The letter to Spectrum 10K researchers, obtained by Liam O’Dell on Monday, comes after the watchdog confirmed that it had finished reviewing the “significant amount” of feedback about the study.
In an update sent on Friday, a HRA spokesperson said: “The HRA and the REC [Research Ethics Committee] have reflected on the ethics opinion issued to the study in June 2020. Whilst the original opinion […] still stands, some of the issues raised as part of the complaints process could have been considered during the original review.
“For now, the further information requested from the study team is important to facilitate progression of the research.”
After asking for a list of the requested information last week, this website has now received a copy of the correspondence sent to Spectrum 10K researchers on 26 November.
While the favourable opinion of the REC remains in place, the HRA write that it “may review” the opinion “in the light of concerns raised” where they present “new information not originally considered” by the REC – such as social or scientific value; safety or integrity risks to participants; the study’s feasibility; the adequacy of the site or facilities and the “competence or conduct” of the study’s sponsor or investigators.
As part of its request for further information, the regulator asked for additional details on assessing capacity among adult participants and questioned whether adults lacking capacity needed to be included in the research.
“The Committee agreed that there was currently no way of confirming that the participants had been accurately assessed for capacity or whether the personal consultee was sufficiently familiar with the participant. Therefore, it would be preferable if assessments of capacity by professionally trained individuals could be conducted,” it reads.
The REC also asked for clarification as to whether researchers still feel they need 10,000 participants to “answer the research question” of the study, and whether “this was achievable”.
On participant safety, the committee requested changes to informed consent documents to “detail the potential for participants becoming distressed”, support organisations they can contact and measures they’ll take if an individual’s safety is “at risk”.
The REC also pointed out that while the study’s application referenced research data being anonymised, the option for participants to withdraw from the project with “no future use of the samples” taking place means they “would not be considered fully anonymised”.
Other comments made include participant documents not being “sufficiently clear” for readers to “fully understand” what the requested data might be used for when it comes to “optional future uses”, and there appearing to be “no means for researchers to confirm that participants had been diagnosed with autism”.
The REC also referred to a letter sent last month which asked for more information about the study, including how researchers were investigating “allegations that ambassadors have used racist and transphobic language”.
Amid concerns over the study team’s stance on trans issues, a spokesperson told Liam O’Dell earlier this month: “The Spectrum 10K team is welcoming and respectful of all autistic people, including those who are transgender.”
The committee also wrote: “Please can you advise us whether there are any members of the study team who have: published opinions or are conducting research that conflicts with the stated aims of the study; links to the development of Applied Behaviour Analysis (ABA), Cure Autism Now or Autism Speaks.”
ABA, a proposed treatment for autism which focuses on changing a person’s behaviour – has been criticised by autistic activists and researchers, with one academic paper saying it “continues to neglect the structure [of] the autistic brain”.
“[It neglects] the overstimulation of the autistic brain, the trajectory of child development, or the complex nature of human psychology, as all of these factors were ignored in the response and are ignored in ABA practice itself.
“Providing a treatment that causes pain in exchange for no benefit, even if unknowingly, is tantamount to torture and violates the most basic requirement of any therapy, to do no harm,” the article, published in April, reads.
Meanwhile, Cure Autism Now was an organisation which, in 2007, merged with Autism Speaks – an American charity which has been branded a “hate group” by autistic advocates. It removed its support for funding research into the “prevention” of autism and a “possible cure” from its mission statement in 2016.
- Related: Research committee asks for ‘further information’ about Spectrum 10K study following complaints
According to Spectrum News, Spectrum 10K’s co-principal investigator Daniel Geschwind was the first chair of Cure Autism Now’s scientific review committee.
When approached by indy100 for a comment on his involvement with the organisation, Dr Geschwind said: “Cure Autism Now (CAN) was founded by parents of children with autism in the late 90s to fund research and bring attention to autism. CAN was acquired by Autism Speaks and has not existed for over 10 years.”
The final ask outstanding from the REC’s October letter related to several requests for comment on concerns raised with them – including that it is not clear “who future collaborators may be” or “why the collection of DNA is required to accomplish the aims of the trial” around improving autistic people’s wellbeing.
Liam O’Dell has contacted the Spectrum 10K team for comment and the full letter from the Health Research Authority can be viewed below.
Update – 01/12/2021 – 13:15: In response to a request for comment, a Spectrum 10K spokesperson said: “We have only received this letter ourselves in the last few days and are working through our responses.
“We will not be able to comment further until our responses are complete.”
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
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