NUS-IRB: Submission Instructions for New HBR Applications


"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) before they are conducted."

**For queries on submissions, please contact us at irb@nus.edu.sg.

 

General Information

  • An Institutional Review Board (IRB) is an independent committee established within the university that conducts scientific and ethical review on research involving human research participants.

    The purpose of the IRB is to review all human participant research proposals before the research is conducted.

    IRB monitors research, by way of receiving feedback, continuing review or regular reports, as determined by the IRB.

  • The closing date for all applications requiring full review 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. For applications qualifying for (i) expedited review or (ii) exemption from full IRB review, please proceed to submit as and when they are complete and ready as the closing date does not apply to these two review categories.

  • The NUS-IRB follows the Singapore GCP, ICH GCP guidelines, BAC guidelines, Human Biomedical Research Act and the applicable laws and regulations of Singapore.

  • The Principal investigator (PI) can apply for either (i) full IRB review, (ii) expedited review or (iii) exemption from full IRB review. However, the final determination as to the review category will be determined by the IRB.

  • Different guidelines and forms apply depending on whether the research is Human Biomedical Research (HBR) or Social, Behavioural and Educational Research (SBER) Please refer to the NUS-IRB overview of our guidelines on research for more information.

  • A key contributor to delays in protocol approval is an incomplete application submitted to the NUS-IRB office. It is strongly recommended that researchers take time to send in a complete application the very first time so that the review process can go smoothly.  Before completing an application, refer to and read the relevant guidelines and complete online CITI training before submitting your application. Researchers may request for a research ethics consultation (REC) with the IRB secretariat (via email) on special topics prior to initial submission.

 

Documents To Be Submitted (Click for HBR Forms)

New HBR applications for NUS-IRB review are to be submitted in 1 set. The complete set should comprise the following documents:

  • For Full / Expedited Review: NUS-IRB Application Form for HBR.

  • For Exemption from Full Review: NUS-IRB HBR Exemption Form AND Research Protocol (our template is preferred)
    - All sections should be completed.

  • A copy of the grant approval letter if the research is supported by a grant.

  • Participant Information Sheet & Consent Form (PIS & CF) - please see Guidelines for HBR.

  • Documents for recruitment and data collection (e.g. Advertisement, Data Form, Questionnaire etc.)

  • Supporting documents (e.g. Catalog details of cell lines, Material Transfer Agreement, correspondence of willingness etc.)

  • List of PI and investigators with their signatures* and their CVs (not more than 3 pgs per investigator). *If you are applying for exemption from full review, please submit the signatures using our template in the "Administrative" section of the Forms page.

  • For NUS biomedical researchers only: Collaborative Institutional Training Initiative (CITI) certificates. Please refer to Training for more details.


**Kindly provide version numbers and dates (e.g. Version 1 dated dd/mm/yyyy) on the right footer of all documents submitted, where applicable.

 

All new applications and requests for application forms, guidelines and enquiries should be addressed to :

  The Secretariat
National University of Singapore
Institutional Review Board
Clinical Research Centre (Blk MD 11)
Level 5 #05-09
10 Medical Drive
Singapore 117597


Click here to contact us.

 

Financial Statement (for commercially-sponsored research only)

    The financial statement should include the following :
    • Quantum of compensation for expenses to subjects;
    • Amount of payment to each site of research;
    • Insurance coverage/ provision of treatment/ provision of compensation for subjects in the event of research-related injury;
    • Indemnity arrangement for the investigator / institution;
    • Declaration of potential conflicts of financial interest.

     

     

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