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A survey to find out what is known, believed and done in relation to weighing risks and benefits of planned clinical research studies by members of ethics committees

Knowledge, Attitude and Practices regarding Assessment of Risks and Benefits of Proposed Clinical Research Studies by Ethics Committee Members: A Questionnaire-Based Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/10/028515
Enrollment
75
Registered
2020-10-21
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

None listed

Interventions

None listed

Sponsors

Indian Society for Clinical Research
Lead Sponsor
Department of Pharmacology and Therapeutics Seth GSMC and KEM Hospital Mumbai
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. EC Members ( including and preferably member secretaries) who have been serving on a DHR and DCGI registered EC for a minimum of one year 2. Reviewing regulatory clinical trials, interventional studies, biomedical and health research studies for minimum one year

Exclusion criteria

Exclusion criteria: Those not willing to participate

Design outcomes

Primary

MeasureTime frame
Descriptive analysis of level of awareness of EC members regarding risks, benefits and risk-benefit assessmentTimepoint: 6 months after obtaining IEC approval—

Secondary

MeasureTime frame
Descriptive analysis of attitude and practices of EC members regarding risk-benefit assessmentTimepoint: 6 months after obtaining IEC approval—

Countries

India

Contacts

Public ContactDr Harshad Kesari

Seth GS Medical College and KEM Hospital

pam2671@gmail.com

Outcome results

None listed

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