FAQ

All research conducted by SUTD staff and Students involving the use of human subjects must be reviewed and approved by the SUTD Institutional Review Board (SUTD-IRB) before they are conducted.
 
Do contact us at irb@sutd.edu.sg for clarification if you are unsure.

The IRB defines "research" as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalisable knowledge".

The design to contribute to generaliaable 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.

The "human subject" means a living individual about whom the Principal Investigator conducting research obtains data through intervention or interaction with the individual or through identifiable private information.

Yes. All research conducted by SUTD students involving the use of human subjects, or personal data must be reviewed and approved by the SUTD-Institutional Review Board (IRB).

Please fill in a hardcopy of the IRB application form and submit all supporting documents to us at our office. Please note that all applications require original signatures (hand written).
 
Please send all applications (soft and hard copy) to:
 
IRB Secretariat 
SUTD Institutional Review Board
Building 3, Level 5
8 Somapah Road, Singapore 487372

Email: irb@sutd.edu.sg

Access the documents here. 

Please note that the link is accessible to SUTD researchers only. Please contact irb@sutd.edu.sg for assistance.

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 will take 6 weeks and 4 weeks respectively.
 
Applications that require full review will take longer.

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

A protocol amendment constitutes any changes made to an ongoing approved application. This includes addition/removal of investigators.

Please fill in the protocol amendment form and submit all the documents 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.

Please note that as a general rule, the SUTD-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. 

The Principal Investigator (PI) is the team leader of the research study, who is responsible for the following:

• Design and oversee the research process and be responsible for the conduct of the investigators and research staff at all study sites.
• Conduct of research in accordance with local regulations, SUTD-IRB and sponsoring agency policies and procedures.
• Protect the safety and welfare of research participants.
• Ensure that informed consent is appropriately obtained from all participants and that participants are treated with respect and dignity.
• Protect participants' privacy and confidentiality according to SUTD-IRB policies and procedures.
• Complete all required human research training and ensure that investigators and key study personnel complete required training.
• Ensure the timely continuing review of protocols and the submission of all re-approval applications before the protocol's expiration date.
• Submit proposed changes to the research in the form of protocol amendments to SUTD-IRB before the changes are implemented.
• Report promptly to SUTD-IRB if any adverse events or unanticipated problems occur during the course of the research.
• Submit the Final Report to SUTD-IRB once it is completed.

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 way. These individuals may be staff or students 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.

The IRB Chair 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. E.g. A research study involving vulnerable populations may require a full review while a research study that only involves one time anonymous survey is likely to qualify for an exemption from full review.