Incident Reporting – Suspected Offence or Contravention (SOC)
Compliance with HBRA is mandatory. Criminal penalties (fine and or imprisonment) applicable to contraventions are explicitly stipulated in the HBRA. SOCs have to be promptly reported to your Research Institution (RI) or Tissue Bank (TB).
Description of SOCs
- Failure to obtain IRB approval or waiver from approval for the study
- Unapproved protocol deviations, especially those which place subjects/donors at risk of harm
- Failure to protect individually-identifiable information or human biological material from loss, unauthorised access, disclosure or re-identification without consent etc
SOC Reporting Process*
Who to Report to
- Your reviewing IRB
- Your RI’s/TB's Principal Person in Charge (or his/her designated officers), who will assess if the incident caused harm/death or potential to cause harm for purposes of reporting to MOH.
When to Report
- As soon as possible
NUS Researchers are required to report SOCs within 1 working day
What to Report
- For SOCs causing harm/death or having the potential to cause harm, your RI/TB is required to report to MOH using the MOH SOC Reporting Form A1 (HBR) and Form B1 (tissue-banking) within 7 calendar days of awareness of the SOC.
- For all other SOCs, your RI/TB will maintain a yearly log of SOCs. The log is required to be submitted to MOH during the annual compliance declaration. Please see the MOH SOC Tiered Reporting Form for RI and TB.
* Please check if your RI/TB has stipulated any specific SOC reporting procedures. For NUS Researchers, please see NUS Policy on Reporting of Serious Adverse Events, Contraventions and Other Reportable Events in Additional Resources (last page).