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How to Apply ERC?

INFORMATION FOR APPLICANTS WHO ARE APPLYING FOR ETHICAL CLEARANCE AT ERC, FMAS, RUSL

Special Notice

Submission of ethics review applications during the present COVID-19 pandemic

 

An online application submission procedure has been established to ensure the safety and convenience of the researchers and to ensure the uninterrupted review process during the present COVID-19 pandemic.

Instructions to applicants:

  1. All the documents should be saved in PDF format
  2. e-signatures or names in full should be included where the signatures should be inserted
  3. All the documents should be submitted via the official email of ERC, erc@med.rjt.ac.lk
  4. One set of printed documents should be submitted via post
  5. Payments should be deposited in the following account and payment confirmation or deposit slip should be submitted with the other documents:
  • 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 READ ALL THE INSTRUCTIONS GIVEN BELOW

The applicants are advised to read the ‘Instructions to fill the ERC application’ available with the application.

1. Application for Ethics Review

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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.sssssssssss

 

2. Checklist for applicants

1 copy of the following (attached to the master file of the research proposal)

  • Cover letter
  • Receipt of payment

3 hard copies and a soft copy of the following

  • Part 1 & Part 11 of the application
  • Research Proposal
  • Diagrammatic representative (flow chart) of the research procedures
  • Academic supervisors’ letters (if relevant)
  • 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)

21 copies of the,

  •  Project summary (refer section 1.10 of this application) with principal investigators name and the project title

One file of the application containing the cover letter and the receipt of payment should be labeled as the master file. Other two files should be labeled as copy files. Project summaries should be included in a separate file. All files should have the principal investigators name and the project title on the top.

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3. Handing over the application

 

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.

 

4. Payments

The fee structure for reviewing and processing an application will be

a. For undergraduate students of Rajarata University of Sri Lanka
– No charges
b. If the principle investigator is a member or from the teaching faculty of the  FMAS, RUSL
– Rs 2000/=
c. For all other principle investigators
– Rs 3000/=
d.International applicants
– US$ 100
e.Applicants from South Asian countries
– US$ 50
f. For industry (non-pharmaceutical)
– Rs 10,000/=
g. Pharmaceutical industry sponsored
– Rs 100000/=
h.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 9.00 – 16.00 hours of working days. Please note that all payments are non-refundable.

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5. Submission deadline

 

Twelve ERC meetings will be held per year. ERC meetings are held every first 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 approvalff

 

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.

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7. Decisions

 

The ERC, after consideration of an application at the monthly meeting, will make one of the following decisions:gggggg

  • 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

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Ethical approval letter can be collected from the ERC office at FMAS, RUSL. 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.