2. To approve all relevant projects, in accordance with the Good Clinical Practice (GCP) and Bioethics Advisory Committee (BAC) guidelines and the applicable laws and regulations in Singapore that govern or regulate research involving human subjects.
3. To monitor research projects, by way of regular reports, as determined by the NUS-IRB.
4. To submit an annual report, and such other reports, as may be called for by the President of NUS, or any other relevant authority.
1. All NUS activities related to human subject research, regardless of funding sources, will be guided by, but not limited to, the following laws / regulations and guidelines (both local and international):
|- Human Biomedical Research Act (2015)|
|- Personal Data Protection Act (2012)|
|- Medicines Act [Chap. 176]|
|- Guidelines by the Bioethics Advisory Committee, Singapore|
|- NMEC: Guidelines on Research Involving Human Subjects (Sep 1997)|
|- US National Health Act|
|- International Guidelines|
2. All NUS activities related to US federally conducted or supported human subject research will comply with both:
(a) The Terms of the Federalwide Assurance (FWA) for International (Non-U.S.) Institutions as stated in the US Department of Health and Human Services (DHHS) website; and
Our DHHS IRB registration number is IRB00003876 - Natl U Singapore IRB #1.
Our International IRB Organisation registration number is IORG0003245 - Natl U Singapore.
The Federalwide Assurance registration number is FWA00006418.