3. Ethics Committee (EC)/Institutional Review Board (IRB)

3.1 Provide a list of documents needed to be submitted for EC/IRB review and approval including the number of copies and/or translations as relevant. 

The Thai FDA accepts paper and electronic clinical trial application submission packages.

For paper submissions, sponsors must submit two (2) original sets and one (1) copy of the completed Nor Yor Mor 1 form to the Thai FDA as well as one (1) complete set of application files (MS Word or PDF) on a CD. 

The requirements may differ according to each Ethics Committee. Two examples of the listed document requirements are provided.

1) Ethics Review Committee for Research in Human Subjects, Ministry of Public Health (ECMOPH)

According to the Ethical Review Committee for Research in Human Subjects, the Ministry of Public Health (ECMOPH) requires investigators (applicants) to submit the following documentation for ethics approval:

1. One (1) original set and 20 copies of the protocol in Thai, and one (1) copy in English for review
2. Ethical considerations
3. Combined information sheet and informed consent certificate for research participants
4. Budget details and funding source
5. Curriculum Vitae (CV) for each research team member
6. Letter of approval from the implementing institution
7. Results of ethical review by EC of implementing institution, if available
8. Data collection/questionnaire tools
9. Letter signed by PI’s supervisor
10. For an international project, Thai and foreign PIs required for each side
11. Material transfer agreement for the transfer of blood or biomedical samples
12. References

2) Central Research Ethics Committee

Investigators applying for a new research project review by the Central Research Ethics Committee (CREC) should submit the following:

1. Research proposal (one (1) set)
2. Proposal for ethical consideration (CREC forms AP 04-S04 or AP 05-S04) signed by the investigator/co-investigator (or advisor) (four (4) sets)
3. Research protocol transcript (in Thai and/or the complete English version specifying the version and date); or the Thai version if only the complete English outline of the proposal is included (four (4) sets)
4. Documents detailing the joint research project data/books consent (e.g., the Information Sheet/Consent Form), if required; must include page number/version, date, and details specifying if any participants are children and/or if assent forms are required
5. Investigator/co-investigator CVs (four (4) sets)
6. Evidence of good clinical practice (GCP) training or research ethics training by PIs/joint investigators (four (4) sets)
7. Conflict of Interest Form completed by PIs/joint investigators (CREC form AP 06-S04) (four (4) sets)
8. CD containing one (1) copy of the research project electronic files

The CREC also requires the following information from pharmaceutical companies submitting proposals for review:

1. Researcher guide (IB) (include page numbers, version, and date) (In the case of IB medical device research project, CREC form AP 01-S07)
2. IP information (if IPs are used, documentation should include Thai FDA approval information, if available, including Thai FDA certificate number and series)
3. Injury compensation insurance documents (indicate if still valid in the current year)

https://clinregs.niaid.nih.gov/country/thailand#submission_process

3.2 Time required for EC/IRB review and approval process and turnaround time if any query is raised during the review process. 

• Central Research Ethics Committee (CREC): 2 – 4 months.
• Other recognized ECs: 1 -3 months.

3.3 Does EC/IRB have any fast-track or expedited review process? 

No, Thailand does not have a fast-track process.

3.4 Does EC/IRB need to be registered and/or accredited/approved by RA/CA? 

Yes, EC committees need to be approved by the Thai FDA. See Section 2.2 of this guidebook.

3.5 How frequently do the EC/IRB meet?

The schedule of each EC differs. Most committees meet at least monthly.

3.6 Is any additional approval required apart from the EC/IRB (e.g. scientific committee, subject matter expert committee, etc.)?

No. No additional approval apart from the Thai FDA is required for EC.

3.7 Process of EC/IRB Submission for Clinical Trial Approval

Ethics Review Submission

If a trial site is not affiliated with a Thai FDA-recognized EC, the investigator(s) usually needs to apply to two (2) ECs for approval—the unaffiliated local EC and a central EC approved by the Thai FDA. 

Ethical Review Committee for Research in Human Subjects, Ministry of Public Health (ECMOPH)

The ECMOPH, which is one (1) of the ECs recognized by the Thai FDA to approve clinical research protocols, requires one (1) original and 20 copies of the protocol submitted in Thai, and one (1) copy submitted in English for review purposes.

Investigators can electronically submit applications to the ECMOPH to obtain approval for new research projects or to request other services via the ECMOPH e-submission login page. 

ECMOPH Home Page

Central Research Ethics Committee

The CREC requires the protocol to be submitted in Thai and/or the complete English version specifying the version and date; the Thai version should be submitted if only the complete English outline of the proposal is included.

3.8 What is the relevant EC/IRB fee in local currency/USD? (e.g., is the fee different for notification/approval, initial submission, amendment, study with IMPD and study without IMPD, investigator site addition, etc.)? 

The fee for a clinical trial application is typically 50,000 Baht (= USD 1,500).

3.9 Does EC/IRB accept checks or payment can be made electronically? Please provide details on (1) A/C number; (2) A/C Name; (3) Sort Code; (4) Swift Code; (5) Bank address, etc. Where can remittance advice notices be sent? 

The payment method differs for each Ethics Committee, but electronic payment is generally accepted.

3.10 Is there any guidance tool available for making electronic applications? If yes, provide the link and/or step-by-step instructions. 

A link is available to the electronic applications portal. This is only available in Thai.

https://www.fda.moph.go.th/Pages/

3.11 Does EC/IRB require any mock screens/screenshots of participant-facing material on the app? If yes, do these need to be submitted in the local language?

Yes, where patient-facing materials are provided electronically, screenshots should be presented and these need to be in Thai.

3.12 Does the EC/IRB have any template or specific element requirements on ICF and/or other participant-facing materials?

There is no specific template for the ICF.

3.13 Is there any guidance tool on participant compensation including clinical study-related injury per local requirements?

As specified in the International Council for Harmonization’s Guideline for Good Clinical Practice E6(R2) (THA-28), the sponsor or his/her designated contract research organization (CRO) is responsible for providing information related to compensation in the event of trial-related injuries or death to research participants and/or their legal heirs. The sponsor must also inform the participants of any available medical treatment in the event of trial-related injuries. Per an in-country subject matter expert, Thailand is implementing THA-28.

3.14 Are there any specific local safety reporting requirements for clinical studies?

Please refer to Section 2.15.

3.15 Does the EC/IRB require any periodic study reporting?

Please refer to Section 2.15.