The ethics application feedback for the controversial Spectrum10k study make for an extremely interesting read.
Regular readers of my articles will know that I like to platform the words of others. The author of this piece is a colleague in the BoycottSpectrum10K team and one of many who contributed to this open statement regarding the Spectrum10K study and has written this piece on the Spectrum10K ethics.
To find out more about the Spectrum10K Study and it’s lead protagonist, Sir Professor Simon Baron-Cohen please visit my most recent article ‘Spectrum10K, Autism, Autistic people and the controversy of SBC‘
By Katie Munday
For those of you not already in the know, Spectrum10k is a large-scale study being conducted by the Autism Research Centre at the University of Cambridge in collaboration with the Wellcome Sanger Institute and the University of California. Spectrum 10k aims to collect and analyse questionnaires, medical records and DNA samples from 10,000 Autistic people (and their family members) in the UK.
The Autistic communities’ concerns over this study have been well documented, however there are new concerns over the ethics application of Spectrum 10K and, as an Autistic autism researcher, I would like to explore them.
The document I refer to throughout this piece is the Minutes of the meeting of the London – Queen Square Research Ethics Committee, which was held on 18 June 2020 at 5:00 pm, via Zoom and which was obtained through a freedom of information request.
The ethics committee minutes goes on for 17 pages, showing that a considerable amount of time was spent reflecting on the original ethics application before it was denied. An unfavourable opinion from an ethics committee seems rather odd for a team of ‘experts’ with well over 100 years’ worth of experience. Stranger still are some of the decisions they made as well as the gaping holes in their safeguarding policies and procedures.
The first and most confusing issue for me is the ever-changing participant numbers. On page 8, the ethics committee, quoting the original ethics application, write that the researchers aim to recruit “at least 10,000 autistic individuals…[and] where possible, up to their third-degree relatives (so in total up to 40,000 individuals).” The committee asked for clarification of the final sample size as the application mentioned using both 10,000 and 100,000 participants.
Why is this worrying? Final recruitment numbers are still unclear, even after two rounds of ethics applications and several statements from Spectrum10K. This vagueness shows a lack of direction and a slap-dash approach, not quite the organisational skills I would like from a study which wants to harvest my DNA.
Pairing this approach with unclear study aims makes me more tense – do Spectrum10K want to know about environmental and genetic factors of autism? Our wellbeing? How Covid-19 protocols has affected us? Or whether we have ‘co-morbid’ conditions? Apparently, all these aims would do nicely.
Bizarrely, despite continued proclamations of the need for DNA to understand co-occurring conditions, Spectrum10K have no intention of feeding back medical information to participants. They have stated that telling participants “about a condition they can do nothing about is potentially more distressing and burdensome than not giving them any feedback” (p.11). In other words, Spectrum10K are in no way concerned about co-occurring conditions and would much rather wrongly assume that all conditions need to have medical interventions.
Paradoxically, work on co-occurring conditions, or any of the other aims, could make for large-scale study which, if done appropriately, could be incredibly useful to Autistic people and our communities. Alas, that is not the intentions of Spectrum10K.
Vagueness continues to reign supreme as participants are frequently referred to as ‘consultees’ in the ethics application – perhaps the research itself is the “consultation period” which Simon Baron-Cohen keeps referring to? Consultation can and should be done throughout the course of any study however this needs to be based on a robust foundation of primary consultation with all stake holders (yes this does include Autistic people and not just our parents!) for it to add to strong ethical and research standards. Consulting during or after the study, whilst ignoring the many concerns Autistic people gave in writing before commencement, does not a consultation make.
The largest areas of improvement recommended by the research committee, were on mental capacity and assent. Research participants, and people in general, are protected by the Mental Capacity Act (2005), which states that decisions can only be made for those considered without capacity if it is in their best interests. Spectrum10K has made clear that participants do not gain anything from participation. So, can participants have assent given on their behalf if they have no mental capacity and there are no advantages to participating? It seems like this really shouldn’t be the case.
The ethical committee also asks whether those who do not have capacity to consent should be assumed to have capacity to complete the questionnaires. They were especially worried about the risk to vulnerable people when confronting with very distressing questions, specifically ones on sexual abuse. Vulnerable people are being asked very invasive questions which they are not given a clear choice to decline answering. These participants may also be put in very harmful positions if they are answering these questions alongside the person or persons who have abused them. The safeguarding concerns around these areas for me where not considered deeply enough on the original application or by the ethics committee themselves. Especially considering the higher rate of Autistic people experiencing domestic abuse and sexual abuse, substance abuse and filicide.
Worse than all of this, participants will not be removed from the study if they lose their capacity, unless it is specifically requested of the researchers. So those who lose capacity over the two-year recruitment period are not able to withdraw their consent and data, unless they have someone who can do it on their behalf? This again leaves the most vulnerable of our community in a very defenceless position.
The ethics committee did request additional information from Spectrum10K about mental capacity, but unfortunately I do not have access to this information (I will likely write about this once it becomes public knowledge). Additionally, the committee recommended that capacity was assessed on a regular basis throughout the study for all participants. Suggesting that this could be completed every three months once the process of assessing capacity was agreed. As this was a recommendation it would not need to be responded to or carried out by Spectrum10K before they commence the study. Such assessment would cost time and money which S10K have not accounted for and therefore it is unlikely this recommendation has been taken up.
Capacity is a huge factor in assent, which is always a difficult element of research, especially when recruiting vulnerable children and adults. Spectrum10K wanted to circumnavigate such issues by giving friends and relatives of the Autistic participant extraordinary powers to assent for them based on shared clinical tools. These tools, as the ethics committee rightly pointed out, are to be used by trained clinicians and would not be appropriate for families to use. Putting such accountability on parents and carers is rather worrying, especially as most are vulnerable themselves. Unfortunately, this is not unusual in parent-led research on Autistic children and adults, which do not centre the experiences of the Autistic person themselves.
More worryingly, these powers were also given to the direct care team of Autistic people in hospital or clinical environments. This is hugely unethical as Autistic and disabled people are often victims of abuse in such ‘care’ environments. This is incredibly ironic (in the most unfunny way) as physical and emotional abuse has been perpetrated by staff at Mendip House, which is run by the National Autistic Society, of which Simon Baron-Cohen is a Vice-President. I could easily write a whole blog on this one point alone.
(Intervention by Kieran, I have! Spectrum10K, Autism, Autistic people and the controversy of SBC)
The researchers at Spectrum10K did suggest that if participants and those assenting for them had any questions they were free to contact them in the first instance. We are all aware by now that emails sent to the key researchers and institutions are being ignored. Are questions only answered after we have signed our DNA, medical records and life experiences away?
Unfortunately, the insidiousness of abuse and stigma of Autistic people, embedded and reaffirmed in neurotypical-led autism research, is not being barred by ethics committees, and until such time, shall not be research which I can trust.
Katie Munday is studying a Masters in Research, gathering and sharing Transgender Autistic narratives. They also have started working as a Research Assistant, co-creating post-school pathways with Autistic people.
They coach wheelchair basketball and run social groups for Disabled children and also write for AIM for the Rainbow, a website which shares information and experiences to help LGTBQ+ Autistic children and adults.
You can find Katie’s work on Facebook and Twitter where they are known as ‘Autistic and Living the Dream’ and share information on Disability Rights issues and more general thoughts on being Weird, Queer and Autistic.
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