The Institutional Ethics Committee (IEC) of Indira Gandhi Govt. Dental College & Hospital, Jammu, is constituted in accordance with the ICMR National Ethical Guidelines for Biomedical and Health Research Involving Human Participants (2017) and the New Drugs and Clinical Trials Rules, 2019. The IEC serves as an independent body that safeguards the rights, safety, dignity, and well-being of all research participants and ensures that research conducted at the institution conforms to the highest ethical standards.
No research project involving human participants, human biological material (blood, tissue, cells, DNA, etc.), or identifiable personal data may commence at IGGDCJ without prior written approval from the IEC. The committee operates independently of institutional management, funding agencies, and investigators to maintain impartiality and integrity of review.
Core Functions of the IEC
- Review and ethical approval of all research proposals and clinical trials involving human participants.
- Ensuring compliance with ICMR National Ethical Guidelines for Biomedical and Health Research involving Human Participants.
- Ensuring compliance with DCI ethical guidelines and Schedule Y of Drugs & Cosmetics Act.
- Monitoring ongoing approved research projects for continued ethical conduct throughout their duration.
- Reviewing adverse events and protocol deviations reported by investigators during ongoing studies.
- Maintaining systematic and complete records of all ethical approvals, reviews, and correspondences.
- Educating students, interns, and faculty about research ethics, bioethics, and responsible conduct of research.
- Providing independent, competent, and timely review to facilitate high-quality ethical research at the institution.
Current IEC Composition (Reconstituted 2024)
| # | Name of the Member | Qualification | Role / Designation | Gender | Affiliation |
|---|---|---|---|---|---|
| 1 | Chairman | B.Com, M.Com, PHD | Male | Dr. Keshav Sharma | External |
| 2 | Member Secretary | BDS, MDS (Periodontology) | Male | Dr. Manik Sharma | Internal |
| 3 | EC Member (Clinician) | BDS, MDS (OMFS) | Female | Dr. Parveen Akhter Lone | Internal |
| 4 | EC Member (Clinician) | BDS, MDS (Orthodontics) | Male | Dr. Akshay Gupta | Internal |
| 5 | EC Member (Clinician) | BDS, MDS (Conservative & Endo) | Male | Dr. Azhar Malik | Internal |
| 6 | EC Member (Clinician) | BDS, MDS (Prosthodontics) | Female | Dr. Reecha Gupta | Internal |
| 7 | EC Member (Clinician) | BDS, MDS (Pedodontics) | Female | Dr. Bhavna Kaul | Internal |
| 8 | EC Member & Social Scientist | M.A (Sociology), PHD (Edu) | Female | Dr. Renu Nanda | External |
| 9 | Scientific Member | PHD Biotechnology | Male | Dr. Dhiraj Vyas | External |
| 10 | Legal Member | BSc LLB. | Male | Mr. Subodh Jamwal | External |
| 11 | Non Medical Member | MSc, PHD (Statistics) | Male | Mr. Rahul Gupta | External |
| 12 | Lay Person | MSc, Dip. in Business Mgmt. & Industrial Mgmt | Male | Mr. Vijay Saraf | External |
| 13 | EC Member | MBBS, MD (Community Medicine) | Male | Dr. Rakesh Bahl | External |
| 14 | EC Member (Basic Medical Scientist) | MBBS, MD (Pharmacology) | Female | Dr. Sharminder Kaur Johar | External |
* IEC reconstituted as per ICMR guidelines. Quorum requires presence of at least 5 members including Chairperson, Member Secretary, and at least one external member.
Prepare Your Protocol
Draft a complete research protocol / synopsis. Prepare Participant Information Sheet (PIS) and Informed Consent Form (ICF) in English and a local language.
Obtain HOI Approval
Obtain a signed forwarding letter / approval from the Head of Institution (Principal & Dean, IGGDCJ) before submitting to IEC.
Submit Application
Submit the completed IEC application form with all required documents (5 copies) to the IEC Secretariat, Principal's Office, IGGDCJ, Rehari Chungi, Jammu.
Primary Review & Queries
The Member Secretary conducts a preliminary check for completeness. The IEC may raise queries or request clarifications. Investigator must respond in writing within the stipulated time.
IEC Meeting / Decision
The protocol is reviewed in an IEC meeting (full board / expedited / exempt as applicable). Decision — Approval, Modification Required, or Rejection — is communicated in writing.
Approval Letter & Monitoring
Upon approval, the investigator receives the official IEC Approval Letter. Periodic progress reports must be submitted. Any amendment to the approved protocol requires fresh IEC review.
Important: Research must NOT commence before receipt of the official IEC Approval Letter. Initiating a study without IEC approval is a violation of research ethics norms and may disqualify the study from publication.
Exempt Review
Research involving no more than minimal risk with no direct interaction with participants (e.g., secondary data analysis, record reviews with waiver of consent).
Expedited Review
Research involving minimal risk — reviewed by Chairperson and two members without convening a full committee meeting. Results announced within 2 weeks.
Full Board Review
Research involving greater than minimal risk or vulnerable populations — reviewed at a full committee meeting. Convened monthly or as needed.
📋 Mandatory Documents
- Completed IEC Application Form (prescribed format)
- Research Protocol / Study Synopsis (5 copies)
- Participant Information Sheet (PIS) in English and local language
- Informed Consent Form (ICF) in English and local language
- Investigator's CV / Curriculum Vitae
- Data collection tools / Questionnaires / Case Record Forms
- Approval letter from Head of Institution / Principal
- Proof of funding / grant details (if applicable)
- CTRI registration number (for clinical trials)
- Any other supporting documents relevant to the study
📌 Submission Guidelines
- Submit 5 hard copies of the complete dossier.
- One soft copy (USB/CD) of the protocol and forms.
- PIS and ICF must be in English and Dogri/Hindi/Urdu.
- All pages must be signed and dated by the Principal Investigator.
- Clinical trials must have CTRI registration number enclosed.
- Submit during office hours only (Mon–Fri, 10 AM – 4 PM).
- Incomplete applications will be returned without review.
- Non-refundable processing fee applicable as per institutional norms.
IEC Application Forms and templates for PIS/ICF are available at the IEC Secretariat, Principal's Office, IGGDCJ. Investigators are strongly advised to consult the Member Secretary before preparing the protocol to ensure full compliance with current requirements.
Any study at IGGDCJ involving human participants, human biological material, or identifiable data requires IEC approval before commencement.
Exempt review: ~1 week. Expedited review: ~2 weeks. Full board review: decided at next scheduled meeting (monthly). Ensure submission is complete to avoid delays.
Yes, for all clinical trials and interventional studies. CTRI registration must be completed before participant enrolment begins.
No. Commencing a study without IEC approval is a serious ethical violation and may lead to rejection of your research for publication or academic purposes.
Submit a written request along with the original approval letter, details of the proposed changes, and revised documents to the IEC office.