For the continued use of human tissues collected prior to 1 Nov 2019, researchers are to ensure the following:
- For continued use in individually-identifiable form:
PIs are to ensure that the storage, supply and use of human tissue removed prior to the activation date have been consented by the donor containing these 3 'core' information:
- Research purpose for which the tissue is intended to be used;
- The donor's right to withdraw his/her consent;
- Extent to which donor records will be kept confidential.
- For continued use in completely de-identified form:
PIs are to irreversibly de-identify tissues if the above consent (or re-consent) has not been obtained prior to the activation date. These tissues will then be termed as "legacy human biological material".
Note1: To de-identify samples, PIs are to irreversibily remove identifiers (e.g. name, NRIC, etc) linked to the samples and replace them with randomly generated ID codes. However, data on the characteristics of the samples can be retained.
Note2: If de-identified samples are deemed to be still identifiable (e.g. small sample size, very unique samples that can be easily linked, etc), the requirements of HBRA would still apply (i.e. obtaining appropriate consent from donors).
Legacy Human Biological Material (HBM) refers to HBM which had been (1) removed from the donor's body and (2) rendered non-identifiable prior to the activation of the Human Tissue Framework.
Such HBM may be used in research without appropriate consent.
Legacy HBM are exempt from HBRA requirements, other than the following areas:
- prohibited HBR (Section 30)
- restricted HBR (Section 31)
- prohibition against commercial trading (Section 32)
- advertisements relating to prohibition against commercial trading (Section 33)
Imported Tissues: If you did not collect tissues from the donors yourself, and you have obtained the tissues from tissue repositories, please refer to our guidance on import of HBM.
If tissues were obtained through collaborative research studies, please ensure that the main PI has obtained the relevant consent requirements for cotinued use of the tissues.
IMPORTANT: Even if you are not personally collecting tissues from donors, the storage, import and export of HBM falls under the Tissue Banking Activities of the Human Tissue Framework under HBRA. Please register your collection with NTU-RIEO to ensure that you are compliant with legislative requirements.