IRB-IEC. composition and working process

Research,

1. INSTITUTIONAL REVIEW BOARD / INDEPENDENT ETHICS COMMITTEE IRB & ICE

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.

3. Responsibilities of IRB/IEC

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.