You have notified the REC that your study has ended. The next step is to send a Final Report to the REC by completing and submitting this form

This is a UK-wide Final Report for all project-based research studies that have been reviewed by a REC within the UK Health Departments' Research Ethics Service.

The information contained in your Final Report helps the Research Ethics Service to monitor whether the research was conducted in accordance with the REC favourable opinion and applicable transparency requirements. For more information on the process please see the 'Ending your project' Final report on the research section of the HRA website and the Final Report – Frequently Asked Questions.

Please submit your Final Report within 12 months of the conclusion of the end of study.

You will notice that one of the fields in the Final Report asks for a lay summary of results. Guidance on how to write the lay summary of results is available on the HRA website.

Please note that the lay summary of results has a 5000-character limit.

The lay summary of results provided in this form will be published alongside the research summary record on the Research Summaries section of the HRA website. The HRA may also publish aggregate data collected from the Final Reports on the HRA website, as part of their annual research transparency reporting. This will not contain any personally identifiable information. Further information is available in the HRA privacy notice.

Submit your Final Report

Please complete all visible fields to enable submission. If a question is not relevant to your study, please enter ‘N/A’. Please complete this in one sitting as it is not possible to save partially completed information and return to it at a later point.

Once you have submitted the information, you will receive an email confirming that the Final Report has been received. This acknowledgement email will be sent to the Chief Investigator and sponsor contact, as well as the person who submitted the Final Report (if different), within 30 calendar days of submission. It will contain a copy of the information you have submitted, which you can save should you wish to keep a copy for your records. If you have not received your acknowledgement after 30 working days, then contact the REC or approval staff managing your study.

Name of Chief Investigator – Enter the full name i.e. Title, Forenames and Surname

Telephone Number of Chief Investigator – Enter the Chief Investigator’s work or professional telephone number. Personal contact details should not be provided.

Email address of Chief Investigator – Enter the Chief Investigator’s work or professional email address. Personal contact details should not be provided.

Chief Investigator ORCID ID – Chief Investigator ORCID ID – The ORCID ID is an identifier unique to a researcher throughout their research career. More information is available on https://orcid.org. Enter N/A if there is no ORCID ID.

Email address of person submitting the Final Report – Enter the work or professional email address of the person completing the form. Personal contact details should not be provided. If the Chief Investigator is completing the form they will need to enter their details here as well.

Full Study Title – Enter the full study title. This should be the same as the full title provided in the IRAS application form.

IRAS ID – Please enter your REC reference if you do not have an IRAS ID.

Name of the Research Ethics Committee that issued a Favourable Opinion for the study

Sponsor Organisation Name – Enter the sponsor organisation name in full - do not use acronyms.

Study start date – This should be the date the study actually started in the UK as defined in the study protocol. It may be different to the proposed start date stated in your initial IRAS application.

Study end date – As defined in the protocol. If not defined, in most cases, the definition of the end of study will be the date of the last visit of the last participant or the completion of any follow-up monitoring & data collection described in the protocol.

Funder's reference number – Enter the funder's reference number for each funding arrangement. If there are multiple reference numbers, please enter all reference numbers in the box.

Name of Registry – Enter the name of the public register where the study is registered. For clinical trials, it is a condition of the REC favourable opinion for the study to be registered on a WHO or ICMJE registry. More info on HRA website. Enter “N/A” if not registered.

Study Registration Number/Identifier – A study is provided with a unique registration number once it is registered on a publicly accessible register. Enter the registration number(s) here. If your study is not registered, enter “N/A”.

Date of registration – Enter the date, when the study was first registered on a publicly accessible register. If your study is not registered, enter “N/A”.

Is the study protocol publicly available? – In the interests of transparency, you are encourage to make your protocol publicly available.

Yes

DOI/URL for most recent protocol – Enter the Digital Object Identifier (DOI) or the website URL where the protocol is hosted.

Date original protocol was published – Enter the date when the protocol was initially made public.

Lay summary of study results – The summary should be written in Plain English. Technical terms should be explained and acronyms described in full. Further guidance is available on the HRA website. It is not possible to upload files or graphics but you can include URL links.

Has the registry been updated to include summary results? – All results of individual research studies, whether positive, negative or inconclusive, should be shared publicly. For clinical trials, registry records should be kept updated as the study progresses. If your study is not on a registry, answer No.

Yes

If yes - please enter the URL to summary results – Enter the URL to the study record here. Where the study results have been updated on multiple registries, enter all URLs to all records.

If no – why not? – Any entry in a publicly accessible register should be updated to include study results. If you are planning to publish the study results on the registry, but this has not been done yet, provide a date when this can be expected.

Did you follow your dissemination plan submitted in the IRAS application form (Q A51)? – Select ‘Pending’ if you are intending to follow the dissemination plan outlined in your IRAS application (question A51) but this is still in progress.

Yes

Pending

If yes, describe or provide URLs to disseminated materials – Provide details and include URLs where possible e.g. URLs to publications on websites or articles in journals.

If pending, date when dissemination is expected – This should be the date when you expect that the dissemination of the study results to be completed.

If no, explain why you didn't follow it – Where you have not followed the original dissemination plan, provide details why. Where you have followed an alternative dissemination plan, provide details and include URLs where possible e.g. URLs to publication websites or articles in journals.

Have participants been informed of the results of the study? – You should disseminate the results of research to participants. This provides feedback to participants on the outcome of research towards which they have contributed. Any information provided needs to be accessible and easy to understand.

Yes

Pending

If yes, describe and/or provide URLs to materials shared and how they were shared – Provide details on what information was shared with participants and how the results were shared with them. If possible, provide URLs to relevant materials.

If pending, date when feedback is expected – Enter the date when study results are planned to be shared with participants.

If no, explain why they haven't – Where participants have not been notified of the study results, explain why.

Have you enabled sharing of study data with others? – You should enable the sharing of study data, with appropriate safeguards in place, to other interested groups and communities. Sharing data maximises and respects the contribution of participants and enables and supports further research.

If yes, describe or provide URLs to how it has been shared – Where you have shared study data with others, provide details here. Where possible, include URLs to any relevant material.

If no, explain why sharing hasn't been enabled – Research data should be shared with other interested groups or communities. Where the data has not been shared, explain why.

Have you enabled sharing of tissue samples and associated data with others? – You should enable the sharing of tissue samples, with appropriate safeguards in place, to other interested groups and communities. Sharing tissue maximises and respects the contribution of participants and enables and supports further research.

If yes, describe or provide a URL – Where you have enabled the sharing of tissue samples and associated data with others, provide details here. Where possible, include URLs to any relevant material.

If no, explain why – Where tissues samples and associated data have not been shared, explain why.

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