Updates to NHG DSRB Informed Consent Form and Assent Form Templates

19 AUG 2025

UPDATES TO THE NHG DSRB INFORMED CONSENT FORM AND ASSENT FORM TEMPLATES & IMPACT OF ICH E6 (R3) GCP GUIDELINE ON DSRB REVIEW

(1)   Updates to NHG DSRB Informed Consent Form Template

The NHG DSRB Informed Consent Form Template (Version 14.1, dated 01 August 2025) has been revised to:

  • Harmonise with the SingHealth CIRB Informed Consent Form Template, facilitating a more streamlined IRB submission process for cross-cluster studies

  • Clarify that participant data from other institutions stored in Next Generation Electronic Medical Records (NGEMR) may be accessed and utilised when relevant to the study

  • Update the website URL for clinical research participation information and DSRB details to directly link to the NHG Office of Human Research Programme (OHRPP) website

  • Implement various administrative and formatting improvements

Impact on DSRB submissions

  • New studies are strongly encouraged to adopt the updated ICF version

  • Ongoing studies need not revise their currently approved ICF unless incorporating new objectives, such as adding socio-economic data collection under "Confidentiality of Study and Medical Records"

Please refer to the updated Informed Consent Form Template^ and Summary of Changes at DSRB Templates for Study Documentation.

^As ICH E6(R3) will take effect from 1 January 2026, we will be releasing an updated consent form template in late 2025 to ensure compliance with these requirements.

(2)   Updates to NHG DSRB Assent Form Template

The NHG DSRB Assent Form Template (Version 03, dated 01 August 2025) has been updated to:

  • Align with the SingHealth CIRB Assent Form Template

  • Streamline the IRB submission process for cross-cluster studies

  • Provide enhanced information for child participants

Impact on DSRB submissions

  • New studies are strongly encouraged to use the updated Assent Form version

  • Ongoing studies need not revise their currently approved Assent Form

Please refer to the updated Assent Form Template and Summary of Changes at DSRB Templates for Study Documentation

(3)   Impact of ICH E6 (R3) GCP Guidelines on DSRB Review

Study teams with ongoing HSA-regulated Clinical Trials should:

  • Conduct a thorough review of the ICH GCP E6(R3) &

  • Complete a gap analysis and implement necessary changes to align with the new guideline

DSRB will check if the consent form meets the updated GCP guidelines when the study team next submit changes.

While you're not required to submit any changes before 1 January 2026, you should consider updating the consent form through an amendment if your risk assessment suggests it would be beneficial to do so.

If you have any questions, please contact us at nhggroup.OHRPP@nhghealth.com.sg