NUS-IRB: Mission & Principles

Mission Statement

1. To conduct independent reviews of the ethical merits of research [1] projects that involve human subjects [2] or human tissues, proposed by academic NUS staff.

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.


Our Guiding Principles

The NUS-IRB is guided by the following principles when we consider and approve all research projects submitted by faculty members.

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):

 

REGULATIONS

  - Human Biomedical Research Act (2015)
  - Personal Data Protection Act (2012)
  - Medicines Act [Chap. 176]
 
   
 

GUIDELINES

  - 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

(b) ICH E6 Good Clinical Practice.


Registration with OHRP

The NUS IRB has been registered by the Office of Human Research Protections (OHRP), (U.S.) with effect from 3rd November 2003.

Our DHHS IRB registration number is IRB00003876 - Natl U Singapore IRB #1.

Our International IRB Organisation registration number is IORG0003245 - Natl U Singapore.

 

NUS has been granted Federalwide Assurance (FWA) approval by OHRP on 6th February 2004.

The Federalwide Assurance registration number is FWA00006418.

 

[1] - "Research" is defined as a systematic investigation designed to develop and contribute to generalisable knowledge. [back]
[2] - "Human Subject" is defined as a living individual about whom an investigator obtains identifiable private information or data through intervention or interaction with the individual. [back]