Research & Institutional Ethics Committee
Research at Giridhar Eye Institute
Research at GEI is overseen by its Institutional Ethics Committee, functioning since 2009.
Institutional Ethics Committee
The Institutional Ethics Committee (IEC) of Giridhar Eye Institute has been functioning since 2009, providing independent ethical oversight for all research involving human participants conducted at the Institute. The Committee functions under the Chairmanship of Justice M. R. Hariharan Nair, Retired Judge, High Court of Kerala.
The IEC is registered with the Central Drugs Standard Control Organisation (CDSCO) under the New Drugs and Clinical Trials Rules, 2019, and with the Department of Health Research (DHR), Government of India. It has a multidisciplinary composition of twelve members, drawn from medical, scientific, legal, social science and lay backgrounds.
The Committee reviews in-house investigator-initiated studies, clinical research projects and multi-centre collaborative studies undertaken with other institutions and research organisations. Its review covers scientific validity, ethical principles, participant safety, informed consent and regulatory compliance.
Composition of the Ethics Committee
| Sr. No. | Name of member | Qualification | Role/Designation in Ethics Committee |
|---|---|---|---|
| 1 | Mr. Hariharan Nair M R | BSc., B.L., MA (Law) | Chairperson |
| 2 | Dr. Anna Elias | MBBS, DNB (Ophthalmologist) | Member Secretary |
| 3 | Dr. Dinu Varghese | MBBS, MD (Pharmacology) | Medical Scientist |
| 4 | Dr. Thomas Kuriakose | MBBS DNB FRCs (Edin) (Ophthalmology) | Clinician |
| 5 | Mr. Ravindra Krishnan | BA, CAIIB, MFM | Member |
| 6 | Ms. Lakshmi Ramachandran | BA, MA, M.Phil (Teaching/Mentoring) | Lay Person |
| 7 | Dr. Vinod B Nair | MBBS, MS (ENT Head Neck Surgeon) | Clinician |
| 8 | Dr. Marian Pauly | MBBS, MS DNB, FMRF (Ophthalmologist) | Scientific Member |
| 9 | Ms. Karthika Sukumaran | BA, LLB, LLM (Specialization in Law) | Legal Expert |
| 10 | Mr. Murukan P Velayudhan | BBA, PGDHHM (Management) | Other Supporting Staff |
| 11 | Mr. P V Sasikumar | BSc LLB, ML, M.Phil, PhD | Social Scientist |
| 12 | Dr. Tom Babu | MBBS, MD, DNB, MBA (Endocrinologist) | Clinician |
Submitting a study for ethics review
- Protocol preparationThe guide/mentor supervises the preparation of the protocol.
- Technical committee submissionUpon completion, the protocol is shared in print with the Research Technical Committee (3-member team).
- Technical review and presentationThe team evaluates it and asks the investigator to present it in a PPT on a fixed date before the research committee.
- Protocol revisionThe research team's suggestions and comments are then incorporated into the protocol by the investigator.
- Scheduling of full reviewWhen the final protocol with supporting documents is ready, the Chairman decides a date for the full review.
- Ethics Committee reviewThe investigator presents the study before the EC team, and the EC team decides on approval, modification or rejection.
- Approval letterOnce the approval is accorded, an approval letter is issued by the Member Secretary to the principal investigator to iniate the study.
