• Research studies conducted by staff (individuals, or organizations affiliated with the Faculty) and students of the Faculty of Tropical Medicine
• Research studies involving human subjects, volunteers, or patients admitted to the Hospital for Tropical Diseases
• Research studies conducted by other organizations requesting ethics approval from the Ethics Committee of the Faculty of Tropical Medicine

* (Please note that in the case of thesis research, it is required that the supervisory committee has been established, and has approved the thesis proposal. The date of approval of the thesis proposal must be recorded on the ethics protocol cover sheet)

2. Required documentation

• The application, in the format required by the Ethics Committee (for number of copies, see below). Please note that all items need to be filled in; if any item is not relevant, please note “not relevant”.
• Proposal Submission Checklist for Principal Investigator
• Full research proposal (one copy only)
• Participant information sheet (in Thai)
• Informed Consent form (in Thai)
• Assent Form (in Thai, if applicable)
• Questionnaire(s)/ advertisement used in the research (in Thai, if applicable)
• All document files submitted saved to a computer CD or diskette

We require 12 copies of all documentation for clinical trials or clinical research, 9 copies for non-clinical trials or non-clinical research.
The original copy of the Application Form must be submitted with the rest of the photocopies

3. Ethics Review Fee / Submission Fee

According to Mahidol University Regulation and Announcement, dated 25 July 2008, and the Faculty of Tropical Medicine Regulation and Announcement, dated 1 September 2008, research studies submitted for ethics review are subject to a fee, as follows:

• If the research is funded by an institution under Mahidol University , or in-country funded, and the organization is not-for-profit, the review fee is 5,000 Baht per project
• If the research is funded by a for-profit sponsor, in-country or non-Thai Government funded; or project funded by international organization, the review fee is 10,000 Baht per project

The fee should be paid at the Finance Unit, Office of the Dean, Faculty of Tropical Medicine, Mahidol University. A copy of the payment receipt must be attached to the submitted protocol.

*Note: The review fee will be waived for TropMed students for their research for theses or thematic papers for all programs of the Faculty of Tropical Medicine, Mahidol University.

4. After the Approval Has Been Granted, What Happens?

• The Certificate of Ethical Approval (CEA) is valid for one year
• An annual renewal is required each year until the end of the nominated study duration, or study completion, whichever comes first . Two months before the expiry date, the investigator should fill in form FTM ECF-008-00 (Certificate of Ethical Approval Extension Request Form) , and send it to the EC to request approval for extension. If the study is complete, a Notification of Study Closure form (FTM ECF-010-00) is required.
• Where a project has been determined for revision or report before the expiry date (i.e. every 3 or 6 months), an Application of Continuing Review Form (FTM ECF-009-00) must be submitted to the EC on the date indicated in the approval notification document.
• If there are any changes to the research project (Change in the principal investigator or any co-investigator(s), Protocol, Participant information sheet, Informed consent form, Advertisement document, Questionnaire, etc,.) after it has been approved, an amendment must be submitted to, and approved by, the EC before the revised research project is implemented. A Request for Protocol Revision Form (FTM ECF-012-00) is required for approval. Please indicate the version date on the footer of every page. Please note that a 2,000 Baht fee is charged on the third amendment after the approval of the protocol.
• For clinical research projects, any adverse events, or serious adverse events, occurring during the study must be reported to the EC in writing within 5 days of the event notification to the investigator. The investigator may use the sponsor's SAE report form, or FTM ECF-014-01 (EC's SAE report form) to report to the EC
• Once the study is complete or terminates under any other circumstance, the investigator must inform the EC of the study termination using the Notification of Study Closure Form (FTM ECF-010-00) and send it to the EC with the additional documentation indicated in the form.

5. Submit complete documentation to:

Secretariat Office
Ethics Committee of the Faculty of Tropical Medicine, Mahidol University
c/o Research and Academic Services
4^th Floor, The 60^th Anniversary of His Majesty the King's Accession to the Throne Building
Faculty of Tropical Medicine, Mahidol University
420/6 Ratchawithi Road, Bangkok 10400, Thailand
Phone: 66 (0) 2354 9100-19 ext. 1349, 1525; or 66 (0) 2643 5578
Fax: 66 (0) 2354 3466
E-mail: tmpww@mahidol.ac.th