The Indian Institute of Technology Gandhinagar Institutional Ethics Committee (IITGN IEC) is now provisionally registered with the National Ethics Committee Registry for Biomedical and Health Research (NECRBHR) as mandated by the Department of Health Research (DHR), Government of India. Reg. No. EC/NEW/INST/2025/4964). 

About the IEC

The progress of the scientific community depends on robust research, which must be carried out in accordance with universal ethical values, human rights, and international scientific standards. The Indian Institute of Technology Gandhinagar Institutional Ethics Committee (IITGN IEC) reviews and evaluates all research proposals to ensure adherence to universally accepted norms of ethical conduct and safety, which prioritize the participant’s free will, dignity, and confidentiality, to minimize any harm and risks related to the research process. The IEC operates as per the Indian Council of Medical Research (ICMR) National Ethical Guidelines for Biomedical Research involving Human Participants. It is mandatory for all IITGN members to secure an IEC clearance for any research project involving human participants and human biological material before the start of the project.

Application process

Read these tips for submitting applications on the e-EC portal:

1. First-time applicants: The submissions of all IEC applications should go through the PI's account (i.e., faculty advisor/ course supervisor's account). The PI can register for an account in the e-EC portal by the following steps:

- In the main page, search for "Indian Institute of Technology Gandhinagar" and click Go.

- In the log-in page, click "Register".

- In the Registration page, fill in the PI's details. The entries marked with an asterisk (*) are mandatory for registration. Upload the PI's Curriculum Vitae (the CV format is provided below). If a Good Clinical Practice (GCP)/ ethics training is available, please upload it as well. 

- Review the Terms and Conditions and check the box if you accept them. Then, click Submit. 

- The IEC Admin would need to approve the PI's registration. Please wait until the PI receives an email about successful registration. The PI can then initiate a project as per the instructions provided in this website.

2. After creating a new project, choose the Project Type: "Investigator Initiated". The IITGN e-EC portal is programmed to only accept Investigator-Initiated projects. However, the IEC understands that there are other project types, e.g., thesis/dissertation, NGP-sponsored, etc. and considers these project types after the submission is received in the portal and during the review process.

3. Submit only PDF documents. The portal has limitations viewing Word documents.  

4. Faculty PIs can assign co-investigators (e.g., students, project staff and collaborators) to fill the application web portal by viewing the specific project (eye button) and selecting "Study Team Member" on the left menu bar. After inputting the details of the "Investigator/ Co-investigator", click "Authorize", and the investigator's details will appear in the Study Team Member List. The investigator will receive an email to finish creating an e-EC account. Select "Delegate Access" to allow the investigator to fill the application. 

5. For more information, please see our Frequently Asked Questions (FAQs) page.

Templates for application submission 

* Please download and save the following templates to your computer, and edit your saved copies for submission as PDF files.

1. Cover Letter (doc template, to be uploaded as a PDF file in e-EC portal)

2. Application Form for Initial Review (doc template draft, information to be entered in e-EC Project Initial Submission form)

3. Research Proposal (doc template, to be uploaded as a PDF file in e-EC portal)

4. Application Form for Exemption from Review (doc template draft, information to be entered in e-EC portal)

5. Application Form for Expedited Review (doc template draft, information to be entered in e-EC portal) 

6. Application Form for Socio-Behavioural and Public Health Research (doc template draft, information to be entered in e-EC portal)

7. Application Form for Clinical Trials (doc template draft, information to be entered in e-EC portal)

8. Application/ Notification Form for Amendments (doc template, to be uploaded as a PDF file in e-EC portal)

9. Curriculum Vitae of Investigators (doc template, to be uploaded as a PDF file in e-EC portal)

10. Participant Information Sheet (doc template with instructions on information to include, to be uploaded as a PDF file in e-EC portal)

11. Informed Consent Form (doc template with instructions on information to include, to be uploaded as a PDF file in e-EC portal)

After receiving written approval

After the investigators receive written approval of the study, the investigators must abide by the following terms:

• Respond in a timely fashion to all requests from the IEC for additional information about a research study.

• Investigators should not make any amendments / revisions to approved proposals without obtaining prior written approval from the IEC. If changes to the approved proposal are necessary to avoid harm or to eliminate immediate hazards to participants and/or the changes are only logistical or administrative in nature, the investigators are required to submit the list of amendments, the previously approved proposal, and the amended proposal for an Expedited Review.      

• The investigators are responsible for reporting all Serious Adverse Events (SAEs) related to the study to the IEC within 24 hours of knowledge. Reporting of SAE may be done through email communication (including on non-working days). A report on how the SAE was related to the research must be submitted within 14 business days from the date of occurrence.  Please download and save the following templates to your computer, and edit your saved copies for submission.

  • • Serious Adverse Event Reporting Form (Biomedical Health Research) (doc template)

    • Serious Adverse Event Reporting Form (Clinical Trials) (doc template)

•  If the study duration is more than one (1) year, the investigators should submit the Continuing Review/ Annual Report Form (doc template) one (1) year from the date of written approval of the study. 

• If the study has been terminated prematurely/ suspended/ discontinued, the investigator must submit the Premature Termination/ Suspension/ Discontinuation Report (doc template).

• If a violation or deviation from the approved protocol has occurred, a Protocol Violation/ Deviation Reporting Form (doc template) must be submitted.

• Once the study has been completed, the  Study Completion/ Final Report Format (doc template) must be submitted with a list of the outputs of the research study (patents/manuscripts/reports/invited lectures/PhD theses/master’s projects/conference presentations). The actual outputs need not be attached. The plans for archival of records/ record retention in a secure location must be described clearly. You should submit the Completion Report through the e-EC portal (instructions are provided in the User Manual) and in our FAQs page: Question 26.

Archiving of data : As per the present regulations, after a project has been completed, the investigators are expected to store all the relevant data in a secured location (i.e., a secure room, a locked file cabinet, a safe, or other secure place) for at least three (3) years. Documents related to regulatory clinical trials must be archived for five (5) years after the completion/termination of the study or as per regulations.

Relevant resources

• Indian Council of Medical Research (ICMR): National Ethical Guidelines for Biomedical and Health Research involving Human Participants, 2017

• Indian Council of Medical Research (ICMR): National Ethical Guidelines for Biomedical Research involving Children, 2017

• Ethical Guidelines for Application of Artificial Intelligence in Biomedical Research and Healthcare, 2023 

• Guidelines for ICMR Network of institutions- Joint ethics review of multicentre research, 2023

• Ethical Requirements for Systematic Review & Meta-Analysis Proposals: An Addendum to ICMR National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, 2017 

• Indian Council of Medical Research (ICMR): National Guidelines for Ethics Committees Reviewing Biomedical and Health Research during COVID-19 Pandemic, 2020

Contact Details

For any queries, please email iec@iitgn.ac.in. All communications with the IEC should be made through this email. If you have submitted an application through the e-EC portal, please include your Project No. in the email. 

Committee members

The IIT Gandhinagar IEC is multi-sectorial and multi-disciplinary. The composition of the IEC effective from 15th May 2025 is as follows:

Chairperson

Dr. Barna Ganguly, P.S. Medical College, BKU, Karamsad

Member Secretary

Dr. Karla P. Mercado-Shekhar, Biological Sciences and Engineering, IIT Gandhinagar

Alternate Member Secretary

Dr. Yogesh Kumar Meena, Computer Science and Engineering, IIT Gandhinagar

Members

• Dr. Anjani Singh Tomar, Gujarat National Law University

• Dr. Jigna Shah, Nirma University

• Dr. Deepika Jain, Shishu Child Development & Early Intervention Centre, Ahmedabad

• Ms. Sherin Shabu, Pratham Education Foundation, Ahmedabad

• Ms. Krutika Patel, Sajeevta Foundation, Ahmedabad

• Dr. Deepak Singhania, Humanities and Social Sciences, IIT Gandhinagar

• Dr. Arka Chattopadhyay, Humanities and Social Sciences, IIT Gandhinagar

• Dr. Vaibhav Tripathi, Cognitive and Brain Science, IIT Gandhinagar

Secretarial Assistant: Mr. Pavitra Rout, Humanities and Social Sciences, IIT Gandhinagar

Student TA: Ms. Pinky Arya, Cognitive and Brain Sciences, pinky.a@iitgn.ac.in