Collecting, Procuring, Importing, and Transfer-In of HBM

PROHIBITION AGAINST COMMERCIAL TRADING OF HUMAN TISSUES

Effective 1 Jan 2017, HBRA prohibits commercial trading (i.e. buying and selling) of human tissue, as well as advertisements relating to such trading. This prohibition upholds the principle that human tissue should be obtained only through altruistic donations.

This may affect you if you make use of human tissue in the course of your work. If you have previously made arrangements to obtain and/or supply human tissue, please ensure that your arrangements are not in contravention of the prohibitions in the HBRA. Further information can be found on MOH's website. A guide is available here.

What about Human Blood Products? 

Note that HBRA Section 32(6) and HOTA Section 14(4) have provisions for the purchase of human blood products and plasma fractions for research.  

• For human blood, reimbursement for any cost and expenses incurred is not allowed under HOTA. 
• Notwithstanding, blood products that have been subjected to processing or treatment are exempted from this prohibition under HOTA.   
  

What about Tissue Products and Tissue Derivatives? 

These are usually made from human biological material and would have already undergone substantial manipulation and processing. Where these are not considered to be human tissue, they can be bought and sold on a commercial basis. This would include cell lines. 

How to obtain human tissues lawfully from commercial vendors? [#1 in Figure]

While the HBRA prohibits commercial trading of human tissue, it allows for payment to reimburse the reasonable costs and expenses incurred in the process of collecting and supplying human tissue – including the removal of tissue from the donor, and the subsequent transportation, preparation, preservation, quality control and storage of the tissue. The payment must not be for the purchase or sale of the tissue itself.

In this regard, obtaining tissue from sources that are part of a tissue sharing network or exchange programme, whether local or international, and paying only reasonable costs and expenses in relation to such sourcing, would generally be permitted. In contrast, sourcing for tissue from foreign commercial suppliers or tissue banks that routinely charge a price for selling the tissue itself, should be done cautiously.

When making arrangements to obtain human tissue, it is advisable to clarify the arrangements with the supplier providing the human tissue to ensure that the supply of the tissue is on a cost-recovery basis. These arrangements and transactions with the supplier should be documented accordingly.

Please also see section below regarding the requirements for documentary evidence and submission of HTF Declaration/ Notification form.

Transfer-in of human tissues from Collaborators / Partners [#2 in Figure]

Local Partners: For the transfer-in of human tissues from local collaborators/ partners, PIs are to obtain documentary evidence from the source that consent was obtained in accordance with HBRA requirements. 

Overseas Partners: For the transfer-in of human tissues from overseas collaborators/ partners, PIs are to obtain documentary evidence from the source that consent was obtained in accordance with the legal/ ethical requirements of the country where the tissue came from. 

Documentary Evidence: This should be obtained prior to the import of the human tissues, and could be in the form of email correspondences or official documents stating that consent has been obtained in accordance with the legal or ethical requirements of the country from where the human tissues came from. Additionally, the import documents (e.g., Courier manifest, airway bill, delivery order/tax invoice) should include the Tissue/Donor code and the tissue type, and be archived for records keeping by the PI. 

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 submit the HTF Declaration/ Notification form to ensure that you are compliant with legislative requirements.

Self-collection of of human tissues [#3 in Figure]

For PIs who are self-collecting human tissues for your research (i.e. recruitment of participants/donors), appropriate consent must be obtained from your tissue donors. The consent form used must contain all the Section 12(2) elements under HBRA. This must be approved by NTU-IRB before tissue collection can proceed.

Although PI's own HBRA projects are exempted from the Human Tissue Framework of HBRA, PIs are to note that any storage of leftover tissues for future research is considered a Tissue Banking Activity. Hence when closing your HBRA study, such PIs are to submit the HTF Declaration/ Notification form to ensure that you are compliant with legislative requirements.