The two consent forms are part of the latest batch of documents released by Medway NHS Foundation Trust, as part of their ongoing response to a Freedom of Information request by Liam O’Dell.
After reading the information sheet for adult participants, those interested in taking part in Spectrum 10K – which looks to “investigate the genetic and environmental factors that contribute to autism and related physical and mental health conditions” – are required to complete a consent form confirming they have “had the opportunity to consider the information, ask questions and have had these answered satisfactorily”.
The consent form also stresses that participants are “free to withdraw at any time without giving any reason, without my medical care or legal rights being affected” and that personal details and contact details can be “stored long-term on a secure database” for the Spectrum 10K study team to use to contact them.
The duration of “long-term” access is not made clear in the document.
An individual’s NHS number and date of birth will be shared with national organisations like NHS Digital in England and eDRIS in Scotland, which “may be used to provide information about my health status, care and treatment for autism (if applicable) and other health conditions relevant to this research”.
Potential participants are asked to give permission for “authorised individuals” from Spectrum 10K to access, analyse and store medical and health-related records “long-term”. Medical notes and data collected may also be seen by staff from the University of Cambridge, Cambridge and Peterborough Foundation Trust (CPFT), regulatory authorities or the applicable NHS Trust “where it is relevant to my taking part in this research”, the form goes on to add.
Individuals interested in the study may also be contacted by Spectrum 10K to take part in other studies being carried out at the Autism Research Centre in Cambridge, based on the person’s “questionnaire, clinical or genetic information”.
DNA from participants will be “stored anonymously [and] long-term for analysis, which may include the reading of the entire genetic code”, and copies of the consent form will be given to the participant, kept in their medical notes and stored in a file at the NHS research site they attended.
Meanwhile, the form for children to assent – a process separate to consent, which they are not legally empowered to give – asks them four questions: “have you asked any questions you would like to”; “have you had your questions answered so you understand”; “do you understand what this project is about” and “are you happy to take part”.
If the child answers ‘no’ to any of the four questions, they are told not to sign their name. Children who are happy to take part must write their name on the form and obtain the signature of their parent or legal guardian.
The Spectrum 10K team has previously told Liam O’Dell that they are unable to provide press comments until 4 January 2022.
By Liam O’Dell. Liam is a Deaf, dyspraxic and autistic freelance journalist and campaigner. This report is the latest in his series ‘The Spectrum 10K Files’.
Read the previous articles in this series below:
- Researchers hope knowledge from DNA study will lead to ‘improvements in autism’
- Health official slammed ‘messy’ ethics application from controversial autism DNA study
- Autism study ‘did not open’ at NHS hospital while project was paused, trust says
- Researchers warn NHS Trust not to respond to Twitter ‘trolls’ criticising autism DNA study
- Team is ‘welcoming and respectful of all autistic people’, researchers say
- Research committee asks for ‘further information’ about study following complaints
- Health Research Authority’s request for further information about autism study revealed
- Controversial autism study considered £10,000 ‘prize draw’ to encourage participants
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