Study Protocol Adherence & Study Status Reporting
Ensure that you comply with all conditions of the approval letter issued by your Reviewing IRB.
Submit study status reports, including the study final/completion report, within the timelines stipulated by your Reviewing IRB.
Upon expiry of ethics approval and prior to renewal of approval, prospective research data should not be collected and no procedures on human subjects or human biological materials should be performed for the study.
- Non-compliance with the HBRA is punishable by fines and/or imprisonment which can go up to $100,000 and 10 years, depending on the nature of the offence.
- A researcher’s contravention (such as a failure to report or timely report a SAE or SOC) could cause your Research Institution (RI) or Tissue Bank (TB) to contravene its statutory obligations and be criminally liable.
- MOH can order immediate stoppage of the study and even blacklist the researcher or RI/TB by prohibiting future research.
- For NUS researchers, a breach of the NUS Code & Procedures on Research Integrity governing the proper conduct of research, could also result in disciplinary action.
Hence, all researchers are reminded to pay attention to and comply with the rules when you conduct biomedical research involving human subjects, data or biological material.