1.1 All research conducted by NUS
staff involving the use of human subjects, tissues, or personal data
must be reviewed and approved by the NUS Institutional Review Board (NUS-IRB).
2.1
The closing date for all applications will be the first day of
each month, or the next working day if the first falls on a Saturday,
Sunday or a public holiday. Applications will be reviewed within 30
working days of the closing date.
2.2 The NUS-IRB follows the Singapore GCP, ICH GCP guidelines,
BAC guidelines and the applicable laws and regulations of Singapore.
2.3 Principal
investigator (PI) can apply for either full NUS-IRB review, expedited review or exemption from full IRB
review. Please refer to NUS-IRB guidelines on research that can be
exempted from full IRB review (GUIDE-006). Other guidelines (e.g. on writing a
research protocol, informed consent form) can be found on the web at
http://www.nus.edu.sg/irb/Guide.htm.
2.3.1 Applications
for NUS-IRB review are to be submitted in 1 set (1 original).
The complete set should comprise the following documents:
a. NUS-IRB Application Form
or
NUS-IRB Application Form (Social Sciences)
- All sections should be completed
b. A copy of the grant approval letter if
the research is supported by a grant
c. Participant Information Sheet & Consent Form (PIS &
CF)
d. Other
relevant documents (i.e. Questionnaire, Advertisement, Data Form etc.)
e. CVs
of PI & co-investigators (not more than 3 pgs for each investigator)
Kindly provide version numbers and dates (e.g. Version 1
dated dd/mm/yyyy) on the right footer of the documents for item c
and d.
2.3.2 Applications for exemption from full
NUS-IRB review are to be submitted
in 1 set (original copy). The complete set should comprise the following
documents:
a. NUS-IRB Exemption
from Full IRB Review Form
- All sections should be completed
b. Full
research protocol (with version and date) and a copy of grant
application form (if applicable)
c. Supporting documents (i.e. Catalog details of cell
lines, Material Transfer Agreement etc.)
d. List
of PI and investigators with their signatures and their CVs (not more
than 3 pgs per investigator).
e. A copy of the grant approval
letter if the research is supported by a grant
2.4 All new applications and requests
for application forms, guidelines and enquiries should be addressed to :
The Secretariat
NUS Institutional Review Board
Clinical Research Centre
Blk MD 11, #03-02
10 Medical Drive,
Singapore 117597
(For Commercially Sponsored Research Only)
3.1
The financial statement should include the following :
a. Quantum of compensation for expenses to subjects;
b. Amount of payment to each site of research;
c. Insurance coverage/ provision of treatment/ provision of compensation
for subjects in the event of research-related injury;
d. Indemnity arrangements for the investigator / institution;
e. Declaration of potential conflicts of financial interest.
