Number, Date of Birth, Name, Postcode, Gender and a unique person ID) for the cohort to be linked with NHS England data, to link with non-health data and non NHS England health data and to allow validation of the linkages.

NHS England will provide the relevant records from the HES, deaths, cancer, demographics, mental health, maternity, CSDS, IAPT and NHSBSA datasets to the University of Bristol’s ALSPAC Data Safe Haven. The Data will contain directly identifying data items including NHS Number, Date of Birth, Name, Postcode and Gender which are required to link the Data at record level with data already held by the recipient.

After NHS England have sent the linked Data to the University of Bristol, the Data is processed in the following ways before access is granted to bone fide researchers:

Process Stage 1: Data processing in the ALSPAC Data Safe Haven

i. Assess Data & Data Linkage Quality: The data extract is compared against the agreed extract specification to ensure the content (both in terms of variables supplied and patients included) is correct. The linkage between ALSPAC participant and NHS record is quality checked using check variables (e.g. NHS ID to ALSPAC ID link is checked using date of birth and gender). The data values will be subject to logical error checks to assess if the value is consistent with the expected values (as defined in the source documentation). Inconsistent values will be recoded to missing (i.e. ALSPAC will not attempt to infer a correct value);

ii. Derivation: Derived data are created in order to assist in the de-identification of the data (e.g. Age in days at the time of a health event will be derived from Date of Birth and the event date) and to distil records extracted from multiple sources into a cohort longitudinal record (e.g. age in days will allow accurate sequences of events to be created when combining NHS England data with other data), and to assist the research process (e.g. 1) a range of read codes, hospital admissions and prescription data are used to derive an indicator to whether an individual has had any interaction with the NHS relating to/or being coded as asthma, and 2) routine records are used to inform statistical techniques, such as multiple imputation, which can address missing self-reported data). All derivation routines are applied through computer syntax, which is stored along with a documented record of the derivations;

iii. Linkage: The extract is linked to the internal ALSPAC individual ID numbers. The quality of the match is checked (see above). Linkage success or failure is assessed and documented within the data set (e.g. ALSPAC attempts to distinguish between failure to link due to a patient not seeking consultation, with failure to link due to insufficient identifiers and failure to link as the individual is resident outside of the catchment area of the data extract in question). The extract is processed to ensure it is harmonised with the ALSPAC longitudinal data set;

iv. De-Identification: The Safe Haven de-identification processes are designed to minimise the risks of disclosure through either: direct identification of an individual from a dataset (either accidentally or maliciously); through inference or through the potential of variables in combination to identify individuals; or the potential of inappropriately described outputs to identify individuals. The data are pseudonymised through removing NHS ID, name and address (where present). The extract is stored, within the Data Safe Haven, until information from it is requested for a research investigation.

v. Collation, Storage & Archiving: Copies of the data shared with researchers will be held securely within the Data Safe Haven. These will be used for audit purposes, to keep a record of research project sample selection (in order to allow follow-up assessments) and to fulfil the requirements that peer-reviewed findings are reproducible.

The identifiable data are only used for these data processing purposes, i.e., to facilitate and support research. The Identifiable data are not used in research investigations.

Process Stage 2: Participant Tracing Data

Where the data extracted from the NHS England relates to participant contact details and status (e.g. left England and Wales, fact of death) the members of Data Safe Haven staff will swap the ID used to extract the data for ALSPACs internal system ID and will then pass the information to the ALSPAC team whose role it is to maintain communications and relationships with participants. Neither NHS IDs or clinical data (beyond ‘alive/deceased’ status) will be provided to this team. The details are then used to update ALSPACs administrative database. These details are not provided to researchers, although address information is used to derive spatial identifiers and other values which are used in some research projects in a non-disclosive form.

ALSPAC will use an MRC Farr Institute ‘UK Secure eResearch Platform (UKSeRP) as a ‘secure research environment’ to combine records from different sources and to manage access to effectively anonymous sub-sets of combined records to specific researchers at a project level. UKSeRP is the technological infrastructure which supports the SAIL databank of Welsh routine health and administrative records. UKSeRP was developed by the Welsh MRC Farr Institute and is operated by two organisations: Digital Health and Care Wales (DHCW) and the University of Swansea Health Informatics Research Unit (HIRU). HIRU, through the MRC Farr Institute are making the UKSeRP infrastructure available to other research organisations. This means ALSPAC can make use of the full advantages of the secure research infrastructure developed to support SAIL by contracting the University of Swansea to provide a copy of the infrastructure to host ALSPAC data and data linked to ALSPAC. In this contractual arrangement, the University of Swansea will be Data Processor working to instruction from the University of Bristol who will be Data Controller (the contract will bind the University of Swansea to the same conditions (where relevant) as the University of Bristol have agreed to in their contract with the NHS England). UKSeRP has ISO27001 certification. This principle has been previously agreed as suitable for hosting linked NHS England records.

Process Stage 3: Linking ALSPAC participants to the UKSeRP

(this stage has already taken place and will not need repeating).

UKSeRP operates on a ‘split file’ approach to handling data; where identifiers are handled separately from clinical or individual attribute data. Identifiers are processed by DHCW (within the confines of the NHS); where they are processed by an algorithm which consistently converts incoming identifiers (e.g. NHS ID, name, date of birth) into an encrypted ‘Anonymous Linkage Field’ (ALF). In this way identifiers relating to the same person coming from multiple sources can be linked to the same ALF.

ALSPAC have already sent the identifiers to DHCW along with an externally meaningless ID number (KEY ID). DHCW have used the identifiers to create ALF IDs for ALSPAC participants. This is managed in such a way that 1) neither ALSPAC nor HIRU (who manage clinical data) are able to trace back ALF to a person’s identity and 2) ALSPAC are able to send clinical and other attribute data linked to KEY ID into the system which can then be automatically replaced with ALF in a ‘black box’ process.

Process Stage 4a & 4b: Sending NHS England and ALSPAC data from ALSPAC into the UKSeRP

ALSPAC research staff will replace the IDS on the de-identified data from the ALSPAC resource with the Key ID. The data will then be securely sent (using AES-256bit encryption) into the ALSPAC UKSeRP via the automated ‘gateway’ upload appliance.

ALSPAC data safe haven staff will also conduct the same process on the de-identified (see Stage 1) NHS data. The NHS data will then be securely sent (using AES-256bit encryption) with Key ID into the ALSPAC UKSeRP via the automated ‘gateway’ upload appliance.

Process stage 5:

The UKSeRP automated gateway system automatically replaces Key ID on incoming data with ALF ID (yet the system has no access to identifiers of the individuals used to produce ALF as these never leave the NWIS trusted third party). The data are then deposited in the ALSPAC UKSeRP. Meaning the ALSPAC staff have no means of linking ALF back to the ALSPAC databases yet can use ALF to join records coming in from different sources or at different times (e.g. longitudinal updates).

Process Stage 6: Sub-setting and further anonymization of data prior to analysis

The researchers with approval to access the ALSPAC HES and MHSDS data will be created project specific ‘containers’ in UKSeRP that they can access. ALSPAC Data Safe Haven staff will sub-set the extracted data to minimise it to only the information needed to conduct the project investigation. Each project data set will be given its own unique ID. The researchers will not have access to the ALSPAC administrative database and therefore – given the technological, contractual, training and data management steps involved – the data can be considered to meet the Information Commissioner’s Office ‘effectively anonymous’ requirements (as defined in the ICO Anonymisation Code Of Practice – a separate document is included describing how University of Bristol's process meets the ICO requirements).

Project specific datasets are risk assessed and disclosure control is applied as deemed appropriate. Further disclosure control ranges from suppression of rare values and outliers to a state where the possibility of disclosure is rendered so challenging that the data can be considered as being effectively anonymised in line with the HSCIC Anonymisation Standard for the publication of Health and social Care Data. Case selections will be assessed for risks of disclosure through inference (e.g. where a sample selection is made on the basis of a health condition), where this is a risk the Safe Haven staff will add control or masking cases.

The ALF used in the hypothesis specific dataset will undergo secondary encryption (reversible by ALSPAC) using an algorithm specific to each project. This means that a researcher with multiple project will not be able to join data across the different datasets using ALF.

The ALSPAC Data Linkage Research Database will continue to be run and maintained within a Secure Research Environment (SRE). The steps used by ALSPAC to link to participants’ third-party data, once the data linkage is agreed between the parties and a formal Data Sharing Agreement is signed are described below:

1. ALSPAC agrees minimal participant identifiers (demographics) and formatting with the third party (data provider). This minimises the chance of missing matched records. A unique study ID is generated for each participant. Note: some of these identifiers will have been obtained under s251 support and so will require the ongoing support of HRA CAG.

2. ALSPAC demographic data is encrypted to AES-256 standard, and password protected.

3. ALSPAC data is sent via a Secure File Transfer (SFT) protocol. The password is sent through an independent channel.

4. The third party combines the ALSPAC dataset together with their own demographic information.

5. The third party identifies individuals common to both datasets. Participant demographics are no longer required and are dropped at this stage.

6. The records of only the matched individuals are extracted from the third party’s database. All agreed data items are extracted. Individual participants are indicated by only their study IDs.

7. The third-party data is encrypted to AES-256 standard and protected with a new password (a mirror of stage 2, above).

8. The third-party data is sent via a Secure File Transfer (SFT) protocol. The password is sent through an independent channel (a mirror of stage 3, above).

9. The raw third-party records are initially integrated into ALSPAC using the Study IDs.

10. The data is lightly processed to minimise any risk of participant re-identification.

11. The de-identified data is ingested into ALSPAC’s SRE in UKSeRP.

12. Researchers can request data items from these third-party datasets, relevant to their project, and perform analyses within the SRE.

The ALSPAC Data Linkage Team are responsible for sourcing and managing data from third-party sources. They work closely with the Data Access Team to approve, cost, and generate the datasets so researchers can securely and appropriately access linked ALSPAC data, within a safe environment.

Process Stage 9: Researcher access to data

Researchers are all contracted to University of Bristol. They will only be able to access the sub-partition(s) of the ALSPAC UKSeRP where their project specific data set is located. The UKSeRP technology restricts the actions that researchers can take, for example, it is not possible to plug in a USB stick, or to copy and paste or to connect from within UKSeRP to the internet. These restrictions – in conjunction with the training and binding agreements the researchers enter into – ensure good governance is maintained. Furthermore, the anonymization processes undertake (stages 3 and 6) are sufficient to reduce the risks of participant identifiably to a point that they are so remote that the data can be appropriately treated as effectively anonymous.

Researchers are allowed to remove data outputs (e.g., statistical findings, graphs, tables of aggregated findings) from UKSeRP through a controlled process where each output is reviewed and assessed for disclosure risk by ALSPAC Data Safe Haven staff prior to being released. ALSPACs Data Access policies require that researchers submit all publications, prior to submission for publication, to the ALSPAC Executive. The Executive Committee assess the publications for issues including checks for potential disclosure risks (e.g., tables summarising statistical outputs containing small cell counts). Disclosure checks will ensure compliance with the small number suppression rules contained within the NHS Analysis Guide.

Information Security: ALSPAC are committed to maintain high standards of information security and recognise that this is a key component of the trust relationship with participants and data owners alike. To achieve these standards ALSPAC have developed an Information Security Management System and associated management and governance structure that has been certified as meeting the ISO/IEC 27001:2022 Information Security standard. ALSAPC annually submit an NHS DSP Toolkit assessment.

The Data will be stored on the ALSPAC Data Safe Haven at the University of Bristol and UK Secure eResearch Platform (UKSeRP)

The Data will be accessed by authorised personnel via remote access.

The Controller(s) must confirm and provide evidence upon audit by NHS England that access via any remote device complies with the data security obligations within this DSA and the Data Sharing Framework Contract.

For remote access:

- Remote access will only be from secure locations situated within the territory of use (as further restricted elsewhere within the DSA if so done) stated within this DSA;

- Access controls granting users the minimum level of access required are in place;

- Remote access is only via secure connections (e.g., VPNs or secure protocols) to protect data;

- Multifactor authentication (MFA) is required for remote access;

- Device security, including up-to-date software and operating systems, antivirus software, and enabled firewalls are utilised for the remote access;

- All remote access is undertaken within the scope of the organisation’s DSPT (or other security arrangements as per this DSA) and complies with the organisation’s remote access policy.

The above applies in addition to any condition set out elsewhere within the DSA (e.g. who may carry out processing, and for what purpose)

Remote processing will be from secure locations within the UK. The data will not leave the UK at any time.

Access is restricted to employees of the University of Bristol who have authorisation from the Principal Investigator, and approved sublicensees.

Data will be accessed by individuals with an honorary contract with the University of Bristol. The individuals will act as an agent of the University of Bristol at all times under supervision from employees of the University of Bristol. Aside from these individuals, access is restricted to employees or agents of the University of Bristol who have authorisation from the Principal Investigator or Executive of ALSPAC.

Employees of other organisations under sublicence are permitted to access pseudonymised data only.

All personnel accessing the Data have been appropriately trained in data protection and confidentiality.

The Data will be linked at person record level with the following data:

Health Data:

- Optum – Primary Care

- BadgerNet (SystemC) – Maternity Data (currently supported but not yet realised)

- STORK – Maternity Data

- Local datasets from NHS trusts – such as AvonCAP, Bristol Self Harm Register, HeartSuite, AWP (MH) and Local and National health registers containing ALSPAC participants

- UKHSA and other Department of Health & Social Care agencies and bodies – National datasets and registers containing ALSPAC participants

- Other commercial organisations which provide software and data management services across the NHS, and which contain datasets and registers including ALSPAC participants.

Non-health Data:

- Department for Education – Key Stage data (1-5), school absences and exclusions. Also, Higher Education and Further Education (already held for G1, will request data for G2 in future).

- Ministry of Justice – National justice data; this will include crimes (cautions, convictions), and information about status as a suspect or a victim of crime (application pending).

- Avon & Somerset Police – Local crime data; relating to crimes (including information about cautions and convictions, suspect or victim) in the local area to Bristol (already held for G1, will request data for G2 in future).

- Geodata – Local and National data on the community and environment (some already held, based on address histories of participants).

- Project specific data provided by researchers – this will be linked into the ALSPAC datasets by ALSPAC staff in a manner preserving confidentiality.

The identifying details will be stored in a separate database to the linked dataset used for analysis. All analyses will use the pseudonymised dataset. There will be no requirement and no attempt to reidentify individuals when using the pseudonymised dataset.

The University of Bristol will ensure that an appropriate legal basis for the processing, and linkage of the datasets listed above is established and maintained. The University of Bristol will also ensure that all necessary local governance approvals and agreements are in place prior to undertaking any such data collection or linkage activities.

The Data will be stored on a secure encapsulated virtual machine called the Data Safe Haven located at the University of Bristol. The Data Safe Haven is kept separately from the ALSPAC administrative database which contains participant identifiers. The Data Safe Haven design has been adopted to restrict access to identifiable data used for secondary purposes and to support the de-identification of the data prior to the bulk of the data uses.

The ALSPAC Data Safe Haven was designed in accordance with NHS policy. Incoming, identifiable, data is stored in an encrypted format on encrypted and firewalled demarcated server space. Access to this server space is restricted to the Data Safe Haven team (by user access controls and access is only permitted from a small number of desktop computers based in secure offices at the University of Bristol). On entry to the Data Safe Haven a copy of the data is archived.

Researchers from the University of Bristol and approved sublicensees will analyse the Data for the purposes described above.

The expected outputs of the processing will be:

- Submissions to peer reviewed journals

- Presentations at appropriate conferences

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:

- Journals

- Workshops

- Conferences

- Newsletters aimed at participants (both print and via social media)

- Local and national press/media engagement. ALSPAC will work with the University of Bristol press office and the team at Understanding Patient Data to promote the findings from these investigations. The participants will be informed of the outputs through University of Bristol's press-release system.

- Social media: Twitter/X posts and Facebook articles

- Work with local attractions, such as the MSHED museum of Bristol Life

Outputs will be produced and disseminated on an ongoing basis. Some early outputs include the following journal submissions:

- Preliminary work from the “Investigating the accuracy of current estimates of self-harm” study has been published in Archives of Suicide Research and has been selected as a case study by the Wellcome Trust ‘understanding patient data’ taskforce. The academic lead for STITCH (“Improving Care in Self-Harm”) is the PI of this project and will feed back relevant findings into NHS and Public health strategy.

- Maternal smoking during pregnancy and intellectual disability'

- A Population-Based Cohort Study Examining the Incidence and Impact of Psychotic Experiences from Childhood to Adulthood, and Prediction of Psychotic Disorder

- Continence Problems and Mental Health in Adolescents from a UK Cohort

- Child maltreatment and parental domestic violence and abuse, co-occurrence and the effect on lifetime outcomes in the Avon Longitudinal Study of Parents and Children (ALSPAC)

- Mapping neurodevelopmental trajectories: A focus on autism with comparisons to psychosis

ALSPAC anticipates more outputs as projects mature, and new projects start.

The ALSPAC investigations each have defined primary objectives to improve the understanding amongst some of the most concerning and prevalent areas of health; e.g., those relating to depression, psychosis, self-harm and suicide and substance use. Through this innovative use of a cohort study of adolescents linked to health records ALSPAC can study exposure/outcome associations in marginalised groups (i.e., those in need/in care and those suffering from mental health conditions). Secondary objectives relate to a better understanding of self-reported measurement error which will be used to inform interpretation of evidence emerging from longitudinal research studies and therefore improve the accuracy of evidence informing health and social care policy development.

ALSPAC is in the unique position of being able to use the NHS data in the research database in combination with other longitudinal datasets. The ALSPAC Research Database will integrate linked, third-party, administrative data from several sources, primarily NHS England, with its own data collected directly from participants. These directly collected data (Study Data, Clinical Data and Biological Samples) are described here for context because most projects request a combination of linked NHS data and ALSPAC data. Researchers using ALSPAC - NHS health data in the database are doing so for a medical purpose, as required by the NHS Act (2006, s251), which includes medical research. All researchers requesting access to ALSPAC - NHS data are asked ‘How will the outputs from using this data generate benefits for the Health and Social Care system?’ as part of their proposal.

The use of the data could:

- help the system to better understand the health and care needs of populations.

- lead to the identification or improvement of treatments or interventions, or health and care system design to improve health and care outcomes or experience.

- advance understanding of regional and national trends in health and social care needs.

- advance understanding of the need for, or effectiveness of, preventative health and care measures for particular populations or conditions such as obesity and diabetes.

- inform planning health services and programmes, for example to improve equity of access, experience and outcomes.

- support knowledge creation or exploratory research (and the innovations and developments that might result from that exploratory work).

The participants themselves do not expect to benefit directly or immediately from the research. The participants take part for altruistic reasons and understand that ALSPAC research is intended to contribute to improving the health and care of the wider community as a whole.

ALSPAC is an internationally recognised research database, and over 3,000 publications have made use of ALSPAC data. Allowing non-ALSPAC researchers the ability to access ALSPAC NHS data will enable many more projects to proceed than ALSPAC alone could manage, and will enable experts from outside ALSPAC to conduct research using the full data available from our database. There are many experts outside ALSPAC who will be able to conduct their research using ALSPAC data and who will have the ability to influence public health beyond the capabilities of ALSPAC alone.

ALSPAC has a good relationship with local media and regularly update their own webpages and social media. Staff from ALSPAC attend, and often contribute to, conferences in the UK and beyond, and all research is published through peer-reviewed outlets, to enable the research findings to reach a wide audience.

ALSPAC work with NHS clinicians and advisors in a range of disciplines. Current projects include work conducted with: Director of the National Chlamydia Screening Programme, NHS ‘Bristol Health Partners’ Director of the Sexual Health Improvement for Population and Patients Health Integration Team, National Suicide Prevention Strategy Advisory Group member, NHS ‘Bristol Health Partners’ Director of the Addictions Health Integration Team and Chair of the National Advisory Group to Welsh Government on Suicide and Self Harm prevention. In this way, it is ensured that the improved understanding of health and social care generated by the use of ALSPAC-NHS England Data are flowing back into the NHS, through: academic routes (publication and conferences such as the Society for Academic Primary Care and Farr Institute Conferences); clinical groups (e.g. the Bristol Health partners HITs) and advisory boards (e.g. National Suicide Advisory Group); direct feedback into improving service provision (e.g. National Chlamydia Screening Programme); and feedback into Government policy (e.g. ALSPACs contributions to the Marmott Review ‘Fair Society, Healthy Lives’).

A past example of this is the role ALSPAC played in the ‘back to sleep’ intervention that aimed to reduce rates of sudden infant death syndrome (aka ‘Cot Death’). ALSPACs used its early life information to research the long-term development pathways of children put to sleep on their back. ALSPAC's findings reassured sceptical health professionals (concerned that putting children to sleep on their backs impacted on child motor development) and contributed to policy change in the UK and overseas; a policy change which has subsequently been credited with substantially cutting rates of sudden infant death.