Management of protocol submission

3.1. Purpose

The purpose of this section is to guide the IRB secretariat in the management of protocol submission.

3.2. Scope

  • Management of submitted documents for new research proposals.
  • Management of submitted documents after correction of research protocols.
  • Management of submitted documents for amendment of research proposals after IRB approval.
  • Management of submitted documents for continuing review/annual report.

3.3. Responsibility

All research proposals submitted as soft and hard copies for review should be in the prescribed format along with all required documents

(see box 1 for the checklist of the required documents).

The IRB secretariat is responsible for receiving documents, recording and distributing the research protocols for review by the SC and EC of IRB as well as communicating the decisions to the PI in a standard format.

3.4 Detailed process

3.4.1   Receiving the documents.

The PI can submit research proposals to the IRB for review and approval under any of the following:

  • Initial review application.
  • Resubmission after initial review with the recommended correction (s).
  • Protocol amendment or other amendment during the course of the study.
  • Annual/continuing review report.
  • Study completion/final report.

3.4.2   Verification of the submitted documents.

  • Check the applicable documents to ensure that all required forms and materials are present (box 1 shows the list of the documents to be submitted for EC review).
  • Verify the contents of the application form for IRB review.
  • Check for completeness of all required forms and materials and signatures at all appropriate places in the application form for IRB review.
  • Check for related documents necessary for initial review.

3.4.3 Documentation for IRB Secretariat.

  • Sign and date on the cover letter confirming receipt of the documents.
  • Maintain register for giving unique identification number. All projects should quote the unique identification number.
  • Make a photocopy of the completed document receipt and return the original copy of the application form to the applicants for their own records.
  • Count for the required number of hard copies.
  • All hard and soft copies of received and verified research projects are to be stored. The hard copies are to be stored in locked cupboards in the IRB office. All soft copies are to be stored in a designated IRB office computer.
  • Notify the PI in case if received documents are incomplete.

3.4.4 Details of the documents to be submitted for EC review.

Box 1 adapted from the national ethical guidelines for biomedical and health research involving human participants by ICMR, 2017 shows the details of the necessary documents to be submitted for EC review 2. 

  1. Application form for review (whichever is applied for).
  2. Declaration and checklist form (signed)
  3. The correct version of the informed consent document (ICD) is in English and the local language(s). Translation and back translation
  4. Questionnaire.
  5. Recruitment procedures: advertisement, notices (if applicable)
  6. Patient instruction card, diary, etc. (if applicable)
  7. Investigator’s brochure (as applicable for drug/biologicals/device trials)
  8. Details of funding agency/sponsor and fund allocation (if applicable)
  9. Brief curriculum vitae of all the study researchers.
  10. A statement on COI, if any.
  11. GCP training certificate (preferably within 3 years) of investigators (for biomedical research if applicable).
  12. List of ongoing research studies undertaken by the principal investigator.
  13. Undertaking with signatures of investigators
  14. Regulatory permissions (as applicable)
  15. Relevant administrative approvals (such as HMSC approval for International trials or exchange of biological materials)
  16. MoU in case of studies involving collaboration with other institutions (if applicable)
  17. Decisions of other ethics committees (if required/ask for)
  18. Insurance/Indemnity policies, indicating who is covered
  19. Any other information related to the study.

3.5. Resubmission after initial review with the recommended correction (s)

  • The PI will submit one copy of the amended protocol and related documents along with the justification for amendment, and clearly highlighting demarcated sections which have been amended.
  • The IRB secretariat will verify the completeness and reconfirm that the copy contains the modification highlighted with respect to the earlier protocol and review the application.
  • The documents already submitted in the initial IRB review which do not require changes need not be submitted again.

3.6 Protocol amendment or other amendment during the course of study.

  • The PI will submit the proposed protocol amendment using the appropriate application form and other related documents for justification to the IRB secretary.
  • The IRB secretariat will verify and check the completeness of the application form and related documents.

3.7 Annual/continuing review reports of approved protocols

  • The PI is required to give updates on the ongoing study using the continuing review/annual report form.
  • The IRB secretariat will verify and check the completeness of the report form and will sign and date the documents.
  • The progress of the reports will be tabled in the full IRB board meeting.

3.8 Study completion/final report.

  • IRB will give a reminder of the annual report to the PI, 15 days prior to the expiry date of approval (1 year from the date of the approval letter).
  • The IRB will receive a copy of the study completion report using the prescribed latest format.
  • The IRB secretariat will verify and check the completeness of the report form and will sign and date the documents.
  • The progress of the reports will be tabled in the full IRB board meeting.