This site uses cookies. By continuing to browse the site you are agreeing to our use of cookies.

Spectrum 10K, how the HRA manages your feedback

Last updated on 13 Sep 2021

The Health Research Authority (HRA) has received a number of questions and concerns about the Spectrum 10K research study. The study, being led by the University of Cambridge, the Wellcome Sanger Institute and the University of California Los Angeles and funded by the Wellcome Trust, 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. It intends to recruit 10,000 people to take part.

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.

Back to news & updates