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Ethics Committee
Ethics Committee
ETHICS COMMITTEE
Independent body Levels : Institutional/Regional/National/Supranational Constitute : Group of scientific and Non-scientific members Size : The Ethics Committee shall consist of a maximum of 6 members . Skills : Members shall have qualifications and expertise in key areas of the work of the Ethics Committee.
Medical terms :
General/Government hospitals
Private hospitals Organisations
ETHICS COMMITTEE
SIMILARITIES IN IRB/IEC
They are two sides of the same coin :
Ethics Committee Functions Procedures Composition
DIFFERENCES IN IRB/IEC
IRB
Members are attached Institutions/ Organisation
IEC
Independent or more than one organisation
The CEC will function as per the policies and SOP document and will maintain a
record of the proceedings and will be accountable for adhering to the regulation governing the supervision of research in human subjects.
MEMBERS
Number : at least 5-7 (sometimes 7-12)
At least 1 from non scientific area i.e. layman
RESPONSIBILITIES
RIGHTS SAFETY & WELL-BEING DECISION
EMERGENCY
PAYMENT
DOCUMENTATION
QUALIFICATION
PROCEDURES
Review & maintain information of the investigator & subject
DOCUMENTS
1. PROTOCOL
2. INFORMED CONSENT FORMS 3. RECRUITMENT PROCEDURES
RECORD KEEPING
The committee must retain the relevant records
At least for 3 years, usually outside India And for a period of 15 years in India The condition and confidentiality of the records must be maintained
No trial is conducted without the approval from ethics committee Every step needs approval