Institutional Review Board

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 associated protocol amendments.

Institutional Review Board

Collaborative Institutional Training Initiative Certification

Principal Investigators and Co-Investigators of IRB studies must be certified by the Collaborative Institutional Training Initiative (CITI). CITI Program is a US-based organisation, dedicated to promoting the public’s trust in research enterprises 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 this training, 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, and adheres to Singapore’s Human Biomedical Research Act (HBRA). This will ensure that research protocols are conducted with integrity, and are of reliable quality, such that the health, welfare and safety of research participants remain the paramount consideration at all times.

Researchers will also be taught the principles of data protection, focusing on healthcare-related privacy, information security requirements, educational records and data-related requirements, which also complies with Singapore’s Personal Data Protection Act (PDPA). Researchers must ensure both the rights of individuals to protect their personal data, including rights of access, correction, and the needs of organisations to collect, use or disclose personal data for legitimate and reasonable purposes.

FAQs

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    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 involving human gametes or human embryos, cytoplasmic hybrid embryos 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.
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    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.

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    What is a “human subject”?

    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 human biomedical research.

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    Who can apply for IRB approval?
    • Applications should be submitted by SIT staff and students as the PI or Co-I in the study.
    • 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.
    • 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.
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    How can I apply for IRB approval?

    The application forms can be downloaded from Sharepoint, which can only be accessed by SIT staff.

    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 if you are unsure.

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    How can I determine if my study is HBR or SBER?

    Please refer to Q4 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.

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    What are the documents I need to submit?

    The following documents need to be submitted to the IRB for review. 

    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

    The application must be sent via email to the Secretariat IRB@SingaporeTech.edu.sg.

    Note: The review process will only commence when the full application package is received.

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    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 requirements, Chairman (IRB) will approve the application and a softcopy of the approval letter will be emailed to the PI. A hardcopy approval letter is available upon request.

    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:

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    Who is the Principal Investigator (PI) and what are the PI's roles and responsibilities 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 the 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.

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    Who selects the Co-investigator (Co-I) and collaborator?

    The PI decides who to include in the study team, and their specific roles in the study.

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    What are the Co-I's responsibilities in the research study?

    Co-Is may be SIT staff, students, or external personnel. They may have direct contact with the participants and are aware of 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 is designed and conducted in compliance with applicable laws and regulations and institutional policy governing the conduct of research involving human subjects. The Co-I must be properly briefed by the PI to conduct his/her duties.

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    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).

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    What types of consent are there?
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    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.

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    Can the PI design the Participant Information Sheet and Consent Form?
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    How many types of reviews are there?

    There are 3 types of reviews. The IRB will assess each application and determine the review type regardless of the application form the PI uses.

     

    Full Review

    Expedited Review

    Exempted Review

    Risk Exposure

    More than minimal risk e.g. research involving vulnerable populations, involving sensitive questions, etc

    Minimal risk or remote risk e.g. surveys or interviews on sensitive topics

    No likelihood of harm e.g. anonymous surveys or interviews

    Expected Duration of Review

    4 weeks and above

    Between 2 to 4 weeks

    At least 1 week

    Note: Review duration will depend on PI’s response time to address queries, provide clarifications and make amendments based on the secretariat’s and/ or reviewer’s comments.

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    When can I start my research study?

    Upon notification of approval from the IRB.

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    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 the addition or removal of investigators. PI should only implement the changes when the IRB has approved the protocol amendment.

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    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 a change in PI/ Co-I a copy of the curriculum vitae (CV) and CITI certificate has to be submitted along with the application form.

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

    IRB does not conduct retrospective reviews on research 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.

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    What sort of training is available for researchers to ensure proper ethical practice?

    The Collaborative Institutional Training Institute (CITI) certification is a good place to start. SIT has registered with CITI, and you may take their online modules to learn and attain their certification. Please contact the secretariat for details.

    The Personal Data Protection Commission (PDPC) of Singapore provides online learning on data protection, data security, personal data protection, etc. Please view the PDPC Interactive learning tool for more information.

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