How to Apply

Instructions to applicants

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Please ensure that your application is properly filled, the relevant documents are correctly prepared, as incomplete applications will be rejected without any evaluation. Your application (both hard and soft copies and the receipt for the payment of the application processing fee; if applicable) request will be included in the agenda for the next available ERC meeting, provided it is received by relevant deadline and is complete.

Poorly planned and designed research that causes inconvenience to participants with possible risks will not produce useful or valid results and is considered to be unethical. Researchers should be responsible to ensure that his/her research is of good scientific quality before making an application for ethics review. The ERC may return the application if it is flawed in research methodology and fails to demonstrate adequate scientific validity.

Who Can Apply

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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 CINEC

· Staff members attached to the hospitals in Western Province

· Undergraduates/Postgraduates of CINEC and other higher education institutes

· Trainers and trainees of CINEC and other higher education and research institute

· Scientists/Members from recognized industries/ institute

Type of Research qualifies for applying

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Research projects involving human subjects are considered for ethical reviewing.

The ‘human research projects’ include, but are not limited to, research involving pharmaceuticals, medical devices, medical radiation and imaging, surgical procedures, biological samples, medical records and clinical databases, as well as epidemiological, social and psychological investigations using human subjects.

Filling the application form

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The current application form is available to download in our website

· The application form should be completely filled, giving relevant information according to instructions given

· Please do not leave any sections blank. 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

Check list for first submission

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Applications should be accompanied by the following documents (03 copies from each)

1. Cover letter written to Chairperson signed by the applicant

2. Declaration of Applicant

3. Submission Check List

4. Research proposal

5. One-page summary proposal

6. Information Sheet and Consent Form in English and Sinhala and in Tamil where appropriate

7. Other relevant documents (i.e. questionnaires) in English and Sinhala and Tamil where appropriate (Please note that the translated questionnaires should be certified by a professional translator)

8. Approval letter from the relevant Board of Study for postgraduate study protocols

9. Updated Curriculum Vitae of principal investigator and all the co- investigators. In general, each CV should not be more than 2-3 pages, unless a complete CV is specifically requested

PLEASE NOTE:

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· All these must be submitted as a soft copy and hard copy

· All documents must be printed, and no handwritten documents are accepted

· Email the soft copy with a complete set of documents in a single pdf file. Email -ethics.committee@cinec.edu Your application will not be processed until all required documents are received by the ERC office!

Submission Deadline

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Duly completed applications are accepted by the ERC office from Monday through Friday (except on public holidays) during office hours (9.00am to 4.00pm). The deadline for receiving the complete application is 12 noon on the last working day of each month, by which time the complete application must be received at the office of the ERC. This must include the soft copies, hard copies and the receipt for the payment of the application processing fee; if applicable.

YEAR 2024 – ERC Meeting Dates

First week Friday of every other month from 9.30 a.m. onwards

ERC decision types

The full board review of a research proposal will result in one of the following actions

· Approved: The research proposal is approved as submitted.

· Conditional approval: If the full board approves a research proposal in principle subject to minor modifications (‘Conditional Approval’), principle investigator should submit the revised project proposal which will be reviewed and approved by the subcommittee. When the requirements are met, a letter of approval will be issued.

· Revise and resubmit: The research proposal is not approved as submitted either because there is insufficient information to make a decision or the proposal is not ethically sound. However, the proposal can be resubmitted for full board review after addressing all the comments of the first review. The revised documents will be discussed in a full board meeting.

· Reject: The research proposal is ethically or scientifically unacceptable. If the CINEC ERC determines that a project is ethically unacceptable, the notification of the ERC decision will include the grounds for rejecting the project with reference to the FERCSL Guidelines or other relevant pieces of legislation.

Notification of Decisions

·Ethical clearance approval letter/conditional approval letter/ revise and submit/ rejection letter of your proposal can be collected from ERC office two weeks after the monthly ERC meeting.

· All correspondence will be emailed to the principle investigator.

· If the ERC determines that further information, clarification or modification is required for the consideration of a project, principle investigator should submit the requested before commencing the project.

Check list for resubmissions

Resubmissions should be made within 03 months from initial ERC decision. In resubmissions, please submit hard copies (03 copies from each) which include the following accordingly;

1. Cover letter to the Chairperson

2. Copy of the comment letter issued by the ERC

3. A table indicating the corrections (reviewer comments/original wording/responses or revisions done/page number) should be included in the cover letter

4. Revised document (proposal/questionnaire/consent form etc). Underline all changes in the proposal

5. Email a single PDF document to ethics.committee@cinec.edu

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.

Fee Structure

All applications will be subject to a handling fee as decided by the Board of Management of CINEC

Application processing charges for ethical approval

Category		Fee effective from 1st January 2021
CINEC – Undergraduate degree research components		Free
External Undergraduate students research components		Rs 1000
Funded research projects
Budget < Rs 100,000 and self funded research projects		Rs  2000
*Budget Rs 100,000 -500,000		Rs  5000
*Budget Rs 500,000 – 1 M		Rs  10,000
*Budget Rs 1 M –  5 M		Rs  20,000
*Budget > Rs 5 M		Rs  50,000
Application for establishment of database		Rs
Reviewing Significant amendments to the already approved studies		Rs  3000
Industry-sponsored studies/ clinical trials (Irrespective of   affiliation of the   applicant)	Initial Application	US$ 1000
	Reviewing Significant amendments   to the already approved studies	US$ 100

 Fees once paid will not be refunded. 

Account Name – CINEC Campus (Pvt) Ltd

Account No. 0039 1000 6648

Bank . Sampath Bank Malabe

Currency- LKR

Account type – Current A/C

FOLLOW-UP

ERC approval holders (primary investigator) must submit progress report and final report. Progress report must be submitted every 6 months and should indicate any deviations from the original protocol. Templates for progress report and final report are available in Download section.