The HRA (Health Research Authority) is responding to feedback from patients and the public in the UK by issuing guidance on information to be provided for participants at the end of a study.
This follows feedback from study participants who have reported that they have sometimes feel neglected at the end of study and often don’t receive a ‘thank you’.
The guidance issued by the HRA is part of the overall HRA transparency agenda that supports the sharing of study findings with participants.
The guidance sets out the areas which should be covered in the information to be made available to participants as their time in a study comes to a close and includes:
What participants can expect to happen to them at the end of a study, including the arrangements in place for treatment when the study stops and any requirements for ongoing monitoring of side effects.
How those who have participated in the research can access the study results. As a rule, all participants should be routinely informed as to how they can access the study findings.
How those who would rather not see the findings can opt out of the process, if this has not been covered already.
An acknowledgement of the contribution they have made to research and the improvement of healthcare.
The guidance only applies to clinical trials and other studies with a clinical intervention, including diagnostic studies. It should be noted that the guidance does not apply to Phase 1 studies of healthy volunteers. Relevant studies that are still live should apply the guidance where they have participants that are yet to complete their time in the study. Researchers are not expected to apply the guidance retrospectively to participants that have already completed the study.
As long as the information provided at the end of a study complies with the patient information sheet agreed with the Research Ethics Committee (REC) at the beginning of the study then further ethical review is not necessary, even if reference has not been made to this document in the initial application to the REC.
Where the proposed information at the end of study conflicts with what was agreed with the REC, then the researcher is expected to submit the proposed document to a REC for ethical review.
This guidance was developed with input from patients, researchers and industry representatives and a draft was circulated for comment in 2014.