Spectrum 10K: Health official slammed ‘messy’ ethics application from controversial autism DNA study

The email is one of several new documents – released under the Freedom of Information Act – which have been obtained by Liam O’Dell.

The message, disclosed by the Health Research Authority under the legislation, came after Spectrum 10K applied to the Scotland A-REC (Research Ethics Committee) for approval to carry out the research.

The committee, along with the London Queens Square research committee, both went on to grant permission for the University of Cambridge-led study to go ahead.

However, in an email, one health official wrote: “To be honest this is a little bit of a messy [sic] of an application. To me they are creating a registry/DNA bank of a vulnerable group ‐ not sure it should have gone through as basic science.”

The collection of documents – requested by PhD student Adam Roberts – also contained one detailing “key messages” about the study.

“Autism runs in families. Thousands of genes contribute to the likelihood of autism. So far, only a fraction of these genes have been identified and all of them need to be identified to understand autism,” the researchers wrote.

Another explanation of the project, revealed in an earlier draft of Spectrum 10K’s easy read information sheet, stated that “sometimes”, part of a person’s genes can “get lost or changed”.

“We think that this may explain why some people have problems with their physical and mental health. If we know more about genes, we may be able to help autistic people live happy lives,” it reads.

Elsewhere, other information disclosed through Freedom of Information requests found that Spectrum 10K researchers had received a £3,182,054 grant from the Wellcome Collaborative Award – of which £1,172,333 were for salaries.

Following an outcry from autistic advocates online, the study was paused in September pending a consultation, though an “additional risks” section of the protocol for Spectrum 10K explained what would happen if a low number of participants were recruited onto the project – something the researchers considered a “medium” risk.

Writing that this would “reduce the statistical power”, the study team said they had come up with seven different “strategies” when it came to recruitment.

“This includes targeted recruitment strategies through NHS child development centres, other autism assessment centres, special education needs schools, and more global recruitment strategy through a dedicated PR campaign.

“Each of these methods has been discussed with local paediatricians, support groups, and PR agencies.

“Further, we will recruit participants into the study for the entirety of the four-year period of the grant, with the initial set of analyses focussing on individuals recruited in the first three years,” they said.

The team then went on to add that they believe the approach would help them meet their 10,000 participant target, but if they hadn’t reached the milestone by the fourth year of the project, then they would use two methods.

“We will: 1. Run a second PR campaign to boost numbers; 2. Recruit from outside the UK (in Europe) using the network of research collaborators as a part of the AIMS-2-TRIALS initiative (at no extra cost to the Wellcome Trust),” they said.

It is not known when the consultation will be carried out by Spectrum 10K researchers, but the team said in their September statement that the process could take “several months”.

The latest disclosure of documents related to the controversial study comes after Liam O’Dell published correspondence between the project and the Health Research Authority earlier this month, with researchers saying that they hope the findings will lead to “improvements in autism”.

Update – 18/10/22: After approaching the Health Research Authority (HRA) this week for comment, a spokesperson told Liam O’Dell: “The use of the word ‘messy’ did not refer to the Spectrum 10K study. It was used in an email between staff to refer to the complexities of managing the review of studies involving adults lacking capacity to consent for themselves which take place in both Scotland and England.

“Separate reviews are currently needed due to the different legislation in these two nations. The choice of words reflects the opportunity to improve and streamline processes for research projects which require approval under both the Mental Capacity Act 2005 (which applies in England and Wales) and the Adults with Incapacity (Scotland) Act 2000.”

When asked what the comment around “basic science” related to, the HRA declined to comment further but said it was “not unusual for staff to discuss applications between themselves”.


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