INFORMATION FOR APPLICANTS WHO ARE APPLYING FOR ETHICAL CLEARANCE AT ERC, FMAS, RUSL
The Ethics Review Committee, Faculty of Medicine and Allied Sciences, Rajarata University of Sri Lanka provides independent guidance, advice and decision on health research or other specific research protocols involving human subjects conducted by researchers of or conducted in North Central, or neighbouring provinces (Northern, North Western, Eastern or Central) of Sri Lanka. The proposals of principal investigators attached outside RUSL will also be considered for review provided that they are submitted through the recommendation of the respective heads of their institutions.
The applicants are advised to read the ‘Instructions to fill the ERC application’ available with the application.
1. Application for Ethics Review
Application for Ethics Review (latest version 2018) can be downloaded from the ‘Applications’ menu under ethics review committee (ERC) of the faculty web site. Samples of patient information leaflet and consent form can also be downloaded.
2. Checklist for applicants
One full hard copy and a soft copy (soft copy should be saved in PDF format) of the following
- Cover letter
- Receipt of payment
- Part 1 & Part 11 of the application
- Research Proposal
- Diagrammatic representative (flow chart) of the research procedures
- Academic supervisors’ letters (if relevant. However, the applicants who follows Diplomas/Undergraduate/Postgraduate Degrees should submit an academic supervisors’ letter)
- Ethics approval from other institutions
- Instruments (questionnaires/interview guides/ checklists/ data extraction forms) to be used in the research in English with appropriate translated version (Sinhala, Tamil or both)
- Participant information leaflet in English and with appropriate translated version (Sinhala, Tamil or both)
- Informed consent form (for adult participants/guardians of children) in English and with appropriate translated version (Sinhala, Tamil or both) with the principal investigator’s contact information and contact number for any complaints
- CV of Principal investigator and the other relevant co-investigators (if the PI is not the subject specialist)
- Project summary (refer section 1.10 of this application) with principal investigators name and the project title
The file of the application containing the cover letter and the receipt of payment should be labeled as the master file. It should have the principal investigators name and the project title on the top.
3. Handing over the application
- The printed copy of the applications should be submitted to the ERC office at FMAS, RUSL. Submission can be done between 9am to 4pm from Monday to Friday except on public and mercantile holidays.
- In addition, the printed copy can be sent via registered post to reach “The Secretary, Ethics Review Committee, Faculty of Medicine and Allied Sciences, Rajarata University of Sri Lanka, Saliyapura.”
- The soft copy should be in PDF format and send to erc@med.rjt.ac.lk.
- E-signatures should be included where the signatures should be inserted in the soft copies of the application and the cover letter.
4. Payments
The fee structure for reviewing and processing an application will be
- For undergraduate students of Rajarata University of Sri Lanka – No charges
- If the principle investigator is a permanent member of faculty of the FMAS, RUSL – Rs. 2,000/=
- For all other principle investigators – Rs. 3,000/=.
- International applicants – US$ 100
- Applicants from South Asian countries- US$ 50
- For industry – Rs. 10,000/= (non-pharmaceutical)
- Pharmaceutical industry sponsored Rs. 100,000/=
- For major corrections 50% of the above mentioned amount has to be paid
(However fee waiver can be considered on request for those who have financial restrictions).
Payment should be made to the Shroff counter, FMAS, RUSL between 09:00- 16:00 hours of working days or deposited directly into the following university bank account.
- Name of the Account: Rajarata University of Sri Lanka
- Bank: Bank of Ceylon (BOC) [SWIFT Address: BCEYLKLX]
- Branch: Mihintale [Branch Code: 335]
- Account No: 5500331
Please note that all payments are non-refundable.
5. Submission deadline
Twelve ERC meetings will be held per year. ERC meetings are held every second Tuesday of the month, unless postponed due to some extraneous reasons.
The deadline for the submission is 15th (If it falls on a holiday should submit on the next working day) of each month for it to be considered in the next Ethics Review Committee meeting. Proposals submitted after the deadline will be considered at the meeting of the following month.
6. Time Frame for ERC approval
All duly filled applications are sent to two primary reviewers (can be external or internal) and the review reports are expected to be submitted before the next ERC meeting. ERC approval could be delayed due to incomplete applications or deferred reviewer reports.
7. Decisions
The ERC, after consideration of an application at the monthly meeting, will make one of the following decisions:
- Approved – no changes required
- Minor corrections – would be eligible for Chairperson’s or Secretary’s approval once ERC receives the primary reviewers’ comments on
- Major corrections – would require full board review once the resubmission is done with the major corrections
- Rejected – reasons will be conveyed to the
8. Ethical approval certificate
Ethical approval letter will be sent by the ERC office, FMAS, RUSL via email. It contains the conditions of the ERC approval, duration of the ERC approval, frequency at which submission of the progress reports are needed and the date of submission of final report.
