Announcement
Dear Investigator(s) and Study Coordinator(s)

Appointment order

1. 25 January 2023 Bumrungrad International-Institutional Review Board
2. 25 January 2023 Member list

Quality Assurance

1. The Strategic Initiative for Developing Capacity in Ethical Review – Forum for Ethical Review

Committees in Asia and the Western Pacific (SIDCER-FERCAP) 

Bumrungrad International-Institutional Review Board was awarded international recognition by the Strategic Initiative for Developing Capacity in Ethical Review-Forum for Ethical Review Committees in Asia and the Western Pacific (SIDCER-FERCAP) in 2016 (1st), 2019 (2nd) and 2023 (3rd)
 

Contact Staff

Contact Channel

Papatporn Fongissara
Senior IRB Officer
Telephone +660 201 14157
Email: [email protected]

Relate Links

• FWA (Federal Wide Assurance)
• FDA Thailand
• U.S. FDA
• HHS (The U.S. Department of Health and Human Services)
• OHRP (The Office for Human Research Protections)
• ICH GCP
• NECAST (National Ethics Committee Accreditation System of Thailand)
• FERCIT (Forum for Ethical Review Committee in Thailand)
• FERCAP-SIDCER
• MEDICAL COUNCIL OF THAILAND
• GDPR (The European General Data Protection Regulation) 
• CITI - Collaborative Institutional Training Initiative (citiprogram.org)

• IRB 1.01 version 6.0 date 05 January 2026
  • Chapter 1 Preparation of Standard Operating Procedures
• IRB 1.02 version 6.0 date 05 January 2026
  • Chapter 2 Constitution of the Institutional Review Board
• IRB 1.03 version 6.0 date 05 January 2026
  • Chapter 3 Management of Protocols for Initial Review and Approval
• IRB 1.04 version 6.0 date 05 January 2026
  • Chapter 4 Guideline of Review Process
• IRB 1.05 version 6.0 date 05 January 2026
  • Chapter 5 Committee Meeting and Minutes
• IRB 1.06 version 6.0 date 05 January 2026
  • Chapter 6 Continuing Review of Research Projects after Approval
• ​IRB 1.07 version 6.0 date 05 January 2026
  • Chapter 7 Management of Study Files
• IRB 1.08 version 6.0 date 05 January 2026
  • Chapter 8 Site Monitoring Visit
     

1. The Belmont Report

     1.1 รายงานเบลมองต์ (ไทย)

     1.2 The Belmont Report (English)

2. Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants

    2.1 มาตรฐานและแนวทางการดำเนินการสำหรับการทบทวนพิจารณาจริยธรรมการวิจัยทางสุขภาพที่กระทำในมนุษย์(ไทย)

    2.2 Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants (English)

3. WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects

    3.1 ปฏิญญาเฮลซิงกิของแพทยสมาคมโลก(ไทย)

    3.2 WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects (English)

4. International Ethical Guidelines for Health-related Research Involving Humans

    4.1 แนวทางจริยธรรมสากลสำหรับการวิจัยในมนุษย์ (ไทย)

    4.2 International Ethical Guidelines for Health-related Research Involving Humans (English)

5. ICH GCP

    5.1 แนวทางการปฏิบัติการวิจัยทางคลินิกที่ดี (ไทย)

    5.2 E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) (English)
    5.3 2016 European medicines agency-ICH-E6-R2-Guideline-GCP-Step-5
    5.4 2017_ICH_E18_Guideline Genomic data
    5.5 2021_ICH-Guideline-E8-R1-general-considerations-clinical-studies_Effective042022
    5.6 2025_ICH_E6(R3)_Step4_FinalGuideline

6. The Nuremberg Code

    6.1 กฎนูเรมเบิร์ก (ไทย)

    6.2 Nuremberg Code(English)
    6.3 Nuremberg Code_A Critique_2011-PCR-2-72
    6.4 OHRP_Nuremberg Code_ Directives for Human Experimentation

7. National Health Act B.E. 2550 (A.D. 2007)

    7.1 พระราชบัญญัติสุขภาพแห่งชาติ พ.ศ. ๒๕๕๐ (ไทย)

    7.2 National Health Act B.E. 2550 (A.D. 2007) (English)
    7.3 2550_พระราชบัญญัติสุขภาพแห่งชาติ พ.ศ.2550 สนง คณะกรรมการกฤษฎีกา

8. ราชกิจจานุเบกษา_ระเบียบกระทรวงสาธารณสุข ว่าด้วยการคุ้มครองและจัดการข้อมูลด้านสุขภาพของบุคคล พ.ศ. ๒๕๖๑ (ไทย)

9. Personal Data Protection Act B.E. 2562 (A.D.2019)

     9.1 พระราชบัญญัติคุ้มครองข้อมูลส่วนบุคคล พ.ศ. ๒๕๖๒ (ไทย)

     9.2 Personal Data Protection Act B.E. 2562 (A.D.2019) (English)
10. CFR
       10.1 revised-common-rule-reg-text-unofficial-2018-requirements-19112021
       10.2 CFR-title45-vol1_Public welfare-2021
       10.3 CFR-2020-title45-vol1-part46
       10.4 CFR_permission from parent_guardian-19052022
11. 2565_ข้อบังคับแพทยสภาว่าด้วยการรักษาจริยธรรม-การศึกษาวิจัยและการทดลองในมนุษย์ 2565-HL060123
12. 2550_Thai_Ethical_Guidelines_Full_FERCIT
13. 2021_FERCIT_Guidance_Template_ICF_CT_Thailand
14. 2562_พระราชบัญญัติคุ้มครองเด็ก 2546 เพิ่มเติม 2562
15. 2551_พรบ.เครื่องมือแพทย์ พ.ศ. 2551 และฉบับแก้ไขเพิ่มเติม
16. 2562_พระราชบัญญัติเครื่องมือแพทย์ (ฉบับที่ 2) พ.ศ.2562 (ราชกิจจา)
17. 2564_NRCT Ethical
18. 2011_AE_Guidance_publish
19. บทเรียนและกรณีศึกษาด้านจริยธรรมการวิจัย
20. 2025_NRCT_Handbook-National Policy-Ethics Oversight-Ethical Guidelines

• Review Procedures
  • Management of Protocols for Initial Review and Approval
  • Management of Protocols for Full Board Review
  • Management of Protocols for Expedited Review
  • Management of Protocols Exempt from IRB Review
• IRB Decision

Forms for New Research Protocol Submitted for Initial Review

1. Initial Review Submission Form (Word)
2. Initial Review Submission Form (Excel)
3. Research Proposal for Submission for Initial Review and Approval
4. Instruction for Writing Research Proposal
5. Investigator’s Curriculum Vitae
6. Conflict of Interest Declaration Form for Investigator
7. Research Participant Information Sheet (PIS)
8. Informed Consent Form for Participation in Research Project (ICF)
9. Material Transfer Agreement (MTA) Form
10. Self-Assessment Form for Principal Investigator-Research Protocol
11. Completeness Checklist of Research Project Submitted for Initial Review

Forms for Protocol Corrected According to Suggestion

1. Research Project Correction-Amendment Form

Forms for Protocol Amendment after Approval

1. Research Project Correction-Amendment Form

Forms for Progress Report and / or Renewal

1. Progress Report Form

Forms for Deviation / Violation

1. Report of Protocol Deviation / Violation

Forms for Final Report and Project Closure

1. Final Report Form

Other Forms

1. Suspect Adverse Drug Reaction Form
2. Serious Adverse Event Report Form for Non-Clinical Research Project

Instructions for Investigator

1. Instruction for Submission of Research Project for Review and Approval
2. Instruction for Writing Research Proposal
3. Instruction for Investigator after Receipt of Notification of BI-IRB Decision
4. Instruction for Investigator of BI-IRB Approved Research Protocol

• BI-IRB Meeting Schedule and Submission Deadline for Full Board Review, Year 2026

Bumrungrad International-Institutional Review Board

16th Floor Building C (Bumrungrad Tower Building), located at 33, Soi 3 (Nana Nua),

Sukhumvit Road, Khlong Toei Nua Sub-district, Vadhana District, Bangkok Metropolis 10110
 

Telephone: +660 201 14156 , +660 201 14157

Email: [email protected]
 

Map to Bumrungrad International Hospital

Bumrungrad International - Google Map