Spectrum 10K, how the HRA manages your feedback

13 September 2021

We are continuing to investigate the issues raised with us about the Spectrum 10K study. We have collated the concerns to identify the ones that are within our remit and contacted the people who wrote to us to check that they are happy that we share their concerns with the study team. This is a key part of the work to identify whether there have been failings in our processes, or on the part of the study team.

We have reviewed the study documentation. The Spectrum 10K study was approved by a Research Ethics Committee in England and a second committee in Scotland. This is because whilst most research approvals apply across the four nations, research involving adults lacking capacity to consent is covered by different legislation in Scotland than it is in England and Wales. We are working with our partner organisations in Scotland as part of our investigation.

We have written to the study team with the concerns raised with us and have asked them to reply. This doesn’t mean that they have done anything wrong, but is the way that we manage complaints in line with our process. We understand that people who have raised concerns are waiting for an answer to the points raised, but it’s important to fully investigate whether anybody involved in the study, including the HRA, could or should have done anything differently, and this takes time.

The research team took the decision to voluntarily pause the Spectrum 10K study when concerns were raised with them so that they could be fully considered. This is good practice. Such a pause (or resuming the study after such a pause) is a substantial amendment to an approved research project and was reviewed by a Research Ethics Committee. We are also in contact with the study team so that we are ready to review Spectrum 10K again if we are asked to.

There has been and continues to be significant media and social media coverage of the Spectrum 10K study. Not all of this has been entirely accurate, and some has used language which could be distressing. We need to wait until our investigation is complete to be able to fully comment on the study. When we have a full conclusion we will publish it on our website, as well as sharing it with those who raised concerns with us.

Update 29 November 2021

The Queen Square REC, which issued the favourable ethics opinion for the Spectrum 10K study, has reviewed the feedback and concerns raised with us about the study. This review is in line with our Standard Operating Procedures.

As a result, the REC has requested further information from the research team, including an update on the progress of the consultation they are undertaking with the autism community. The REC has also requested some changes to the supporting documentation for the study.

The HRA and the REC have also reflected on the ethics opinion issued to the study in June 2020.

While the original opinion, which was issued after a thorough review of the study and extensive dialogue with the researchers, still stands, 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.

We are continuing to liaise with the research team, and hope to be able to provide a further update no later than Tuesday 21 December.

We will publish a full report on the outcome of our investigation into complaints and concerns raised when this is complete.

Update 20 May 2022

You can read our full update.

In summary

Our previous statement set out that we were of the view that 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:

1. Concerns that have been raised with the research team about the conduct of the study’s ambassadors have not been addressed.
2. The history and affiliations of the research team includes collaboration with geneticists working in the field of curing autism.
3. The project team have ignored concerns raised by autistic people and autistic voices do not appear to be centred in the study.
4. Support and information have not been provided to autistic people who may have been triggered by the nature of the study.
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.
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.
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.
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.
9. 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 has also used the pause as an opportunity to involve more people in a wider consultation.
• The REC is supportive of the researchers’ proposal to undertake further engagement with the autism community and has 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.

Update 30 January 2025

The Spectrum 10K study has been paused since September 2021 while a consultation was carried out by an independent company.

The Spectrum 10K team have now informed us they are closing the study.

The study aimed to investigate the genetic and environmental factors involved in autism and better understand the physical and mental health challenges that autistic people face. It was run by the Autism Research Centre at the University of Cambridge and funded by the Wellcome Trust.

The study received a favourable opinion from the London Queen Square REC in June 2020 and was also approved by a second committee in Scotland in October 2020. This is because whilst most research approvals apply across the four nations, research involving adults lacking capacity to consent is covered by different legislation in Scotland than it is in England and Wales. The study started in August 2021.

Concerns were raised by autistic people about the study, with specific concerns raised directly with the HRA regarding a number of issues that they felt should have been considered as part of the REC’s ethics review. The concerns and our response are all detailed in previous updates in this section of the HRA website.

The Spectrum 10K study was voluntarily paused by the research team, so that a consultation could be carried out by an independent company. This is good practice and constituted a substantial amendment to the study.

The consultation process took two years and in the time since, the research team have been reflecting on the results of the consultation and exploring the practicalities of a redesign.

The Spectrum 10K team have made the decision to close the study as since the initial grant application was written five years ago, autism research has advanced considerably and there are now bigger genetic and health databases to support research in this area. The research team now plans to look for other ways to conduct research to better understand the physical and mental health of autistic people.

The full consultation report and further information is now available on the Autism Research Centre website.

The HRA understands the decision to close the study, and supports the publication of the consultation report so that the learnings and feedback are shared for the benefit of others. We are also pleased to hear that the Autism Research Centre is committed to embedding the learnings from the consultation into their future research proposals, and support its reasons for conducting further research into autism and health for the benefit of future generations.