Welcome to the official website of the Ethics Review Committee (ERC) of the Teaching Hospital Jaffna.

This website gives you

  • Detailed information about what we do
  • How we may be able to help you in promoting and adhering to ethical principles in research including obtaining ethics clearance for your research project

Our website also provides an ongoing repository of our past activities and evolution of the field of biomedical research ethics in Sri Lanka.

It also provides information about forthcoming events in the field.

What we do:

The ERC Teaching Hospital Jaffna is being established for the first time to provide ethics review for biomedical research projects involving humans carried out at Teaching Hospital Jaffna. Our ERC will also extends it’s services to other district general hospitals and base hospital in the Northern Province where there are no institutional ERCs.

The ERC of Teaching Hospital Jaffna will regularly conducts open programs that help review issues, train committee members and researchers, and develop appropriate societal or institutional responses.

Recognition:

The ERC Teaching Hospital Jaffna is recognized by the Ministry of Health, Sri Lanka as an institutional ERC.

How we function:

The Committee has been formulated in accordance with the by-laws of the Ministry of Health and functions under the supervision of the Director Teaching Hospital Jaffna. Its members are appointed by the Director, Teaching Hospital Jaffna. The Committee has developed standard operating procedures (SOPs) in accordance with the guidelines of the FERCSL.

  • Who can apply

    In order to accept an application for ethics review, at least one of the investigators must belong to at least one of the following categories:

    1. A member of the ministry of health – consultants / medical officer attached to Teaching Hospital Jaffna / any other hospital under the purview of the ministry of health.
    2. A member of the faculty of the Faculty of Medicine, University of Jaffna.
    3. Undergraduate and postgraduate students of any recognized medical faculty/ university.
    4. Trainers and trainees of the Postgraduate Institute of Medicine (PGIM), University of Colombo
    5. A researcher who is conducting the research project on behalf of any of the institutions with which the ERC Teaching Hospital Jaffna has entered into a memorandum of understanding (MOU). These institutions will be decided on a case by case basis.
    6. A researcher who is conducting the research project on behalf of the Ministry of Health
  • What type of research qualifies for applying?

    Research projects of the following types are considered:

    1. Biomedical research involving human participants of their specimens or data.
    2. Health-related research involving communities or healthcare systems, including health policy research

    Clinical trials and animal research will not be accepted until further notice.

  • Your complete application

    The complete application consists of all of the following:

    1. Duly completed application form (which can be downloaded from this website at Downloads and Resources)
    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, Teaching Hospital Jaffna.
      You may contact the committee if you wish to seek clarifications, record any concerns or make complaints about the study by calling 0212222302/ 0212222303/0212222301  (between 9am and 4pm) from Monday to Friday (except on public holidays) or by sending an email to info.ethics@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, up to date curriculum vitae of each investigator (including members of the ERC or its subcommittees)

      Please note that all these must be submitted as a soft copy and a hard copy.t
      he hard copy must be unbound, in triplicate (in three separate sets), printed on both sides of the paper. 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. All documents must be printed, and no handwritten documents are accepted.

    The soft copies of Translations may be submitted as :

    1. PDF document

    or

    2. MS-Word document. (Must carry the fonts used in the Sinhala and Tamil translations)How

  • Fees

    There will be no application processing fees.

  • Deadline

    The deadline for receiving the completed application is 12 noon on the last working day of each month.

    The complete application which includes 3 sets of hard copies and a soft copy must be received at the office of the ERC.

  • What happens after your application has been accepted?

    • Once we have received your complete application, the Executive Committee will examine it, normally on the following Tuesday of the following month, 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.

    • Your application will be taken up for discussion at the next meeting of the ERC, which will be in the afternoon of the second Tuesday of the month starting after your application deadline.  (For instance, if you handed over the complete application on March 15th, you have met the deadline of the last working day of March, and your application will be discussed at the ERC meeting on the second Tuesday of April.)

    • During the time up to 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 15th, 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 15th.)  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).

Research Ethics Course Conducted By The Ethics Review Committee Teaching Hospital.

These would include courses for reviewers and researchers which may be conducted by suitably qualified ERC members or by invited speakers with the idea of improving the standards of research.

Resource Material

  • Emanuel et. al., What Makes Clinical Research Ethical, JAMA 2000;283:2701-2711
  • Emanuel et. al., What Makes Clinical Research in Developing Countries Ethical, The Journal of
  • Infectious Diseases 2004;189:930–7
  • Forum of Ethics Review Committees Sri Lanka, Ethics Review Committee Guidelines, 2007
  • Dissanayake et. al. Research ethics and ethical review committees in Sri Lanka: a 25 year journey, Ceylon Medical Journal; 2006;51(3):110-113.
  • Application Forms
  • Applicants guide
  • Information sheet template
  • Confirmation sheet template
  • TOR version 1
  • SOP version 1

Visiting us

The ERC office is situated in XXXX, which is in the XXXXX of the Teaching Hospital Jaffna. The office is open from 9.00 am to 3.00 pm on weekdays except public holidays. It is closed during lunch, from 12 noon to 2.00 pm.

Calling us

Telephone: (+94) 0212222301 / 0212222302/ 0212222303.

Writing to us

Secretary, Ethics Review Committee,
Teaching Hospital Jaffna,
Hospital Road,
Jaffna 40000
Sri Lanka.

Emailing us

ercthj@gmail.com