Guidelines for submitting proposals to ERC(Amended in 2018)

1. List of items to be submitted

1.1. Three (3) copies of project proposal in separate files (This should include protocol, Participant information sheet, consent form and Questionnaires)
1.2. Duly filled application form (1 original with 2 copies)
1.3. Twelve (12) copies of one-page summary of the study included by the title of the project.
1.4. Evidence for payment (Paying voucher)
1.5. Approval letter from the relevant institution where research will be conducted (If any)
1.6. Approval letter from the relevant postgraduate institution (for Postgraduate degrees)
1.7. Supervisor’s letter (for Postgraduate degrees)
1.8. Brief CVs of all investigators (maximum 2 pages)
1.9. All submitted documents except the application form and payment receipt must be emailed to the erc_fhcs@esn.ac.lk

2. For clinical trials
Apart from the above, the following documents must be submitted

2.1Investigator brochure
2.2 Clinical record forms
2.3 In case of multi centered studies, listing of overseas centre(s) and ERC/IRB approval status if relevant and copies of ERC/IB approval letters from other centers
2.5 Product liability letter or insurance certificate
2.6 Patient recruitment procedures
2.7 Patient’s diary cards
2.8 Justification for use of placebo (if any)

3. Proposal from undergraduate of FHCS

3.1. Two (2) copies of project proposal in separate files (This should include protocol, Participant information sheet, consent form and Questionnaires)
3.2. Duly filled application form
3.3. 12 copies of one-page summary of the study with the title

4. Resubmissions

4.1. Resubmissions

• Period of resubmission is one month from the date of notification.
• One copy of corrected proposal(with changes highlighted) with a covering letter
• One copy the relevant documents corrected and the version should be mentioned to all the resubmitting documents

5. Amendments and Extensions

5.1. Amendments
• Those who seek approval for any amendments in the proposal which has been previously approved by the ERC, should submit 2 copies of the amended proposal (in which the amendments should be highlighted) with a covering letter.
• The covering letter should state the nature of the proposed amendments and reasons for the request for amendment and a self-assessment of any ethical implications, arising as a result of amendment.
• The version number and date should be mentioned in each page of the proposal.
5.2. Extensions
• Those who seek approval for any extension of the period of validity of ethical clearance for a study proposal which has been previously approved by the ERC, should submit a request letter stating the reasons for the request for extension and a self-assessment of any ethical implications, arising as a result of extension.
• Such requests should be made not later than 30 days prior to the expiry of approval.

6. Fees levied as processing charges

Categories	Fees
Non-industry sponsored research studies	LKR 3000
Industry sponsored research studies	LKR 10000
For non-Sri Lankan principal investigators	USD 100
Reviewing amendments for industry sponsored studies	LKR 2500
Post graduate degree research	LKR 3000
Undergraduate degree research of other universities	LKR 2000
If principal investigator is EUSL staff member for Non-industry sponsored research studies	LKR 1000

 

7. Submission of documents

Project proposals are accepted on working days (Monday – Friday, except on public holidays) from 8.30am - 4.00pm at the Department of Medical Education and Research, Faculty of Health-Care Sciences, Eastern University Sri Lanka..

8. The approval

Ethics Review Committee meet on every 3rd/4th Tuesday of each month. Proposals which are submitted before the 30th of each month before 3.00 pm will be considered in the next ERC meeting and the approval will be granted in the subsequent meetings.

If there are any deficiencies in the submitting documents, those proposals will be directed back to the principal investigators and will be considered by the ERC only after receiving the complete documents.

If the proposal is approved by the committee, the principal investigator will be notified through post and email.