A pilot study to check if we can successfully audio-record consent discussions with research participants, identify good practice as well as communication, that can be improved, and provide feedback to staff members to improve the consent process
- Registration Number
- CTRI/2020/12/029464
- Lead Sponsor
- Seth GSMC KEM Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. Randomised Controlled Trials: Ongoing RCTs in the Department of Clinical Pharmacology that are open to recruitment will be purposively selected for this study, based on whether they a) have sufficient recruitment period remaining and b) regularly screen patients.
2. Patients: Adults over 18 years of age, who go through the informed consent process in the selected RCTs will be approached for consent to the OrION-I study.
3. Recruiters: The healthcare professionals and/or other researchers involved in the process of obtaining informed consent from patients will be approached for consent to the OrION-I study.
1. RCTs where the sponsor denies permission for the RCT to be included in OrION-I.
2. The potential patient participants or the recruiters in the selected RCTs who decline consent for this study (or where patient is unable to provide consent).
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Interviewees feedback on the consent process and suggestions to improve the informed consent appointmentTimepoint: Day 1
- Secondary Outcome Measures
Name Time Method Partenrship and networking activities between Bristol University and Seth GSMC & KEM hospital for a larger multicentric studyTimepoint: 1 year