CAN I APPLY FOR AN IRB APPROVAL AFTER I HAVE COMPLETED MY RESEARCH STUDY?

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. 

DO I NEED TO APPLY FOR AN IRB APPROVAL?

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.
 
Kindly note that for the time being, SUTD-IRB will only review social, behavioural and educational research. For biomedical research, SUTD staff is encouraged to partner a clinician/ medical staff affiliated with a medical institution with which an IRB review of the biomedical research could be conducted.
 
Do contact us at irb@sutd.edu.sg for clarification if you are unsure.

HOW ARE REVIEW TYPES DETERMINED?

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.-

HOW CAN I APPLY FOR AN SUTD-IRB APPROVAL?

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 BoardOffice of Research and Industry CollaborationsBuilding 3, Level 58 Somapah Road, Singapore 487372E-mail: irb@sutd.edu.sg

HOW DO I APPLY FOR A PROTOCOL AMENDMENT?

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.

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

HOW MANY TYPES OF REVIEW ARE THERE?

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

IS IRB CLEARANCE REQUIRED FOR SURVEY / INTERVIEW DONE ON SUTD STUDENTS?

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).

WHAT ARE THE DOCUMENTS I NEED TO SUBMIT?

Please see below for a list of documents. Please submit those that are applicable to your research study.  We will request if we are missing any of your required documents.
 
 
The documents may include:

 
Documents that will be used in the study Supporting documents
SUTD-IRB Social, Behavioural & Educational Research Form Grant application form
Study Protocol 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 catalogue
Letter/s of invitation Relevant publications
  Subject payment details

WHAT IS A PROTOCOL AMENDMENT?

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

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.

WHAT IS THE DEFINITION OF "HUMAN SUBJECT"?

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.

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.

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. All IRB members have to approve the application.
 
An application that requires an expedited review will be approved by two IRB members and IRB Chair.
 
An application that is exempted from full review will be approved by the IRB Secretariat and IRB Chair.

WHEN CAN I START MY RESEARCH STUDY?

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

WHO DETERMINES THE REVIEW TYPE AN APPLICATION REQUIRES?

The IRB Chair determines the type of review an application requires.

WHO IS THE PRINCIPAL INVESTIGATOR (PI) AND WHAT ARE THE PI'S RESPONSIBILITIES / ROLES IN THE RESEARCH STUDY?

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.

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 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.