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End of Study Reports

Research Ethics Committee Requirements

For all types of study, a summary of the final report on the research should be sent, by an individual acting on behalf of the Sponsor (usually the Chief Investigator) to the REC that gave a favourable opinion of the research within 12 months of the end of the study.

The summary of the final report may be enclosed with the end of study declaration, or sent to the REC subsequently. The REC would also find it helpful to know how the research findings are to be disseminated.

This report should be sent to:

• Main REC that provided a favourable opinion – REC contact details
• Competent Authority – MHRA

• Research Sponsor – where LTHT/UoL is the sponsor, please send documentation to the R&D Department
• R&D Department - if the Trust or University is not the Sponsor, please send the report to the R&D Department
  
  

Funding Body Requirements

Funding bodies require a final report outlining how their funds have been used and the outcomes of the study. If your grant is being administered by the University of Leeds, please see the Research Support Unit's guidance:

Final reports for Government and Research Council Grants

Guidance on the Dissemination of Research Findings

Health and social care research is conducted for the benefit of patients, users, care professionals, and the public in general. Therefore, all those pursuing health and social care research must open their work to critical review through the accepted scientific and professional channels.

The obvious route to inform the research community is through publication in scientific journals. It is recommended that the CONSORT guidelines are followed when preparing a manuscript for a clinical trial. This ensures that all relelvant information about the trial is reported in the publication

Dissemination strategies should include:

Publication in scientific journals; presentation at local, regional and national conferences & meetings; informing research participants of research findings and informing service users of findings

Informing Participants of Research Findings

Once established, findings must be made available to those participating in research (including relatives of deceased patients who have consented to the use of organs or tissue in research). Research involving human participants can only be achieved through the good will of those agreeing to be involved in research. Researchers therefore have a moral obligation to inform participants of research findings. Feeding back the findings of research to participants should therefore be one of the main strands of the dissemination strategy.

Strategies for feeding back findings to participants and the wider community obviously need to be different to those of scientific dissemination and findings should be presented in an understandable format and in lay terms.

Informing service users can be achieved through newspaper article, local radio, support group website, public presentations, l eaflets in hospital/ clinical research centre waiting rooms etc. These are a good ways to promote research participation and demonstrate that research findings have improved current clinical practice.

Publications by Members of Staff

The R&D Department compiles the annual register of research publications by members of staff in the Trust. To view the current brochure, and brochures for previous years, please click on the appropriate link below:

Retention of Research Records & Archiving

For guidance on archiving for Clinical Trials of Investigational Medicinal Products please see the relevant section of the Clinical Trials Toolkit

Further guidance: