2. Responsibilities of IRB/IEC
• The IRB/IEC is responsible for the ethical review of the trial.
– Clinical trial protocol/amendments
– Written informed consent process
– Investigator's Brochure (IB)
– Payments/compensation to subjects
– Form 1572/CVs
– Subject recruitment procedures (ads)
– Subject information
– Safeguard the rights, safety and well-being of the subjects.
– Review of proposed clinical trials
– Review of ongoing clinical trial at least once a year.
4. Responsibilities of IRB/IEC
• The IRB/IEC is responsible for the ethical
review provide following documents.
– Provide approval
– Modifications required
– Disapproval
– Termination/suspension
– Reasons for (if applicable) in writing
5. Composition, Functions and Operations of
IRB/IEC
• Composition:
– At least five members;
• Chair Person
• 1-2 Basic medical scientists
• 1-2 clinicians from various institutes
• One legal expert
• One social scientist / philosopher / atheist
• One lay person
• Member secretary.
6. Composition, Functions and Operations of
IRB/IEC
• Composition:
• An IRB/IEC should make its decisions at announced
meetings at which at least a quorum, as stipulated in
its documented operating procedures, is present .
• Only members who participate in the IRB/IEC review
and discussion should vote/provide their opinion
and/or advice.
• An IRB/IEC may invite non-members with expertise in
special areas for assistance.
7. Composition, Functions and Operations of
IRB/IEC
• Functions and Operations :
– IRB/ICE functions as per the written SOP.
– Documents related to a study must be safeguarded
for 3 years after study is closed/completed.
– Following reports should be always be constantly
available for audit review
• The SOP all correspondence with the investigator
• Records of all gatherings, meetings and their timeframe.
