Participants at the end of study
At the end of the research study you will be expected to fulfil commitments made to research participants. This may include:
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. Please refer to the guidance document for more information.
You should submit copies of any end of study information sheets that have been provided to participants, alongside your final report to the REC.
This guidance applies to the study types (as referenced above) from 1 April 2015. This includes studies that are underway on this date and where there are participants still in the study. Researchers are not expected to apply this guidance to participants that have already completed studies.
If you have any comments on this guidance then we would welcome your feedback. Please send your comments to amanda.hunn@nhs.net by 30 September 2015.