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.Managing the proper conduct of the Co-Is and Collaborators.Ensuring proper and efficient disbursement of payment, incentives, inconvenience fee, etc (if any) to the participants.Maintaining proper conduct and management of the study site.Ensuring the safety and security of all the research participants at all times.Management and integrity of the design, conduct, and reporting of the research project.The PI’s responsibilities are detailed below: 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. Secondary use of data (containing personal identifiers) that are not in the public domain.Human biomedical research includes any research involving human gametes or human embryos, cytoplasmic hybrid embryos etc.įor the avoidance of doubt, research involving any of the following methods needs to be reviewed by the IRB: (iii) the use of any individually identifiable health information. (ii) the use of any individually identifiable biological material obtained from the human body or (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 (c) the performance or endurance of human individuals, (b) the restoration, maintenance or promotion of the aesthetic appearance of human individuals through clinical procedures or techniques or
(a) the prevention, prognostication, diagnosis or alleviation of any disease, disorder or injury affecting the human body human participants) must be reviewed and approved by the Institutional Review Board (IRB). 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.Īll human biomedical research conducted by staff and students involving the use of human subjects (e.g. 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). 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. 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). 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. Principal Investigators and Co-Investigators of IRB studies must be certified by the Collaborative Institutional Training Initiative (CITI). Collaborative Institutional Training Initiative Certification
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