The results of research should be reported, whether through publication in peer reviewed journals or other means of dissemination. Negative as well as positive results should be published, or at least made publicly available.
It is good
practice to disseminate the results of research to research participants and
other interested groups or communities. This provides feedback to
participants on the outcome of research towards which they have
contributed. Consideration should be given to providing a summary sheet
of the findings or letting participants know where they can access the results.
In addition, it may be important to inform patient groups or communities of any findings that are relevant to future care.
Information about publication arrangements should be included in the participant information sheet.
Publication of Clinical Trial Results
Sponsors of Clinical Trials of Investigational Medicinal Products (CTIMPs) are required to publish a research summary of their findings on the EuDRACT database within one year of the study’s completion. This timeline is reduced to six months for paediatric studies. This requirement does not apply to Phase 1 studies.
Sharing research findings with the study participants at the end of a study
It is good practice to disseminate the results of research to research participants and other interested groups or communities. This provides feedback to participants on the outcome of research towards which they have contributed. Consideration should be given to providing a summary sheet of the findings or letting participants know where they can access the results. This may include:
- Care after research: there are ethical and practical issues, in particular when participants may wish to continue on the study intervention after the study. As there are various guidelines and legislation, we have produced a document that presents a framework of questions to help RECs and their applicants.
- Participants in clinical trials (excluding Phase 1 studies of healthy volunteers) and other interventional studies including diagnostic studies should be given information at the end of a study explaining:
- How their care might change
- When they can expect the summary findings to be made available
- How they will be given access to the summary findings.
You should refer to the HRA guidance on information at the end of study. This HRA guidance applies to those undertaking clinical trials and other interventional (i.e. studies involving clinical interventions) or diagnostic studies involving patients. It does not apply to early phase clinical trials in healthy volunteers.
You should submit copies of any end of study information sheets that have been provided to participants, alongside your final report to the REC.