Guidelines for submitting proposals to ERC(Amended in 2018)

1. One (1) copy of the project proposal (This should include research protocol, participants’ information sheet, consent form and questionnaires if any)
2. Duly filled application form (original)
3. One copy of one-page summary of the study including the title of the project
4. Evidence for payment (Pay-in voucher)
5. Approval letter from the relevant institution where research will be conducted (If any)
6. Approval letter from the relevant postgraduate institution (for postgraduate degrees)
7. Supervisor’s letter (for postgraduate degrees)
8. Brief CVs of all investigators (maximum 2 pages)

All submitted documents including the application form and payment receipt must be scanned as one document and emailed to erc_fhcs@esn.ac.lk

1. Investigator brochure
2. Clinical record forms 
3. In case of multi centre studies, listing of overseas centre(s) and ERC/IRB approval status if relevant and  copies of ERC/IB approval letters from other centres
4. Product liability letter or insurance certificate
5. Patient recruitment procedures 
6. Patient’s diary cards 
7. Justification for use of placebo (if any)

1. One (1) copy of project proposal (This should include research protocol, participants’ information sheet, consent form and questionnaires if any)
2. Duly filled application form (original)
3. One (1) copy of one-page summary of the study with the title

All above documents must be scanned as one document and emailed to erc_fhcs@esn.ac.lk

1. Period of resubmission is one month from the date of notification
2. One (1) copy of corrected proposal (with changes highlighted in the proposal) with a covering letter tabulating the reviewers’ comments and the relevant responses/changes made in the proposal
3. One (1) copy of the relevant documents corrected (e.g. information, consent form, questionnaire) 
4. The current version number of the document should be mentioned on all the resubmitted documents

All above documents must be scanned as one document and emailed to the erc_fhcs@esn.ac.lk

1. Amendments

   1. Those who seek approval for any amendments in the proposal which has been previously approved by the ERC, should submit one (1) copy of the amended proposal (in which the amendments should be highlighted) with a covering letter
   2. 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
   3. The version number and date should be mentioned in each page of the proposal

2. Extensions

   1. 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
   2. Such requests should be made not later than 30 days prior to the expiry of approval

Project proposals are accepted only on working days Monday – Thursday, (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.

Ethics Review Committee meet on every 3rd Thursday of each month. Proposals which are submitted before one week of each ERC meeting 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 submitted 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 email.