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Survey of challenges faced by Ethics Committees while reviewing protocols during COVID-19 pandemic

An International Survey of Ethics Committees (ECs)/ Institutional Board Review (IRBs)- Challenges and Practices Arising During Public Health Emergencies (PHEs)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/02/031079
Enrollment
1500
Registered
2021-02-08
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: Not Applicable: Not Applicable

Sponsors

The study is Internationally coordinated by Good Clinical Practice Alliance Europe GCPA
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Members of Ethics Committees registered with DHR

Exclusion criteria

Exclusion criteria: Ethics Committee members not involved in reviewing protocols related to vaccine trials during public health emergencies. Those who do not give Informed Consent.

Design outcomes

Primary

MeasureTime frame
The expected outcome of the survey is to have identified the specific ethical values, issues, procedures and practices that ethics committees have encountered in their ethical review of COVID-19 research or other previous Public Health Emergency research particularly with respect to vaccine clinical trials.Timepoint: upto 31st May 2021—

Secondary

MeasureTime frame
The survey also seeks to identify how normal operations of ethics committees are affected by public health emergencies.Timepoint: upto 31st May 2021—

Countries

Chile, India, Iran (Islamic Republic of), Liberia, Malaysia, Nigeria, Turkey

Contacts

Public ContactDr Roli Mathur

ICMR Bioethics Unit, ICMR- National Centre for Disease Informatics and Research (NCDIR)

mathurr@ncdirindia.org91-80-22176301

Outcome results

None listed

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