Please read this section carefully to ensure that your application and the relevant documents are correctly prepared.

Who can apply?

• A member of the permanent academic staff of KDU (including probationary staff)
• Undergraduate and postgraduate students of KDU
• Trainees of the Postgraduate Institute of Medicine (PGIM) trained under the supervision of a permanent academic member of KDU
• The staff of the military Hospitals

What type of research?

All biomedical research involving human and animal subjects must receive approval from the ERC. Therefore, if your research meets the definitions of both research and human/animal subjects, you must complete the ERC process.

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
3. Animals research that is conducted to study questions that are relevant to human health

Submit your application

Following documents are required in order to process your application.

1. Duly completed application form (can be downloaded from this website at “Downloads” Page)
2. Checklist (Available in the end of the application form), signed by the Principal Investigator
3. The detailed research protocol including a section on ethical considerations (Format can be downloaded from this website at “Downloads”). It must be correctly numbered and paginated.
4. Information sheets, consent forms, assent forms and questionnaires in all three languages.
5. Data collection forms, study tools, duly signed material transfer agreements and other relevant documents (Please refer the checklist given in the last page of the application form).
6. Brief, updated curriculum vitae of all investigators.

• All documents must be typed and printed, and no handwritten documents are accepted.
• Three hard copies of all aforementioned documents need to be submitted. The hard copies must be unbound and printed on both sides of the paper.
• Soft copies of all documents should be submitted in a CD AND should be emailed to ethicsreviewcommittee.fom@kdu.ac.lk
• The soft copies of Sinhala/Tamil translations must be submitted as PDF documents.
• The above documents should ONLY be handed over to the Secretarial Assistant, Ethics Review Committee, Faculty of Medicine, KDU after placing your signature in the logbook.
• Submission of the documents and collection of amendments/approval letters should ONLY be done by one of the investigators of the study.

Application process

The ERC-FOMKDU will be held on the last Wednesday of the month. Once a complete application is received, the Executive Committee will examine it and decide whether it should go into expedited review or exemption from review or full ERC review. If it goes into full ERC review, two specific reviewers will be appointed by the ERC to review your application. After discussing in the ERC and based on the reviewer comments, the final decision will be made at the earliest ERC meeting possible. The decision of the ERC will be informed to the principal investigator during the week following the ERC meeting. Letter indicating the decision of the ERC can be collected from the Secretarial Assistant, Ethics Review Committee, Faculty of Medicine (3rd floor), KDU.

When submitting amendments:

A cover letter with justification and relevant page numbers and other relevant documents with the amendments highlighted should be submitted.

Deadline

Applications are accepted between 9.00 am to 3.30 pm on working days.
The deadline for submission is the last Thursday of each month for a new protocol and the first Thursday for a re-submission.
The above documents should ONLY be handed over to the Secretarial Assistant, Ethics Review Committee, Faculty of Medicine (3rd floor), KDU after placing your signature in the logbook.
Submission of the documents and collection of amendments/approval letters should ONLY be done by one of the investigators of the study.