For a thorough and complete review, all research proposals should be submitted with the following documents:
• Name of the applicant with designation.
• Name of the institute/ hospital / field area where the proposed research is to be conducted.
• Detailed protocol of the proposed research.
• Ethical issues in the study and plans to address these issues.
• The proposal should be submitted with all relevant enclosures like proformae, case report forms, questionnaires, follow-up cards, etc.
• Informed consent process, including patient information sheet and informed consent form/ assent in local language(s).
• For any drug/ device trial, all relevant pre-clinical in-vitro and animal data and clinical trial data from other centres within the country/ countries, if available.
• Curriculum vitae of all the investigators with relevant publications in last five years.
• Any regulatory clearances required.
• Sponsor(s) and source(s) of funding; budget of the study.
• Other financial issues including those related to insurance.
• An agreement to report serious adverse events (SAE) to the IRB.
• Statement of conflict(s) of interest, if any.
• Agreement to comply with the relevant national and applicable international guidelines, as applicable.
• A statement describing any compensation for study participation (including expenses and access to medical care) to be given to research participants; a description of the arrangements for indemnity, if applicable (in study-related injuries); a description of the arrangements for insurance coverage for research participants, if applicable; all significant previous decisions (e.g. those leading to a negative decision or modified protocol) by other ethics boards or regulatory authorities for the proposed study (whether in the same location or elsewhere) and an indication of the modification(s) to the protocol made on that account. The reasons for negative decisions should be provided.
• Plans for publication of results - positive or negative - while maintaining the privacy and confidentiality of the study participants.
• Any other information relevant to the study.
