The study start-up process begins with the planning of a research study and designing the research protocol. To conduct a research study, it requires processes from various functions to start the study properly. This is to ensure that ethics, regulatory and institution expectations are met for the conduct of research.
The diagram below shows the various processes that lead to the initiation of the research. Please access the Human Subject Research Start-up course via the SingHealth eLearning portal.
The flowchart below will help researchers determine whether their study is a Human Subject Research (HSR) requiring IRB submission.
Is your project Human Subject Research (HSR) requiring IRB submission?
SHS-RSH-CIRB-4234 Statement of Confirmation by PI for Project not requiring submission to CIRB
Differentiating Research from Service Evaluation, Clinical Audit, Surveillance and Outbreak Investigation
Scope of Human Biomedical Research Act (HBRA)
• Research will fall within scope of the HBRA if it satisfies at least one Purposive element and one Methodological element or where it involves Sensitive research.
• Research involving the use of individually identifiable health information/human issue where it also meets the Purposive element (e.g. the prevention, prognostication, diagnosis or alleviation of any disease, disorder or injury affecting the human body) will be regulated under HBRA.
• Clinical trial involving the use of investigational drug falls out of scope of the HBRA.
Obtaining Consent
• Appropriate consent has to obtained in accordance to HBRA for a HBR study.
• Waiver of consent may be approved by the IRB if the study meets the criteria for a waiver.
Research Process and Study Workflow: SHS-RSH-CTCC-CWP-201 (Intranet Only)
