Institutional Review Board (IRB) protects the rights and welfare of individuals participating in research conducted by the university. The IRB is an independent committee, comprising of scientific and non-scientific members, that reviews and approves research studies involving human subjects and protocol amendments.
Principal Investigators and Co-Investigators must be certified by the Collaborative Institutional Training Initiative (CITI). CITI Program is US-based organisation, dedicated to promoting the public’s trust in the research enterprise by providing high quality, peer-reviewed, web-based educational courses in research, ethics, regulatory oversight, responsible conduct of research, research administration, and other topics pertinent to the interests of member organisations and individual learners.
Through these trainings, researchers will ensure that all human biomedical research carried out follows the law and principles of good clinical practice relating to ethics, science, information, health and safety of participants, adhering to Singapore’s Human Biomedical Research Act (HBRA). This will ensure that research protocols are conducted with integrity, and of reliable quality, such that the health, welfare and safety of research participants remain paramount consideration at all times.
Researchers will also be taught on the principles of data protection, focusing on the healthcare-related privacy, information security requirements, the educational records and data-related requirements, which also complies to Singapore’s Personal Data Protection Act (PDPA). Researchers must ensure both the rights of individuals to protect their personal data, including rights of access and correction, and the needs of organisations to collect, use or disclose personal data for legitimate and reasonable purposes.
1. Does my research study require IRB review and approval?
All human biomedical research conducted by staff and students involving the use of human subjects (e.g. human participants) must be reviewed and approved by the Institutional Review Board (IRB).
(a) the prevention, prognostication, diagnosis or alleviation of any disease, disorder or injury affecting the human body;
(b) the restoration, maintenance or promotion of the aesthetic appearance of human individuals through clinical procedures or techniques; or
(c) the performance or endurance of human individuals,
where the research involves –
(i) subjecting an individual to any intervention (including any wilful act or omission) that has a physical, mental or physiological effect (whether temporary or permanent) on the body of the individual;
(ii) the use of any individually-identifiable biological material obtained from the human body; or
(iii) the use of any individually-identifiable health information.
Human biomedical research includes any research any research involving human gametes or human embryos, cytoplasmic hybrid embroys etc.
For the avoidance of doubt, research involving any of the following methods needs to be reviewed by the IRB:
- Observational Studies
- Interventions within specific groups
- Surveys or interviews
- Educational tests
- Analysing human subject data
- Secondary use of data (containing personal identifiers) that are not in the public domain.
Please contact the Institutional Review Board (email: [email protected]) for clarification if necessary.
2. What is a “research” study?
The IRB defines “research” to mean any systematic investigation with the intention of developing or contributing to generalisable knowledge including publication, seminar, public sharing.
3. What is the definition of “human subject”?
The “human subject” is a human being. In the context of research the human subject may be a participant in the study.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.
4. Who can apply for an SIT-IRB approval?
a. We only process applications submitted by SIT staff and students if they are the PI or Co-I in the study.
b. If the PI is external, and the SIT staff/ student is the Co-I, we will only process the application if the PI’s institution does not have an IRB to apply to.
c. If the PI is external, and has received approval from his/ her institution’s IRB, the SIT Co-I would still need to apply to the SIT-IRB if the subjects are SIT staff/ students and/ or SIT premises will be used in the study.
5. How can I apply for an SIT-IRB approval?
The application forms can be downloaded from Sharepoint, which can only be accessed by SIT staffs.
Please determine if your study will require Exempted or Expedited/ Full Board Review, and download the appropriate form from Sharepoint. You may check with the IRB is you are unsure.
6. How can I determine if my study is HBR or SBER?
Please refer to Q4 in this link for the definition of Human Biomedical Research (HBR) as defined by the Ministry of Health, Singapore. If your research does not meet the definition of HBR, it is SBER.
7. What are the documents I need to submit?
The following documents need to be submitted to the IRB for review. The application must be sent via email to the Secretariat: [email protected].
|Documents to Submit|
|1||IRB Application form, duly signed by PI, Co-I, and the Cluster Director or his/ her representative. Note: In Expedited/ Full-Board Applications the collaborator(s) must sign as well.|
|2||Participant Information Sheet and Consent Form (PIS-CF)|
|3||Survey Questionnaire / Interview guide|
|4||Data collection form|
|5||Advertisement(s) and/ or invitation emails|
|6||CITI Certification of the PI and Co-Is|
|7||CVs of PI, Co-Is & Collaborators|
|Note: The review process will only commence when the full application package is received.|
8. What happens after submission?
The secretariat will check the application to ensure all the necessary information and documents have been submitted. Secretariat will examine the merits of the application and contact the PI if it requires clarification, more information, amendments, etc.
The application will then be assessed by IRB reviewers and the PI will be given the reviewers’ request for more information, amendments, etc.
If the final submission meets the IRB’s recommendations, Chairman (IRB) will approve the application and a softcopy of the approval letter will be emailed to the PI. The PI may request for the hardcopy.
9. Who is the Principal Investigator (PI) and what are the PI's responsibilities / roles in the research study?
The Principal Investigator (PI), is the main person-in-charge of the research study who will be held accountable for all aspects of the study. The PI’s responsibilities are detailed below:
1. Management and integrity of the design, conduct, and reporting of the research project
2. Ensuring the safety and security of all the research participants at all times
3. Maintaining proper conduct and management of the study site
4. Ensuring proper and efficient disbursement of payment, incentives, inconvenience fee, etc (if any) to the participants.
5. Managing the proper conduct of the Co-Is and Collaborators
6. Reporting immediately to the IRB if there is a study deviation and to hold the study progress until/ unless the IRB has given approval to proceed.
7. Promptly applying for a protocol amendment if there are foreseeable changes to the study for which the projects was approved by the IRB.
Note: The PI must have attained the CITI certificate and a copy of it must be included in the application form.
10. Who decides on who the Co-investigator (Co-I) and collaborator should be?
The PI decides on who to be included in the study team, and their specific roles in the study.
11. What are the Co-I's responsibilities in the research study?
Co-Is may be STI staff, students, or external personnel. They may have direct contact with the participants and are knowledgeable on the research protocol, functions and objectives. Their responsibilities may include the following:
a. Engaging potential participants and explaining the study details to them;
b. Facilitate consent taking;
c. Administration of the survey, interview, research activity;
d. Data collation, recording, storage, etc.
e. Assist the PI to disburse inconvenience fees, transport cost, appreciation vouchers, etc (if any) to the participants.
While the PI has ultimate responsibility for the conduct of a research project, Co-Is are obligated to ensure the project isdesigned and conducted in compliance with applicable laws and regulations and institutional policy governing the conduct of human subjects research. The Co-I must be properly briefed by the PI to conduct his/ her duties.
12. What are the Collaborator’s responsibilities in the research study?
Collaborators have only minimal contact with the participants in the conduct of the study, if any. Their primary function is to facilitate the study by providing information e.g. scientific advice or industry knowledge. They may not be directly involved in the research activities as detailed in the roles of the Co-I (above).
13. What types of consent are there?
Essentially there are 2 types. Implied and Expressed.
Implied: Participant (in interviews or surveys) is anonymous i.e. personal identifiable data will not be collected. Participating in the study is proof of consent. There is no need for the participant to sign a hardcopy consent form. All participants must be given a participant information sheet detailing the nature of the research, expectation of the participant, etc. Only SBER applications can have implied consent.
Informed (Written) Consent: The participant’s personal identifiable data is taken as it is essential for the study e.g. longitudinal studies which may require contacting the participant intermittently during the duration of the study. Participant must sign the consent form prior to his/ her involvement in the study.
14. When taking informed consent, is it necessary to have a witness present?
It is essential under HBRA to have a witness present, who must also sign off in the consent form. Criteria for the witness is as follows:
a. 21 years of age or older;
b. Has mental capacity; and
c. Must not be the same individual taking the appropriate consent.
Note: Witness may be a member of the research team.
The Witness must take reasonable steps to ascertain –
(a) the identity of the individual giving the appropriate consent; and
(b) that the consent was given voluntarily without any coercion or intimidation.
15. Can the PI design Participant Information Sheet and Consent Form?
No. PIs must use the IRB template and delete all the clauses that are not applicable to their respective study.
16. How many types of reviews are there?
There are 3 types of review - Full review, Expedited review, and Exemption from full review.
Exempted – no likelihood of harm (e.g. anonymous surveys/ interviews)
Expedited – minimal risk or remote risk (e.g. surveys/ interviews on sensitive topics)
Full board review – more than minimal risk (e.g. research involving vulnerable populations, sensitive questions, etc)
The IRB will assess each application, and determine the review type regardless of the application form the PI uses.
17. How long will the review/ approval process take?
Exempted ≥ 1 week
Expedited > 2 weeks
Full board review > 4 weeks
Note: duration will depend on PI’s response time to address queries, provide clarifications and make amendments based on the secretariat’s and/ or review’s comments.
18. When can I start my research study?
Upon notification of approval from the IRB.
19. 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.
20. How do I apply for a protocol amendment?
Send the duly filled up protocol amendment form to the secretariat will all the necessary documents to support the request for the amendment. If there is change in PI/ Co-I a copy of the curriculum vitae (CV) and CITI certificate has to be submitted along with the application form.
21. Can I apply for an IRB approval after I have completed my research study?
The SIT-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.
a. Research participants were not informed that their participation in class activities was part of a research study
b. Consent had not been sought for their participation or participant did not agree to their data being used forresearch purposes.
22. What sort of training is there available for researchers to ensure proper ethical practice?
a. The Collaborative Institutional Training Institute (CITI) certification is a good place to start. SIT has registered with CITI, and you may take their online module(s) to learn and attain their certification. Please contact the secretariat for details.
b. The Personal Data Protection Commission (PDPC) of Singapore provides online learning on data protection, data security, personal data protection, etc. Please view PDPC Interactive learning tool for more information.
To find out more about our research practices or provide feedback on any of our research projects, please email us at [email protected].