Protocol Submission Guidelines

  • Research where FTM staff members/ students are Principal Investigator conducting their research within or outside FTM facilities. Where the research is conducted outside FTM facilities, the Principal Investigator must also submit the research to the local EC for consideration; or

  • Conduct the research in FTM facilities with Investigator(s) affiliated with FTM
(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)

Click here to see policy and scope for review.

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".

No. Submitted Documents No. of Photocopy
1 Cover letter from Principal Investigator’s Department or Unit 1 original copy
2 Receipt of Submission Fee
(Exempt for FTM student's projects and projects
funded by FTM Resarch Fund)
1
3 FTM-EC Research Proposal Submission Form
(FTM ECF-019-06)
5*
(1 original + 4 photocopies)
4 Research Proposal Submission Checklist for Principal Investigator
(FTM ECF-006-05)
1
5 Full research protocol 4
6 Thesis proposal (for student only) 4
7 Evaluation of the thesis/thematic paper proposal examination (GR33) or
Result of a revision of the thesis/thematic paper proposal examination (GR37)
(for student only
4
8 Informed Consent Form, Informed Assent Form, and Participant Information Sheet (if applicable) 5*
9 Case Record Form (if applicable) 5*
10 Questionnaire, advertisement, recruitment materials (if applicable) 5*
11

Letter of permission from authorized person to use stored specimen (for study using stored specimens)

5*
(1 original + 4 photocopies )
12 Letter of permission from authorized person of the implementing institution (if the study is to be conducted outside FTM) 5*
(1 original + 4 photocopies )
13 Material Transfer Agreement (if applicable) 5*
14 Investigator's Brochure (if applicable) 4
15 CVs of all investigators/or Thesis Committee Members 1
16 Copy of Certificate of GCP Training, or Human and Subject Protection Training of PI and all Co-PI
Click here to see the policy for certificate of training requirement.
1
17 A CD or A diskette of all documents above 1
*Only 3 copies are required for Retrospective Study

Under the Regulation and Announcement of the Faculty of Tropical Medicine, dated 25 November 2016, research studies submitted for ethical review are subject to a fee, according to the following schedule:

Initial Review
Type of Fund Fee (Baht)
1
  • Domestic Thai Fund under Mahidol University
  • Domestic Thai Non-Profit Organization
5,000
2
  • International Fund
  • Pharmaceutical Company
  • For-profit Sponsor
Remark: Additional submission fee of 10,000 Baht for approval of the full protocol.
10,000
3
  • Fast-track review for all fund types
Double the normal rate
4
  • Principal Investigator (PI) is a TropMed Student
  • Faculty of Tropical Medicine, Mahidol University Fund (Research fund)
Waived
5
  • No Fund
Requires approval from the EC Chairperson to waive the fee


Continuing Review
Certificate of Ethical Approval (CEA) Extension
Type of Fund Fee (Baht)
1st CEA Extension Waived
2nd CEA Extension Waived
3rd CEA Extension (and subsequent): Domestic Thai Fund under Mahidol University or Domestic Thai Non-Profit Organization Waived
International Fund or Pharmaceutical Company or For-Profit Sponsor 5,000/time
Major Amendment
Type of Fund Fee (Baht)
1st Amendment Waived
2nd Amendment Waived
3rd Amendment (and subsequent): Domestic Thai Fund under Mahidol University or Domestic Thai Non-Profit Organization 2,500/time
International Fund or Pharmaceutical Companies or For-Profit Sponsor 5,000/time

Fees should be paid at the Finance Unit, Office of the Dean, 5th floor, The 60th Anniversary of His Majesty the King's Accession to the Throne Building, Faculty of Tropical Medicine, Mahidol University, before the submission of documents to the Committee for consideration. A copy of the payment receipt must be attached to the submitted documents.

  • 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-008-04 (Progress Report Form and CEA extension request form) ,and send it to the EC to request approval for extension. If the study is complete, a Notification of Study Closure (FTM ECF-010-03) is required.

  • Investigator is required to submit the progress report annually after approval together with request for CEA extension and report according to EC requirement depending on risk involve by using FTM ECF-008-04 (Progress Report Form and CEA extension request form) If an Investigator fails to submit a progress report by the scheduled review date, the EC will not extend the Certificate of Ethical Approval. Official notification letter will be provided to Investigators.

  • 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 Amendment Form (FTM ECF-023-04) is required for approval. Please indicate the version date on the footer of every page. Please note that a 5,000 Baht fee is charged in the case the project being funded by private- or foreign institution/company, and 2,500 Baht fee is charged in the case the project funded by government institution on the third amendment after the approval of the protocol. If it is amended in major revision (such as changing the information in synopsis, change or add main objective/ major issues ext.), the PI needs to submit it as a new research proposal.

  • The FTM EC will require that PI report all deaths that occur while the research participant is participating in a research study to the EC Chairperson. This must be accomplished in writing within five working days of the death notification to PI.

    The FTM EC will require that PI report all SAE, SUSAR, any unexpected situation affect serious to research project while the research participant is participating in a research study to the EC Chairperson (e.g., medication errors, unexpected complications, protocol violations). This must be accomplished in writing within five (5) working days of the event notification to PI, while the protocol deviations must be submitted in 1 month.

    SAE reports shall be forwarded to Primary Reviewer(s) who will review the reports and determine the relevancy of PI's causality assessment and report its suggestion/recommendation to EC at the following convened meeting.

    Unless the EC Chairperson believes an urgent meeting should be convened to discuss the death and/or unexpected adverse event related to investigational product, EC members will review the written report at the next regular meeting.

    Investigators will submit the serious adverse event to the EC using the sponsor-required documentation. If such documentation is not available, the Investigator may use the SAE Report Form FTM ECF-014-03 (SAE report form).

    The EC will require that PI report all Adverse Events related and not related to the study to the EC Chairperson. This must be accomplished in writing in one year of the event notification to PI

    Investigators will submit all safety information to the EC using the sponsor-required documentation.

  • 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 (FTM ECF-010-03) and send it to the EC with the additional documentation indicated in the form.
Secretariat Office
Ethics Committee of the Faculty of Tropical Medicine, Mahidol University
c/o Office of Research Services
4th Floor, The 60th 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 9100-4 ext. 1349, 1525; or 66 (0) 2306 9126
Fax: 66 (0) 2306 9126
E-mail: tmectropmed@mahidol.ac.th