• วิธีดำเนินการมาตรฐานฉบับที่ 1.0

• ประกาศจริยธรรมระดับชาติและระดับนานาชาติที่เกี่ยวข้อง

(1) WHO Operational Guidelines for Ethics Committees (WHO, 2000) 

• WHO IRIS – Operational Guidelines Overview 

• WHO IRIS – Full Document

(2) Title 45 CFR Part 46, Subpart A – The Common Rule (HHS, 1991; Revised 2018) 

• HHS Summary Page 

• eCFR Full Text 

• Cornell Law Overview 

(3) International Ethical Guidelines for Health-Related Research Involving Humans (CIOMS, 2016)

• CIOMS Official Publication 

• CIOMS Website (CH) 

• NCBI Summary 

(4) ICH Harmonised Guideline – Good Clinical Practice E6(R2) (ICH, 2016) 

• FDA Integrated Addendum (E6(R2)) 

• EMA Step 5 Version (PDF) 

• CITI Program – Summary of 2016 Update 

(5) Protection of Human Subjects: Expedited Review Procedures (HHS/FDA, Federal Register, 1999) 

• Federal Register Notice (Vol 63, No 216) 

(6) Code of Federal Regulation (CFR) 21, Volume 8, Part 812, April 2003, Food and Drug

Administration, U.S. Government Printing Office via GPO Access.

• eCFR Full Document 

(7) Operational Guideline for Ethic Committees that Review Biomedical Research 

(World Health Organization)

• TGHN Media Resource 

(8) Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects 

(WMA, 2013) 

• WMA Official PDF 

(9) National Ethical Guidelines for Human Research (Thailand, 2007) 

• Thai Journal (RDI) PDF 

• FERCIT Thailand Website 

(10) The Belmont Report – Ethical Principles and Guidelines for the Protection of Human Subjects of 

Research (HHS, 1979; Thai Translation 2008) 

• HHS Official Report 

• NIH PDF Version 

(11) International Ethical Guidelines – Post CIOMS/WHO Development (IHRP, 2009) 

• IHRP Thailand Publication

(12) Regulations of the Medical Council on Professional Ethics (Thailand, 2001) 

• Mahidol University PDF (2004/2009) 

• Rama Mahidol University Notice 

• Royal Gazette Publication 

(13) National Standard for Human Research Ethics Committees (NRCT, Thailand, 2017) 

• NRCT Official Document