(Allow about 3-4 months from first application to recruitment of personnel)
Step 1
Policies and Procedures document of the IRB
Read the Declaration of Helsinki, The ICMR Bioethics Guidelines (2006), Schedule Y of the Drugs and Cosmetics Act, The Indian GCP Guidelines
Use appropriate format for proposal from IRB applications site on the intranet. (This applies to internally and externally funded research)
View Appendices
One soft copy on CD with all supporting documents and checklist and one hard copy signed by all investigators and checklist and all supporting documents with a covering letter (through HOD/HOU) to be sent to the Office of Research (Additional Vice Principal Research). Should reach before 1st of the month.
Step 2
The combined meeting of the Research & Ethics Committees (IRB) will be held on the 3rd Wednesday of every month at the CREST/SACN conference room at the centre for Stem Cell Research at Bagayam. Be present for the IRB meeting at the required time to answer clarifications. It is preferable that the guide be also present for PG dissertations
Step 3
The IRB will provide clearance from the Research and Ethics committees at one sitting for studies involving humans
If any amendments are suggested please send the revised proposal to the IRB at the earliest or re-submit for the next meeting if required to do so.
If the study involves animals, only research committee approval will be provided and separate clearance is required from the Animal Ethics committee
Step 4
After final approval/go-ahead from the IRB, a letter is needed to the Treasurer to start an account and to activate fluid research money, For personnel and capital items, AC approval is needed. Write to respective Admin heads (Principal / MS / GS) depending on category of staff to be employed.
Step 5
After AC approval, advertise and recruit through respective Administrator. Get two or more quotes for capital items and raise a purchase request.
Step 6
Progress report and final report to be submitted to the committee (This applies to internally and externally funded proposals)
Appendices
Appendix I Clinical Trial Registry-India Dataset and Description
Appendix II Instructions for registering trials in the Clinical Trials Registry- India (www.ctri.in)
Appendix III CONSORT Statement 2010
Appendix IV QUADAS tool for studies of diagnostic test accuracy
Appendix V The STARD Checklist for the reporting of studies of Diagnostic Accuracy
Appendix VI STROBE Statement—checklist of items that should be included in reports of observational studies
Appendix VII CHECKLIST FOR INFORMED CONSENT
Appendix VIII Application for permission for Animal Experiments
Appendix IX Submission of progress/final report to Animal Ethics Committee
Appendix X DSMB Template
