Introduction

The Institutional Ethics Committee (IEC) of Indira Gandhi Institute of Dental Sciences (IGIDS), located in Puducherry, India, has been at the forefront of promoting ethical clinical research since its establishment in 2012. Committed to safeguarding the rights and safety of study participants, IEC serves as a vital regulatory body within the institute. Its ethical guidelines serves as a benchmark for all individuals involved in clinical research, including undergraduates, postgraduates, Ph.D. scholars, and faculty members.

With a primary focus on adhering to the principles of ethical research, IEC plays a pivotal role in ensuring that all research proposals involving human participants are thoroughly reviewed. The committee operates in accordance with the Indian Council of Medical Research (ICMR) guidelines established in 2017, ensuring that all research endeavors meet the highest ethical standards.

Recognizing the significance of risk assessment, IEC utilizes a comprehensive review process to evaluate the potential risks associated with each research proposal. Proposals with less than minimal risk are exempted from full review and a waiver requested while maintaining a diligent approach to methodology.

IEC is registered with the Department of Health Research (DHR). It is ensured that members of ethics committee are trained in Good clinical practice, bioethics and New drugs and clinical trial rules 2019. The term of the members is for a period of 3 years which is then subject to change. The Ethics clearance certificates are valid for a period of 3 years. Upon completion of a project, a completion certificate is issued to the investigators, and the project is monitored till completion for adherence to protocol.

CDSCO- New Drugs and Clinical Trials Rules 2019.

CIOMS-International Ethical Guidelines for Health-related Research Involving Humans.

ICH Good Clinical Practice Guidelines E6 (R2). The International Council for Harmonisation (ICH).

ICMR 2017-National Ethical Guidelines For Biomedical And Health Research Involving Human Participants.

National Guidelines for Ethics Committees Reviewing Biomedical & Health Research during COVID-19 Pandemic – April 2020.

WHO Guidelines on ethical issues in public health sureilance – 2017.

WHO Standards and operational guidance for ethics review of health-related research – 2011.

WMA Declaration Of Helsinki – Ethical Principles For Medical Research Involving Human Subjects – 2013.

Reconstitution of IEC 2023, authority and office order
Constitution of IEC 2021, DHA Registered
Organogram 2023

General Standard Operating Procedures , IGIDS
1. Preparation of Standard Operating Procedures for Institutional Ethics Committee (IEC), IGIDS
2. Establishing and Constituting the Institutional Ethics Committee (IEC), IGIDS
3. Procedure to Appoint  Suitable Members of (IEC), IGIDS
4. Responsibilities and Training Requirement of Members of (IEC), IGIDS
5. Procedure for Convening and Conducting IEC Meetings, IGIDS
6. Procedure for Submission of  Research Project  for Review by Ethics Committee, IGIDS
7. Procedure for Initial Scrutiny of Proposals, IGIDS
8. Procedure for Decision Making Regarding the Research Project, IGIDS
9. Procedure for Communicating the Decision of IEC to the Investigator (Fresh Research Proposal), IGIDS
10. Procedure for Communicating the Comments of IEC To the Investigator (On-Going Research Project), IGIDS
11. Conditions which should be Intimated to the IEC, IGIDS
12. Procedure for Documentation and Archiving of Documents and Communications of IEC, IGIDS
13. Procedure for Reviewing the Research Proposals Involving Vulnerable Population, IGIDS
14. Procedure for Reviewing Proposals Regarding Clinical Evaluation of Drugs/Vaccines/Devices/ Diagnostics/ Herbal Remedies
15. Approval of Research Proposals, IGIDS
16. Policy to Monitor or Prevent Conflict of Interest, IGIDS
17. Procedure for Follow-Up Of Research Projects with Respect to Serious Adverse Events (SAE), IGIDS
18. Standard Operating Procedures for Audit of Institutional Ethics Committee (IEC), IGIDS

Application Form for Initial Review

DHA Registration Provisional

Circular July 2023
Circular March 2023

Minutes of the Meeting – IEC  20 February 2024, IGIDS
Minutes of the Meeting – IEC  23 August 2023, IGIDS
Minutes of the Meeting – IEC  27 & 28 March 2023, IGIDS
Minutes of the Meeting – IEC  06 & 07 July 2022, IGIDS
Minutes of the Meeting – IEC  27 & 29 January 2021, IGIDS
Minutes of the Meeting – IEC  05  October 2020, IGIDS
Minutes of the Meeting – IEC  16 July 2020, IGIDS
Minutes of the Meeting – IEC  16 December 2019, IGIDS
Minutes of the Meeting – IEC  20 May 2019, IGIDS
Minutes of the Meeting – IEC  14 December 2018, IGIDS
Minutes of the Meeting – IEC  22 October 2018, IGIDS
Minutes of the Meeting – IEC  18 January 2018, IGIDS
Minutes of the Meeting – IEC 27 February 2017, IGIDS
Minutes of the Meeting – IEC 16 December 2016, IGIDS
Minutes of the Meeting – IEC 11 June 2016, IGIDS
Minutes of the Meeting – IEC  20 January 2016, IGIDS
Minutes of the Meeting – IEC  25  July 2015, IGIDS
Minutes of the Meeting – IEC 20 January 2015, IGIDS
Minutes of the Meeting – IEC 21 JANUARY 2015, IGIDS
Minutes of the Meeting – IEC 03 JANUARY 2014, IGIDS
Minutes of the Meeting – IEC 30 September 2013, IGIDS
Minutes of the Meeting – IEC  10 January 2013, IGIDS