NUS INSTITUTIONAL REVIEW BOARD
The terms of reference of the NUS-IRB are:
1. To conduct independent reviews of the
ethical merits of research
projects that involve human subjects
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.
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 the Declaration of Helsinki,
The Belmont Report, and all relevant
laws and regulations in Singapore.
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.
Composition of members of NUS-IRB
NUS-IRB has a total of 12 staff
members from Faculty of Medicine, Arts and Social Sciences,
Dentistry, Law, and 2 non-NUS affiliated members (lay-persons) and a
biomedical scientist who is not affiliated with the
institution.
Every NUS-IRB review meeting shall have a
quorum of 5 members, with varying backgrounds to promote complete and
adequate review of the research.
Disciplines represented in the NUS-IRB are as follows:
-
Saw Swee Hock School of Public Health
-
Faculty of Law
-
Department of Malay Studies
-
Department of Medicine
-
Department of Pharmacology
-
Department of Philosophy
-
Department of Psychology
-
Department of Restorative
Dentistry
-
Department of Sociology
-
Department of Obstetrics and Gynaecology
-
Department of Microbiolgy
-
Department of Management & Organization
-
Genome Institute of Singapore, A*STAR
-
2
non-NUS affiliated members (lay-persons)
NUS-IRB has been registered by Office of Human Research
Protections (OHRP), (U.S.) with effect from 3rd
November 2003.
The DHHS IRB registration number is
IRB00003876 - Natl U Singapore
IRB #1.
The 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.
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