INSTITUTIONAL ETHICS COMMITTEE |
||||
Introduction |
||||
North – Eastern Indira Gandhi Regional Institute of Health and Medical Sciences (NEIGRIHMS) is an autonomous institute under the Ministry of Health and Family Welfare established for medical education, research, and patient care especially in the north – eastern India. One of the mandates of the NEIGRIHMS is to conduct research in various branches of medical sciences involving human beings. The involvement of the human beings raises issues of ethics in research. Institutional Ethics Committee is required to be constituted in every such institute to ensure the ethical practices by the researchers. NEIGRIHMS complies with all the regulations as stated by CDSCO (DCGI) and also, drug and cosmetic rule 1945 of the schedule Y and other regulatory requirement of ICMR. Today the ICH GCP guideline is followed globally for clinical research. This guideline elaborates the composition and functioning of an Institution Ethics Committee to review clinical research proposals. In India, Ethics Committee for Research on Human Subjects presently functions according to the requirements laid down in Schedule Y and is guided by the ICH GCP guidelines for Good Clinical Practice, ethical principles set forth in the Declaration of Helsinki and the Ethical Guidelines for Biomedical Research on Human Subjects laid down by Indian Council of Medical Research. The IEC, NEIGRIHMS is registered with CDSCO vide Registration No.ECR/978/Inst/MG/2017/RR-21 dt.07.12.2021 and with NECRBHR vide Registration No.EC/NEW/INST/2022/ME/0138 dt.30.08.2022. |
||||
Members of IEC |
||||
1. Dr. (Mrs.)Sandra Albert - Chairperson & Public Health Expert |
||||
Dr. Iadarilang Tiewsoh, Associate Professor, General Medicine has been appointed as Sub-Dean(Ethics) and functions as Admin for the IEC. |
||||
Submission Process |
||||
Since May 2024, the IEC has adopted the e-Ethics Committee software which is a web-based IEC manager. All proposals approved by the NSAC and those multicentric studies which have been approved by other IECs may be submitted on this software throughout the year as per the instructions provided. IEC meetings will be scheduled at regular intervals depending on the submissions received. For proposals which have been approved earlier, the annual reports/completion/amendment and other such forms provided in the ‘Forms (Annexures)’ provided in the link may be used. |
||||
Office Location: Office of the IEC |