Since the beginning of this study, over 700 families (including you!) in England, Germany, the Netherlands, Sweden, and Italy have participated in the Longitudinal European Autism Project (LEAP). 

This study is currently the largest study in the world to identify variability in autism in terms of behaviour, cognition, co-occurring conditions, outcomes, brain structure/function, and genetics. 

We are immensely grateful to you and all of our volunteer families for your time and commitment.

Through an improved understanding of the variability between autistic people, our goal is to identify ‘subgroups’ of individuals with similar characteristics and needs who may benefit most from particular support strategies (e.g., for sensory sensitivities, epilepsy, anxiety), rather than taking a ‘one size fits all’ approach.

The goal of the AIMS-2-TRIALS external database is to share AIMS-2-TRIALS data with the wider global research community. 

‘External’ refers to researchers outside of the AIMS-2-TRIALS consortium. The AIMS-2-TRIALS external database is hosted via ELIXIR, located in Luxembourg.

This is different from ‘internal’ data sharing, which means data sharing only between researchers within the AIMS-2-TRIALS consortium. The AIMS-2-TRIALS internal database is hosted via OWEY, located in Paris, France.

Data sharing is a crucial element of research. Sharing of scientific data among researchers helps to speed the rate of scientific progress enormously. More data from more people allows researchers to be more confident that the results of their analyses are accurate (can be replicated more than once by different researchers) and representative.

Sharing AIMS-2-TRIALS data will make it easier for researchers to find and explore data from multiple datasets, so that analyses can include, for example, several thousand people, rather than several hundred. Data sharing has many other benefits such as encouraging transparency and accountability, and facilitating collaboration between research groups around the world. 

The AIMS-2-TRIALS external database is hosted on a platform called ELIXIR. The goal of ELIXIR is to make life science data easier to find, share, put together, and analyse.

Each country that is a member of ELIXIR has a “node”, which is the collection of research institutes that work for ELIXIR in that country. The AIMS-2-TRIALS external database will be hosted on the ELIXIR Luxembourg node.

ELIXIR (and its Luxembourg node, specifically) was selected as the best fit for hosting the AIMS-2-TRIALS external database, as it is an existing GDPR compliant European infrastructure for long-term sustainability of life sciences data.

Data will be stored by ELIXIR, an organisation based in Luxembourg. Researchers outside of the AIMS-2-TRIALS project can apply for access to the data via ELIXIR. ELIXIR will manage the application process with input from the study sites and the external database review committee. 

A copy of the data will be stored by Institute Pasteur based in Paris who have hosted the data throughout the project. For more details on the ‘internal database’ see our website.

ELIXIR is a data hub for medical science research. They host a secure database for sharing research data. ELIXIR (and its Luxembourg node, specifically) was selected as the best fit for hosting the AIMS-2-TRIALS external database, as it is an existing GDPR compliant European infrastructure for long-term sustainability of life sciences data.

Researchers wanting to access the data will need to apply for access. This process includes writing a proposal and providing evidence of ethical approval/ code of conduct as well as agreeing to our data access policy.

All project proposals will be reviewed by the project review committee which includes autism community members and researchers from the AIMS-2-TRIALS consortium. The review committee will check the proposals for a number of key requirements this includes checking proposals are in line with original consent wording, and checking they meet our Consortium Principles (Beneficence, Inclusion/Engagement, Culture/Language, Minimising Risk). See ‘When access to LEAP data is requested for research, how is this reviewed and approved’ for more details.

Autistic people and parents of autistic people also advised on the design of the data sharing and review process. 

Data collected as part of the Longitudinal European Autism Project (LEAP), which included MRI brain scans, eye tracking measures, questionnaires, computer tasks and interviews.

You can read more about LEAP in our LEAP leaflet. Currently only data from the first and second time point of the study will be shared in this way (from 2013-2015) but there are also plans to share data collected later.

AIMS-2-TRIALS is funded by the Innovative Medicines Initiative (grant agreement No. 777394) until November 2026. In-kind contributions (such as time and resources) have also been given by pharmaceutical companies (Hoffmann La Roche, Janssen) and charities (Simons Foundation for Autism Research, Autism Speaks, Autistica) to support this research programme.

The external database of AIMS-2-TRIALS data will be supported by ELIXIR for a minimum period of 15 years. The consortium are currently seeking funding to support ongoing data sustainability beyond the current AIMS-2-TRIALS grant such as supporting internal hosting, data processing and funding the review committee.

To apply for LEAP data access, the project team needs to have a registered account in ELIXIR Luxembourg. They must sign that they have read and understood the AIMS-2-TRIALS data access information, procedure and policy.

Investigators need to be affiliated to a University, research institute, or registered company (and/or a professional body with a robust code of ethical conduct) to ensure compliance with European data security, ethical, and legal standards.

We strongly encourage researchers applying for access to AIMS-2-TRIALS data to work with lived experience experts, who should be indicated as affiliated to the Lead Investigator’s Institution (if they are not currently affiliated to a University, research institute, or registered company).

The project team must provide a project proposal that describes how they will use the data for research. This proposal must be ethically approved (or comply with relevant codes of conduct) and align with the AIMS-2-TRIALS Consortium Principles.

Project proposals are reviewed by the AIMS-2-TRIALS LEAP Project Review Committee (LEAP PRC). The LEAP PRC includes representatives of the autistic community (including autistic people, parents, and carers), AIMS-2-TRIALS project leads, and analysis experts relevant to the project proposal submitted.

We review proposals against the following checklist:

1. Must comply with participant informed consent wording
2. Must comply with each of our Consortium Principles (Beneficence, Inclusion/Engagement, Culture/Language, Minimising Risk) and language guidelines
3. Must have submitted proof of ethics approvals/code of conduct
4. Must have submitted a data management plan (how data will be stored/used)
5. Must have clear and specific aims
6. Must detail analysis plan clearly
7. Must be within the scope of one scientific paper
8. Must make a unique contribution to science

Data are only available to researchers beyond the AIMS-2-TRIALS Consortium from participants who explicitly consented to this.

The AIMS-2-TRIALS LEAP Project Review Committee (who review project proposals) also check that the project proposal is in line with the research themes that participants consented for their data to be used for in the original consent forms.

Researchers applying for access to AIMS-2-TRIALS data must submit proof of ethics approvals (and/or relevant codes of conduct) and data management plan for their project proposal and consider the ethical implications of their project (in consideration of the AIMS-2-TRIALS Consortium Principles).

When you took part in the LEAP study, we asked you (or your parent where appropriate, for instance, if you were a minor at the time) about your consent preferences for different parts of the study. If you were a minor and your parent consented on your behalf, but you have now turned 18 and wish to check/alter your consent preferences, please see the corresponding FAQs. Please note, if you are a LEAP participant from the Karolinska site, Sweden, you were not asked to provide consent for external data sharing and your data will not be included in the AIMS-2-TRIALS external database. 

One of these consent preferences was for data sharing with researchers within the AIMS Consortium (‘internal’ data sharing). This is done using our AIMS-2-TRIALS internal database OWEY, located in Paris, France. 

The other of these consent preferences was for data sharing with researchers beyond the AIMS Consortium (‘external’ data sharing). This is done using the AIMS-2-TRIALS external database on the ELIXIR Luxembourg node. Your data will only be shared via ELIXIR if you said ‘Yes’ to data sharing beyond the Consortium. If you said ‘No’ to data sharing beyond the Consortium, your data will not be shared via ELIXIR (even if you said ‘Yes’ to data sharing within the Consortium). 

If you wish to check your consent preferences, please contact your local research team (where you took part in the study):

London – eu-aims@kcl.ac.uk /info-compliance@kcl.ac.uk 

Cambridge – cambridgeleap@medschl.cam.ac.uk in the first instance or dpo@admin.cam.ac.uk 

Nijmegen – aims.leap3@gmail.com  /gegevensbescherming@radboudumc.nl 

Mannheim ZI_AIMS2trials_Team@zi-mannheim.de/ datenschutzbeauftragter@zi-mannheim.de  

If you participated in Rome, or Utrecht your data will not, at present, be shared with the external database (if you have any questions, please contact your local research team where you took part in the study). We will update this page with any updates on data sharing from the different study sites. 

If you participated in Karolinska, you were not asked to consent to this and your data will not be shared in this way at any time.

If you wish to change your consent preferences, please contact your local research team (where you took part in the study):

London – eu-aims@kcl.ac.uk/info-compliance@kcl.ac.uk

Cambridge – cambridgeleap@medschl.cam.ac.uk in the first instance or dpo@admin.cam.ac.uk

Nijmegen – aims.leap3@gmail.com /gegevensbescherming@radboudumc.nl

Mannheim – ZI_AIMS2trials_Team@zi-mannheim.de/datenschutzbeauftragter@zi-mannheim.de

Please note that it will not be possible to withdraw your data from projects that have already taken place. For example, if a researcher has already completed a project that included your data, they will not be able to remove your data from that project. 

Of course! If you no longer wish for your data to be shared, you can withdraw your data from the external database at any time. You do not have to give us a reason. 

This will not affect your medical care or legal rights in any way. It will also not affect your right for travel reimbursement and participant payment up until that point. 

Please be aware that, at this time, withdrawal of your data will be for all future projects (rather than on a project by project basis). However, you can also opt back into external data sharing at any time. 

Please note that it will not be possible to withdraw your data from projects that have already taken place. For example, if a researcher has already completed a project that included your data, they will not be able to remove your data from that project.