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.
The HRA is one of a number of bodies responsible for the regulation and governance of health and social care research in the UK. Our primary role is to protect and promote the interests of patients and the public in research.
Researchers wanting to undertake a study apply to us for HRA Approval, which includes independent Research Ethics Committee (REC) opinion.
The HRA is the appointing authority for RECs in England. We are responsible for setting up and running RECs as well as appointing members, and it is the members’ responsibility to consider the ethics of a research application. RECs are made up of volunteers. They are a mixture of experts such as doctors and lay members who are not healthcare professionals. This balance is a legal requirement.
The Spectrum 10K study has received all relevant approvals, including a favourable ethical opinion from a REC.
When concerns are raised with us about a study which has been approved by the HRA, they are overseen by a group of senior staff. This group includes the Chief Executive of the HRA, the Head of Corporate Governance and the Director of the Approvals Service. The group must first establish whether this is a complaint about the HRA, for example that we did something wrong, or about a study. If it’s the latter, then we need to make sure that the concerns raised are within the remit of the HRA. We then investigate concerns either in line with our Complaints Policy or our third party complaints procedure. We publish these policies and procedures on our website so that people communicating with us know what to expect.
Our investigation might include reviewing the documents submitted by the study team and that were used to make the ethics decision. We may talk to staff and the volunteer REC members involved in the review, and usually contact the study team to ask questions about the concerns raised. We contact the complainant to let them know we have received their complaint and when they will hear the outcome of our investigation. Depending on the type of study and the type of complaint, we may also need to work with other regulators.
In the case of serious concerns, for example if new information comes to light, the REC can suspend or withdraw its ethics opinion to give it time to consider this information. Favourable ethics opinion is a legal requirement of research studies involving NHS patients, their tissue or their data, so in this case, the study would need to be paused until a new opinion was in place.
We have received both complaints about the HRA’s approval of the Spectrum 10K study and concerns about the research itself and we are now working to understand all aspects which are within the remit of the organisation. We commit to a transparent investigation and will publish our findings on our website, following the same process as other complaints and concerns.
Last week the Spectrum 10K team announced that they had voluntarily paused the study so that they could consider concerns raised with them. This does not change our process for handling the concerns raised with us, but recognises that participants’ rights and wellbeing should always be at the heart of a research study. We commit to working closely with the study team in the coming weeks.