AIMS-2-TRIALS has released the first dataset to the autism research community, marking a significant milestone for the project.This follows a collaborative effort between AIMS-2-TRIALS researchers and autism community members with the data sharing platform ELIXIR to developdata sharing plans, procedures and documentationto ensure ethical and data security due diligence. Researchers external to the AIMS-2-TRIALS consortium who wish to access the data may submit requests for consideration by the project review board.
This focus on collaborative development of data sharing plans with the community has not only led to practical solutions for data sharing but also a broader consideration and discussion on community priorities for ethical data sharing.
Dr Beth Oakley, Lecturer in Neurodevelopmental sciences and AIMS-2-TRIALS Scientific co-ordinator, said:
‘It has been a privilege to learn from, and work with, AIMS-2-TRIALS A-Reps colleagues in launching AIMS-2-TRIALS data via ELIXIR Luxembourg. Data sharing, particularly in autism research, is an incredibly sensitive area. It has been of utmost importance to design a rigorous data access process that prioritises community concerns and preferences and is delivered to the highest ethical standards. This would not have been possible without community input.’
What data does this include?
This includes data from the first and second timepoints of the AIMS Longitudinal European Autism Project (LEAP). LEAP includes data from autistic and non-autistic children/young people and adults (6-30 years of age at the first timepoint) collected over approximately 4 years between 2014 and 2017. The data includes pre-processed or summary data from MRI, eye tracking, EEG, questionnaire data, coded interview data, cognitive task, and genetics data collected from research sites in the UK, the Netherlands and Germany.
More details on this project can be found on our website and in our LEAP leaflet.
Where is the data being hosted?
The AIMS-2-TRIALS external database is hosted on a platform called ELIXIR. ELIXIR’s own goal is to make life science data easier to find, share, put together, and analyse. 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.
How can researchers apply for access to the data?
Researchers can apply for access to the data via ELIXIR’s platform by filling out a project proposal form including details of the requested measures, importance of the proposed project, planned statistics and data management plan and how the proposed research fits with the consortium’s ethical principles. Details of the application process can be found on the ELIXIR website.
How have we considered the ethics of data sharing and involved community perspectives?
It is vital that data sharing is carried out with due consideration of the ethics and privacy of research participants, as well as considering the implications for the wider autism community. Steps have and will be taken to ensure these critical issues are addressed. This includes autism community consultation, development of data access policies and consortium principles, and a review committee with both scientific and community representation.
AIMS-2-TRIALS autistic representatives (A-Reps) have been involved in the planning process through a dedicated data sharing working group, including advising on key ethical considerations around data sharing, reviewing and editing our data sharing policies/procedures. A-Reps are a group of autistic people and parents/carers of autistic people who have worked with AIMS-2-TRIALS researchers across the course of the grant to consult and input into the project. Working with autism community members to develop our data sharing plans has been key to understanding and addressing issues of importance to the community surrounding these endeavours (e.g. unethical or unintended use, data security, biased data interpretation). More details on this process can be found in our FAQs.
Our A-Reps shared their experiences throughout this process:
‘Having A-Reps input on the data sharing plans and procedures via a dedicated data sharing working group has been essential to help ensure that ethical safeguards are implemented to protect autistic participant’s study data.’
Sarah Douglas, AIMS-2-TRIALS A-Rep
‘Since the beginning of the project, the involvement of the A-reps has played an important role in shaping the direction of the work. This collaboration has helped ensure that the data sharing approach is practical, relevant, and built around the real needs of the autism community.’
How proposals will be reviewed?
For each external project proposal request that AIMS-2-TRIALS receives, the LEAP Project Review Committee will review to decide if the data can be shared. The review committee for project proposals includes A-Rep members and researchers from the AIMS-2-TRIALS consortium. Review by the committee will include a check that each project proposal is in line with the research themes that participants originally consented to. Reviewers will also consider the content of the proposal to ensure it meets the consortium’s ethical principles (Beneficence, Inclusion/Engagement, Culture/Language, Minimising Risk), as well as ensuring the scientific validity of projects.
What safeguards will be in place when researchers access the data?
Researchers applying for access to AIMS-2-TRIALS data will need to submit proof of ethics approvals (and/or relevant codes of conduct), a data management plan for their project proposal and consider the ethical implications of their project. Researchers who wish to access AIMS-2-TRIALS data will also need to confirm that they have read, understood, and acknowledged our data access policy/procedure.
AIMS-2-TRIALS data will only be shared in the manner participants have agreed to, including the sharing of data beyond the AIMS-2-TRIALS consortium. If participants wish to change their data sharing preferences, they are free to do so at any time. To protect participant privacy, secure identification codes were assigned to each individual’s data. All study assessments use these codes, rather than names or any other personal identifiers. The ELIXIR platform also uses two factor authentication for those accessing the data, as an additional layer of security.
Further information:
For more information on general data access, please see this website page: Protected: Data Sharing
For more information on data access if you were a participant, please see this website page: Protected: Data Access: Participant
For more information on the LEAP project, please see this website page: LEAP project page
Image: Network People by ktsimage from Getty Images via Canva.com
