IMPORTANT INFORMATION FOR SUBMISSION TO IEC

• Institute Ethics Committee (IEC) meetings for Observational and Interventional studies will be held every month on specified dates as mentioned in the Call for proposals circular.
• IEC meetings for Nursing studies will be called for during specific timing of the calendar year.based on submission of the proposals
• All research proposals by Faculty, PhD scholar, P.G. and U.G. Students must be submitted to Institutional Ethics Committee review after approval by JSAC/PGRMC/PhD doctoral committee/SCTRC/GJ-STRAUS.

a).Instructions for Initial project submission to IEC:

Kindly use the link https://iecmanager.org/institution/283 for filling the online version of JIEC application form and relevant annexures. PIs are required to upload the soft copies of their signed declaration form, consent forms and scientific proposal after filling the online application.

A .Creating an account with eEC portal:

Step – 1: Click the link https://iecmanager.org/institution/283 to visit the eEC portal. Click on Register as Principal Investigator to open Online Application Form.

Step – 2: In the online form, investigators are required to fill their background information. After submission of the online form, investigator will receive an e-mail to create a password for their account. Password must include an uppercase letter, a lower-case letter, a number, and a special character.

B) Procedure for Online application for Ethics approval

Step – 3: Reopen the webpage again and login with user ID (Personal E-mail ID) and password as Principal Investigator.

Step – 4: Click on Submit new project on the left menu.

Step – 5: Fill the required details under Project Summary.

Under Review type, choose one of the following:

Step – 6: Answer the FILTER QUESTIONS suitably to proceed with online filling of the application form:

1. Does your research involve human genetic testing? Yes No
2. Will participants be prospectively recruited? Yes No
3. Is your research socio-behavioural and/or public health research? Yes No
4. Is your research a clinical trial? (both academic and regulatory clinical trials of drugs, devices, innovative procedures, IND, BA, BE, ISM,) Yes No

Step 7: Fill the Application form for Initial review as per project requirements.

Step – 8: Download the Declaration page and affix signatures of all the investigators. If required, use an additional blank sheet. Scan and upload on the same webpage. Click save and Continue.

Step – 9: Fill the checklist page as required. Continue filling the Annexures.

Step – 10: In the Documents section, upload essential documents after selecting the appropriate option from drop-down menu (Covering letter forwarded by guide, JSAC Protocol INCLUDING data collection proforma, Informed Consent Documents in English &Tamil)  in pdf format only and click on save button.

Step – 11: Once you click Next, the incomplete sections will be highlighted in orange. Revisit the sections and complete the must enter fields in the suitable formats.

Step – 12: The last tab on CV can be used to save your CV profile on the website for future use.

Step – 13: Finally, all the tabs appear green. Click on Submit to IEC review button to finish the submission.

 C. For downloading the filled in application for hard copy submission

Step - 14: In the home page, click on My projects tab and look for your submission. Click on the eye icon for project overview.

Step - 15: Click on the Projects documents tab and check the bottom half for downloading the IEC application.

Step – 16: View the application and download it.

 D.) Submission of hard copy to the IEC office

One set of hard copies of the following documents is required to be submitted to Member-Secretary, Institute Ethics Committee (IEC) at Institute Ethics Committee office, First floor, Administrative block, JIPMER.

• Covering letter
• Download of the online IEC application
• Signed Declaration form
• Consent forms
• Research proposal (JSAC ver. July 2020)
• JSAC/ UGRMC/PGRMC certificate
• Data collection proformas

PIs are required to upload the soft copyof their proposal on the e-EC portal at https://iecmanager.org/institution/283 before the last date as intimated in the Announcements section. PIs / Student Researchers should ensure that they upload the soft copy of their proposal on e-EC portal failing which it will not be taken up for the discussion.

b). Instructions for resubmission to IEC:

• Minutes of the meeting will be available in your eEC portal. It will be communicated to the PI as a query in your mail.
• Please submit the revised protocol highlighting the changes with a yellow highlighter.
• The covering letter should be accompanied by a reply letter signed by PI / Guide in tabular format mentioning page number enumerating the comments from the IEC minutes for their proposal, with point to point mention of where the revision has been highlighted.
• One original copyof revised proposal must be submitted to IEC Office (Room No: 106, Next to Dean Research Chamber, 1st floor, Administrative Block)
• The Investigators are required to upload the soft copy on e-EC portal @ https://iecmanager.org/institution/283.

1. Covering letter forwarded by Guide.
2. Reply letter signed by PI / Guide in tabular format mentioning page number.
3. Single PDF file of Revised Protocol incorporating suggestions of IEC (changes must be highlighted).

• Please label the proposal as revised, along with the IEC number (JIP/IEC/2020/…..) and meeting number (eg. 7th observational studies – 28.06.2020) in the header of the first page of the proposal and covering letter correctly.
• Kindly submit corrected protocol with both English and Tamil consent forms stapled together. Protocols and consent forms submitted separately will not be considered for approval process.
• If the revision is satisfactory, the approval certificate will be issued on e-EC portal.
• The investigators whose proposals need major corrections to be submitted for full board review are required to submit one original and a xerox copy of revised proposal along with soft copy to IEC and it will be taken up in the next meeting for consideration of approval.

c). Other submissions related to IEC:

• Annual report to IEC should be submitted every year for ongoing studies, including project completion report.
• • Report of any Serious Adverse Events (SAE) should be intimated by mail to IEC (iechumanstudiesjipmer[at]gmail[dot]com) with a copy to the Member secretary of the concerned IEC within 24 hours of knowledge. A detailed report must be submitted to the IEC within 14 days of knowledge of SAE in prescribed formats. They should be informed to the IEC office through email.
• • Amendments, protocol deviation/violation, premature termination or discontinuation need to be reported to the IEC in prescribed formats.
• Specified formats are available in the JIPMER website (Link to download IEC forms)