• All ongoing projects that have been given ethical approval have to submit their annual reports to the IRB 12 months after approval was granted. These would then be tabled at the next IRB meeting.
• The final report should be submitted at the completion of the study.
• All severe adverse events (SAEs) and the action interventions undertaken for the same should be intimated to the IRB chairperson and/ or member secretary, ideally immediately, and within 72 hours of occurrence. In the event of non-availability of the chairperson and/or the member secretary, the same shall be notified to other member(s) of the IRB, which shall be notified to the chairperson and/or the member secretary not exceeding one week after the reporting of the SAE by the researcher/research team member. If case of delay in reporting the SAE by the researcher/research team member, prompt and appropriate action against the researcher shall be initiated by the IRB. It can even be decided to suspend/ terminate the project as decided by the IRB. The decision of the IRB shall be final.
• All protocol deviation(s), if any, should be promptly informed with adequate justifications for the same to the IRB chairperson. The chairperson will then decide if fresh approval is indicated. Any major deviations (such as change in design, target sample, inclusion of a new intervention component) will require resubmission for fresh approval.
• Minor amendment(s) to the protocol (such as increasing or decreasing number of people to be interviewed) do not need fresh approval from the IRB – the chair and secretary can give the necessary permission for inclusion of the change to the original protocol. All such information should be recorded and communicated to the IRB through the annual reports.
• Premature termination/ suspension of study should be duly notified with appropriate and adequate justifications along with the summary of the data obtained so far.
• Any change of investigator(s) / site(s)/ sponsor(s) / funding(s) should be duly informed to the IRB within one week failing which appropriate and prompt action against the investigator shall be initiated by the IRB.
