Newcastle University

• Child’s name, DOB & gender
• ASD diagnosis, age at diagnosis, and diagnosing clinician
• Additional diagnoses; e.g. ADHD, learning disability, dyslexia, dyspraxia, epilepsy
• Information about  child’s learning ability;  estimates of age equivalent of child’s ability
• Level of support required
• Left or right handed
• Speech & language, age at first speech
• Current school
• Emotional and behavioural issues
• Loss previously acquired skills (regression)
• Siblings with ASD, family history of ASD or behavioural rigidity (Broader Autism Phenotype)
• Social communication – as measured by the Social Communication Questionnaire

Applications are welcomed from any UK ASD researcher intending to undertake a high quality research project that aims to improve our understanding of ASD, and which may lead to significant advances in the care and treatment of children with ASD. UK researchers working in international collaborations on a research study can also recruit through the databases. Most applicants will have strong connections to the NHS or UK Universities, or will be commercial organisations.

All researchers wishing to recruit families from the Databases should initially contact us by email (asd-uk@ncl.ac.uk) to let us know you wish to make an application. We will then timetable your application to be reviewed at the next available Databases Research Committee meeting slot and ask you to send us the following at least two weeks before your allocated meeting:

• The study protocol, and evidence of peer review (we may ask you to arrange independent peer review if this has not been done previously)
• Information on how your research is funded – including an award letter if applicable
• The participant’s information sheet(s) (to include parent/carer’s, children’s and young person’s where applicable)
• Consent form(s)
• Questionnaires if applicable
• Anything else you would like us to send to families, e.g. email text or expression of interest form (this should include space for parents to provide you with their contact details) 
• A list of criteria for recruitment, e.g. number of participants you would like to recruit, geographical location, inclusion/exclusion criteria
• Evidence that ethical approval has been granted, or provide evidence this is not necessary
• A letter confirming sponsorship of the research (i.e. which organisation will take overall responsibility for conduct of the research, governance, and insurance)

The Databases are committed to supporting high quality research and providing families with appropriate research materials.

Criteria for research likely to be approved include:

• Relevance and importance for individuals with ASD and their families
• Originality
• Scientific value
• Good design
• Feasible, i.e., can be completed within the timescale
• Evidence of appropriate costing/funding
• Likely to have positive impact

Your application documents will be reviewed by the Database Research Committee, which includes experienced professionals, researchers and parents. We will give you the opportunity to provide further information to the Database Research Committee via a short Skype or telephone call during the meeting where possible. We will then contact you within four weeks of receipt of the study documentation to let you know whether your application has been successful and if so, discuss the practicalities of helping with recruitment. As would be expected from our aims, most applications to recruit through the Databases are supported. Where an application lead is a member of the Research Committee, that individual will not be involved in the discussions.

ASD-UK/Daslⁿe are mindful of not overloading families with research requests. In principle, the same family will not be approached about more than one project at a time – this approach is overseen by our Parent and Steering committees. Thus it is possible that some research studies may be delayed in starting recruitment. We now hold a list of applications to recruit to ASD-UK – if you would like to approach us about a certain project and register your interest to recruit, while seeking funding, we are happy to hear from you. The list of recruitment applications is held by the ASD-UK leads, and is subject to independent oversight by the Steering Committee chair. As the list contains researchers’ private Intellectual Property, its content will not be discussed with researchers. Where multiple groups wish to contact ASD-UK families about the same or very similar project, the first applicant to the database will have first opportunity to conduct their project – this process is overseen by the independent Steering Committee Chair.

The research committee gives feedback to researchers, and here are some pointers in advance that may help your application go through smoothly.

• Think about the child participants. What do they need to know about the study? What information will help the parents prepare them for taking part?
• Child information sheets should be written at levels suitable for the target age group(s). It usually is helpful to include illustrations or photographs. Children up to the age of 8 should give assent, and 8 years and older give consent.
• Give your study a simple title, and possibly a logo, to enhance its appeal.
• Consult the Health Research Authority guidance on writing consent forms and information sheets (http://www.hra-decisiontools.org.uk/consent/examples.html). If your study is complex, also create a summary sheet (or introductory letter to potential participants) to get over the main points.
• Say how long the tasks in your study will take and where they will take place.
• Clarify what information will be fed back to families (individually, or as a group) and when.
• Mention payment of travel expenses where appropriate.
• Get feedback from some parents and/or children to find out what is clear and not clear about your information sheets and consent/assent forms.
• Please note the Databases will not support requests or opportunities for researchers to add participants to their own recruitment databases following participation in a study.

Discussions with senior UK clinicians and researchers during the pilot phase of ASD-UK showed there is broad agreement that there should be a modest cost for recruitment through the Databases.

The costs of reviewing your initial documentation are covered by the Databases through grant funding from Autistica, and through Newcastle University. Autistica and Newcastle University also fund some of the staff time needed to perform relevant data searches about which families to contact, and time spent contacting and reminding families; there is therefore an expectation that some of the work is funded by a researcher contribution. The Database team staff time costs ranges from £250 to a maximum of £950; most projects will cost us between £250 and £600 on staff time (excl. VAT). This range of costs was calculated by working out the actual staff time required to administer previous projects supported by the Databases. ASD-UK and Daslⁿe will only charge you for the number of staff hours we need to spend on your project – we will let you an exact figure when we have reviewed your application.

Here are some of the tasks the Database team needs to do to support your application: Prepare our covering letter to go with your materials or emails; complete searches for Database families who meet your criteria and who haven’t been contacted about another project very recently; prepare envelopes, contact families; record on our database who has participated; send reminders to non responders; complete final participation data on our database; receive and edit your project summary.

We suggest that researchers apply for the funds needed to recruit through the Databases when making research funding applications; this has been done successfully by a number of research groups. To help you, we are happy to have discussions around your project and likely costs before you submit your funding application.

Please note that we are only able to generate an invoice if a purchase order is provided. Payment can alternatively be made by card or bank transfer.

Yes, we welcome approaches from commercial organisations. The research Databases are funded through grants from the research charity Autistica and by Newcastle University, and receives support from NHS sites and voluntary sector organisations regarding recruitment. The Databases will therefore support research recruitment to publicly funded research at 'cost', but recruitment for commercial organisations will cost more. We are happy to discuss with commercial organisations how the Databases can support research and development, and recruitment to studies, and the costs associated with that. In addition, some companies may wish to commission the ASD-UK/Daslⁿe team to undertake surveys and consultation about research. We will be very happy to discuss this with organisations on an individual basis.

Finally, any potential projects led by companies will be reviewed by a Database research committee in the usual way; if peer review is needed, we will arrange this and let you know the associated cost. Where there are any concerns about conflict of interest, the Database Steering Committee will be consulted.

We will ask you for a short lay summary (100-200 words) about your project, and we will put this on the ASD-UK/Daslⁿe websites. Please use language that is as non-technical and engaging as possible to help recruitment.

By using our core dataset about children, the Databases team will identify families who meet study criteria. You will be asked to supply us with everything needed to contact parents about your study:

•  For anonymous online surveys or questionnaires, you should send us the link to the final version of your survey and the text of an email you’d like us to send to families.
• Where you would like us to contact families by post, researchers will be asked to supply the Databases team with information packs about their study. These information packs should include all project information sheets. We recommend that you also include an expression of interest form (or consent form where appropriate) with space for families to provide their contact details and a stamped addressed return envelope with your research team name and address. Alternatively, you should include contact details for your research team that families can use to express their interest. These should be sent to us in blank, unsealed envelopes with sufficient postage attached taking into account the size and weight of the envelope and content. The Databases team will then enclose a covering letter from ASD-UK/Daslⁿe encouraging families to consider taking part, attach address labels and post the study information to the families.

For all studies, the first contact with the family will be made through the Databases team - we are unable to provide you with names and addresses of families contacted. Families who are interested in taking part in a study will then return the expression of interest form directly to your research team, or contact you by phone or email, and you would then recruit them according to your study protocol.

If your protocol involves collecting data from families who give you their name and contact details, you then need to let us know which families have participated. After an agreed interval (usually around 4 weeks) we will send a reminder to families you have not heard from.

Researchers will be required to provide a summary of the findings on completion/publication of the study. This information will be posted on our website and may be included in our biannual newsletter.

Yes. ASD-UK and Daslⁿe are undertaking a number of initiatives to make research participation 'family friendly', and use data most effectively. These are all aimed at reducing the time children and parents spend on research (including having the same assessments many times), making data collection easier for researchers, and providing the ASD research community for opportunities for best use of data in the future.

• If you would like us to share Database data with you about the child/family (for example, SCQ score), you would need to get their consent for us to do that – we will send you a consent form for this on request, or wording to add to your consent form. Without that, we cannot share data about an individual family/child. You can find out the types of data we collect from families here.

• You are required to inform the ASD-UK team about which families are taking part, so that the families’ participation can be recorded on the database. This means that family might not be contacted by us about another study in the near future.

• In order to keep our core dataset up to date, we may ask you to provide us with some of the data on the children, young people or families that you have collected from during your research. When we know what you will be collecting, we will request a list of your data items on which we will request data sharing, a consent form for parents about this, and a standard data format file. By gathering up to date information, this helps us contact the right families for the right studies in the future – helping families to hear about the projects that are most relevant to them, and helping other UK researchers.

• If you perform standardised ASD or other commonly used assessments (e.g. ADI-R, ADOS, cognitive assessment), we may ask you for copies of individual data from those assessments so that we can share these with researchers who might recruit the family in the future. We will provide you with a list of Database data items on which we will request data sharing, a consent form for parents about this, and a standard data format file. By gathering data about some measures you have used with a named family, this means there will be additional data analysis opportunities for you and other researchers in the future. By doing this the Databases are providing opportunities that may not have been available previously to bring data together, and add value to your research and that of others through data analysis projects that you can participate in. 

On completion of your project we would like you to provide a lay summary of your main research findings, their impact, and importance for children and families. This can link to any research papers that are open access or other dissemination sites.

We would be grateful if your research publications could mention ASD-UK and/or Daslⁿe in the research methods and acknowledge the Database's role in recruitment, and our funder, Autistica. Standard paragraphs for this are pasted below:

For the methods section of your paper/presentations: 'Recruitment was through the Autism Spectrum Database-UK (www.ASD-UK.com) and/or Database of Children with ASD Living in the North East (www.daslne.org). Families whose children met the study criteria were initially sent information about the study by email or letter, and reminders were sent to non-responders.'

For the acknowledgements section of research papers/presentations: 'We are grateful to the Autism Spectrum Database-UK team (www.ASD-UK.com) and/or Database of Children with ASD Living in the North East (www.daslne.org) for assistance with recruitment. ASD-UK/Daslⁿe is funded by the UK autism research charity Autistica.'

Yes. The Database team are committed to providing data to researchers where publication will advance our knowledge about ASD, or lead to high quality research projects being funded. A list of data that we have gathered is available here

ASD-UK and Daslⁿe have clearly stated to parents that identifiable data will never be released to anyone else (without them consenting to do so). ASD-UK and Daslⁿe Steering Committee parents have previously supported the sharing of anonymous data given by parents where their use may advance our knowledge about ASD.

Researchers connected to a UK University or NHS Trust can apply to receive a defined amount of anonymous data by completing this Data Management Form. UK researchers working in international collaborations on a research study can also receive data. The application will be reviewed in the usual way by a Database research committee; if the application is successful a data sharing agreement will be required between you and the Database leads. Due to our staff time in preparing data a data file and ensuring no families could be identified through the data, funding will be required to pay for staff time. The staff time costs range from £250 to a maximum of £950; most projects will cost us between £250 and £600 on staff time (excl. VAT). The Database team will only charge you for the number of staff hours we need to spend on your project – we will let you an exact figure when we have reviewed your application.

Here are some of the tasks the Database team needs to do to make your dataset ready for sending: Prepare the data sharing agreement; search for and extract relevant data from the database; complete anonymisation of the data (both simple and complex– for example, some families could potentially be identified through relatively uncommon combinations of characteristics).

Whilst it is not a requirement, we hope most applicants will want to conduct data analysis with a degree of collaboration from us.

Over the last 10 years, we have learnt a lot about how the databases can best support researchers. We have made changes to our processes following feedback from researchers and parents. If you have suggestions about the processes around recruiting from the Databases, please email asd-uk@ncl.ac.uk.