Table 1 The regulations and international guidelines on ethical review. Files from the official website of the Chinese government and the US Office for Human Research Protections and World Medical Association
Name | Issuer | Time | |
|---|---|---|---|
China | “Guidelines for the construction of clinical research ethics committees involving human subjects” | Office of Medical Ethics Expert Committee of China National Health Commission | in 2019 |
“Measures for Ethical Review of Biomedical Research Involving Human Subjects” | China National Health and Family Planning Commission | in 2016 | |
“Drug Administration Law of the Peoples Republic of China” | The Twelfth Meeting of the Standing Committee of the 13th National Peoples Congress of China | in 2019 | |
“Guiding Principles for Ethical Review of Drug Clinical Trials” | China State Food and Drug Administration | in 2015 | |
“Administrative Measures for the Clinical Application of Medical Technology” | National Health Commission | in 2018 | |
“Administrative Measures for Drug Registration” | China State Administration for Market Regulation | in 2007 | |
“Measures for Ethical Review of Biomedical Research Involving Human Subjects (Trial)” | National Health and Family Planning Commission | in 2016 | |
“Guiding Principles for Clinical Trials of In Vitro Diagnostic Reagents” | State Food and Drug Administration | in 2014 | |
“Regulations on Clinical Trials of Medical Devices” | State Food and Drug Administration | in 2004 | |
“Pharmaceutical Clinical Trial Quality Management Standards” | State Food and Drug Administration | in 2003 | |
“Regulations for the Implementation of the Drug Administration Law of the Peoples Republic of China” | Order of the State Council of the Peoples Republic of China | in 2016 | |
International | The Nuremberg Code | Nuremberg Military Court | in 1949 |
The Belmont Report | Belmont Convention Center | in 1964 | |
The Declaration of Helsinki | World Medical Association | in 2013 | |
“International Ethical Guidelines for Human Biomedical Research” (CIOMS) | International Committee of Medical Scientific Organizations | in 2002 |