Reporting clinical trial results appropriately to participants (RECAP)

  • Research type

    Research Study

  • Full title

    Reporting clinical trial results appropriately to participants - the RECAP project.

  • IRAS ID

    238717

  • Contact name

    Katie Gillies

  • Contact email

    k.gillies@abdn.ac.uk

  • Sponsor organisation

    University of Aberdeen

  • Duration of Study in the UK

    1 years, 11 months, 31 days

  • Research summary

    It is good practice for researchers, running clinical trials, to feedback findings to the participants of the trial either during and/or at the end of the trial. However, too often trial participants are either not informed of the findings or it is done inappropriately e.g. by forwarding details of where the scientific publication can be found.

    This project will explore the feedback process and trial stakeholders’ preferences and views. The aim of the project is to develop recommendations for researchers, running clinical trials, to help them in the feedback process. Trial stakeholders are here defined as people with and without experience of taking part in a trial, Research Ethics Committee members, trial funders, trial sponsors and anyone designing and conducting trials.

    The project consists of four sequential interlinked studies. Firstly, a systematic literature review will be carried out to see what is known in the area in addition to a survey of current practice in the clinical trial community. Secondly, trial stakeholders will be interviewed about importance of content of the feedback. Thirdly, in focus groups the way feedback is delivered will be discussed. Lastly, findings from all the studies will be presented and discussed at a deliberative focus group. The deliberative focus group will also decide the recommendations to be taken forward.

  • REC name

    London - Brent Research Ethics Committee

  • REC reference

    18/LO/0634

  • Date of REC Opinion

    6 Apr 2018

  • REC opinion

    Favourable Opinion