If you’re considering getting involved in the controversial Spectrum 10K research project you need to know what the researchers have signed up to, not just the marketing material appearing on the project’s website.
I have now received that document, eleven months and three days after having asked Simon Baron-Cohen for it. It took a further two freedom of information requests to the University of Cambridge, one review by the University’s Information Compliance Office and a decision notice by the Information Commissioner’s Office. The University of Cambridge eventually complied:
As a result of that Decision Notice, we hereby attach new versions of the information with very limited redactions in accordance with the Notice.
Here is the 97-page Spectrum 10K research application (PDF 3.6 MB) document. (You can also check the 48-page pre-submission version (PDF 11.9 MB).)
This version now includes the names and details of the researchers, the letters in support of this application, the list of biobanks involved in Genome-wide association studies (GWAS) and much more that Simon Baron-Cohen and the University of Cambridge tried to hide for reasons unknown.
Contrast Spectrum 10K’s aims and objectives as listed on p. 27 of the application:
Objective: To accelerate gene-discovery, genetic stratification, and biomarker identification in autism. Aims:
- To recruit 10,000 autistic individuals from the UK and where possible, their families;
- Where possible, to deeply-phenotype the 10,000 autistic individual (UK Autism Biobank), link to Electronic Health Records (EHRs), and provide a rich resource for gene discovery and recall-by-genotype studies in autism;
- To conduct a GWAS [Genome-wide association studies] and CNV [Copy number variation] meta-analysis of 100,000 autistic individuals with data collected from the UK (10K), the US (SPARK, N = 50K), Australia (N = 10K), the iPSYCH and Psychiatric Genomics Consortium (N = 20K), the Autism Sequencing Consortium (5K) and other cohorts (5K) (Autism meta-analysis);
- To conduct a parallel GWAS of autistic traits (250,000, UK Biobank, and other sources), and conduct a multi-trait GWAS of autism and autistic traits;
- To perform fine-mapping of significant loci and identify functional genes by integrating gene expression (e.g., integration of human cell atlas and BRAIN initiative databases), meQTL, eQTL and chromatin interactions data from neural tissues;
- To investigate how polygenic scores for autism alter normative developmental trajectories, and brain structure and function in adolescents and adults;
- To investigate if polygenic scores can identify sources of heterogeneity based on sex, IQ, social and non-social domains of autism, and related co-morbidities;
- To identify modifiable risk factors for autism using Mendelian Randomization and related methods.
with the short description on Spectrum 10K’s website About page:
Spectrum 10K aims to investigate the genetic and environmental factors that contribute to autism and related physical and mental health conditions to better understand wellbeing in autistic people and their families.
and the slightly longer one on the website’s FAQ page:
Spectrum 10K is a research study of 10,000 autistic individuals and their immediate families. It aims to investigate biological and environmental factors that contribute to autism and common physical and mental health conditions for autistic people, such as gastrointestinal problems, epilepsy, anxiety and depression. For this, we would like to obtain a saliva sample from all participants to extract their DNA and study their genetics. We also want to collect information about social circumstances, such as employment status, education, vulnerability, autistic traits, and wellbeing and physical and mental health conditions through questionnaires and links to electronic health records. Taking part in Spectrum 10K is entirely voluntary.
Among the more concerning outcomes, which can help pre-natal testing and lead to eugenics, we can read:
We will investigate the biological correlates of autism: which tissues, gene-sets, cell types, and developmental periods are enriched for common genetic risk for autism. We will further investigate heritability across subtypes, sex-specific effects, and effects of social and non-social domains of autism.
And anyone still considering participating should be aware that their DNA and health information might be shared further:
Access to data and code. This includes both summary statistics of the full GWAS which will be made openly available to all researchers, and individual level data of the UK Autism Biobank, which will be available after a short application process.
Bootnotes
Spectrum 10K (S10K) claims to be ‘the largest study of autism in the UK’. Many autists have had serious concerns about this project. It has published a promotional website, but not the detailed grant agreement so details are unclear. I tried to shine some light by initially requesting the grant agreement from Simon Baron-Cohen by email on 2021-09-12:
There’s so much about S10K that is being uncovered by Autists independent of S10K. It’s a real shame that no lesson seems to have been learnt from AIMS-2-Trial [the EU Autism Innovative Medicine Studies-2-Trials project].
A concrete practical simple initial step you could take that would demonstrate increased transparency would be to publish the full S10K grant agreement as this would give a context for any future engagement around S10K.
Also this would demonstrate a change from when you initiated a chain reaction, when you learnt that I had published the AIMS-2-Trials grant agreement (still available on my website - and as far as I know nowhere else), that resulted in IMI [Innovative Medicines Initiative 2 Joint Undertaking] sending me threatening requests to take down the grant agreement before they eventually agreed with letting me keep publishing it although with redactions including of the ethics chapter (oh the irony).
As Simon didn’t respond, I sent a Freedom of Information (FoI) request to the University of Cambridge on 2021-09-27 and a follow-up request on 2021-10-18. Unfortunately the University of Cambridge sent only a few extensively redacted documents and rejected my request to review these redactions. This led me to complain to the Information Commissioner’s Office (ICO) on 2022-01-14. The ICO eventually assigned a case officer on 2022-09-05 who, after having concluded an investigation, has just issued a decision notice, copied below. The ICO found that the University of Cambridge must ‘[d]isclose copies of all the information it has withheld [...] within 35 calendar days’. So by November 23rd we should eventually have some more transparency on what the researchers involved agreed to and which organisations supported that agenda.
Bootnote: for a lot more information on Spectrum 10K, I recommend Liam O’Dell’s excellent investigative work that is published on his website.
Freedom of Information Act 2000 (FOIA) Decision notice
Reference: IC-150303-X4F6
Date: 19 October 2022
Public Authority: The Council of the University of Cambridge
Address: The Old Schools
Trinity Lane
Cambridge
CB2 1TN
Complainant: Panda Mery
Address: panda@gizmonaut.net
Decision (including any steps ordered)
The complainant has requested information relating to an application for a research grant for the Spectrum 10k project. The Council of the University of Cambridge (“the University”) provided a redacted version of the information, but relied on section 22A (research) and section 40(2) of FOIA (third party personal data) to withhold some information.
The Commissioner’s decision is that section 22A of FOIA is engaged, but that the balance of the public interest favours disclosure. A small amount of the withheld information is exempt under section 40(2) of FOIA.
The Commissioner requires the University to take the following steps to ensure compliance with the legislation.
• Disclose, to the complainant, copies of all the information it has withheld. The University may react individual contact details.
The University must take these steps within 35 calendar days of the date of this decision notice [that is by November 23rd]. Failure to comply may result in the Commissioner making written certification of this fact to the High Court pursuant to section 54 of the Act and may be dealt with as a contempt of court.
Request and response
On 18 October 2021 the complainant requested information of the following description:
“The grant award letter for the 'Collaborative Award, ‘Common Variant Genetics of Autism and Autistic Traits (GWAS) Consortium’' project you sent in https://www.whatdotheyknow.com/request/f... mentions that it is based on the application made by the University of Cambridge to the Wellcome Trust. Please send all the documents held by Cambridge University which are held in relation to this application, including, but not limited, to all the documents sent by Cambridge University to the Welcome Trust for this award.”
On 11 November 2021, the University refused the request as the cost of compliance would exceed the appropriate limit. It explained that it would be able to provide a copy of the application, but that “there are several hundred, if not thousand [sic], documents within scope, many of which (e.g. drafts or emails held by various members of the project team) are not indexed or filed formally.”
On 12 November 2021, the complainant contacted the University again to refine their request:
“consider this as a request for all the documents held by Cambridge University in relation to the application for the 'Collaborative Award, ‘Common Variant Genetics of Autism and Autistic Traits (GWAS) Consortium’' project, including, but not limited, to all the documents sent by Cambridge University to the Welcome Trust for this award, that are either indexed or filed formally.”
On 10 December 2021, the University responded. It provided the complainant with a copy of the application letter, but redacted some of the information, relying on section 22A and 40(2) of FOIA in order to do so.
The complainant requested an internal review on 11 December 2021. The University sent the outcome of its internal review on 13 January 2022. It upheld its original position with regard to redactions – although it had identified two additional documents that it provided to the complainant.
Scope of the case
The complainant contacted the Commissioner on 14 January 2022 to complain about the way their request for information had been handled.
The University indicated in its submission that it was relying on both the cited exemptions to make each redaction and for broadly the same reasoning. Given that some of the information does not relate to any individual (identifiable or otherwise), the Commissioner is unclear how such information could possible fall within the scope of section 40(2). He has therefore considered section 22A of FOIA first. If and to the extent that that exemption does not apply, he will consider whether section 40(2) of FOIA applies to any of the residual information.
Reasons for decision
Section 22A of FOIA states that:
“(1) Information obtained in the course of, or derived from, a programme of research is exempt information if—
(a) the programme is continuing with a view to the publication, by a public authority or any other person, of a report of the research (whether or not including a statement of that information), and
(b) disclosure of the information under this Act before the date of publication would, or would be likely to, prejudice—
(i) the programme,
(ii) the interests of any individual participating in the programme,
(iii) the interests of the authority which holds the information, or
(iv) the interests of the authority mentioned in paragraph (a) (if it is a different authority from that which holds the information).
Section 22A is not a commonly-cited exemption, but it works in the same way as any other prejudice-based exemption. First the public authority must identify an applicable interest relevant to the exemption. Second, the public authority must explain why and how that interest could be harmed by disclosure. Finally, the public authority must decide on the likelihood of the harm occurring.
Section 22A will apply in situations where a programme of research is ongoing and where premature disclosure of information relating to that programme is likely to impede the programme or impede the programme’s ability to take credit for or exploit its work – including commercial exploitation.
The exemption may apply in situations where a person has sought raw data held by the programme or sensitive details of the precise methodology being used (or being proposed to be used) where disclosure would allow others to exploit the benefit of the programme’s work for free. The exemption might also apply in situations where disclosure might prevent an individual from participating in such a programme.
The information the University has identified as falling within the scope of the request is a copy of the project application made to the Wellcome Trust, a pre-application form made to the same organisation (and containing the same information as the full application), letters of support from various academic or charitable institutions and an exchange of emails regarding the precise award of the grant.
The University explained to the Commissioner that the information in question related to a programme of research on autism known as the Spectrum 10k project. It confirmed that, whilst the project represented a major collaborative research initiative, the project’s leaders had, in establishing the project, confirmed that a number of academic publications were envisaged and that they intended to publish the project’s research.
The Commissioner is satisfied that the University has identified an applicable interest relevant to this exemption.
The University stated that its own interests would be prejudiced by disclosure as well as the interests of the various individuals who had provided statements of support. The University explained that these individuals’ interests would be prejudiced by disclosure because:
“Following the launch of Spectrum 10K, the project encountered a substantial public backlash. This included commentary on Twitter and other social media platforms , the formation of a public petition called “Stop Spectrum 10K” and the formation of a group called “Boycott Spectrum 10K” . A protest against the Spectrum 10K study was also held outside Douglas House where the study team’s offices are based. Arguments put forward as part of the backlash included concerns that the project was associated with eugenics and that genetic research would lead to the eradication of autistic people. This has included concerns that some principal investigators within the Spectrum 10K study have been involved in organisations associated with seeking a cure for autism. The study has repeatedly and explicitly stated that it is anti-eugenics, does not seek a cure for autism and continues to call for the inclusion, acceptance and dignity of autistic people. Given the volume of negative attention and misinformation, the disclosure of the names of both individual and organisational partners (including partners in the form of pre-existing scientific datasets and databases) providing support to the project may subject those collaborators to unfair scrutiny and negative attention, jeopardising scientific collaboration and the aims/integrity of the Spectrum 10K project both now and in the future.”
The Commissioner’s view
The Commissioner recognises that Spectrum 10K is a project that has rightly or wrongly, attracted controversy. He accepts that there will be those who feel strongly that particular individuals should or should not be contributing to such a project.
However, the Commissioner is not persuaded that the University has made a particularly persuasive case that prejudice would be likely to result from disclosure.
Firstly, the Commissioner notes that much of what the University has redacted relates to previous research projects that the various project collaborators have worked on as well as papers they have published. He considers that the majority of this information is already in the public domain – particularly the published papers.
The Commissioner notes that many of the grant awards have already been made public – although not always the quantum of the grant. However the University has not put forward any arguments to explain why, when an individual is known to have received a research grant, the precise quantum of that grant would be likely to prejudice their involvement in Spectrum 10k or the project’s aims.
The Commissioner has not been provided with evidence to suggest that any of the individuals or organisations named in the withheld information has indicated that their interests would be harmed by disclosure or that they would be less inclined to participate in the project if their involvement was disclosed.
The University has noted that some of the withheld information relates to existing sources of data on which Spectrum 10k wishes to draw. The Commissioner does accept that, were this information to be made public, there is a possibility that those whose data is contained within those databases may seek to prevent their data from being accessed by Spectrum 10k or seek to have their own data removed from such databases entirely. The Commissioner accepts that this is more than just a hypothetical possibility (given the strength of feeling in some quarters about the Spectrum 10k project) and one which might potentially hinder the project’s work.
He has therefore, by a narrow margin, been persuaded that the exemption is engaged.
Public interest test
Even where information could harm ongoing research projects, it must still be disclosed unless it can be demonstrated that the balance of the public interest favours maintaining the exemption.
As the Commissioner has accepted that the lower bar of prejudice is engaged, there will always be some inherent public interest in preventing that harm from arising. However, given that he was only just satisfied that the exemption was engaged, it follows that the public interest in maintaining that exemption will be weak.
Having considered the matter, the Commissioner is convinced that the balance of the public interest lies strongly in favour of disclosure.
Spectrum 10k is an ambitious project, but not one without controversy. In particular, as the University’s submission indicates, questions have been raised about the suitability of some of the collaborators, based on their previous research projects.
Whilst the Commissioner recognises that this might be uncomfortable, he considers that such arguments are actually arguments in favour of increasing transparency. If the University attempts to cloak the collaborators’ previous work in a shroud of secrecy, it is only likely to fuel suspicions that there is something to hide. It also assists those with a malign agenda to paint a partial and misleading picture of each collaborator’s previous work. Much of this information is already in the public domain anyway for those sufficiently motivated to search for it, so the Commissioner sees little value in the University attempting to prevent disclosure.
The University argued that the public interest should favour withholding the information in order to protect:
“the fundamental ability of the scientific community to establish and explore collaborations at an early stage of project development – collaborations that often are crucial to the successful running of scientific studies – without public scrutiny that could lead to these collaborations being challenged or withdrawn as a result of adverse commentary and activity.”
Where institutions have pledged their support to Spectrum 10k, there is a public interest in understanding which institutions they are so that those institutions can have their individual roles scrutinised appropriately.
“Adverse commentary and activity” is not a valid reason for withholding information even if this does “challenge” collaboration. Public authorities should be sufficiently robust and able to withstand a certain level of scrutiny and criticism. The Commissioner also notes that Spectrum 10k has already paused its work to rethink parts of its approach – apparently because of adverse commentary. Valid criticism can be a positive force if it leads to beneficial changes.
The Commissioner recognises that it is possible that disclosure may open up lines of legitimate journalistic enquiry. However, once again, he considers that a spirit of openness is, in the long term, more likely to help than hinder the outcomes the project is able to achieve.
The University has provided no evidence that any of the collaborators has, or is likely to, withdraw from the project. Given the negative reactions already experienced (which presumably have already dissuaded the easily-dissuadable), the Commissioner considers that such arguments are speculative.
With respect to data sources, even though this is the area where the Commissioner has found there to be the highest possibility of harm, he nevertheless considers that the balance of the public interest favours disclosure.
Firstly, where various research projects hold personal data about individuals, those individuals have rights over the way that their personal data is processed. Depending on the basis on which this information is currently being processed, those individuals may have the right to withdraw their consent to have their data processed by the current controller, to prevent their data from being passed to Spectrum 10k or to ask the data controller to delete their personal data altogether. It is important that those people can? exercise their data protection rights if they do not wish to have their personal data passed to Spectrum 10k – even if that hinders the project’s work.
Whilst the Commissioner recognises that a reduction in the quality of data available may make it more difficult for Spectrum 10k to go about its work, he is unconvinced that any loss of access to data will be of a level significant enough to cause issues. Furthermore, he also considers that the higher the degree of transparency, the more confident individuals will be in allowing Spectrum 10k access to their personal data.
The Commissioner is therefore satisfied that the balance of the public interest favours disclosure.
Section 40(2) - Third party personal data
Section 40(2) of FOIA allows a public authority to withhold information that is the personal data of third parties and where its disclosure would contravene data protection legislation. In particular, there must be a specific lawful basis on which the information could be published to the world at large (which is what FOIA requires).
Information will be personal data if it relates to a living individual who is identifiable, directly or indirectly, from the withheld information.
The Commissioner considers that the redactions the University has made to withhold information about research projects from which Spectrum 10k will draw is not personal data as it does not identify any individual. Nor will the names and addresses of the various organisations that provided letters of support to Spectrum 10k’s application.
However, information about the previous areas of research the various collaborators have been involved in will be their personal data, as will individual contact details.
The Commissioner is not aware that any of the data subjects has given their consent for the information to be disclosed to the world at large. He has therefore proceeded on the basis that consent has not been provided and therefore the only possible lawful basis for disclosure would be if disclosure were necessary to satisfy a legitimate interest.
The Commissioner notes that Spectrum 10k is a large, highly ambitious project that intends to better understand how genetics and environmental factors affect those with autism and their families. He also notes that it is a project that has attracted criticism because of perceived links to eugenics (the practice of attempting to “improve” the genetics of a population by attempting to eradicate genetic conditions deemed to be undesirable).1 In August 2021, the National Autistic Society urged those considering participating to “look into this study carefully, and consider the potential benefits and harms, before deciding whether or not to participate” because of concerns about the way the project was intending to handle personal data such as DNA samples.
1 It is appropriate to note that the Spectrum 10k project’s founders have insisted that they are anti-eugenics and that this is not what the project is seeking to achieve. )
In the circumstances, the Commissioner considers that there is a very strong legitimate interest in understanding which researchers form part of this project and what their previous fields of expertise and research are. There is also a broader, though weaker, legitimate interest in general transparency around research projects.
Disclosure will be “necessary” to achieve a legitimate interest if it is a proportionate means of achieving a legitimate aim. If the legitimate interest can be satisfied by other, less-intrusive means, then disclosure will not be necessary as the same aim can be achieved in a manner that requires less intrusion into the privacy of the individuals concerned.
The Commissioner does not consider that disclosure of individuals’ contact details is necessary to achieve the legitimate interest. He is therefore satisfied that the University is entitled to rely on section 40(2) of FOIA to withhold this information.
However, in this case, the Commissioner considers that disclosure of the remaining information is necessary to achieve the legitimate interest as it could not be achieved via other means. The Project’s website does provide a list of its main staff and an overview of their previous areas of research – but it does not provide the level of granular detail set out in the withheld information.
Even where disclosure of personal data is necessary to satisfy a legitimate interest, the Commissioner must still balance that interest against the rights of the data subjects.
The University has argued that disclosure of the information being withheld would be contrary to the reasonable expectations of the data subjects and (presumably) would therefore cause them distress if it were disclosed.
The Commissioner is not satisfied that this is a reasonable expectation of the data subjects and, even if it were, disclosure is unlikely to cause them considerable distress.
Firstly, most of what the University has withheld relates to published papers that the various collaborators have previously authored or contributed to. To that extent, the Commissioner considers that most of what has been withheld is, in reality, already in the public domain – albeit that it will mostly be available in relatively niche academic publications and is not centrally collated. Information on previous academic posts held is, again, often already found in the public domain. It is not a reasonable expectation that the University will refuse to confirm that a particular individual has published a scientific paper when that individual is named on the paper.
The information in question relates to the work of the various academics involved and could not reasonably be said to relate to their private life – beyond indicating the areas of study which are of personal interest to them. To the extent that disclosure would intrude on their privacy, the Commissioner considers that any effects would be minimal.
The Commissioner is therefore satisfied that, in the circumstances of this case, the legitimate interest in disclosure outweighs the rights of the data subjects. Therefore the University would have a lawful basis on which to disclose this information.
As the information can lawfully be disclosed, the Commissioner does not consider that the University is entitled to rely on section 40(2) of FOIA to withhold it.
Right of appeal
Either party has the right to appeal against this decision notice to the First-tier Tribunal (Information Rights). Information about the appeals process may be obtained from:
First-tier Tribunal (Information Rights) GRC & GRP Tribunals,
PO Box 9300,
LEICESTER,
LE1 8DJ
Tel: 0203 936 8963
Fax: 0870 739 5836
Email: grc@justice.gov.uk
Website: www.justice.gov.uk/tribunals/general-regulatory-chamber
If you wish to appeal against a decision notice, you can obtain information on how to appeal along with the relevant forms from the Information Tribunal website.
Any Notice of Appeal should be served on the Tribunal within 28 (calendar) days of the date on which this decision notice is sent.
Signed [signature redacted]
Roger Cawthorne
Senior Case Officer
Information Commissioner’s Office Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF
EXE Magazine, initially .EXE Magazine, the UK software developers' magazine, ran from 1986 to 2000. I joined it in June 1994 as a feature editor and became its editor in October 1995 until the end of 1999.
I scanned all the copies I had and uploaded the PDFs. You can find and download all the issues from July 1994 to March 2000 and the June 1988 issue here.
Dinah first suggested we meet in 2014 initially to discuss the Autistic Space Kit app. One aim for that app was to help prevent Autists being wrongfully arrested. This was the beginning of our deep friendship.
In that same year we wrote our first joint letter, with other Autistic activists and friends (about our concerns with the National Autistic Society). I discovered that Dinah was a prolific letter writer, often to raise concerns and suggest improvements but also to congratulate when good service did happen.
Not finding a venue was a common occurrence. Dinah always arrived well in advance, but also had a knack to lose both herself and her possessions. It was interesting trying to help Dinah find a conference we were both attending after receiving a text saying she was lost! Eventually we both permanently shared our locations on our phones, which made this much easier. Dinah was the first person, and one of only two, I ever trusted with my location.
Attending exhibitions, seeing films, joining Autistic gatherings, having a meal together, walking in nature, looking for mushrooms and taking photographs were some of Dinah’s many passions. I was fortunate to occasionally share some of these moments. On occasions the journey was much more fun than the event we were traveling to and we cherished these trips.
Hugging is something else Dinah was fond of. I am not so keen. When Dinah visited London briefly in April, we met at the C. Road house where she had welcomed her friends on so many occasions and did hug, for the last time. For a while Dinah used to sign off with this quote from Bob Dylan: ‘Everything passes, everything changes. Just do what you think you should do.’
I miss my friend Dinah very much.
Read about aspects of her life in A Productive Irritant: A Celebration of the Life of Dr. Dinah Murray and Fergus’ My ‘Rather Weird’ Mum.
‘I am carrying this everywhere in my pocket’ - Dinah, 2021-05-05
Last edited on 2021-08-14
AT-Autism’s annual conference on ‘Rough Justice? How is the justice system serving autistic people?’ was distressing for many of the autistics attending (and some had to leave because of it). Most of the presentations were about tinkering on the edges of the system: improving prisons, the Broadmoor high secure psychiatric hospital, probation services, etc. Very little was said about changing a system that discriminates and oppresses the autistic minority. It is likely that the lack of openly autistic speakers contributed to this.
Gary McKinnon and Lauri Love, whose extradition to the USA were both blocked, were mentioned several times. However Talha Ahsan who was extradited a week before Gary McKinnon’s extradition was blocked was only mentioned when I did in a question. There was no talk of intersectionality, even though autistics are not all white men!
No presentation either was about the injustice of all the innocent autistics caught in the criminal justice system. My unlawful arrest by the Metropolitan Police Service, that luckily didn’t go to court, was so traumatic that it has been life changing. It is difficult to imagine what the fellow autistics who have had to or are going through court, prison, secure hospitals, probation, etc., many of them innocent of the offence they are suspected of or charged of, have to endure. Even some autistics convicted and sentenced to a life term for murder have not committed the crime for which they have been convicted for, such as is the case for Alex Henry, thanks to the law of joint enterprise.
Kleio Cossburn, a former police officer, made a very interesting presentation in which she talked about how she found, after a traffic accident, how different things were on the other side of the desk where police officers usually sit. However not many police officers experience this, and fewer realise the trauma they often cause when arresting autistics, especially when innocent. Karen Todner, in her fascinating and harrowing presentation of several of the cases she has worked on, pointed out that when she started her 30-years career legal aid solicitor offered as good representation as private ones, and prison was a safe environment. This is no longer the case. She quoted a probation officer describing the current situation as: ‘we have gone back to the dark ages and we lock up those who are autistic because we don’t know what to do with them’. And that includes innocent, black, women, muslim, etc. autistics, not just autistic white men having committed an offence. We don’t need more autistics having a better time in the criminal justice system, we need a system in which autistics are not locked up.Joe Lo, a London-based freelance journalist has written an article looking at some of the concerns the autistic community has about the disturbing Autism Innovative Medicine Studies-2-Trials (AIMS-2) European research project. The article, titled Why a European autism research program has sparked fears of eugenics, was commissioned by The Establishment, an American ‘multimedia site run & funded by women’. Here's an excerpt:
...
Panda Mery is a university researcher in London and a former journalist, lecturer, and software engineer. He’s also autistic, and when he found out that a huge U.S.-based charity called Autism Speaks was involved in the AIMS-2 project, he grew highly suspicious of what “solutions” this research was seeking out.
“[Autism Speaks] are basically a hate speech organization,” he told me in an interview. “They treat autism like a cancer[*]. You want to get rid of the cancer. You want to get rid of the autism. But autism is part of your identity. It’s like, how can you get rid of the Britishness of someone? How can you get rid of the Jewishness of someone? How can you get rid of the autism of someone?”
...
With alarm bells ringing, Mery requested a copy of the AIMS-2 grant agreement under EU transparency rules. On receiving the 664-page document, the alarm bells’ decibels became deafening — one section in particular troubled him:
Currently, there are no effective medical treatments for the core symptoms of Autism Spectrum Disorder. Our overall goal is to address these shortcomings by adopting a precision-medicine approach to better target treatments to patients through the use of validated stratification biomarkers and by testing novel or repurposed drugs.
For Mery, targeting the symptoms of autism sounds a lot like ‘curing autism’ — but autism is not a disease, it does not need curing. Cos Michael also objects to this language of “core symptoms.” What are they? Are they good things? Bad things? Who decides? Because they keep changing. Through history, the ‘core symptoms’ of autism have changed. It’s about what other [non-autistic] people call them. And ‘targeting them’? Why? Because we want to take them out? It’s so full of…well, hate, frankly.”
...
Read the full article.
*I mentioned to Joe Lo the Tree House Town Hall 2008 talk by Bob Wright, the ex-Chairman and founder of Autism Speaks, in which he explained ‘I see autism through the lens of cancer’. (The video is a bit shaky, but it’s wonderful to see Jon Snow encouraging all present to flap.) That talk followed Something About Us, an excellent film about the rights and voice of autistic people by Dinah Murray and Jes Benstock.
Bootnote
For more details about AIMS-2 check out these blog posts:
This post explores how repair activities and, more specifically, community repair events are well suited to many autistics and other neurodivergents, and how to ensure that these events are welcoming to all neurodivergents. Its content is based on notes that have been refined in presentations and discussions at Fixfest 2017, Fixfest UK 2018 and the PARC Autistic Fringe (Glasgow) 2018.
Community repair, an activity well suited for neurodivergents
Repair is a combination of manual, intellectual and emotional activities
Community repair is more than just repairing
Social justice in action
Identifying potential issues
Some recommendations (mostly for events’ hosts)
(*) Spoons refer to Christine Miserandino’ spoon theory, a metaphor for managing one’s energy. Spudgers are flat plastic or metal tools essential to open most electronic devices (and apparently originating from late Middle English spuddle (“short knife”)).
About the Restart Project
The Restart Project helps people learn how to repair their broken electronics, through our Restart Parties: free community repair events where participants can work with a skilled volunteer to fix anything with a plug or a battery. They’re spaces for learning skills and reflecting about how we consume in the first place. Repair is fun, it’s social, it saves money, and helps us be creative and constantly learn.
The Restart Project has been proactive in encouraging inclusivity across genders, in particular with the Rosie the Restarter skill shares. Nothing similar yet exists for neurodivergents.
About neurodiversity and autism
‘Autism is a way of being. It is pervasive; it colors every experience, every sensation, perception, thought, emotion, and encounter, every aspect of existence.’ Jim Sinclair
‘Neurodiversity is the diversity of human brains and minds – the infinite variation in neurocognitive functioning within our species.’ Nic Walker
Autistics have spiky profiles, an unusual combination of abilities and challenges. Autistics can find some tasks easy and others difficult, and this may change depending not just on the task, but also on the environment, and recent experiences. It is common for autistics to be over (hyper) and/or under (hypo) sensitive to some of their senses; and there are more than five, e.g., sight, hearing, taste, smell, touch, temperature, pain, kinaesthetic sense (proprioception), balance, etc. Processing sensory information can be overwhelming.
A few links
If you have other suggestions to make community repair events welcoming to neurodivergents, you can post in this Restarters.net thread (free registration required).
An Auternative: A Society Fit for Autistics is a research project funded by Disability Research for Independent Living and Learning (DRILL) which aims to create recommendations for overcoming the barriers faced by autistic people, challenging the prevalent stereotypes and enabling autistic people to take their place in the world. The research, of which I am a partner, is being carried-out by an autistic-led group consisting mainly of autistic people and has an all-autistic advisory committee.
We have now published our questionnaire and are looking for autistics, 16+ year old, participants. If you are autistic, please fill in our questionnaire. We’d also appreciate if you can promote it to other autistics you are in touch with and/or through your social media.
This post appeared first on the Participatory Autism Research Collective (PARC) blog.
Written by: Panda Mery
As so little information has been made available on 115 million euros Autism Innovative Medicine Studies-2-Trials (AIMS-2-Trials) research project, we suggested to Autistica to publish their project agreement. They didn’t. Using the access to information scheme of the Innovative Medicines Initiative 2 Joint Undertaking (IMI2 JU), we also requested a copy of the ‘Autism Innovative Medicine Studies-2‐Trials (AlMS-2-Trials) grant agreement and its appendices’. After extending its deadline, the IMI2 JU sent us a partly redacted copy of the grant agreement. The redactions are explained in a cover letter.
The grant
agreement document, even redacted, weighs in at 19 MB and 664 pages [The linked document is now only 112 page long; see the Update 2018-10-24 at the bottom of this post for an explanation; note that the page numbers indicated in the post were referring to the original document].
To help all those curious about this project to get a quick grasp on the
project priorities, its ethical commitments and how it will involve
autistic people, we are providing a summary in the form of a FAQ.
1. Will AIMS-2-Trials address the autism community’s priorities?
No.
‘Currently, there are no effective medical treatments for the core symptoms of ASD […] Our overall goal is to address these shortcomings by adopting a precision medicine approach to better target treatments to patients through the use of validated stratification biomarkers, and by testing novel or repurposed drugs in a highly trained European-wide clinical trials network for ASD that links to other international efforts’ (p. 165).
None of the top 10 autism community’s research priorities include ‘treatment for the core symptoms of ASD’.
2. Will AIMS-2-Trials really only target the core symptoms of ASD?
No, but mostly.
For instance, epilepsy is an important co-morbidity for autistic people that has a large impact on their quality of life and is likely well suited for a pharmaceutical intervention.
The grant agreement briefly acknowledges this: ‘We also specifically include younger populations, and target core symptoms that are relatively under investigated together with associated symptoms impacting on quality of life and mortality (e.g. epilepsy).’ (p. 184).
Searching for ‘epilepsy’ reveals that out of all the seven work packages, out of the 34 deliverables of Work Package 2 ‘Validation of stratification biomarkers’, only three deliverables are about epilepsy: 'D2.4-6 Epilepsy: First study subject approvals package completed (registered in WHO or ICMJE, Ethics approvals delivered to the IMI); Midterm recruitment report; Report on status of posting results’ (p. 117).
3. Has AIMS-2-Trials an ethics board?
Yes. Two ethics board are described.
The 'External Ethics Advisory Board (EEAB). The EEAB will report to the SSC [Study Steering Committee]. An external independent ethics advisor (Professor John Suckling) has been appointed to oversee, with impartiality, the ethical concerns involved in this research. He will chair the board and be supported by a Deputy Director (Prof. Dr. Marcella Rietschel, University of Heidelberg) and other relevant experts including Prof Dr Ulrike Schulze, Zentrum für Psychiatrie Baden-Würtemberg.’ (p. 198).
'Professor John Suckling, Chair of the Psychology Research Ethics Committee, University of Cambridge, has kindly agreed to lead this aspect of our work. Through regular (quarterly) meetings, the Ethics Board will ensure that our ethical approaches are consistent across work packages and across countries wherever appropriate; provide expert advice to the rest of the consortium on any specific ethical issues arising in particular studies; engage key experts to provide additional advice where necessary (e.g. new EU legislation as it arises); and develop strategies to explore the ethical implications of novel results as they emerge from the consortium (see below). Professor Suckling will ensure that the Ethics Board includes relevant independent expertise to monitor the ethics issues in this project and how they are handled. The Board will be consulted at least on the following points (inclusion of fetuses, infants at risk, imaging, animal models, genetic information, dedication, clinical trials and data protection). A report by the Ethics Board will be submitted as a deliverable at the end of each reporting period.’ (p. 309)
And the 'Data Monitoring and Ethics Board (DMEB). The DMEB will report to the SSC. There will be an independent DMEB that consists of a researcher/clinician with expertise in ASD, a statistical expert, and an ethical expert. The DMEB operates in accordance with a charter that follows the guidelines of the DAMOCLES study group for charters on clinical trial data monitoring committees [118]. The aim of the DMEB is to protect and serve the clinical study participants (especially re: safety) and to assist and advise the TSB [Trial Steering Board] as to protect the validity and credibility of the clinical study/trial. The DMEB will receive a summary report of the study progress every 6 months, and review the progress and accruing data of this trial and provide advice on the conduct of the trial to the TSB. To this purpose, the DMEB will meet face-2-face or by teleconference not later than within 6 months after the start of the study and thereafter every 4 months or more often if needed. The DMEB will support risk management and review incidents associated with data collection (including brain imaging) of vulnerable participants, as well as monitoring data curation and stewardship. This will run in parallel with the institutional Clinical Governance system which oversees clinical and radiological safety issues.’ (pp. 198 and 403).
4. Was ethics an overriding concern of AIMS-2-Trials?
No.
The Ethics requirements work package (WP7) was a late add-on to the
agreement. The history of changes shows that ‘An Ethics WP has been
added: WP7 with deliverables D7.1-8’ (p. 162). This change is listed as
having been introduced in version 6 of that part of the agreement, which
is dated 2018-06-13, just five days before the project’s launch press-release. ‘Figure
14 Overview of the AIMS-2-TRIALS governance structure’ still only shows
six work packages (p. 197). WP7 is the only work package which still has
no figure (‘N/A’) listed for its ‘total number of person-months
allocated’ to it (p. 94).
All of the eight deliverables of WP7 (defined as GEN – Requirements No. 11 to 18) will be ‘Confidential only for members of the consortium (including the Commission Services)’ (pp. 147-148).
The second paragraph in a section on ethics explains the overall approach as: 'Any consideration of ethical issues has to be set in a context of the potential benefits and risks of the overall project. Undoubtedly, better options are needed for treating ASD. AIMS-2-TRIALS will address this issue using the latest techniques of animal and cellular models, genetics, proteomics, imaging and behavioural/cognitive phenotyping.’ (p. 309). That seems to indicate that the benefits and risks of the project may overrule any ethical concern.
(‘benefit’ is used on 30 pages, but with no clear definition, nor a list of what may be the benefits of AIMS-2-Trials for autistic people. For instance, here’s another use in the context of actions for investors: ‘the Actions include ‘Sensitize investors to AIMS-2-TRIALS potential benefit to patients and market opportunity, to support commercial ramp-up post regulatory clearance.’ p. 192).
The secrecy about the project’s approach to ethics goes further. Although the grant agreement mentions 'Activities raising ethical issues must comply with the ‘ethics requirements’ set out as deliverables in Annex 1.’ (p. 59), the covering letter to the redacted agreement explains 'the Annex 1 is withheld in its entirety considering that access to a redacted document would be meaningless;’ (I have requested a review of that redaction, and a response is due by 2018-10-05).
5. Will the ‘universities, research organisations, public bodies [and] non-profit groups’ involved receive any funding?
Yes.
The IMI will distribute 55 million and one euros to them. King's College London will receive 20 060 301 euros. The second largest recipient, Servicio Madrileno De Salud-Fibhug, will receive 5 502 025 euros. IMI2 has published the full list on its AIMS-2-Trials summary page. I’ve also updated the spreadsheet I had published earlier with this information.
6. Will the associated partners – Autism Speaks, Autistica and SFARI – receive any funding?
No, none of them will receive any of the IMI funding, however, they will receive benefits in kind.
The logos and mentions of Autism Speaks, Autistica and SFARI, as well as those of the Joint Undertaking and of the European Federation of Pharmaceutical Industries and Associations (EFPIA), and the EU emblem must appear in ‘any dissemination of results (in any form, including electronic)’ (p. 54) and in ‘any communication activity related to the action (including in electronic form, via social media, etc.) and any infrastructure, equipment and major results funded by the grant’ (p. 62). And they ‘must have appropriate prominence.’
7. Will autistic people be involved?
Yes, a few though this is still to happen.
Some autistic persons will be invited to be part of an Autism Representatives Group (A-Reps) and a Patient Advisory Group (PAG); at most one autistic person from each EU country is to be invited to the A-Reps. Of course a few researchers from the organisations involved may also be autistic (at least one openly identifies as autistic).
‘To ensure full collaboration with the autism community, we will create an Autism Representatives Group (A-Reps), using Autistica’s DISCOVER Research Network, to ensure patient and public involvement (PPI) with autistic people, their families and relevant stake-holders (e.g. autism charities, autism-related professionals) across Europe. The A-Reps group will include representatives from EU countries (an autistic person/family member, and a charity/professional rep in each country).’ (p. 135).
'The PAG [Patient Advisory Group] will report to the SAB [Scientific Advisory Board]. It will consist of representatives from patient organisations and individuals with first hand knowledge of ASD. We have agreements from Autism Europe and Autistica, who will work together with our Autism Representatives Group (A-Reps) that includes representatives from the Catalonian Autism Society, Gautena society, Federation Autism Madrid, Dutch Autism Society, and the Phelan McDermid Syndrome Foundation. The PAG will provide a focus of expertise in patient experience, and offer a natural vehicle for patient engagement in the consortium’s activities. It will meet formally once a year as part of the General Assembly meetings.’ (p. 199).
Note that the organisations that will be represented on the ‘Patient Advisory Group’ are not autistic organisations.
8. What is this patient and public involvement (PPI) the A-Reps will participate to?
‘The PPI will focus on the following objectives of Task 1: We will (a) develop Clinical Guidelines for Autism across the EU; (b) produce a ‘Time for Change’ ten-point Public Health Autism Plan, (c) translate these into 6 main European languages for dissemination to national governments and clinicians, (d) present these to European decision-makers and the UN, working with MEPs... All work will take place in consultation with AE, A-Reps and the KCL Policy Institute. Research on comorbidities and precision medicine policy development will be disseminated via conference presentations at the Annual INSAR and ECNP Meetings, Autism Europe, through the AIMS-2-TRIALS Clinical Network, and via webinars and press releases in collaboration with WP1 and WP5.2-3. Outputs: Dissemination of evidences based [sic] results to policy makers and the public. [...]
A focus of outreach will be the Autism Representatives Group (including autistic individuals, parents/carers, special educators, clinicians and researchers from across Europe (based on Autistica’s Discover Network; https: //www.autistica.org.uk/our-research/discover-network). In addition, our collaborative effort with co-leads Autistica and Autism Europe and our new Autism Representatives Group will ensure that we include as many Autism Charities in our network as possible. A number of charities across Europe, including those affiliated with Autism Europe such as Aprenem Associacio per a la inclusio de persones amb Transtorn de |’Especter [sic] Autista, Gaurema [sic] (San Sebastian, Spain), Nuevo Horizonte, Phelan McDermid Syndrome Foundation and The Dutch Autism Society, have already agreed to be part of our network. These organisations will be working with us on dissemination and patient and public involvement workshops to receive input from and provide information to the community. This will assist in the effective dissemination of information on educational events, policy initiatives, and newsletters (involving news updates on research, policy, education and other relevant materials). All these efforts will also be available on the new website and through the collaborative dissemination strategy with Autistica, Autism Europe and other partners. We will ensure that feedback is provided to the autism community and other citizens on how these groups interact to provide example of collaborative efforts for other projects, using a framework set-up by Shaping Autism Research (http://www. shapingautismresearch.co.uk).' (pp. 135-136).
9. Are there really 48 participants?
Sort of!
In Attempting to lift the veil of secrecy over AIMS-2 we published the authoritative list of 48 participants we had received from IMI2. The AIMS-2-Trials summary page now lists a 49th organisation: Greater Glasgow Health Board. However it is listed separately as a ‘Third parties’ (despite the plural, there’s only one). It will receive 195 000 euros of IMI funding.
The grant agreement document mentions ‘Greater Glasgow and Clyde Health Board’ (p. 275). This explains why the AIMS-2-Trials press release includes a logo for NHS Greater Glasgow and Clyde.
Autistic power
If after having read this FAQ and perused the grant agreement, this is a research project you want to support contact AIMS-2-Trials with your offer of participation.
If however, you are shocked by the limited autistic involvement, the late ethical considerations, the track records of some of the partners, etc. and have lost faith in this research, you have some power according to none other than Simon Baron-Cohen (the University of Cambridge is receiving 2 808 025 euros in IMI funding): ‘A large part of that collaboration [for genetics research] is with the autism community. If that community loses faith in this research, then progress will slow down. […] I hope the autism community will be willing to trust researchers who nail their colours to the mast in this way.’
You can also contact your Member of the European Parliament.
Table of contents for the AlMS-2-Trials grant agreement document
To help with navigating the 664 pages of the grant agreement, here’s a reconstructed table of contents:
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Section title |
Pages |
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Grant agreement |
1-88 |
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Annex 1 – Research and Innovation action (Part A) |
89-158 |
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(Note that many pages of the document are locked for copying/pasting so some of the quotes have been copied using OCR and typos may have been introduced; though as indicated with [sic] some of the typos in the name of organisations are in the original.)
Related posts
Update 2018-10-05
I have received a response to my request to review the redactions made to the grant agreement I had received. The outcome of this review is that
Following this assessment, I am pleased to inform you that I have concluded that the part of Annex 1 of the Grant Agreement that relates to the ethics requirements may be partially disclosed, with some of its parts redacted based on Article 4(1) (b) of Regulation (EC) No 1049/2001 (protection of personal data).
Two documents were attached: the Ethics-related excerpt of ANNEX I of the AIMS-2-TRIALS Grant Agreement (partly redacted) and the Work Package 7, described in Annex 1 of the AIMS-2-TRIALS Grant Agreement.
In fact this information was already included in the redacted grant agreement that had been sent earlier. Some further redactions have been applied to the documents received today, but the documents have copy/paste enabled making it easier to quote from them. So no further analysis needed.
Update 2018-10-24
The IMI2 JU Access to Documents Team emailed on 2018-10-22 that,
It has come to our attention that, contrary to what was stated in the letter responding to your first request of access to document, the file named ‘Full grant agreement redacted’ sent to you on 10 September 2018 included the annex 1 of the AIMS 2 TRIALS of the grant agreement. This information was shared with you inadvertently.
By publishing it on the internet this is now disclosing sensitive commercial information and personal data which were not intended for publication and for which you do not have any right to publish.
We therefore have to ask you to immediately remove the file from your internet page at the following link: http://gizmonaut.net/autism-documents/Full-Grant-Agreement-777394-AIMS-2-TRIALS_redacted.pdf.
I have replaced the content of the file with a heavily redacted one reduced from 664 to 112 pages.
Written by: Panda Mery, Dinah Murray & Kabie Brook
The Autism Innovative Medicine Studies-2-Trials (AIMS-2-Trials) was launched as the largest ever grant given to autism research on June 18th. Two weeks ago, we wrote some questions about this project and the autistic representation and monitoring, if any. Dr James Cusack, Director of Science, Autistica wrote a response that answered only some of our questions. Some people commented on both these posts (below each).
A key issue that appears pervasive with this project is the secrecy surrounding it. For any monitoring of AIMS-2 to be effective, a monitoring panel would need to a) have access to internal documents and staff of AIMS-2 projects, and b) be able to discuss them publicly. Otherwise either those doing the monitoring will not be able to understand what is happening or they will only be able to express that they have concerns or none, without being able to say about what!
Autistica will contribute £50,00 in-kind (equivalent to €56,274 at the exchange rate on the day I converted it). In-kind contributions from autism charities (the Simons Foundation, Autism Speaks and Autistica) combined will be €55.5 million. And the AIMS-2 grant is €115 million. That means that Autistica’s contribution is about 0.1% of the in-kind contributions from autism charities and less than 0.05% of the total grant; clearly any power that Autistica wields in that consortium is not financial. This makes the release of their agreement with AIMS-2 all the more important and it would help restore some of the lost trust.
The secrecy runs deep. Something as simple and essential as finding out the list of participants is fraught with difficulties. At launch, the AIMS-2 press release (pdf capture on 2018-07-31) stated there were 48 partners… and included 38 logos. We used the Innovative Medicine Initiative’s (IMI2) Access to document scheme to request the full list of participants as well as a copy of the AIMS-2 grant agreement, including its appendices (which should include details of any ethical processes). Requests are handled within 15 working days, unless IMI2 extends this limit, and our request for the agreement is still under consideration. However IMI2 did send us the list of participants. Not to make things too easy, the list was provided in a Word document with two low-resolution scan images (too low for OCR to work) of the print out of the table over two pages! So after a painstaking retyping here’s in exclusivity (the IMI2 JU Access to Documents Team did write that ‘the relevant information will be shortly published’ - we’re already more than a month and half since launch) the ‘List of beneficiaries’ of AIMS-2:
|
No |
Name |
Short name |
Country |
|
1 |
KING’S COLLEGE LONDON |
KCL |
United Kingdom |
|
2 |
F. HOFFMANN-LA ROCHE AG |
ROCHE |
Switzerland |
|
3 |
THE CHANCELLOR MASTERS AND SCHOLARS OF THE UNIVERSITY OF CAMBRIDGE |
UCAM |
United Kingdom |
|
4 |
STICHTING KATHOLIEKE UNIVERSITEIT |
RUMC |
Netherlands |
|
5 |
SERVICIO MADRILENO DE SALUD |
SERMAS |
Spain |
|
6 |
INSTITUT PASTEUR |
IP |
France |
|
7 |
UNIVERSITAT BASEL |
UNIBAS |
Switzerland |
|
8 |
ZENTRALINSTITUT FUER SEELISCHE GESUNDHEIT |
CIMH |
Germany |
|
9 |
BIOSCI CONSULTING |
BIOSCI |
Belgium |
|
10 |
RIJKSUNIVERSITEIR GRONINGEN |
RG |
Netherlands |
|
11 |
THE CHANCELLOR MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD |
UOXG |
United Kingdom |
|
12 |
INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE |
INSERM |
France |
|
13 |
THE UNIVERSITY OF EDINBURGH |
UEDIN |
United Kingdom |
|
14 |
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS |
APHP |
France |
|
15 |
THE PROVOST, FELLOWS, FOUNDATION SCHOLARS & THE OTHER MEMBERS OF BOARD OF THE COLLEGE OF THE HOLY & UNDIVIDED TRINITY OF QUEEN ELIZABETH NEAR DUBLIN |
TCD |
Ireland |
|
16 |
BIRKBECK COLLEGE - UNIVERSITY OF LONDON |
BC |
United Kingdom |
|
17 |
STICHTING BURO ECNP |
ECNP |
Netherlands |
|
18 |
NOLDUS INFORMATION TECHNOLOGY BV |
NOLDUS |
Netherlands |
|
19 |
ARTTIC |
ARTTIC |
France |
|
20 |
DEMCON ADVANCED MECHATRONICS BV |
DEMCON |
Netherlands |
|
21 |
KAROLINSKA INSTITUTET |
KI |
Sweden |
|
22 |
JOHANN WOLFGANG GOETHE- UNIVERSITATFRANKFURT AM MAIN |
GU |
Germany |
|
23 |
UNIVERSITAIR MEDISCH CENTRUM |
UMCU |
Netherlands |
|
24 |
UNIVERSITEIT GENT |
UGent |
Belgium |
|
25 |
UNIVERSITY OF NEWCASTLE UPON TYNE |
UNEW |
United Kingdom |
|
26 |
UNIVERSITAET ULM |
UULM |
Germany |
|
27 |
CENTRE HOSPITALIER REGIONAL UNIVERSITAIRE DE TOURS |
CHUT |
France |
|
28 |
KLINIKUM RECHTS DER ISAR DER TECHNISCHEN UNIVERSITAT MUNCHEN |
TUM-MED |
Germany |
|
29 |
Fondazione Stella Maris |
FSM |
Italy |
|
30 |
UNIVERSIDAD DE SALAMANCA |
USAL |
Spain |
|
31 |
UNIVERSITY OF GLASGOW |
UGLA |
United Kingdom |
|
32 |
COMMISSARIAT A L ENERGIE ATOMIQUE ET AUX ENERGIES ALTERNATIVES |
CEA |
France |
|
33 |
UNIVERSITAETSMEDIZIN GOETTINGEN - GEORG- AUGUST-UNIVERSITAET GOETTINGEN - STIFTUNG OEFFENTLICHEN RECHTS |
UNG-GOE |
Germany |
|
34 |
STELLENBOSCH UNIVERSITY |
SU |
South Africa |
|
35 |
UPPSALA UNIVERSITET |
UU |
Sweden |
|
36 |
UNIVERSIDADE DE COIMBRA |
UC |
Portugal |
|
37 |
FUNDAZIOA POLICLINICA GIPUZKOA FUNDACION |
FPGF |
Spain |
|
38 |
FUNDACIO CLINIC PER LA RECERCA BIOMEDICA |
FCRB |
Spain |
|
39 |
JANSSEN PHARMACEUTICA NV |
JANSSEN |
Belgium |
|
40 |
NOVARTIS PHARMA AG |
NOVARTIS |
Switzerland |
|
41 |
UCB BIOPHARMA SPRL. |
UCB |
Belgium |
|
42 |
TEVA PHARMACEUTICAL INDUSTRIES LIMITED |
Teva |
Israel |
|
43 |
AUTISM SPEAKS INC. NON PROFIT CORPORATION |
AUTISM SPEAKS |
United States |
|
44 |
THE SIMONS FOUNDATION, INC |
SFARI |
United States |
|
45 |
AUTISTICA |
Autistica |
United Kingdom |
|
46 |
AUTISME-EUROPE AISBL |
AE |
Belgium |
|
47 |
UNIVERSITY OF BRISTOL |
UNIVBRIS |
United Kingdom |
|
48 |
STARLAB BARCELONA SL |
STARLAB |
Spain |
(Here’s also the information as a spreadsheet in case you want to explore it further and the original Word document for reference.)
A few days after we received this list, in what must be a coincidence, the press release was updated and now features 48 logos (pdf capture on 2018-08-02 in case it has been changed again). The original 38 logos are a subset of the 48 ones. However if you compare attentively the logos and the list, you will notice that they don’t all match. When I queried this I didn’t get any explanation about the discrepancies, just that ‘we can confirm that the list of beneficiaries sent to you on Monday 30 July is authoritative and does describe all beneficiaries to the project.’
Some of the discrepancies have likely explanations. For instance the logos for 'KIND Center of neurodevelopmental disorders at Karolinska Institutet’ and for 'Karolinska Institutet’ likely are both for the same organisation (entry 21 of the table). For some it is possible that a logo, e.g., for the 'Nuffield Department of Clinical Neurosciences’ may correspond to that of a participant appearing under a different name (entry 11). However these are just guesses and do not explain all these discrepancies. For instance the 'NHS Greater Glasgow and Clyde’ whose logo features on the press release does not seem to fit with any of the participants on the allegedly authoritative list. Same goes for the logos of the Donders Institute and the Radboud University.
Could there be such a gross error in the press release? Or could there be more than 48 participants? We cannot say with the information currently available. And all that confusion is just about the basic information that is the list of participating organisations in the AIMS-2 consortium. If it is so difficult to get such basic information out of AIMS-2, getting access to what is needed for effective monitoring will require an enormous effort at best.
Dr Will Spooren, the EU-AIMS project coordinator (also Group Leader Behavioral Pharmacology at Hoffmann-La Roche) wrote a presentation, titled Precision Medicine Approaches in Autism Spectrum Disorders, giving a bit more details on AIMS-2. This does not mention ethics or autistic participation. Dr Spooren is also a co-author with Professor Dr Declan Murphy, EU-AIMS academic lead, and lead author Dr. Eva Loth, EU-AIMS project coordination, of a related paper titled Defining Precision Medicine Approaches to Autism Spectrum Disorders: Concepts and Challenges. This mentions ethics once: ‘A treatment that is likely only effective in early development would raise important ethical implications for clinical trial designs that usually first test safety, efficacy and side-effects in adults.’ According to these two documents, their only ethical concern is testing drugs on babies, and that would only raise ethical implications so would still be considered. And no mention of autistic involvement either.
So the situation a month and half after launch is we’ve managed to get a list of participants, but found discrepancies with the press release that remain unexplained. We found some further documents that demonstrate little attention to ethical concerns and no interest in autistic participation, other than as test subjects. There is no information at all on the agreement between participants. Autistica is talking about convening a committee to select a panel, but with a lack of clarity on its composition (it could be made of a minority of autistics from what is currently known) and no information on how any monitoring panel can be effective: this does not bode well.
Update 2018-08-23:
> Requests are handled within 15 working days, unless IMI2 extends this limit
The Innovative Medicine Initiative’s (IMI2) Access to document team has extended its deadline:
Your application is currently being handled. However, we will not be in a position to complete the handling of your application within the time limit of 15 working days, which expires on 21/08/2018.
An extended time limit is needed due to the volume of the relevant documentation, some of which originates from third parties which have to be consulted.
Therefore, we have to extend the time limit for 15 working days in accordance with Article 4(3) of the IMI Governing Board Decision IMI-GB-036-24092008 and Article 7(3) of Regulation (EC) No 1049/2001 regarding public access to documents. The new time limit expires on 11/09/2018.
> Or could there be more than 48 participants?
The ‘further particulars’ linked from the University of Cambridge’s job ad for a Research Associate to work ‘as part of the Cambridge team on the education, communication and stakeholder engagement work package of AIMS-2-TRIALS’ includes in its description of AIMS-2:
It involves 75+ partners across Europe, including academic institutions, industry partners, and charities.
So from 38 logos on the initial publication of the AIMS-2 press release, to 48 on the allegedly authoritative list of participants I received, we’re now jumping to 75+ partners, and that’s just for Europe (i.e., not counting the South African, Israeli and American participating organisations).
This post appeared first on the Participatory Autism Research Collective (PARC) blog.
Written by: Panda Mery, Dinah Murray & Kabie Brook
Last month, the Autism Innovative Medicine Studies-2-Trials (AIMS-2-Trials) was launched as the largest ever grant given to autism research – €115 million, with money coming from the EU, pharmaceutical companies and charities.
A month has passed and little has been clarified about what exactly this project is and what autistic involvement there will be.
The Annual Activity Report 2017 of the Innovative Medicines Initiative describes AIMS-2, under its IMI2 Call 10’ as ‘Personalised medicine approaches in autism spectrum disorders’.
It is no wonder that a project on personalised medicine attracts big pharma. If you take a world-wide prevalence rate of autism of 3%, admittedly a slightly high one but it makes calculations easier, then if a participating lab is trying to develop a drug targeting a third of autistics, that drug could be sold to 1% of the world population.
Confusingly, autism is not listed in the strategic research agenda (SRA) for IMI2. The four major axes of research are listed as:
- Target validation and biomarker research (efficacy and safety)
- Adoption of innovative clinical trial paradigms
- Innovative medicines
- Patient-tailored adherence programmes.
New genomic drugs do fit several of the strategic research agenda items though: biomarkers to identify autistics, trials of innovative drugs… and compliance with treatment.
Autistica stated that it is getting involved to ‘ensure that AIMS-2-TRIALS focuses on community priorities and involves autistic people and families at every stage.’ It is ‘contributing £50,000 in staff time and resources’.
Autistica surveyed the autistic community and published a set of 10 community priorities:
- Which interventions improve mental health or reduce mental health problems in autistic people? How should mental health interventions be adapted for the needs of autistic people?
- Which interventions are effective in the development of communication/language skills in autism?
- What are the most effective ways to support/provide social care for autistic adults?
- Which interventions reduce anxiety in autistic people?
- Which environments/supports are most appropriate in terms of achieving the best education/life/social skills outcomes in autistic people?
- How can parents and family members be supported/ educated to care for and better understand an autistic relative?
- How can autism diagnostic criteria be made more relevant for the adult population? And how do we ensure that autistic adults are appropriately diagnosed?
- How can we encourage employers to apply person-centred interventions and support to help autistic people maximise their potential and performance in the workplace?
- How can sensory processing in autism be better understood?
- How should service delivery for autistic people be improved and adapted in order to meet their needs?
Personalised medicine approaches don’t seem to fit with these community priorities. How will this be reconciled?
Nothing was communicated before the launch, and very little in the last month. Even the initial grant agreement of AIMS-2 is confidential – or at least has not been published so will Autistica be able to hold anyone to account ‘publicly’? Publishing the confidentiality agreement binding them would help instil some confidence in such a statement. In the meantime Autistica shared some explanations:
We had two options – neither of which was ideal: refuse to take part and the bid would have gone ahead but with less autistic involvement and less focus on community priorities; or be involved and make the bid more inclusive, respectful and focused on what matters to autistic people and their families. Making that decision was extremely difficult. We would have been criticised either way, but I ultimately believe that it is better to be in the room than not. [...]
We are creating a Europe-wide representative panel which can hopefully act as an independent voice on the project, make suggestions and consider approach in terms of policy. It’s not ideal as a mechanism for involvement, but it is better than what would have been there if we were not involved.
The ‘we’ is Autistica aspiring to represent autistic people in the context of this vast project. Even though they employ an autistic Director of Science, James Cusack, and even though they have been drawing on more and more autistic support over the last few years, can they possibly get this right? At the moment many of those autistic people –who had for example reviewed research proposals, contributed to discussions, given their time towards projects, suggested lines of research, benefitted from grants, joined Autistica’s Discover network; and felt valued– are suffering a sense of betrayal. Yet in the bigger picture of the AIMS-2, Autistica is positioning itself as delivering our voice to the project.
James Cusack added: ‘I am particularly interested in how we can leverage [that] activity for greater impact.’
This remains very vague. What will be the process to select autistics, what will be their access to AIMS-2 documents and people, what will be their power, what confidentiality agreement will they have to sign, etc. Nothing yet concrete that indicates autistics will have a meaningful voice.
At this point, we need to give Autistica the benefit of the doubt and encourage them to extract the best possible outcome, i.e. to aim as high as possible to get more effective autistic representation and scrutiny on the project.
The panel Autistica mentioned should have access to AIMS-2 information and have a meaningful voice in the project. For instance it should:
On Twitter, Autistica also mentioned:
We’re working with @AutismEurope to ensure that the priorities of autistic people are heard and to catalyse an approach that works for autistic people across Europe.’
This is a concern as Autism Europe is not led by autistics and Autistica should be working with autistic-led organisations in all European countries.
The press release for the launch of the initiative included many statements as to what AIMS-2 is, not all of them consistent, and not all fitting neatly under the personalised medicines approach either. AIMS-2 will:
That press release also hints at autistic involvement:
AIMS-2-Trials brings together autistic people and their families, academic institutions, charities and pharmaceutical companies to study autism and provide an infrastructure for developing and testing new therapies.
The embryonic websites lists some of the partners but not who are these ‘autistic people and their families’. This may come later!
A common statement among autistics is ‘once you’ve met an autistic, you’ve met one autistic’. This is meant to make the point that there’s a strong diversity among autistics. AIMS-2 turns that on its head to raise the prospect of lucrative targeted genomic drugs:
All autistic people are different which makes identifying and testing new therapies challenging. AIMS-2-Trials will take a precision medicine approach aimed at tailoring therapies to a person’s biological profiles. Achieving this will require developing tests that can predict how a person’s autism may progress throughout development and their likelihood of developing additional mental health problems.
Another concern is who are the partners. The press release states that there are 48 partners… and lists the logos of 38. Ten partners are missing. Who are they?
Update 2018-08-02: See the Response from Dr. James Cusack to concerns regarding Autistica’s involvement in AIMS-2 on the PARC blog.
The Home Office ran a consultation last year about changes to the Police and Criminal Evidence Act 1984 (‘PACE’) Codes of Practice. One proposed change was about when does an officer decides a suspect is vulnerable, which triggers the requirement for an appropriate adult (AA) to be present for key aspects of the suspect’s time in custody such as their police interview.
The existing relevant section in the current Code C is:
1.4 If an officer has any suspicion, or is told in good faith, that a person of any age may be mentally disordered or otherwise mentally vulnerable, in the absence of clear evidence to dispel that suspicion, the person shall be treated as such for the purposes of this Code. See Note 1G.
The proposed change was:
1.4 If at any time an officer has a reason to believe that a person is a ‘vulnerable adult’ (see paragraph 1.13(d)), in the absence of clear evidence to the contrary, the person shall be treated as such for the purposes of this Code. See Note 1G.
I had sent in some concerns about that specific proposed update. Here’s the full text of my response:
From my experience as both an Independent Custody Visitor (ICV) and being autistic, I find the proposed change to section 1.4 of PACE Code C particularly concerning.
The change from 'has any suspicion, or is told in good faith,’ to the much higher standard 'has a reason to believe’ means that there would now be a strong presumption against calling an Appropriate Adult (AA) as an officer would have to reach the higher threshold of ‘a reason to believe’ to consider the detainee to be vulnerable and that an AA is needed.
Also disregarding ‘is told in good faith’ would be disempowering for the detainee and start the relationship by showing disrespect. Disabilities can be part of someone’s identity. So for instance no longer accepting an autistic detainee telling a custody sergeant they are autistic ‘in good faith’ would be denying their identity. In addition to the lack of respect, by being adversarial about the detainee’s identity and/or lived experience this might negatively affect cooperation and further stress the detainee.
Such a change to section 1.4 would also affect monitoring of whether an AA is called when one must. ICVs, for instance, wouldn’t be able to ensure that an AA has been called for detainees that appear to them to be vulnerable or tell them in good faith they are vulnerable, as an ICV cannot know the custody sergeant and/or interviewing officer’s belief, which is how a detainee would be deemed to be vulnerable.That what a detainee may say in good faith about their vulnerability would no longer be relevant will mean, if these changes happen, that ICVs will likely encounter situations where a detainee tells the ICVs that their vulnerability has been ignored while the custody sergeant tells ICVs they don’t believe that detainee to be vulnerable, basically creating an impossible situation where a detainee would have to prove their vulnerability to get access to an AA.
The Home Office recently published a summary of the responses it received (pdf). In that document, I’m identified as ‘11. Member of the public – independent custody visitor.’ Here’s the bit about section 1.4:
2.2.2 The main concerns were that certain safeguards for juvenile and vulnerable suspects were not sufficient and respondents proposed a number of further changes to address these issues. [emphasis in the original] These responses argued that:
- the police were not adequately trained to recognise when a suspect needed an appropriate adult;
- the proposal to raise the threshold for determining whether a suspect was vulnerable from ‘suspicion’ to ‘belief’ would exclude many who needed help and should not be implemented;
- [...]
The revised Code C (pdf), taking into account the responses received, has also been published and will come into force 21 days after The Police and Criminal Evidence Act 1984 (Codes of Practice) (Revision of Codes of Practice C, E, F and H) Order 2018 is made. (All the revised PACE Codes are published on the Consulation’s page.) Here’s the final revised text of section 1.4:
1.4 If at any time an officer has any reason to suspect that a person of any age may be vulnerable (see paragraph 1.13(d)), in the absence of clear evidence to dispel that suspicion, that person shall be treated as such for the purposes of this Code and to establish whether any such reason may exist in relation to a person suspected of committing an offence (see paragraph 10.1 and Note 10A), the custody officer in the case of a detained person, or the officer investigating the offence in the case of a person who has not been arrested or detained, shall take, or cause to be taken, (see paragraph 3.5 and Note 3F) the following action:
(a) reasonable enquiries shall be made to ascertain what information is available that is relevant to any of the factors described in paragraph 1.13(d) as indicating that the person may be vulnerable might apply;
(b) a record shall be made describing whether any of those factors appear to apply and provide any reason to suspect that the person may be vulnerable or (as the case may be) may not be vulnerable; and
(c) the record mentioned in sub-paragraph (b) shall be made available to be taken into account by police officers, police staff and any others who, in accordance with the provisions of this or any other Code, are required or entitled to communicate with the person in question. This would include any solicitor, appropriate adult and health care professional and is particularly relevant to communication by telephone or by means of a live link (see paragraphs 12.9A (interviews), 13.12 (interpretation), and 15.3C, 15.11A, 15.11B, 15.11C and 15.11D (reviews and extension of detention)).
See Notes 1G, 1GA, 1GB and 1GC.
...
1.13 In this Code:
(d) ‘vulnerable’ applies to any person who, because of a mental health condition or mental disorder (see Notes 1G and 1GB):
(i) may have difficulty understanding or communicating effectively about the full implications for them of any procedures and processes connected with:
- their arrest and detention; or (as the case may be)
- their voluntary attendance at a police station or their presence elsewhere (see paragraph 3.21), for the purpose of a voluntary interview; and
- the exercise of their rights and entitlements.
(ii) does not appear to understand the significance of what they are told, of questions they are asked or of their replies:
(iii) appears to be particularly prone to:
- becoming confused and unclear about their position;
- providing unreliable, misleading or incriminating information without knowing or wishing to do so;
- accepting or acting on suggestions from others without consciously knowing or wishing to do so; or
- readily agreeing to suggestions or proposals without any protest or question.
...
1G A person may be vulnerable as a result of a having a mental health condition or mental disorder. Similarly, simply because an individual does not have, or is not known to have, any such condition or disorder, does not mean that they are not vulnerable for the purposes of this Code. It is therefore important that the custody officer in the case of a detained person or the officer investigating the offence in the case of a person who has not been arrested or detained, as appropriate, considers on a case by case basis, whether any of the factors described in paragraph 1.13(d) might apply to the person in question. In doing so, the officer must take into account the particular circumstances of the individual and how the nature of the investigation might affect them and bear in mind that juveniles, by virtue of their age will always require an appropriate adult.
1GA For the purposes of paragraph 1.4(a), examples of relevant information that may be available include:
- the behaviour of the adult or juvenile;
- the mental health and capacity of the adult or juvenile;
- what the adult or juvenile says about themselves;
- information from relatives and friends of the adult or juvenile;
- information from police officers and staff and from police records;
- information from health and social care (including liaison and diversion services) and other professionals who know, or have had previous contact with, the individual and may be able to contribute to assessing their need for help and support from an appropriate adult. This includes contacts and assessments arranged by the police or at the request of the individual or (as applicable) their appropriate adult or solicitor.
1GB The Mental Health Act 1983 Code of Practice at page 26 describes the range of clinically recognised conditions which can fall with the meaning of mental disorder for the purpose of paragraph 1.13(d). The Code is published here:
https://www.gov.uk/government/publications/code-of-practice-mental-health-act-1983.
Update 2018-07-14: Following the publication of the The Police and Criminal Evidence Act 1984 (Codes of Practice) (Revision of Codes C, E, F, and H) Order 2018, the revised codes will come into force on 2018-07-31. (On that date, the updated versions will also be added to the Police and Criminal Evidence Act 1984 (PACE) codes of practice web page).
Update 2018-07-31: The National Appropriate Adult Network (NAAN) has published an excellent detailed guide to the PACE Codes changes (PDF).
WhatDoTheyKnow, the website created by mySociety to help make Freedom of Information requests and share the responses, was launched ten years ago. As part of the birthday celebrations, 50 significant news stories that have been uncovered through the site were published.
One of the stories I worked on is featured in the ‘Fact-checking’ section:
Fact-checking
Freedom of Information is one way to counter fake news: it’s great to have facts and figures to link to when the truth is in dispute.
2012
- Information about an incident involving police presence on a mental health ward
- The Voice and the Independent ran this story of the siege and subsequent ‘racist cover-up’.
Very happy birthday to WhatDoTheyKnow!
