Update for REC members in England and Wales
30 June
Request for Further Information (RFI) and Ethics Review Form (ERF) recommendations
When a Research Ethics Committee (REC) decision is shared with an applicant the Health Research Authority (HRA) ask them to share feedback in a user satisfaction survey.
The HRA regularly received feedback in this survey that the Requests for Further Information (RFI) could be clearer.
This includes requests for clarity, justification of the points raised and requests for changes to study documents.
When a REC reviews an application or amendment it is important to ensure that the HRA can communicate the outcome of the ethics review clearly and accurately to the applicant.
When the applicant understands the ethical issue and the reason for change, it enables them to respond correctly.
Ethics Review Form (ERF)
For some time now, the Ethics Review Form (ERF) has been available for REC members to use as a guide for reviews.
However, the HRA has had feedback that not all RECs use this.
To gain a better understanding of the value of the form’s use, and understand whether this could help to standardise the focus of the ethics review, the HRA carried out a pilot last year, involving multiple RECs. Thank you to those of you who took part in this.
The pilot showed that good use of the ERF can help with preparation for a meeting, standardise the approach to raising typographical errors, reduce the length of meetings and improve the quality of the RFI.
Recommendations to support using RFI and ERF documents
Using the feedback shared during the pilot the HRA has developed some recommendations around how to make sure RFI’s are captured clearly in REC meetings to assist the REC in ensuring that the ethical issues are clear and that any requests for clarity or change are comprehensive to improve the quality of re-submissions.
This also includes best practice for using the ERF.
The HRA have also updated their website to provide further guidance to applicants to increase the quality of application and amendments submitted, detailing key criteria which is often missed during the initial submission.
Next steps
These recommendations will be added as an agenda item titled ‘Request for Further Information (RFI) and Ethics Review Form (ERF) recommendations for REC Members’ on your next full REC meeting.
If you have any questions please speak to your Approvals Specialist.