Institutional Ethics Committee
The constitution of IEC is as per ICMR guidelines.
IEC is registered with Central Drugs Standard Control Organization, Director General of Health Services, Ministry of Health and Family Welfare, Government of India with registration number ECR/885/Inst/MH/2017 and National Ethics Committee Registry for Biomedical and Health Research (NECRBHR), Department of Health Research (DHR) with Registration number EC/NEW/INST/2020/687.
IEC works with the following objectives,
- 1.To promote a democratic exchange of scientific and ethical values and concerns, and to critically analyses them while looking for opportunities to enhance the scientific and ethical integrity of the institution
- To ensure competent review and appraisal of all scientific and ethical aspects of research projects received in accordance with the appropriate laws and welfare of participants.
- 3.Consultations for ethics in clinical research.
The terms of reference for the IEC is to ensure the highest scientific and ethical standards of research at VSPMDCRC. The IEC has the following functions
- To maintain a consistent scientific and ethical framework for patient care and research, and for integrating ethical values into practice, policy relationships, and organizational activities.
- To review and approve proposals for clinical, basic or translational research for scientific and ethical content.
- To improve ethical standards and issue guidelines on ethical dilemmas related to patient care services.
- To work as a forum to advise the administration in case of any ethical issues that may arise from patients, families or the public.
The objective of this SOP is to contribute to the effective functioning of the IEC at VSPM’S Dental College and Research Centre, Nagpur so that a quality and consistent ethical review mechanism for health and biomedical research is put in place to all proposals dealt by the Committee.
IEC will review and approve all types of research proposals involving human participants with a view to safeguarding the dignity, rights, safety and well-being of actual or potential research participants. The goal of the research, however important, should never be permitted to override the health and well-being of the research subject.
The research protocol should be submitted in the prescribed format of the IEC in triplicate along with the suggested enclosures till the 7th of every month. IEC meetings are scheduled once monthly, including 2 meetings for approval of synopsis of the final dissertation of first-year PG students. Synopsis presentation of dissertation topics of Ph.D. scholars is also carried out before submission to MUHS University, Nashik. Subject experts are invited to enrich and validate the research protocol whenever required. According to committee decision, all research projects in the institution are undertaken only after written approval from the IEC. It is mandatory that all research projects by staff, Ph.D. scholars, PG, UG students, and interns should be approved by the IEC. The principal investigator of the research project has to give a brief audio-visual presentation of the research project. A certificate of the approval of the research project is issued to the principal investigator. The ongoing research projects are reviewed at regular intervals. The principal investigator has to provide a justification if the research project is not completed in the time period mentioned in the synopsis. All research documents are preserved for a minimum of 5 years after completion of the study. A completion report of the research project has to be submitted to the IEC of all completed research projects in the departments. A completion certificate is issued by IEC on receipt of completion report from the principal investigator in prescribed format.
The IEC will take care that all the cardinal principles of research ethics viz. Autonomy, Beneficence, Non-maleficence and Justice are followed. For this purpose, it will look into the aspect of the informed consent process, risk-benefit ratio, distribution of burden and benefit and provisions for appropriate compensation whatever required. It will review the proposals before the start of the studies as well as monitor the research throughout the study until and after completion by examining the annual report and final reports. The committee will also examine whether all regulatory requirements and laws are complied with or not. The institutional ethics committee of Dental College and Research Centre, Nagpur functions as per Schedule ‘Y’ & ICH & GCP (International Council of Harmonization and Good Clinical Practices) guidelines.