Earlier this year concerns were raised with us about the study Inpatient Safety in Mental Health.
The study was reviewed by the Health and Social Care B Research Ethics Committee (REC) in October 2021. It had Proportionate Review, an ethics review process designed for studies which pose no material ethical issues.
The study received this type of review because the research team told the committee that they would only be analysing anonymised data already collected as part of routine care for the study participants. This approach would not pose material ethical issues because the data is anonymised.
It is the responsibility of the sponsor and applicant to give the committee accurate information about the study to ensure they are considering every aspect before giving an ethical opinion.
Following the Proportionate Review the study was approved and given a favourable ethical opinion.
The concerns raised with us were about how some of that data would be collected, using Oxevision, a vision-based patient monitoring system used by multiple NHS Trusts in mental health wards. They raised concerns that the data collected in this way would not be anonymised.
When concerns are raised with us about research that has been reviewed and approved by a Research Ethics Committee appointed by the HRA, we investigate them using our third party complaints process.
Our investigation might include reviewing the documents submitted by the study team that the REC used to make its 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 can only review issues raised that are within our remit, and act within our powers. The HRA doesn’t have any authority to go and audit or inspect studies when people tell us about breaches of the research protocol, conditions of research approval or where they’ve heard about activity which doesn’t comply with the principles of good clinical practice. However, our Standard Operating Procedures say that a REC can review its favourable ethical opinion of a study in light of concerns raised, where these concerns present relevant new information, not originally considered by the REC.
In August 2024, the Health and Social Care B REC reviewed the concerns raised with us about the study, alongside the documents which had been submitted ahead of the first proportionate review back in 2021.
The committee noted that the complainants had provided evidence that the Oxevision monitoring system was not anonymous in the way they had understood during their first review.
Ethics review is dependent on the information submitted by the research team, and the committee said that they would not have given a favourable opinion had they been aware that the images were not truly anonymous.
The sponsor of the research study has been given chance to respond to the concerns of the REC, which it has done, but it has not reached agreement with the committee on whether the images (data) being collected are anonymous.
For this reason, the Health and Social Care B REC has suspended its favourable ethics opinion of Inpatient Safety in Mental Health. This means that the study needs to be paused until a new opinion is in place.
We have written to the research sponsor, and to our complainants.