FAQs page

FAQs regarding IEC submissions and the e-EC portal:

1. I am new to filling out applications for IEC. How should I get started?

Please go through the FAQs carefully and see the tutorial videos on the IEC website, which are very informative and detailed. You can contact the respective student TA of IEC for any specific clarification or assistance.

2. What is the IEC?

The IITGN institutional Ethics Committee (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.

3. Who should submit their research project to IEC?

All students, research staff, and faculty members working on human participants, their biological samples, and their data must submit their research projects to the IEC.

4. Is ethical clearance mandatory for everyone who is collecting data on human participants?

Yes, any study related to human participants, their biological samples, even the application of lotion or drug on screen, and their data is necessary for approval from the IEC.

5. What are the consequences of conducting research without IEC approval?

Consequences may include the funding for the project may not be sanctioned/ released, projects may be canceled, and research submitted to venues (e.g., thesis repositories, journals, and conferences) may not be accepted/ published.

6. What is the first step of starting my new project?

The first step is to understand the IEC procedures by carefully reviewing the information on the IEC website. You should ask your faculty advisor on how to proceed, as they have extensive experience submitting proposals on your research topic. Your faculty advisor should have a PI account on the e-EC portal and create a project on the portal. The PI can add study members to the specific project and can delegate PI access to the co-investigators.

7. What is the detailed process of IEC submission, and how can I submit my research project for IEC review?

Carefully review the detailed videos and manuals for the process, which are posted on the IEC website.

8. How long does the IEC proposal application review usually take?

• The duration of the review depends on the type of project you are applying for Full committee, Expedited review, or Exempt for review.

• The full committee review application process is scheduled biannually. It is advised to regularly check the IEC official website for updated timelines and deadlines to ensure timely submission. It takes approximately 3-4 weeks to complete the process.

• Applications for Exemption from Review and Expedited Review can be submitted on a rolling basis (i.e. throughout the year). These processes take approximately 15 days to complete, however, it also depends on the availability of the IEC members for the review.

• For detailed information, please read the Submission and Review Procedures carefully to understand the requirements for such reviews.

9. Who will be evaluating my research proposal?

The IEC is composed of internal and external members from the institute who carefully review the proposals. Therefore, it is important that the proposal is written in simple language that can be understood by lay people, i.e., limit jargon from your field of research.

10. What ethical considerations does the IEC evaluate in the research proposal?

Various ethical considerations are taken into account depending on the nature of the project. In general, the IEC considers the risks to both the participants and investigators, as well as the confidentiality and proper storage of data.

11. How can I submit a new project on the e-EC portal?

Your faculty advisor should be registered on the e-EC portal following the steps provided to them. Many faculty members are already on the portal. They can assign co-investigators (e.g., students and project staff) as study team members to fill out the application web portal according to the instructions provided on the IEC website.

12. I need to submit a similar project for already approved ethical clearance, how can I copy from the previous project?

After you select “Submit a new project” on the left menu bar and enter the details for the project, a prompt will appear stating: “Would you like to copy information from a previously- submitted application into your current application?”

Select “no” if it’s a fresh project.

13. I am doing two projects. Do I need to apply for ethical clearance for both separately, or should it be in one application?

If the projects have different research questions, then ethical clearance should be done separately.

14. I am working on secondary data, do I need to apply for ethics clearance?

Yes, if human participants are involved at any point in your research, you must apply for ethics clearance. 

15. I am doing a literature review on secondary data, which also includes data on human participants. Do I need to apply for ethics clearance?

Yes, you would need to apply for ethics clearance. If the data is in a public repository, then you can apply for Exempt from Review. 

16. I would like to perform a survey (i.e., ask several questions to the participants), do I still need to apply for ethical clearance as this may not harm human participants?

If you are interacting directly with human participants and/or collecting their information (i.e., demographics, thoughts on a certain topic, etc.), you must apply for ethics clearance.

17. What is expected for the presentation to the IEC committee?

After responding to queries, a student is asked to give a 5-minute presentation to ensure that ethical considerations in your research do not violate the ICMR guidelines.

18. I am traveling on presentation day, so how can I give my presentation to the committee?

With the special permission of the Member Secretary of IEC, you can request to give an online presentation, which is subject to a case-by-case basis.

19. I had the clearance for an earlier project, but I need an extension of the same project with minor changes. How can I get it extended? How long does it take?

You can apply for Expedited Review by submitting an Amendment. You need to submit the Application/ Notification Form for Amendments (doc template, to be uploaded as a PDF file in e-EC portal). Please highlight the changes you made in your application documents and note them in this Amendments form. It takes about 3-4 weeks to receive a decision from the IEC.

20. I urgently require approval for my study, but there is a delay in my approval letter from the IEC team. What can I do?

Please send an email to iec@iitgn.ac.in to request the status of your application. Please provide the IEC proj. no. that was assigned to your application in the email. The IEC has several submission cycles in a year. Therefore, read carefully the Submission and Review Procedures document on the IEC website to understand the timelines of the IEC process.   

21. How can I respond to the query raised?

A query letter from the IEC will be sent to you in the PI’s e-EC portal account. You will get a notification about the same on the homepage of the e-EC portal website.

22. What happens if I do not respond to the queries on time?

There will be a delay in the approval letter. 

23. Can I make changes to my research proposal after IEC approval?

If you want to make changes (i.e., amendments) to your project, you need to apply for an Amendment through Expedited Review. Also, you need to submit the Application/ Notification Form for Amendments (doc template, to be uploaded as a PDF file in e-EC portal). Please highlight the changes you made in your application documents and note them in this Amendments form.

24. What if my project is rejected for approval from the IEC?

If your proposal receives a “not approved” decision, you are free to appeal

for a repeat review. The application for appeal should include reasons why the IEC needs to repeat the review and an explanation for why the investigator believes his/her proposal

should be granted an “approved” status. Investigators who appeal for a repeat review might be asked to attend the IEC full committee meeting and present reasons why their proposal should be approved.

25. I have applied for ethical clearance and given the presentation, but it has not been approved yet. Can I start collecting data?

You should not collect data before getting the IEC approval letter. Collecting data on human participants is only permitted with IEC clearance. 

26. What else do I need to submit after my project/ thesis has been completed?

You are required to submit a Completion Report to your PI e-EC portal accounts for all completed projects, as per government guidelines. The Completion report should have 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. To submit the Completion Report on the e-EC portal:

• Go to your approved project.

• On the left-hand side of the screen, in the blue navigation panel is an option labelled ‘Submit New Documents’, which has a drop-down menu.

• Select 'Completion", which will open a new page to the web form of the report. The fields marked with an asterisk ‘*’ are mandatory.

• Once completed, click "Save & Next", which will open a Document Upload page; however, no other documents are needed. You can skip this page.

• Click 'Next', which will open the Project Documents/Project Review tab. Click 'Submit for IEC Review'.