The end of study must be declared within 90 days of end of study. All studies must declare the end of study internally by completing and submitting the below webform. Important please select 'Save my responses to edit' once submitted.

Internal Declaration of the End of Study

As part of declaring the end of your study internally, you are required to submit a lay summary of your results to the Clinical Research Governance Team, who reserve the right to publish the lay summary. This has been mandated by the Health and Social Care Research Sponsorship Committee Chaired by the Dean of the Faculty of Health and Medicine. Important if your study involved NHS REC Favourable opinion, this is the same lay summary that you will be required to include in your final report to the research ethics service (see step 4).

Full guidance on how to write a lay summary and what needs to be included can be found on this website:Writing a plain language (lay) summary of your research findings.

In brief using a paragraph format, in around 300 words or less, you should include the following information as applicable to your study:

• Study title
• Who carried out the research? (CI name and lead researcher name where applicable, details of sponsor, funding and any competing interests)
• What public involvement there was in the study (how many people, what their relevant lived experience was, and what they did)
• Where and when the study took place
• Why was the research needed?
• What were the main questions studied?
• Who participated in the study?
• Thank you to study participants
• What treatments or interventions did the participants take/receive?
• What medical problems (adverse reactions) did the participants have?
• What happened during the study?
• What were the results of the study?
• How has this study helped patients and researchers?
• Details of any further research planned
• Where can I learn more about this study?

You can complete your lay summary by:

1. By writing your own freestyle lay summary based on the required content above using a paragraph format in around 300 words or less.
2. Or using our template lay summary which can be found belowand filling in the required information. Please un-bold inserted text and remove the brackets.

Compose in a Microsoft Word document and e-mail to the clinical research governance team.

Examples of lay summaries prepared by both options can be found here:

Example Lay Summaries of Research Findings V1.0 300725

Lay Summary Template

[Title]

[CI Name & Lead Research Name if student]

[Funder]

[Sponsor]

[Start and End date]

We would like to extend our gratitude to everyone who took part in the research study.

Public involvement played a crucial role in shaping this study. A total of [Number] individuals with lived experience of [Condition/Topic] were involved in [Description of Involvement – e.g., designing the study, reviewing materials, etc.].

The research took place [summary of location] and was necessary because [Why the research was needed]. The main questions we sought to answer were [Main Research Questions].

[Number and Type] of participants took part in the study. They received [Treatments/Interventions Given] during the research. Some participants experienced [Adverse Events/Adverse Reactions/Medical Problems], which were carefully monitored and managed.

During the study, [Summary of What Happened – study design, data collection, procedures, etc.]. The key results showed that [Main Findings].

This research has contributed to a better understanding of [Condition/Topic], providing valuable insights for both patients and healthcare professionals. It has also helped researchers design better future studies.

Further research to [Details of Further Research Planned or Future Areas for Research], would build on the findings of this study.

To learn more about this study, you can visit [Website/Contact Info/Link to Publication].

You must also declare the end of study with external regulatory bodies by following the guidelines set out on the HRA Ending Your Project.

In brief, for projects with HRA/HCW approval only, declare end of study by emailing approvals@ha.nhs.uk, including your IRAS number, contact details and notifying them of the date of the end of study.

For studies involving NHS REC favourable opinion, the 'end of study declaration' form provided on the HRA Ending Your Project webpage must completed and e-mailed to the NHS REC which gave favourable opinion. Please note the end of study declaration form from the HRA webpage must be submitted within 90 days of the study ending to the relevant NHS REC. Submission of this form will automatically notify the HRA of your end of study where your study also has HRA approval.

Important please forward all email confirmation of study closures that you receive from the HRA or NHS REC to the Clinical Research Sponsorship Team.

All project-based research (not research tissue banks or research databases) that has been reviewed by a NHS REC, also needs to submit a final report. This report should be submitted to the research ethics service within 12 months of the end of the study. The HRA Ending Your Project webpage contains all the information you need to submit a final report.

You will be required to include a lay summary in your final report to the research ethics service. You can use the lay summary prepared in step 2.

Important please forward all email confirmation of final report submission that you receive from the HRA or NHS REC to the Clinical Research Sponsorship Team.

In addition to the above, you should always check the requirements of any other review bodies that reviewed or approved your study.