All research proposals presenting more than minimal risk that are not covered under exempt or expedited review will be considered for full committee review, some examples are:

  1. Research involving vulnerable populations, even if the risk is minimal;
  2. Research with minor increase over minimal risk (see Table 2.1 of ICMR Guidelines 2017 for further details);
  3. Studies involving deception of participants (see section 5.11 of ICMR Guidelines 2017 for further details);
  4. Research proposals that have received exemption from review, or have undergone expedited review/ undergone subcommittee review should be ratified by the full committee, which has the right to reverse/or modify any decision taken by the subcommittee or expedited committee;
  5. Amendments of proposals/related documents (including but not limited to informed consent documents, investigator’s brochure, advertisements, recruitment methods, etc.) involving an altered risk;
  6. Major deviations and violations in the protocol;
  7. Any new information that emerges during the course of the research for deciding whether or not to terminate the study in view of the altered benefit–risk assessment;
  8. Research during emergencies and disasters either through an expedited review/ scheduled or unscheduled full committee meetings. This may be decided by Member Secretary depending on the urgency and need;
  9. Prior approval of research on predictable emergencies or disasters before the actual crisis occurs for implementation later when the actual emergency or disaster occurs.

List of documents to be included in the application:

  1. Covering Letter (include list of all documents submitted along with version and date, as applicable)
  2. Completed CCDC-IEC Proforma
  3. Full study protocol
  4. Study Summary, not more than 1-2 page(s) (include study flow chart)
  5. Study Questionnaires/Interview guides in English and applicable languages
  6. PIS & ICF’s in English and applicable languages
  7. CV’s of all Investigators (PI & Co-I’s)
  8. Ethical clearances from other EC’s, if applicable
  9. Regulatory clearance letters from HMSC, if applicable
  10. Any other relevant document/information