Concerns about Spectrum 10K: Common Variant Genetics of Autism and Autistic traits (REC reference 20/LO/0873)
The Health Research Authority (HRA) has received a number of questions and concerns about the Spectrum 10K research study, which 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.
We previously set out in September 2021 that we were of the view it would be helpful for us to consider the concerns that had been raised together. The specific concerns that have been raised with us are that:
- Concerns that have been raised with the research team about the conduct of the study’s ambassadors have not been addressed.
- The history and affiliations of the research team includes collaboration with geneticists working in the field of curing autism.
- The project team have ignored concerns raised by autistic people and autistic voices do not appear to be centred in the study.
- Support and information have not been provided to autistic people who may have been triggered by the nature of the study.
- The information contained in the Patient Information Sheet (PIS) and consent form is unclear and there is a lack of clarity as to how data that is obtained will be used.
- There is a discrepancy between the stated aims of the trial and the methodology it uses, with it being unclear why the collection of DNA is required to accomplish the aims of the trial.
- It is unethical to collect and store a huge body of genetic data pertaining to a marginalised group and there are a lack of safeguards protecting how the data may be shared and used in the future.
- The consent process for young people or those who require carers does not allow them to make an informed decision about the holding of their genetic information and the withdrawal policy does not allow for the complete removal of a participants data should they choose to withdraw from the study when they reach the age of consent.
- Previous requests to withdraw data from the study have not been actioned.
These concerns have been considered in accordance with the HRA’s 'Policy and procedure for managing complaints relating to third parties'. Our response is as follows:
- Our investigation of the issues raised has included us liaising with the study sponsor and the Queen Square Research Ethics Committee (REC) which issued the favourable ethics opinion for the Spectrum 10K study. REC members were specifically asked to consider issues relevant to the ethics reviews of the study. The REC has also reflected on its favourable ethics opinion for the study in light of the concerns raised.
- Whilst the original ethics opinion, which was issued after a thorough review of the study and extensive dialogue with the research team, still stands, the committee has requested further information that they consider important to facilitate progression of the study.
- As you will be aware, when the concerns were initially raised with the study team, they took the decision to voluntarily pause the Spectrum 10K study so that the issues raised could be fully considered. This is good practice. We understand that the study team have also used the pause as an opportunity to involve more people in a wider consultation.
- The REC are supportive of the researchers’ proposal to undertake further engagement with the autism community and have specifically requested that the researchers work with representatives from the community to receive input on how the design and conduct of the research can be amended.
- The views of the public and research participant community are extremely important as part of fulfilling our role to ensure that the rights, safety, dignity and wellbeing of participants are respected and to promote high quality, ethical research. This is underlined in our commitment to investigate studies if complaints or concerns are raised with us at a later point.
1. Concerns that have been raised with the research team about the conduct of the study’s ambassadors have not been addressed.
- Whilst the issues raised regarding the conduct of the study’s ambassadors are the responsibility of the sponsor to address, the HRA was keen to ensure that the study team were aware of these concerns and that action would be taken to respond to the issues raised.
- The sponsor has informed us that they are aware that some people felt hurt or insulted by comments made by study ambassadors shortly after the launch of the study, and can see that certain Twitter posts have been interpreted by some people as being racist or transphobic.
- Whilst the ambassador concerned has assured the study team that this was not their intention, they have been reminded of the need to be respectful and to maintain high professional standards. The ambassador has also been asked to remove their ambassador status from their social media profiles in order to distinguish between their private views and those associated with the project.
- The sponsor is in the process of developing clearer guidelines, which will ensure that in the future collective values, responsibilities and expectations are well-defined in terms of what it means to be an ambassador for Spectrum 10K. They also recognise their responsibility, as sponsor, to safeguard the wellbeing of ambassadors who have reported that they have received online abuse.
- The sponsor has apologised and acknowledges that their response to the concerns raised fell below appropriate standards.
2. The history and affiliations of the research team includes collaboration with geneticists working in the field of curing autism.
- As part of our consideration of the concerns raised with us, we asked the sponsor if:
- Any members of the study team had published opinions or were conducting research that conflicted with the aims of the study.
- The study team had links to the development of Applied Behaviour Analysis (ABA), Cure Autism Now or Autism Speaks as specific concerns had been raised with us about both these organisations and the development of ABA.
- The sponsor has stated that no member of the research team has published opinions or is conducting research that contradicts the aims of Spectrum 10K.
- However, they do believe that aspects of some published articles have been misinterpreted or taken out of context, with some people incorrectly believing that the researchers are seeking a prenatal test for autism as a way to prevent autistic babies from being born in the future.
- The sponsor states that it is important to note that the study’s Principal Investigators (PIs) make a distinction between autism and severe neurodevelopmental disorders, the latter being disorders in which the individual may have developmental delays, intellectual disability, epilepsy, and/or motor coordination difficulties, as well as potentially impaired development of other organs. They believe that it is important to distinguish seeking a cure or treatment for such co-occurring conditions, from seeking a cure or treatment for autism itself. They would like to be clear that none of the PIs support seeking a cure or prevention of autism.
- The sponsor has informed us that neither the Autism Research Centre (ARC) nor Professor Baron-Cohen have links to ABA, with Professor Baron-Cohen having written against ‘radical behaviourism’ (of which he would see ABA as one example) as far back as 2014.
- The sponsor has explained that in the 1990s Dr Geschwind chaired Cure Autism Now’s (CAN) scientific advisory board as a neurologist. His research was never funded by CAN, nor did he receive money from CAN for his involvement. Whilst CAN was committed to broadening awareness and understanding of autism, language, concepts and priorities of the autism community have changed over time and the aims stated by CAN nearly 20 years ago are not in line with the aims and values of Spectrum 10K, which Dr Geschwind shares.
- We have been informed that when Autism Speaks took over CAN, Dr Geschwind was on its Scientific Advisory Board. However, he has not been involved with Autism Speaks for over a decade.
- We have also been advised that the ARC and Prof. Simon Baron-Cohen, along with approximately 50 organisations across Europe including other UK universities, are involved in a study called AIMS-2-TRIALS, which receives some support from Autism Speaks. A predoctoral fellowship that ended in 2012, ‘Hypersensitivity in autism: a psychophysiological and neuroscientific approach’ was funded by Autism Speaks.
- Additionally, researchers at the ARC have used pseudonymised genetic and questionnaire data collected as a part of the Autism Genetic Resource Exchange (AGRE), a database funded by Autism Speaks. As a part of Spectrum 10K, researchers plan to analyse summary genetic data from multiple datasets, which, subject to approvals, will also include data from AGRE.
- The sponsor has stated that the Spectrum 10K team and the ARC are ethically opposed to any form of eugenics, believing that autism is an integral part of human neurodiversity.
- The suitability of the Chief Investigator to conduct the research and the potential for conflicts of interests are considered by the REC as part of the ethics review. There were no concerns raised by the Committee in relation to the appropriateness of the investigator.
3. The project team have ignored concerns raised by autistic people and autistic voices do not appear to be centred in the study.
- The study team have advised us that feedback obtained over the last two and half years from an Advisory Panel made up of autistic people, parents and carers of autistic children, clinicians, and autism charity representatives has helped shape the study.
- They have also highlighted that the statement released by Prof. Baron-Cohen on behalf of the Spectrum 10K team on 10 September 2021 acknowledged that the team have heard the concerns that have been raised, and that the study has been paused in order for a meaningful consultation with the autism community to be co-designed.
- Since pausing the study, the study team have begun planning the co-design of a wider consultation and they hope that several different stakeholder groups will be involved in the decision making about this. The study team have stated that they will be transparent about the process and goals of both the consultation co-design, and the consultation itself.
- In light of the concerns raised, the REC had previously informed the research team that involvement with the wider autistic community should be undertaken to receive input on how the design and conduct of the research could be amended. The HRA is committed to supporting and encouraging researchers to involve the public in their work and the REC was pleased with the approach of pausing the study to undertake this consultation.
4. Support and information has not been provided to autistic people who may have been triggered by the nature of the study.
- Spectrum 10K have apologised unreservedly for any distress caused to the autism community. They have stated that there are links on their website to charities and support groups for the autism community should they feel distressed.
- They have also informed us that listening to, and discussing the concerns raised by some people in the autism community and ensuring that they signpost people to appropriate support where it is needed will be fundamental during the consultation.
- The sponsors proposed approach has been notified to the REC. As set out below, the REC is not yet satisfied that sufficient support and information has been provided to those who may be trigged by the nature of the study. The REC has therefore asked that the study team ensure that contact details for support organisations that the reader can contact should they become distressed at any point during or after the research (even if they choose not to participate in the research) are included in the study documentation.
5. The information contained in the Patient Information Sheet (PIS) and consent form is unclear and there is a lack of clarity as to how data that is obtained will be used.
- The sponsor has apologised that they have not been clear enough in communicating the aims of Spectrum 10K to the autism community, they recognise that this has led to confusion and misunderstanding.
- The consultation process will provide a further opportunity to ensure that the wording of the participant facing documents and materials is clear and transparent.
- Any significant changes to participant facing materials will also need to be submitted to the REC as a substantial amendment and will require a favourable ethics opinion before the changes can be implemented.
6. There is a discrepancy between the stated aims of the trial and the methodology it uses, with it being unclear why the collection of DNA is required to accomplish the aims of the trial.
- The sponsor has agreed that they could have been much clearer when explaining the aims of Spectrum 10K for members of the public and this will be addressed during and after the consultation.
- They have explained that the study had been designed to achieve the aim set out on the Spectrum 10K website, to understand how biology and experiences shape wellbeing for autistic people by combining genetics (which is why DNA samples are needed) with other data, such as questionnaires.
- They view understanding the genetic basis for autism as being the first step in developing a better understanding of why some of these genes also cause chronic health conditions experienced by many autistic people. They have stated that the inclusion of genetic information enables them to understand the links and do much more than they could without this information. Furthermore, they believe that these findings can be used in future research to develop treatments for co-occurring conditions and eventually offer the right support and care to those autistic people who need it.
- The sponsor has informed us that they understand why it is felt that there is a lack of clarity as to who future collaborators may be. They have informed us that any applications from potential collaborators to access data from the study will be vetted by a Data Access Committee who will decide whether researchers are granted access to the data.
- As part of the consultation, the membership and structure of the Data Access Committee, its methodology, decision-making processes, and parameters under which data sharing will occur, will be agreed. Whilst it will not be possible to know in advance which future collaborators may approach the study team, the parameters of involvement will be clearly defined. The website and study documentation will be updated to reflect this.
- The sponsor’s proposed approach has been notified to the REC who have asked that they be provided with a copy of the Terms of Reference for the Data Access Committee when it is available. The REC have also requested that the research team publish a summary list of projects which plan to use the data, thereby ensuring that this information is available in the public domain and that the information provided to participants is transparent regarding how their data might be used
- In relation to concerns that the study documentation does not explain the aims of the grant awarded to the researchers, and in turn the grant award summary does not mention the published aims of the study, to improve autistic people’s wellbeing, the sponsor has informed us that they would like to clarify that the published aims are focused on understanding wellbeing. Where wellbeing is mentioned throughout their website and documentation, it is in relation to understanding how biology and experiences shape wellbeing. They see this type of research as forming an important early step in providing evidence that can be used to improve wellbeing in the future, with the direct improvement of wellbeing being outside of the scope of the current research grant.
- They have also asked that it be noted that this is a very early summary, written before the name Spectrum 10K had been decided. Some aspects of the study evolved further after it was written, following consultation with the Advisory Panel and additional ‘wellbeing’ measures, including those relating to quality of life, self-medication, and strengths of autistic people have since been included. Additionally, in response to the pandemic finding that autistic people had poorer outcomes related to COVID-19, measures were added to collect more information relating to this topic.
7. It is unethical to collect and store a huge body of genetic data pertaining to a marginalised group and there are a lack of safeguards protecting how the data may be shared and used in the future.
- The sponsor has advised us that they do not believe that it is unethical to collect genetic data from autistic people if the intention of collecting the data is to increase understanding about which genes influence particular outcomes. They believe that this will ultimately lead to better help and support for those who need it in the future.
- The study team have stated that they intend to co-design a data sharing policy with the autism community. They have set out how data sharing is important in research, enabling advancements in science and medicine and for different researchers to utilise their expertise when analysing it. Many funders, including the Wellcome Trust who fund Spectrum 10K, require data sharing for this purpose.
- The sponsor has also informed us that the security of data is their highest priority. All participant data collected through the study website are pseudonymised, registered with a unique study ID. and stored separately from personal data. The sponsor has advised us that any data that NHS Digital shares from medical records will be anonymised and again stored separately from personal data and we will be requesting further clarification around this.
- The sponsor has also advised us that data are stored on secure servers that are only accessible by approved Spectrum 10K researchers.
- As set out above, any applications by potential collaborators to access data from the study will be vetted by a Data Access Committee who will decide whether researchers are to be granted access to the data. The study team have also informed us that ethical approval would need to be obtained for individual projects to use the data. They believe that whilst it is not possible to know in advance which future collaborators may approach them, or for what purposes, it is possible to clearly define parameters of involvement.
- The sponsor has stated that data will not be shared for the purpose of developing a prenatal test for autism or a cure for autism.
8. The consent process for young people or those who require carers does not allow them to make an informed decision about the holding of their genetic information and the withdrawal policy does not allow for the complete removal of a participants data should they choose to withdraw from the study when they reach the age of consent.
- The sponsor has advised us that Spectrum 10K has included child assent as part of the sign-up process and participants who turn 16 during the study will be asked to consent and confirm they are happy to continue to participate. This is in line with the principles of good clinical practice. They anticipate that the consent process will be discussed during the consultation and hope that study documentation can be made clearer to address this point.
- The sponsor has also explained how it is important that the data within the study and results of the study are verifiable. Part of this relates to how data is collected and stored following participant withdrawal. They have advised that they will discuss this topic with relevant ethics and governance bodies to ensure these concerns are addressed while working within UK governance and legislative frameworks.
9. Previous requests to withdraw data from the study have not been actioned.
- Whilst issues relating to requests for participants to withdraw from the study are a matter for the sponsor, we were keen to ensure that the study team were aware that such concerns had been raised with us and that action would be taken to respond to the issues raised. However, if you have any evidence that suggests that the appropriate action has not been taken, we would be grateful if you could advise us accordingly.
- The sponsor has advised us that all requests to withdraw from the study have been actioned and individuals will have received formal confirmation of withdrawal. For those participants who have requested “No further use” as part of confirmation of how their data will be managed following their withdrawal, any samples submitted have been destroyed.
10. Additional information requested by the REC
- As set out above, the Queen Square REC, which issued the favourable ethics opinion for the Spectrum 10K study, reviewed the concerns relevant to the ethics review of the study. The REC also reflected on its favourable ethics opinion for the study in light of the concerns raised.
- Consequently, the REC requested that further information, and some changes to the supporting documentation, were taken forward by the study team. The REC has also asked that the study team keep them informed as to the progress and outcomes of the consultation with the autism community.
- When RECs provide an ethics opinion on research proposals, this is based on the members being assured that a research project conforms to recognised ethical standards and that the research team is suitably qualified to undertake the project. The REC reviewed this study on the basis of the information provided to it, including the assurances about public involvement. The REC is not in a position to investigate the accuracy of the information presented and therefore on that basis considered that the original study should be given a favourable opinion.
- The REC is disappointed to hear that the assurances it had originally taken about how the study had been developed and designed were misplaced, and that there were in fact wider views that had not been fully addressed. Therefore, the REC is pleased that further work is being done and it has advised the researchers on actions that could help to achieve public confidence.
- We acknowledge that some of the information that the REC has requested relates to areas of the application which could have been considered in further depth as part of the original ethics review in June 2020.[JM1] As noted later, there is a separate process of reflecting on any lessons for the REC to learn from this case.
The further information which the REC has requested from the study team and sponsor and the responses received so far is as follows:
a) Feedback from relatives of adults lacking capacity who have used the tool for assessing capacity or a review of the tool and associated material by an appropriate patient and public involvement group, in order to confirm it is understandable and clear.
- The sponsor has confirmed that they will be happy to seek feedback on the tool.
b) Consideration as to additional support that can be provided to relatives to ensure they are clear on what is meant by capacity and how it is assessed (e.g. including a short instructional video on the registration page for the assessment tool).
- The sponsor has confirmed that these additional suggestions will be included in the consultation.
c) Confirmation as to whether the capacity assessment tool could be formatted so that, depending on what responses are selected by the relative, it will automatically state at the end of the tool whether the individual can be considered as having capacity to consent based on the responses selected, with the reasons why highlighted if the person is deemed to lack capacity.
- The sponsor has advised that the tool will be amended to ensure that it explicitly outlines the reasons, as well as the final decision. Furthermore, after every question, if the tool deems that the participant has capacity to consent to the study on their own, or that their participation is inappropriate, a message will be displayed to that effect.
d) Clarification as to what proportion of the participants currently recruited to the research lacked capacity and required the advice of a consultee.
- The sponsor has advised that before Spectrum 10K was paused, 99 people registered as carers of an autistic adult with intellectual disability who lacked capacity to consent for themselves. This proportion is 2.2 per cent of the 4,388 participants who registered and consented to take part in the study.
e) An estimation of what proportion of the 10,000 individuals that would be recruited to this research would lack capacity to provide informed consent.
- The sponsor has advised that based on the current proportion of adults who registered with Spectrum 10K, they estimate that around 200 (2.2 per cent) of participants would fall into this category. However, they are aiming to recruit a higher number than this to ensure sufficient statistical power to detect a significant result when investigating this cohort.
- The REC has requested that some further context be provided in relation to this. i.e. what percentage of participants in this group, on average, would lack capacity and how the current recruitment sample reflects that.
- The REC has also asked that the sponsor clarify how much higher the recruitment figure needs to be in order to be statistically sound, defining how many participants they anticipate they will need, to ensure that they do not recruit more participants who may lack capacity than required.
f) Clarification as to whether it is still anticipated that it is necessary to involve adults lacking capacity in order to address the aims of the research.
- The sponsor has advised that the inclusion of autistic adults without capacity to consent to participate in this research is important, as it ensures a study population which is fully representative of the autism community and their diverse support needs. They believe that it will also help improve understanding of the relationship between autism and other developmental disabilities and co-occurring health conditions.
- The sponsor has also highlighted that adults without capacity to consent to complex research studies are under-represented in research, meaning that research results fail to reflect the needs of this group, and fewer treatment and support options are developed.
g) Clarification regarding whether the researchers still anticipate that they would need to recruit 10,000 participants to answer the research question, and whether this is achievable.
- The sponsor has advised that a recruitment target of 10,000 autistic individuals was selected for a number of reasons including statistical power and practical feasibility. Furthermore, there is currently no large-scale dataset of this type based on UK participants and globally, there are very few datasets that include questionnaires and performance measures covering as wide a range of topics with links to genetic data and electronic health records.
- The sponsor believes that by combining the genetic data with other data, the Spectrum 10K dataset will provide a better understanding of the underlying genetics of autism and a wide range of co-occurring health conditions. Furthermore, with consent, they will be able to contact participants in the future, if additional research opportunities arise.
- The sponsor believes that this is an achievable target based on participation numbers during the study launch and cohorts that have participated in other studies.
h) Consideration as to whether it would be feasible for capacity assessments to be undertaken by professionally trained individuals and if decreasing the target size to allow for this whilst still being able to address the research question be a potential solution.
- the sponsor has advised that they will review whether it would be possible for the capacity assessments to be undertaken by professionals, as described in their response to the next question. They have also stated that for the reasons outlined in the previous question, reducing the recruitment target is not a feasible solution.
i) Would it be possible for those identified as potentially lacking capacity by relatives to be seen in person and assessed by professionally trained staff?
- The sponsor has advised that prior to the study launch, some sites had already agreed to provide assistance with the process, but this has been limited by resources at each site.
- The sponsor is also aware that requiring a visit to an NHS setting rather than online participation, particularly where this is some distance away, may decrease the number of participants in this group and therefore the representativeness of the sample achieved. However, due to COVID-19, many health professionals have begun providing services online and the sponsor will explore whether this is an additional option.
- The REC have asked the research team to explore whether an online assessment would be suitable, given the complexities of such an assessment and that it is very difficult to assess someone’s capacity if you cannot see them.
j) Clarification regarding whether there are any additional measures in place to confirm that individuals that complete the registration form themselves possess capacity (as individuals may have fluctuating capacity that could mean they complete the form but should still have a consultee identified/approached)
- The sponsor agrees that these are important considerations. Fluctuating capacity was addressed as part of the original ethics application. In line with the Mental Capacity Act, it should be assumed that a person has the capacity to make a decision themselves about whether or not to consent to participate, unless it is proven otherwise, they therefore do not confirm capacity to consent for those who register.
- The capacity assessment confirms the capacity of the person to understand and make the decision to consent and take part in the research study at the time of the decision.
- In the Capacity Assessment Tool, consultees are asked ‘can the decision be put off until such a time as the person regains capacity?’ If the answer is ‘yes’, the relative is not permitted to continue with registration.
- Participant information sheets and consent forms have been created for circumstances when an individual registered by a consultee regains capacity to consent to participate. In that circumstance the re-consent of the individual who has regained capacity is requested.
- In the event that the team is notified that an existing participant has subsequently lost their capacity to consent to participate, they will work to identify a consultee to discuss any further participation.
- The REC has subsequently asked that in the scenario where the participant lacked capacity at the outset but regained capacity at a later point in time, whether consultees would be instructed to inform the researchers of this and whether this instruction was included in the information for consultees with advice on how to go about this.
- The REC has also highlighted areas of concern regarding instances where capacity might fluctuate and have requested further clarification from the sponsor.
k) What measures are (or could be) taken in this research to ensure that attempts are made to identify appropriate personal consultees (who are familiar with the potential participant and have their best interests as the main priority) before approaching a nominated consultee.
- The sponsor has advised that all consultees are asked to state their relationship to the adult they are registering, and measures have been agreed with participating NHS sites, that the care team must identify a consultee in line with the Mental Capacity Act. This ensures that there is a safeguard such that any nominated consultee is required to contact the research team to discuss the availability of a personal consultee prior to registration being finalised. At the point when Spectrum 10K was paused, no nominated consultees had signed up, all consultees were either parents or guardians.
l) Clarification regarding whether ‘paid carers’ refers solely to individuals professionally employed to provide care for the potential participant (i.e. no personal relationship with them) or if this term also encompasses relatives/friends that are receiving a carers allowance.
- The sponsor has advised that in the current study protocol, “paid carers” refers to individuals employed to provide care for the individual and not relatives or friends who are in receipt of the carers allowance. The REC noted that that the original submission was not clear that paid carers related to people employed to look after the participant and requested that the researchers remove paid carers from the study.
m) Details regarding how many participants have been recruited so far based on advice from paid carers and how many based on advice from personal consultees.
- The sponsor has advised that so far, all 99 participants without capacity to consent to participate in the study have been recruited based on advice from personal consultees.
n) In light of the concerns received, the Committee has requested that a number of changes are made to the participant and consultee informed consent documents:
- documents to reflect the potential for participants to become distressed during the research.
- contact details for support organisations that the reader can contact should they become distressed at any point during or after the research (even if they choose not to participate in the research).
- text detailing what measures the researchers will take in the event that during the research they become aware that an individual’s safety, rights, wellbeing or health is at risk.
- participant facing documents to clearly explain what is involved in the planned commercial use of the data (i.e. who the data will be provided to, whether it will be at all identifiable, the security measures in place to protect the confidentiality of the data, what the data will be used for, any potential financial gain for the sponsor from this use of the data).
- documents to be reviewed to ensure the information is clear to the target population and input is sought from public and patient involvement groups in reviewing the clarity of the participant and consultee facing documentation.
- informed consent documents to be reviewed to ensure the anonymity of the samples is accurately described for the reader, with the documents describing who will have access to identifiable data (i.e. fully identifiable and pseudo-anonymised) and up to what point the participant/consultee will be able to request their/their relatives’ samples be withdrawn.
o) That the participant/consultee facing documents be reviewed to ensure that the research specifies precisely what the samples and data collected for this research will be used to investigate and that all optional uses of samples/data (e.g. use of samples in future research) be clearly marked as optional in the information sheets and consent forms.
- The sponsor has advised that with hindsight, they recognise that their information was not sufficiently clear in this area. They have apologised for this lack of clarity and are committed to addressing it with the autism community during the consultation.
- Any applications by those wishing to access Spectrum 10K data will be vetted by a Data Access Committee, who will decide which researchers are granted access to the data. However, before such access could take place, the requesting institution will be asked to obtain ethical approval, at which point the University of Cambridge will put in place a formal and legally binding data transfer agreement.
- The study team believe that whilst it is not possible to know in advance which future collaborators may approach them, or for what purposes, it is possible to clearly define parameters of involvement.
- The REC have asked to be provided with a copy of the Terms of Reference for the Data Access Committee when this is available and also requested that the research team publish a summary list of projects which plan to use the data so that this information is available in the public domain as well as ensuring that the information provided to participants is transparent regarding how their data might be used.
p) Clarification regarding whether there were any measures that could be put in place to ensure that only individuals with autism are able to take part in the research.
- The sponsor has asked us to note, for clarity, that the study is also open to non-autistic family members of autistic participants. Anybody registering to participate as an autistic person is asked to provide a page of a clinical report confirming their diagnosis. If they indicate that they are not able to provide this information, this will be recorded, and the information included in data analysis.
q) After considering the number of complaints which had been submitted, and the nature of these complaints, the REC requested that as well as responding to the points raised by the REC and HRA, the research team also engage with the wider autistic/medical community (e.g. patient and public involvement groups) to receive input on how the design/conduct of the research should be amended to address the concerns raised.
- The sponsor is in agreement that that this is necessary, and the study has been paused whilst they co-design a consultation with the autism community. This consultation is currently planned to take place in three phases:
- Phase 1: Planning the co-design process.
- Phase 2: Co-Design of the Consultation - a series of meetings to decide a general plan for the consultation and to incorporate ideas from Phase 1.
- Phase 3: Consultation
- The sponsor has undertaken to notify the REC and HRA about progress at each stage of the consultation.
The sponsor has informed us that they are grateful to the autism community for raising each of these important issues and appreciate the opportunity to provide further clarification, prior to the Spectrum 10K consultation, which will allow more in-depth discussion.
Whilst the study remains paused, we remain in contact with the study team in relation to the additional information that has been requested by the REC, this includes updates on the progress of the consultation that is being undertaken. It also enables us to ensure that we are ready to review the study again if we are asked to.
As part of our consideration of the issues raised, the HRA and the REC have also reflected on the ethics opinion issued to the study in June 2020. Whilst the original opinion, which was issued after a thorough review of the study and extensive dialogue with the researchers, still stands, we believe that some of the issues raised as part of the complaints process could have been considered during the original review.
In light of this, we have committed to identify if there are any areas of learning that could be shared with RECs more widely to assist with future review processes. Furthermore, we will be conducting an internal review of the original REC review, this will assist in our reflection on the lessons that can be learnt from our review of this study.