Final Report – Frequently Asked Questions

Do all studies need to submit a final report?

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.

Is it mandatory to use the new final report form?

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.

Does the final report form replace the end of study notification?

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.

Where can I find the final report and how do I submit it?

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.

How can I save a copy of the final report?

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.

When does the final report need to be submitted?

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

Will I receive an acknowledgement notification?

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

Is the information provided in the final report made public?

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.

Which final report form should non-REC studies use?

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

Does the submission of the final report apply to all studies, regardless of whether a deferral of clinical trial registration and publication of research summary is in place?

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.

Questions about the Lay Summary of Results section

Part of the final report asks for a lay summary of results, is this mandatory?

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.

Can I upload graphics, figures and PDFs to the lay summary of results?

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.

How much detail is required for the lay summary of results?

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 paediatric clinical trials, is a lay summary of results required within six months?

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.

What information will be published in the HRA research summaries?

The text from the webform textbox ‘Lay summary of study results’ will be published directly below the ‘Research summary’ already published on the research summaries page on the HRA website. This will be placed within the ‘Research Summary’ section under a separate subheading: ‘Summary of Results.’

Can I search for published lay summaries of results?

You can search for a 'lay summary of results' by inputting ‘summary of results’ into the search box on the research summaries page on the HRA website. Please note that there may be some search results which do not include a summary of results. If you select one and it does not, please go back and select another research summary.

It is not possible to filter for the summary of results as this information is being added to the end of the project 'research summary'.

Studies that were approved before 2014 are unlikely to have a research summary published within this database, and we would not publish the summary of results for these studies.

I have completed the final report form – when will the summary of results be published?

The summary of results will be published within 30 calendar days of being submitted.

How can I update or amend the published summary of results?

If you need to amend or update the published summary of results, then you would need to contact the Approval team at approval@hra.nhs.uk with this request. After the Approval team update this information on our system then the details will be updated on the HRA website during the next scheduled update.

Is a final report required for a study that has been abandoned or terminated?

A final report should be submitted for all studies, however if a study is abandoned (never starts globally) or terminated early before recruitment starts then the submission of a final report is at the discretion of the sponsor.

We would still expect a final report to be submitted for a study that received an NHS REC favourable opinion - even if no study activity takes place in the UK. However, there is no requirement to provide a lay summary of results as part of the final report. We would recommend that you do, but if it is not available you can submit the final report without this.

What can I do when my lay summary of results exceeds the 5000-character limit?

If you are unable to reduce your lay summary of results to under 5000 characters, then you can request the REC to manually add the full lay summary results into the system to ensure it is published on our HRA Research Summaries webpage. This will mean that you would be submitting an incomplete final report form. In this case, you should include a letter to the REC clarifying the issue alongside the full lay summary of results text.

Can I delay the submission of the final report or the lay summary of results?

If you are unable to submit the final report within twelve months of declaring the end of your study, then you should contact the REC that approved your study; the staff will be able to advise you further.

If you can submit the report but want to delay HRA publishing the lay summary of results, then you should contact the REC that approved your study for guidance.