The IRB Application process, as defined in the QBRI IRB Guidelines is as follows:
Investigators involved In the conduct of human subject research that falls under the authority of the IRB shall be provided with instructions and guidelines for the submission or research studies and informed consent documents for IRB review and approval.
The following are general procedures for IRB submissions
- The Principal Investigator submits a research proposal application, which includes the research protocol, to the senior Scientific Director who would check the proposal for feasibility.
- The application then forwarded to the IRB Coordinator.
- The IRB Coordinator will check the proposal for completeness and to determine whether the submission needs to be forwarded to the Scientific Review Board to check whether it is scientifically sound.
Incomplete submissions will be returned to the Principal Investigator by the Office of Research for correction. Once all required elements are present, the Office of Research will forward the study appropriately.
The proposal should be composed of:
- The application cover memo (QBRI.IRB-CM/001/2013)
- Protocol and Supporting Materials:
- Current version of the Protocol including all amendments and appendices
- Any recruitment materials or advertisements including but not limited to letters, posters, web text, videos, media advertisements and telephone script (if applicable)
- Any materials that will be distributed to the patient as educational or informational material in association with the research activity, including but not limited to brochures, schedule cards, patient diary or questionnaires.
- Co-Investigator Information and Signature Form (QBRI.IRB-CIF/001/2013)
- Study Budget (if applicable)
- Informed Consent Form (English: QBRI.IRB-ICE/001/2013 and/or Arabic: QBRI.IRB-ICA/001/2013)
- Conflict of Interest Disclosure Form (QBRI.IRB-COI/001/2013) for all key research personnel
- Study Personnel CVs/Certificate of Training for all investigators/co-ordinators:
- Current CV (reflecting professional address and institutional affiliation)
- Human Research Subject Protection Training Certificate (CITI)
- Health Information Privacy Act (HIPA) or Health Information Portability and Accountability Act (HIPAA) Training Certificate
- The Office of Research will review the protocol through its Scientific Review Board (SRB), to ensure that the Research is scientifically sound.
- The research proposal will then be forwarded to the QBRI-IRB for approval.