UPDATES TO THE NHG DSRB INFORMED CONSENT FORM TEMPLATE

21 NOV 2025

(1)   Updates to NHG DSRB Informed Consent Form Template

The NHG DSRB Informed Consent Form Template (Version 15, dated 21 November 2025) has been updated to:

  • Include recommended language to fulfil the 3 new consent elements introduced under ICH E6 (R3) GCP Guideline Section 2.8.10(f), (p) and (v), which will be effective 1 January 2026 and applies to all Health Sciences Authority (HSA)-regulated clinical trials

  • Include the expanded explanation of what constitutes "methods of payment"

  • Add negative statements to comply with the Human Biomedical Research Act (HBRA) requirements where negative statements are required for specific consent elements

  • Implement various administrative and formatting improvements

Please refer to the updated Informed Consent Form Template and Summary of Updates at <DSRB Templates for Study Documentation>.

Impact on DSRB submissions

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

  • Study teams with ongoing HSA-regulated Clinical Trials should complete a gap analysis and implement necessary changes to align with the new ICH E6 (R3) GCP guideline.

  • All other ongoing studies need not revise their currently approved ICF.

(2)   Impact of ICH E6 R(3) GCP Guideline on DSRB Review

Study teams with ongoing HSA-regulated Clinical Trials are reminded to:

  • 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 ICF 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