Guidelines

HBRA Exemption Regulations 2018

MOH has passed new Exemptions to facilitate existing on-going studies to transit into HBRA. 

i. If individually-identifiable health information or human biological material (HI/HBM) was obtained before 1 Nov 2018, AND you are no longer obtaining new individually-identifiable biological material or health information after 1 Nov 2018, but your study is still on-going (analysis stage), then you are exempted from the need to obtain further appropriate consent till 31 Oct 2019. (Thereafter, you are expected to (1) De-identify all HI/HBM after 31 Oct 2019, or (2) Seek re-consent from participants using updated consent form to continue using their identifiable HI/HBM, or (3) Complete your current study.) 

ii. If your on-going HBR study had been granted a waiver of consent by NTU-IRB before 1 Nov 2017, then these studies will be exempted from "Appropriate Consent" requirements up till 31 Oct 2019. For studies to continue beyond 31 Oct 2019, the new HBRA framework will apply, and researchers will need to (1) Seek waiver of consent again from the IRB, or (2) Obtain appropriate consent in accordance with HBRA, or (3) De-identify the HI/HBM.