The Institutional Ethics Committee - Biomedical & Health Research (IEC-BHR) of ICMR-NIRBI functions in accordance with the ICMR National Ethical Guidelines and applicable regulatory requirements. The Committee is responsible for ethical review and oversight of biomedical and health research involving human participants.

Scope of Work

IEC-BHR reviews, approves, and monitors research projects to ensure protection of participants' rights, safety, dignity, and well-being. The Committee reviews:

• Biomedical and health research involving human participants
• Clinical, observational, interventional, and public health studies
• Research involving biological samples, clinical data, or identifiable information
• Student research projects and collaborative/external studies

Which projects are reviewed?

The Committee reviews, but is not limited to, the following categories of research:

• Biomedical research involving human participants
• Clinical, observational, and interventional studies
• Public health research and epidemiological studies
• Studies involving biological samples, clinical data, or personal identifiable information
• Student research projects (MD/PhD/Post-graduate dissertations)
• Collaborative and externally funded research projects

Project Submission System

All research proposals must be submitted to the IEC-BHR in the prescribed format along with the required supporting documents.
Project submission is available throughout the year on all working days.

Researchers are required to:

• Submit a complete application using the approved IEC-BHR forms. A typical submission request for an academic clinical trial may include but not limited to:
  1. Cover letter addressing the chairperson, duly signed by the PI
  2. Initial review form, Protocol (with version no),
  3. Detail of the investigators (name, qualification, affiliation, experience etc.),
  4. CV of the PI (and CO-PI), Recent GCP/ Ethics training certificate of the PI (and preferably of the CO-PI),
  5. Draft consent forms in multiple languages (at least English, Hindi, Bengali and any other language as deemed necessary in the place of the study recruitment), unless applied for waiver of consent with sufficient justification,
  6. Case report form,
  7. Any psychometric tool to be used in the study,
  8. Budget with source of funding,
  9. Any other clearance obtained already.
• Ensure all mandatory documents are enclosed
• Submit revised documents, clarifications, or amendments as requested by the Committee

Details regarding review timelines, meeting schedules, and modes of communication will be intimated by the IEC Secretariat.
Prior IEC approval is mandatory before initiation of any study. Amendments, progress reports, SAEs, and final reports must be submitted as per IEC requirements.

Important Information

• Research must comply with ICMR National Ethical Guidelines
• Any protocol deviation or amendment requires prior IEC approval
• Non-compliance may lead to suspension or withdrawal of approval
• The IEC has the right to conduct periodic and continuous review of the approved projects.

Contact:

Member Secretary, IEC-BMHR
ICMR-National Institute for Research in Bacterial Infections (ICMR-NIRBI)
Email: ethics.icmr.niced@gmail.com

Download Forms

1. IEC-BMHR Initial application form - for new projects - [ Download ]
2. Expedited review form - [ Download ]
3. Exemption from review - [ Download ]
4. Project Extension form - [ Download ]
5. Application for Clinical trials - [ Download ]
6. Application Form for Socio-Behavioral and Public Health Research - [ Download ]
7. Application Form for Human Genetics Testing Research- [ Download ]
8. Protocol Amendment Request Form - [ Download ]
9. Premature termination of project form - [ Download ]
10. Progress Report Format - [ Download ]
11. Protocol Submission Checklist - [ Download ]
12. SAE Reporting Form - [ Download ]
13. Format for Curriculum Vitae for Investigators - [ Download ]
14. Final Study Report Format - [ Download ]
15. Application Form For Amendments [ Download ]