You have decided on a topic and designed your research project. Now it’s time to apply for your Ethics committee approval so that you can go ahead and start your project.
Why do I even need to apply to the Ethics Committee?
Ethics committee approval is mandatory for applications to all journals, grants, stipends, etc. (the ICMR-STS for example). The committee ensures your project is upto code and meets all ethical standards.
All institutions have an Ethics committee and students of KMC can apply to the Institutional Ethics Committee of KMC and KH. The submission is entirely through the IEC portal on the Intranet, which you can access in the library. The IEC meets every second Tuesday of the month to discuss the projects submitted to it.
The IEC requires a number of documents to be included in your application for approval. This list is fairly long and can get confusing. Even though it may be a lot of documents, if organised well, you can prepare your application for IEC pretty fast. The checklist given on the IEC portal is attached below. We made a SRF checklist that is a re-organised version of the original, so that it is easy for students to plan their tasks.
The forms under columns ‘Instant fill’ and ‘Signature Required’ just have blanks that can be filled right away with the second column, quite apparently, requiring signatures. The documents under ‘Work’ will take a little more effort to prepare, keep reading to find out more about them.
Your specific study might need a few more documents. Do check the Ethics Committee checklist which can be downloaded below. This is a general guide for all projects.
3 Steps to submitting your IEC Application
Before going ahead, we recommend downloading the attached documents and viewing the document as you read about it
On filling up the Forms
1. Participant Information Sheet
This document is what you will be giving to each study participant so that they get an idea of the entire study. Therefore it must be explained in simple language with as little medical jargon as possible.
The IEC provides a very clear template which you will just have to modify to suit your study. It will not take a lot of time to get this done and might actually be the most writing you will need to do in this whole process.
If you’ve applied for the ICMR STS, this step will be a breeze. The Protocol for IEC just has a few different sub-headings but otherwise it has exactly the same data as the ICMR-STS protocol.
Do not write 2 months as your study period
The IEC approval will normally take a little more than a month but may take longer if the you are asked to correct some mistakes and re-submit. So if you write ‘2 months’, your ethical clearance would be over before you start your study.
Talk with your guide and after estimating how long you will take to complete your study, add a couple months to it for your study period.
Literature review: this does not need to be an exhaustive literature review and can just be a brief round up of research surrounding you topic (with appropriate references).
3. Receipt of fee paid
Go to the finance section in the edu building and there you can make a payment of 250 rupees. You will be given a receipt for the same and done. Keep in mind that they do not accept cash.
4. IRC approval letter
Fill the attached form and then along with all the documents pertaining to your study, submit them to Dr. Shankar Bakkannavar of the Forensic department. He is the faculty advisor of SRF and will view all the documents related to your study and on approval will give you a reference number.
5. Protocol submission form
This document is sort of like the bio-data of your study. You will need to choose all the options suitable to your study. You might have a few doubts with the terms that you will need to run by your guide.
– SRF reference number : fill it from the IRC approval letter
In the CV, you are just required to fill in the blanks with your details.
Make sure to name the document after your name (Eg: Ramesh CV.pdf)
7. Letter to Chairperson & Declaration by PI and CI
With these documents, you just need to get signatures after filling in some blanks.
Gather all your papers, this is your final piece of work before submission.
Places where you will need your guides signature:
- Letter to Chairperson*,
- Protocol Submission Form and
- Declaration by PI and CI
For your guides signature in the documents, you can either use an e-signature and add it to where it would be necessary or You can Print your filled documents, get them signed by your guide and Scan these ready documents for upload.
* The only place where you will need the signature of someone other than your Co-Investigators is in the Letter to the Chairperson. In it you will either need the signature of the HOD of your guide’s department or the Head of Institute’s signature.
Now that you have all your documents ready, you can go ahead and submit them on the IEC portal.
In this article we have detailed the process to prepare the documents required for IEC specifically. You will also need to submit your respective study documents like a Questionnaire or List of Hospital numbers ready. These have been listed in the IEC Checklist.
The IEC portal can be accessed through the computers in the library or any network that has access to the intranet. (Hostel wifi does not have access to the intranet)
After submission, you will get regular updates through SMS about the progress of your application
This was a lot of details with a lot of documents, but this summary will hopefully give you a clear overview of it all. A suitable summary here would be a story of a person who gets their IEC application ready in the most ideal manner. Here we go…
Ramesh wakes up one morning with the task of submitting his IEC application and goes through this SRF article. After reading it, he’s got all his tasks figured out so he sits down to get to work.
He fills up the blanks in his CV, Letter to Chairperson, Protocol submission form and Declaration by PI and CI. In less than 20 mins he is done with a big chunk of work. He gets up, grabs a coffee and is now ready to finish the Participant Information sheet and also modifies his ICMR-STS protocol to the IEC format.
Now that he is done with the typing, he organises all his documents and goes towards the Library to get them printed. On his way, he pays for and gets his Receipt of Fee in the Edu building. He then heads to the Forensic department for his SRF reference number from Shankar sir.
Finally he heads to his guide’s department, right on time for his appointment with them. He gives his documents to them for verification and gets a copy of their CV. After getting their signature where necessary he also gets the HOD’s signature on the ‘Letter to Chairperson’. Now he is all set and can scan them for upload. He fills ticks off the boxes on the IEC checklist with all his ready documents and submits his IEC application.
Okay, this is almost an extreme ideal case and everyone will take a lot more time. But this was to showcase how the amount of work is actually very less. Ramesh could complete all of it in half a day. The only reason submission to IEC takes so long is because of logistical roadblocks and procrastination. If it is planned well and done systematically, you should be done much quicker than a normal first time applicant.
This article contains a general guide for most IEC applications on the date of publication. You are required to check with the IEC portal for updated guidelines or any additoinal requirements for your specific project.