INSTRUCTIONS TO APPLICANTS


Please read this carefully to ensure that your application is properly filled, the relevant documents are correctly prepared as this would minimize delays in evaluating your application.

1. Badly planned and poorly designed research that causes inconvenience to participants with possible risks will not produce useful or valid results and is considered to be unethical. It is the responsibility of the researcher to ensure that his/her research is of good scientific quality before making an application for ethics review.

2. The ERC may return the application if it is flawed in research methodology and fails to demonstrate adequate scientific validity.

3. All the authors are kindly requested to adhere to the format (Click here) and order of content of the research proposal as appropriate when they submit the research proposal to Ethics Review Committee, Faculty of Medicine, University of Ruhuna.

WHO CAN APPLY ?


Principal Investigator/at least one of the investigators must belong to one of the following categories to accept the application for reviewing;
• A member of the academic staff (permanent/temporary) of the University of Ruhuna
• Staff members attached to the hospitals in the Southern Province
• Undergraduates of University of Ruhuna
• Trainers and trainees of the Faculty of Graduate Studies (FGS), University of Ruhuna
• A researcher who is conducting the research project in a study setting in Southern Province

*Please note that the subsequent proposals from any investigator who do not comply with the submission of the progress review form and/or final reports duly (as specified in the ERC granting letter) will not be accepted.

FILLING THE APPLICATION FORM


The current application form is available online in our website.
• All human and animal research proposals must be submitted on the prescribed application form(s).
• The application form should be completely filled, giving relevant information according to instructions given.
• Please do not leave any sections blank and indicate as 'not applicable' for any questions that are not relevant.
• The relevant sections and page numbers on the proposal must be indicated.
• All documents must have the date and version number as a header and the page number as footer.(E.g. For new submissions: Version 1, for resubmissions: Version 2, 3 accordingly)
• Applications and all other relevant documents including translations should be typed. Hand written applications /documents will not be accepted.
• Once filled, the applicant and the other co-investigators must sign on the hard copy of the application form.
• E-signatures will not be accepted for applicants from Sri Lanka.
• If the principal investigator is from overseas, e-signatures are considered. However one hard copy must be sent via post with the original signature before ERC approval is granted. In such projects there should be a local investigator as co-investigators.
• With special relevance to elective students/foreign investigators, all the documents need to be submitted through a local supervisor/co-investigator.

CHECK LIST FOR FIRST / INITIAL SUBMISSION


• Please submit both hard copies and soft copies.

  • [A] Hard copies

No

Item

No. of hard copies

1.

Cover letter written to Chairperson signed by the applicant

01

2.

Completed application form

01

3.

Letter of consent from supervisor/s where relevant

01

4.

Detailed research proposal (including study instruments, consent form and information sheet in English, Sinhala & Tamil if relevant, permission seeking letters (draft copies)

 

02

5.

Curriculum vitae of the principal investigator (PI)/s

01

6.

Certificates of training of PI/Supervisor (on Research Methodology, Basic Research Ethics, Good Clinical Practice Training)

01

7.

A letter indicating that the investigator(s) have undergone training to handle animals in research settings (if relevant) 

01

8.

Receipt of payment of processing fee (according to payment category)

01

 

No

Item

1.

All the documents from item no. 1 to no. 7 as a single PDF file

2.

A detailed research proposal (item 4 only) as a single PDF file-
This file should include research proposal, study instruments, consent form and information sheet in English, Sinhala & Tamil if relevant, permission seeking letters (draft copies)

Important: Names and affiliations of investigators should be removed from all documents in this soft copy



PLEASE NOTE:

  • All documents must carry the date and version number as a header/footer.
  • The application will not be processed until all required documents are received by the ERC office.
  • The principal investigator/s and/or supervisor/s (in undergraduate research) are requested to submit the evidence (certificates) for the competence in specific fields.
  • For observational studies - Research Methodology, Basic Research Ethics
  • For interventional studies/clinical trials - Research Methodology, Basic Research Ethics, Good Clinical Practice Training
  • For animal studies - Research Methodology, Basic Research Ethics, Training to handle animals in research settings

CHECK LIST FOR SUBSEQUENT SUBMISSIONS

Please submit both hard copies and soft copies

  • [A]  Hard copies

No

Item

No. of copies

1.

Cover letter written to Chairperson signed by the applicant
(Pl. provide the reference/proposal number given by ERC)

01

2.

A copy of the comments issued by the ERC

01

3.

A table of document indicating the corrections (Comment/ correction done/page number)

01

4.

Revised research proposal (proposal/questionnaire/consent form etc) with highlighted corrections

01

 

No

Item

1.

All the documents from item no. 1 to no. 4 as a single PDF file

 

Important: Names and affiliations of investigators should be removed from all documents

PLEASE NOTE

  • All documents must carry the date and version number as a header/footer.

CHECK LIST FOR SUBMISSIONS OF PROPOSALS WITH AN ERC APPROVAL LETTER FROM OTHER ERC (in a multicenter study)

Please submit both hard copies and soft copies

  •  [A] Hard copies

No

Item

No. of copies

1.

Cover letter written to Chairperson signed by the applicant

01

2.

Completed application form

01

3.

Letter of consent from supervisor/s where relevant

01

4.

Detailed research proposal (including study instruments, consent form and information sheet in English, Sinhala & Tamil if relevant, permission seeking letters (draft copies)

 

02

5.

Curriculum vitae of the principal investigator/s

01

6.

Certificates of training of PI/Supervisor (on Research Methodology, Basic Research Ethics, Good Clinical Practice Training)

01

7.

A letter indicating that the investigator(s) have undergone training to handle animals in research settings (if relevant) 

01

8.

Receipt of payment of processing fee (according to payment category)

01

9.

Copy of the ERC letter received by the other ERC

01

 

No

Item

1.

All the documents from item no. 1 to no. 7 as a single PDF file

2.

A detailed research proposal (item 4 only) as a single PDF file-
This file should include research proposal, study instruments, consent form and information sheet in English, Sinhala & Tamil if relevant, permission seeking letters (draft copies)

Important: Names and affiliations of investigators should be removed from all documents

Note: These changes are effective from 01st March 2023.

HOW TO COLLECT YOUR ERC APPROVAL LETTER?

 • Please allow minimum of two months to process and review the proposal.
• Ethical clearance granting letter or comments letter of your proposal can be collected from ERC office during opening hours.
• All correspondence will be emailed to the principle investigator.

Please note that your submission will be kept for three months (three meetings) in the minutes (since the initial meeting where it is reviewed) and will be removed, if you do not respond to the comments.

OPENING HOURS FOR SUBMISSION


• ERC Office is located in the CIU Building
• Opening hours : Monday to Friday - 8.30 am to 3.30 pm (Closed on public holidays, Poya days and weekends)
• Applications and document submissions should be between 9.00 am to 11.30 am and 1.30pm to 3.30 pm.

SUBMISSION DEADLINE


• The ERC, FM/UOR meets every 3rd week of the month (liable to be changed with the academic commitments), except in the months of April and December.
• Duly completed applications and all other relevant documents should be submitted on or before the last working day of the preceding month (before 3.30 pm), to be taken up at the next scheduled meeting (Irrespective whether it is the first submission or a subsequent submission)

Submission and Processing Fee


• Following were the approved fee structure with effect from 1st January 2023..

Category Description Fee (LKR)
I Projects in which the Principal Investigator is a staff member in the University of Ruhuna or in the Extended Faculty (Teaching Hospital, Karapitiya, Mahamodara) 3000.00
II Projects in which the Principal Investigator does not belong to category (I) as mentioned above 5000.00
III Projects (in fulfilment of a requirement of the curriculum) in which the Principal Investigator is an undergraduate of the University of Ruhuna No fee (free of charge)
IV Industry sponsored Clinical trial equivalent to USD 500

• Receipt of payment should be submitted with the application. Payments should be made in favour of Ethics Review Committee to the Shroff Counter, Faculty of Medicine, University of Ruhuna