NUS-IRB: Frequently Asked Questions (FAQ)

  1. Do I need to apply for an IRB approval?

If you are conducting a human research study, in accordance to the University’s guidelines, you are required to apply for an IRB approval. An ethical review by the Institutional Review Board is required for the protection of the rights, safety and welfare of human research subjects.

Do contact us at irb@nus.edu.sg for clarification if you are unsure.

 

  1. What is a “research” study?

The IRB defines “research” as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge". The design to contribute to generalizable knowledge usually implies the publication of a paper from the study in a professional journal or a presentation of the research in an international conference.

 

  1. What is the definition of “human subject”?

By “human subject”, we mean a living individual about whom the PI obtains data:

  • through intervention or interaction with the individual; or
  • identifiable private information.

If you are conducting human biomedical research, the Human Biomedical Research Act (2015) defines a "research subject" as a natural person, whether living or dead -
(a) whom a researcher involves in human biomedical research; or
(b) from whom human biological material or health information is obtained for use in the human biomedical research.

 

  1. Do I need to apply for NUS-IRB approval if I'm using human cell lines or tissues in animal models?

Yes, IRB approval is required. Please refer to the guidelines on human biomedical research.

 

  1. Who can apply for an NUS-IRB approval?

We only process applications submitted by NUS staff and NUS students. NUS students who are conducting research should submit their applications to their departmental ethics review committee (DERC), if there is a DERC in their department. The DERC will then refer the application to the NUS-IRB if required.

 

  1. How can I apply for an NUS-IRB approval?

Firstly, please determine if your study is "human biomedical research (HBR)" or "social, behavioural and educational research (SBER)". You can refer to our guidelines overview page for further information.

After you have determined if you are conducting HBR or SBER, please refer to the respective guidelines and forms for further information.

Please send all applications 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

irb@nus.edu.sg


  1. What are the documents I need to submit?

Different guidelines and forms apply depending on whether you are conducting HBR or SBER. Please refer to the respective guidelines and their submission instructions for further information.

Please see below for a list of suggested documents. This list is not exhaustive. Please submit those that are applicable to your research study.  We will request for the necessary documents if there are missing ones. The documents are:

Documents that will be used in the study Supporting documents
IRB Application form Grant application form
Research Protocol (if applying for exemption from full review) Grant approval letter
Participant information sheet and consent form Investigators’ CVs / CITI certificates
Survey / Questionnaire / Interview guide Financial agreement
Data collection form Letter / correspondence of willingness
Advertisement(s) Product catalog (cell lines only)
Letter of invitation(s) Material transfer agreement
  Relevant publications
  Subject payment details

 

  1. How will I hear from NUS-IRB after the submission of my application?

We will be contacting the PI via email for more information / clarification after an assessment of the application by the secretariat.

 

  1. Who is the Principal Investigator (PI) and what are the PI's responsibilities / roles in the research study?

The Principal Investigator (PI), as the team leader of the research study, has special additional responsibilities over and above that of ordinary researchers, and is held responsible and accountable for the design, conduct, monitoring, analyses and reporting of the protocol.

The PI's responsibilities are:

(i) Design and conduct of the clinical trial/ research project at a trial/study site.
(ii)Conducting objective research that generates independent, high quality, and reproducible results.
(iii) The management and integrity of the design, conduct, and reporting of the research project and for managing, monitoring, and ensuring the integrity of any collaborative relationships.
(iv) The direction and oversight of compliance, financial, personnel, and other related aspects of the research project and for coordination with school, department, and central administration personnel to assure research in is conducted in accordance with local  regulations and NUS’ and sponsoring agency policies and procedures.

The PI of a research study is usually a full-time academic staff or graduate student. For undergraduate students, please assign the role of PI to your supervisor.

 

  1. Who should be designated as a Co-investigator (Co-I) and what are the Co-I's responsibilities / roles in the research study?

The PI of a research project should decide who his/her co-investigator(s) (co-I) should be and determine the role of the Co-I.

Co-investigators are personnel who contribute to the scientific development or execution of a study in a substantive, measurable way. These individuals may be students, research fellows or residents and are considered as key personnel, depending on their involvement in the project.

Co-Is have special responsibilities on research projects. While the PI has ultimate responsibility for the conduct of a research project, Co-Is may be obligated to ensure the project is designed and conducted in compliance with applicable laws and regulations and institutional policy governing the conduct of human subjects research. The Co-I must be qualified by training and experience to conduct his or her responsibilities on the research project.

 

  1. What is the difference between a Co-I and a collaborator?

The differences between the Co-I and the collaborator are the degree of involvement in the scientific development or execution of the project and the effort associated with his/her involvement.  Generally speaking, the collaborator’s role is limited to providing scientific advice or consultation and may not be directly involved in the research activities whereas the Co-I will have a more direct and active role in the research project, e.g. having a responsibility for the consent process and / or direct data collection for the research project.  This may or may not be in addition to the Co-I’s shared responsibility to providing scientific advice or consultation.

Essentially, determination on the designation (Co-I / collaborator) should be decided by the PI as this is normally related to research integrity and publication and not necessarily an ethical issue.

 

  1. How many types of review are there?

There are 3 types of review - Full review, Expedited review, and Exemption from full review. If you are using only commercially-available cell lines or anonymised publicly-available data in your research, you may submit an e-Declaration to the IRB.

 

  1. Who determines the review type an application requires?

The IRB determines the type of review an application requires.

 

  1. How are review types determined?

They are determined by the level of risk that subjects are exposed to while participating in the research study, determination of the review type will be decided by the NUS-IRB.

 

  1. What is the difference in the review types?

An application that requires a full review will be tabled and discussed at the monthly (subject to quorum) IRB board meeting.

An application that requires an expedited review may be approved by the IRB Chairman only, or by the Chairman with one (1) other IRB member.

An application that is exempted from full review will be approved only by the IRB Chairman.

e-Declarations are processed by the IRB Secretariat and research can commence after PI receives the acknowledgement email.

 

  1. How long will the review/approval process take?

Depending on the type of review an application requires, completeness of the application, complexity of the study, response time of the investigator to IRB’s queries etc, applications that qualify for expedited review and exemption from full review may take 4-6 weeks and 3-4 weeks respectively. Applications that require full review may take longer. Please refer to our timelines for more information.

 

  1. When can I start my research study?

You may proceed with your research study once you have received approval from NUS-IRB.

 

  1. What is a protocol amendment?

A protocol amendment constitutes any changes made to an ongoing approved application (e.g. changes in methodology, recruitment method). This includes addition/removal of investigators. PI should only implement the changes when the IRB has approved the protocol amendment.

 

  1. How do I apply for a protocol amendment?

Please fill in the protocol amendment form and submit a copy of the study documents (or new ones) that are affected by the changes. Please highlight the changes made to the study documents for ease of tracking. Please revise the version number and date of the study document as well.

For amendments involving changes to the Principal Investigator (PI) and/or addition of new Co-investigators (Co-I), original signatures of the new PI and/or Co-I are required on the protocol amendment form, to be submitted together with their curriculum vitae.

 

  1. Can I apply for an IRB approval after I have completed my research study?

Please note that as a general rule, the NUS-IRB does not conduct retrospective reviews on research/ studies that have been already completed as these could be problematic. In particular, changes cannot be made to the research methodology if ethical issues are uncovered, e.g., if research participants were not informed that their participation in class activities was part of a research study, if no informed consent had been sought for their participation in the research or participants did not agree to their data being used for research purposes.