Development of an informed consent tool for clinical practice
Research type
Research Study
Full title
Development of an informed consent tool for clinical practice
IRAS ID
348496
Contact name
Stephen Kirk
Contact email
Sponsor organisation
SOUTH EASTERN HEALTH AND SOCIAL CARE TRUST
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Consent is fundamental to medical practice. Informed consent research for the identification of more effective methods aimed to improve and facilitate the consent process is relevant to everyone. Potential implications span the globe for patients, clinicians and researchers across all aspects of healthcare and medicine. We see opportunities for informed consent practically through all patient and clinician interactions at all levels throughout primary and secondary care. Therefore, there is huge benefit to improving and optimising the informed consent process for both patient and clinicians and the wider consent research community. Thus, motivating this current research proposal which follows from previous research in the department.
To standardise measurement of the consent process, a core outcome set (COS) of nine key outcomes, has been developed by Convie et al. This research aims to better understand the COS with a view to developing an informed consent tool for use in research to standardise the measurement of the informed consent process and for practical use by healthcare professionals and patients in clinical practice.
The research study will compromise of three fundamental components.
1. Systematic review of the published literature
2. Ranking survey of the nine core outcomes for informed consent
3. Semi-structured interviews and consensus meeting
Initial phase will include a systematic review of existing published literature alongside an electronic questionnaire to survey a cohort of patients with the aim of determining a ranking across the nine core outcomes. We will use these results to guide which of the nine core outcomes to investigate in more detail. This will involve semi-structured interviews with patients to better understand both the core outcomes and possible measurement instruments for these outcomes.This will be a multisite study with the South Eastern Health and Social Care Trust as lead site. Study duration is anticipated six to twelve months.
REC name
HSC REC A
REC reference
25/NI/0068
Date of REC Opinion
20 Jun 2025
REC opinion
Further Information Favourable Opinion