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. 

My study has been submitted to/ approved by the NHG Domain Specific Review Board (DSRB). Does my study still require NUS-IRB’s approval?
Based on the reciprocity agreement signed between NUS and NHG DSRB, the DSRB will only review studies from Principal Investigators in the Faculty of Dentistry, Yong Loo Lin School of Medicine and Saw Swee Hock School of Public Health (the 3 schools). The agreement also details the types of collaborative studies that qualify to be submitted to DSRB or the NUS-IRB for review.

In addition, DSRB approval will not be extended to cover NUS researchers who are not from the 3 schools or research procedures conducted in NUS’ premises other than those belonging to the 3 schools. In such cases, an NUS‐IRB application will be required to cover the research that is not conducted in the 3 schools.

My study has been submitted to/ approved by the SingHealth Centralised Institutional Review Board (CIRB). Does my study still require NUS-IRB approval?
The service agreement between NUS and SingHealth CIRB is in place for Duke-NUS Medical School studies submitted to CIRB on and after 1 April 2020. This Agreement applies to Duke-NUS research studies that are conducted in collaboration with SingHealth Institution(s) as part of a multi-site study led by a Principal Investigator from Duke-NUS or any SingHealth Institutions. 

My study has been submitted to/ approved by other Ethics Review Board(s). Does my study still require NUS-IRB approval? 
NUS has not signed agreements with other institutions for mutual recognition of ethics approvals. If you are conducting human subject research, in accordance with the University’s guidelines, you are required to apply for NUS-IRB approval.

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

The IRB defines “research” to mean any systematic investigation with the intention of developing or contributing to generalisable knowledge.

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.

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

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.

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 report / forms to irb@nus.edu.sg.

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:

iRIMS-IRB will send an email notification to the PI and Primary Contact to acknowledge receipt of your submission. After the IRB secretariat has completed a preliminary review of your application, the system will send another email notification to the PI and Primary Contact to log in to the system to address the comments.

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.

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.

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.

There are 3 types of review - Full review, Expedited review, and Exemption from full review.

If you are using only commercially-available cell lines and/ or non-individually identifiable human biological materials (excluding human tissues and human stem cells) and/or non-individually identifiable data (including non-individually identifiable health information), you do not require IRB review. Please refer to the guidelines for more information.

The IRB determines the type of review an application requires.

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.

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 co-Chair only, or by the co-Chair with one (1) other IRB member.

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

An application that falls under the "Review Not Required" category (see guidelines) will not be reviewed by the IRB. A Review Not Required Determination letter will be issued and will serve as NUS-IRB's formal determination.

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

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.

Please submit a modification submission via iRIMS-IRB. Please refer to the iRIMS-IRB Researcher User Guide for more information.

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.

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