Research projects of the following types are considered,

• Biomedical research involving human participants of their specimens or data, including clinical trials, genomic research.
• Health-related research involving communities or healthcare systems, including health policy research.
• Animals research that is conducted to study questions that are relevant to human health.
• Please note that if the research has a clinical trial component (as defined by the World Health Organization), the full details of the intervention planned must be submitted in the protocol. In the event that the full details are not yet available because they are planned to be developed by an earlier phase/s of research, the initial application should be made only for these earlier phase/s of the research, and not as a clinical trial, along with an introductory statement that a future clinical trial is planned. Once the full details of the intervention have been worked out, a new application should be made as for a clinical trial.

The complete application consists of all of the following:

• • • • 1. Duly completed application form (which can be downloaded from this website at Resources Page)
        2. Checklist of contents (which can be downloaded from this website at Downloads and Resources), signed by the Principal Investigator
        3. The detailed research protocol, which must be correctly numbered and paginated
        4. Information sheets, consent forms, assent forms and questionnaire forms, where necessary in all three languages. Please note it is mandatory to include the following at the bottom of the information sheet: “This project has been approved by the Ethics Review Committee, Faculty of Medicine, University of Colombo. You may contact the committee if you wish to seek clarifications, record any concerns or make complaints about the study by calling 0112695300 extension 240 (between 9am and 4pm) or by sending an email to erc@med.cmb.ac.lk“
        5. Data collection forms, case record forms, study tools, duly signed material transfer agreements and other documents that are needed to carry out the research project
        6. A short, uptodate curriculum vitae of each investigator (including members of the ERC or its subcommittees)
        7. For clinical trials, please include
           1. one page summary of the clinical trial
           2. a flowchart showing the trial protocol
           3. Certificate of GCP training for at least one member of the research study
        8. Please note that all these must be submitted as a soft copy and a hard copy.
        9. A hard copy must be printed on both sides of the paper, Unbound
        10. The title of the research project must be displayed as a heading at the top of the front page on each of these documents, in the language relevant to that particular document. 
        11. All documents must be printed, and no handwritten documents are accepted.
        12. The soft copies of Translations must be submitted as PDF document

• • • • • For the purpose of determining the application processing fee, six categories of protocols are identified:
          1. Proposals funded by grants or sponsors:
             Budget value < Rs. 500,000 :Fee Rs.5,000
             Budget value Rs. 0.5-1.0 million :Fee Rs.10,000
             Budget value > 1 million :Fee Rs. 20,000
             Budget value above Rs 5 million :Fee Rs. 50,000
          2. Extra-mural research conducted by an institution with a MOU with the ERC : Fee Rs. 5,000
          3. Projects where the principal investigator is a student or academic staff member of the University of Colombo: Fee Rs. 3,000
          4. Projects where the principal investigator is a member of the extended faculty or a trainer or trainee of the PGIM: Fee Rs. 5,000
          5. Industry-sponsored clinical trial: Fee LKR equivalent of USD 1,000
          6. Local Industry-sponsored clinical trials
             Budget value < Rs. 1 million-   Rs.50,000
             Budget value Rs. 1– 5 million- Rs.100,000
             Budget value > Rs. 5 million-   Rs.150,000
          7. Projects which are conducted by an undergraduate student of the University of Colombo, in fulfilment of a requirement of the curriculum: free.
        • Where the application falls under two more of these categories, the higher fee will apply.
        • In the case of research projects funded by grants or sponsors where the grant or sponsor money has not been received yet, the next highest fee will be accepted at the time of submission of the application, along with an undertaking to pay the remainder as soon as the grant or sponsor money has been received.
        • Requests for exemption from fees, in the case of exceptional circumstances, should be made to the ERC and approval obtained before submitting the application.
        • In addition to the above fee, if a previously approved research project requests an amendment to the protocol which is deemed by the ERC as a significant amendment, a further protocol amendment fee of 25% of the original application processing fee will be levied.
        • Cheques should be written in favor of “Faculty of Medicine, University of Colombo”.
        • Cash should be paid to the UCFM Shroff; the Shroff Counter is open on working days from 8.30am to 2.30pm.
        • Fees once paid will not be refunded. 

Applications are accepted between 9.00 am to 3.30 pm on working days of Faculty of Medicine University of Colombo.

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 and the Shroff’s receipt for the payment of the application processing fee.

• • • • • Once we have received your complete application, the Executive Committee will examine it, normally on the subsequent Tuesday, and decide whether it qualifies for expedited review or exemption from review.  If it does, the ERC will contact you in the following few days and inform you of the decision.  The Executive Committee may suggest minor changes to facilitate expedited review or exemption from review.  If such decision is made (i.e., expedited review or exemption from review), you will receive a letter to this effect in a few days.
        • If the application must go into full review, we will forward it to all members of the ERC and appoint two specific reviewers for your application.  If the research project is a clinical trial it will be also forwarded to the CTSC, which will then appoint one specific reviewer from its membership; the CTSC will initially discuss your application at its meeting, which is on the third Tuesday of every month. Similarly, if the research project is an animal research project it will be also forwarded to the ARWSC which will then appoint one specific reviewer from its membership; the ARWSC will initially discuss your application at its meeting, which takes place before the ERC meeting.  However, in either case, the final decision will be made only by the ERC, and the relevant subcommittee acts only in an advisory capacity.
        • Your application will be taken up for discussion at the next meeting of the ERC, which will be in the afternoon of the third Thursday of the month starting after your application deadline.  (For instance, if you handed over the complete application on March 15^th, you have met the deadline of the last working day of March, and your application will be discussed at the ERC meeting on the third Thursday of April.)
        • During the time upto the relevant ERC meeting, one or both of the specific reviewers may contact you to obtain more information on your application.  Normally this will be to help make minor changes to the application that the reviewer feels would help prompt approval.  However, it is important to realize that the final decision will only be made at the ERC meeting itself, and any such discussions that the reviewer/s may have with you are tentative.
        • The decision of the ERC will be informed to the principal investigator by email, during the week following the ERC meeting (i.e. if the application was submitted on March 15^th, the decision will be given during the last week of April). The decision will be one of the following:

* As stated earlier, if the application receives exemption from review or expedited review, you will be informed of this early, and you will receive the letter of exemption from review or expedited review (as the case may be) early, so that you can start the project straight away.  (For instance, in the previous example, this letter will be given to you in the week following March 15^th.)  Once such a project receives approval at the ERC, you will be given a letter to that effect in the last week of April, which will be the letter of full approval.

* Following full ERC review, the ERC may approve the protocol. You will receive the letter in the week following the ERC meeting (in the preceding example, the last week of April).

What does ethics approval mean?

• • • • • The ethics clearance you are given is valid for one year. This approval relates to the ethical content of the study only, and you are responsible to obtain any other relevant approval.
        • If your study is a clinical trial, it should be registered with the clinical trial registry prior to starting the study.

Progress reports/ Final report

• • • • • If the study is continued for a period beyond one year, you are required to furnish an annual progress report for the year and an application for the extension of approval by a further year.  The ERC will issue such extension after consideration of the progress report and any other information it may require from you for this purpose.
        • Progress reports and final reports should be submitted in the recommended template, which can be downloaded from the ERC web page of the Faculty of Medicine, University of Colombo website.
        • In similar manner, you are required to furnish a progress report and an application for the extension of approval for each subsequent year as long as the study is continued.  If no such application is made or extension of approval given, the ethics clearance lapses automatically once the current year of approval is finished.
        • If the progress report and/or the final report is/aredelayed more than one month beyond the due date (which is the final date of ethics approval in force), approval for the study will lapse and you will be required to furnish a new application should you wish to resume or continue the study.
        • If a PI has three or more research proposals in which the progress reports and/or final reports have lapsed in this manner, no further applications for ethics review shall be entertained from such PI.

 Documents required at submission

• • • • • Amendments
          1. Cover letter with Justification and relevant page numbers
          2. Relevant documents with the amendments highlighted
        • Extensions
          1. Cover letter with Justification and relevant page numbers
          2. Progress report – Annual or Final report templateor Clinical Trials CTSC Annual or Final report template