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

Common Forms for Central Ethics Committee on Human Research (CECHR)

• CECHR Initial Review Form PDF  | DOCX

Annexure

1. CECHR Expedited Review Form PDF |  DOCX
2. CECHR Exemption From Review PDF | DOCX
3. CECHR Continuing Report or Annual Report Form PDF | DOCX
4. CECHR Application Form for Amendments PDF | DOCX
5. CECHR Protocol Violation Deviation PDF | DOCX
6. CECHR SAE Reporting Format BMHR PDF | DOCX
7. CECHR Premature Termination PDF | DOCX
8. CECHR Application Form for Clinical Trial PDF | DOCX
9. CECHR SAE Reporting Format Clinical Trials PDF | DOCX
10. CECHR Application Form for Human Genetics Testing Research PDF | DOCX
11. CECHR SocioBehavioural Publics Health PDF | DOCX
12. CECHR Final Report Format PDF | DOCX
13. CECHR CV For Investigators PDF | DOCX
14. CECHR Project Extension Form PDF | DOCX
15. CECHR Form Multicentric Review PDF | DOCX