Final Report – Frequently Asked Questions

For project-based research (not research tissue banks or research databases) that have been reviewed by an NHS REC in the UK, a final report should be completed and submitted to the UK research ethics service within 12 months of the end of the study. This includes phase one trials. This is all explained on our website.

It is a good practice requirement for all project-based research (not research tissue banks or research databases) that have been reviewed by an NHS REC in the UK to submit a final report to the UK research ethics service within 12 months of the end of the study. No matter when your study ended (and the end of study notification was submitted), if the final report is now due then the new final report form should be used.

No, the end of study must still be declared to the REC within 90 days of the end of study. Where your study has been reviewed or approved by other review bodies, you should check their end of study declaration requirements. More information is available on our website.

For studies submitted through combined review, the final report can be found and submitted in the new part of IRAS.

For all other studies, the final report webform on our website should be used.

For studies submitted through combined review, the submitted final report can be accessed via the new part of IRAS.

For studies that use the final report webform, the chief investigator and sponsor contact will receive an acknowledgement email after submission. The email will contain the information that you submitted in the form. You can save this email and share it where necessary.

A final report should be completed and submitted to the UK research ethics service within 12 months of the end of the study.

Once submitted, the chief investigator and sponsor contact will receive an acknowledgement email within 30 days of submission.

The new final report includes a section for lay summary of study results, which we will publish on the research summaries section of our website along with information about the study already published there. If a deferral to publish on our research summaries is in place for your study, then this will apply for the publication of lay summary of study results as well.

From 2022, we will also collate the information submitted in the final report and publish this data annually to show how research sponsors are meeting research transparency requirements and best practice. If a field in the final report is marked as ‘N/A’, this will be marked as ‘not submitted’ in the dataset. Further guidance will be provided about when we will start to collate this information.

There is currently no requirement for studies that have not been reviewed by a REC to submit a final report.

Yes, the final report should be submitted for all project-based studies that have a REC favourable opinion. This is regardless of whether a deferral is in place or not. If a deferral of the research summary publication is in place, then this means the lay summary of results will not be published while the deferral is valid.

While the submission of lay summary of results is voluntary (it is neither a legal nor policy requirement) it ensures sponsors meet research transparency best practice. We encourage all studies to submit a lay summary of results with their final report, but if necessary, it would be acceptable to indicate in the form that the lay summary is not currently available.

At present, the final report can only accept entries in text. It is not possible to upload files or graphics. You may include a URL link to an external page where the summary is available in other formats, which include diagrams and pictures. You may also provide a link to summary information uploaded to a registry.

We understand every study is different, and some will require longer lay summary of results than others. There is guidance available on what to include in the lay summary of results and an e-learning module on the topic.

For Marketing Authorisation Holder (MAH)-sponsored paediatric studies, results must be submitted to the MHRA within six months of the end of study. You are encouraged to publish a lay summary of results within the same timeframe.