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.

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 SUBMISSION


• Please fill the checklist and submit the relevant documents (refer to website).
• One copy each of the following

1. Cover letter written to Chairperson signed by the applicant
2. Completed application form with conflict of interest statement
3. Letter of consent from supervisor/s where relevant.
4. Copy of approval letter from Board of Study (for postgraduate students only).
5. Email the soft copy with a complete set of documents in a single pdf file.Email - ethics@med.ruh.ac.lk
6. A letter indicating that the investigator(s) have undergone training to handle Animals in research settings (if relevant)
7. Curriculum vitae of the Principal investigator/s
8. Certificates of training of PI/Supervisor (Research Methodology, Basic Research Ethics, Good Clinical Practice training)
9. Letter signed by all investigators confirming their participation.

*Please note that 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
10. Six copies of the detailed proposal including study instruments (postgraduate students must submit a copy identical to that approved by the board of study or submitted to the Board of study)
11. Study instruments in English, Sinhala and Tamil translations where relevant.

PLEASE NOTE:
The six(06) copies of the documents submitted must be stapled together to form six complete sets of documents. All documents must carry the date and version number as a header/footer.
Your application will not be processed until all required documents are received by the ERC office!

HOW TO COLLECT YOUR 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.

CHECK LIST FOR SUBSEQUENT SUBMISSIONS


In subsequent submissions please submit hard copies - two sets (02) in minor modifications and four sets (04) in major modifications which include the following accordingly
1. Cover letter to the Chairperson
2. Copy of the comment letter issued by the ERC
3. A table of document indicating the corrections (Comment/ correction done/page number)
4. Revised document (proposal/questionnaire/consent form etc) with highlighted corrections.

Email a single PDF document which includes the project proposal, data collection sheet or questionnaire, information sheet and consent form to ethics@med.ruh.ac.lk


Please note that the 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


• A non-refundable, processing fee of 1000.00 Sri Lankan rupees will be charged from each new application with effect from 1st February 2019. This was approved at the 385th Council meeting held on 13.11.2018. (annexed) link. 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