The Institutional Ethics Committee (IEC) has a legacy of 13 years comprised of 12 Experienced and Qualified members as per the Central Drugs Standard Control Organization (CDSCO) guidelines.Over 200 Research Proposals were Approved, Conducted SAE reviews and Protocol Amendments.We have Directorate General of Health Services Central Drugs Standard Control Organization(DCGI) Registration and Department of Health Research (DHR) Registration in processing.
The Director, Lisie Hospital, Cochin has authorized the formation of Institutional Ethics Committee which operates independently at the Centre since 22/Feb/2007 with an aim to provide public assurance of protection, by, among other things, reviewing and approving the Study protocol, the suitability of the investigator(s), facilities, and the methods and material to conduct clinical research at Lisie Hospital. The Institute is responsible for providing the administrative support and infrastructure to ensure the smooth functioning of the Committee.IEC plays the most crucial role in clinical research and in ethical aspects of research.
The IEC will be multidisciplinary and multi-sectoral in composition.The IEC is composed of 12 members including Chairperson & Member Secretary.The members will include a combination of medical and non-medical, scientific and non- scientific persons including lay persons to represent the different points of view . The IEC is having 50% members who are affiliated to the Institute and 50% members are nonaffiliated to the Institute including Chairperson and Lay person.
The Composition shall be as follows:
- Chairperson (non -affiliated to the Institution)
- One Member Secretary (Institutional)
- One person from basic medical science (Not affiliated to the Institution)
- One legal expert (not affiliated to the Institution)
- One social scientist (not affiliated to the Institution)
- Lay person ( Non affiliated to the Institute)
- Clinicians affiliated to Institute
- Members (2 person affiliated to Institute)
RESPONSIBILITY OF IEC:
- The Chairperson will be responsible for conducting committee meetings, leading all discussions and deliberations pertinent to the review of research proposals.
- The Chairperson will sign documents and communications related to IEC functioning.
- The Chairperson will ratify the minutes of the previous IEC meetings
- The Chairperson will seek COI declaration from members and ensure quorum and fair decision making
- Receive research proposals
- Prepare, maintain and distribute of study files.
- Schedule and organize IEC meetings
- Prepare and maintain meeting agenda and minutes
- Maintain IEC documentation and to archive them.
- Sign documents and communications related to IEC functioning
- Notify the Director, Investigator regarding IEC decisions related to the submitted research proposal.
- Prepare for audits and inspections
- Receive ethics committee review processing fees and issue official receipts for the same.
- Review, discuss and consider research Proposals submitted for evaluation.
- Monitor Serious Adverse Event reports and recommend appropriate action(s)
- Review the progress reports and monitor ongoing studies as appropriate.
- Do on site visits wherever needed
- Evaluate final reports and outcomes
- Maintain confidentiality of the documents and deliberations of IEC meetings.
- Declare any conflict of interest in writing to the Chairperson,if any, at each meeting.
- Participate in continuing education activities in bio medical ethics and bio medical research.
- Provide information and documents related to training obtained in bio medical ethics and bio medical research to the IEC secretariat
- Be updated on relevant laws and regulations.
|Dr. P. P. Mohanan
|MD, DM, FCSI
|Director and HOD Cardiology, Westfort Hi-Tech Hospital
|Dr. Amel Antony
|MD, DNB MNAMS
|Senior consultant And Head Of The Department, Lisie Hospital, Ernakulam
|Justice K. John Mathew
|Retired High Court Judge
|Dr. Sissy Thankachan
|MBBS, MD 37741
|Junior Administrative Medical officer
|Basic Medical Scientist
|Rev. Fr. Dr. Joseph Kaniyamparambil
|B.Th, LPH, B.A PhD
|Theologian Parish Priest
|Dr. Babu Joseph
|MSc Physics PhD
|Cochin University of Science and Technology (Former Vice-chancellor )
|Dr. Laliamma Jose
|Head of HRD Dept, DDRCSRL Private Ltd,
|Dr. Jabir Abdullakutty
|MBBS, MD, DM,FSCAI, FACC,FESC,FRCP 19740
|Senior Consultant Cardiologist
|Dr. T K Joseph
|H.O.D and Senior Consultant Physician, Lisie Hospital
|Dr. Usha Marath
|Principal Lisie college of nursing