FindTrial
Sign In

Developing and sharing techniques in which The informed consent process, "the process by which a potential research participant learns about and understands the purpose, benefits, and potential risks and then agrees to participate in the research" in low- and middle- income countries

Developing and sharing methods to improve Informed COnsent in clinical trials in low- and middle-income settings: India-Vietnam-UK interdisciplinary Network - ICONet

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/01/022847
Enrollment
15
Registered
2020-01-17
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: QuinteT Recruitment Intervention (QRI): This is a behavaioural intervention where qualitative study techniques are used to analyse the informed consent process, style and methiods alrea

Sponsors

Seth GSMC KEM Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: One ongoing RCT in the Department of Clinical Pharmacology will be selected randomly and participants who go through the informed consent process will be included

Exclusion criteria

Exclusion criteria: Sponsor of the RCT denies permission The potential participant of the chosen RCT who is going through the informed consent process denies consent for this study

Design outcomes

Primary

MeasureTime frame
Rate of consent refusalsTimepoint: baseline and at end of 3 months and 6 months—

Secondary

MeasureTime frame
To conduct networking meetings between India, UK and Vietnam partners already working in the field and share experiencesTimepoint: -3 months, 0 month and 3 months post intervention—

Countries

India

Contacts

Public ContactJeffrey Pradeep Raj

Seth GSMC & KEM Hospital

jpraj.m07@gmail.com07904286189

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026