Human Tissue Governance

The Human Biomedical Research Act (HBRA) came into effect on 01 November 2017. The Human Tissue Framework (HTF) was activated on 01 November 2019.

Under the HTF Framework, tissue banks must ensure that all tissue banking activities are in compliance with the HBRA-HTF and its subsidiary legislations and conducted in accordance with the NHG Tissue Bank Policy, Proper Conduct of Tissue Bank (PCT) SOPs and institutional standards, and procedures.

Who will be impacted?

If you are involved in the collection, storage, procurement, importation, supply, provision or exportation of human tissue to facilitate future research, you may be subjected to the requirements of the HTF.

These may include, but are not limited to:

Clinical/ diagnostic laboratories that supply left-over/ waste tissue to researchers;
Researchers who collect tissue in excess for the sole purpose of storage for future research;
Persons in possession of tissue, who are not involved in research, but supply the tissue to other researchers.

Updates to the Governance of Leftover Tissue for Future Research

MOH has affirmed that upon study completion, any leftover human tissue to be stored for future research (research that has yet to obtain IRB approval) will need to come under the governance of the HTF.

If you are storing leftover tissue for future research, please refer to the table below for the required follow-up actions.

Scenarios	ICF Requirements for leftover tissue to be used in future research	Is registration as a tissue bank with the Tissue Compliance Committee (TCC) Required?
You have completed your studies, and have some leftover human tissue. These tissue were collected before 1 Nov 2019.	The ICF used to consent the donors of such tissue must at least have HBRA 12(2)(a), 12(2)(f) and 12(2)(i) elements.	Yes. Your tissue must be registered with TCC. Please submit the TCC tissue bank application form. Otherwise, if the tissue had been made non-identifiable prior to 1 Nov 2019, you can submit using the Legacy Human Biological Materials Declaration form instead.
You have completed your studies, and have some leftover human tissue.These tissue were collected from or after 1 Nov 2019.	The ICF used to consent the donors of such tissue must have all HBRA 12(2) elements.	Yes. Your tissue must be registered with TCC. Please submit the TCC tissue bank application form.
You have an ongoing study, and intend to store leftover tissue for future unspecified research.	The ICF that you use to consent current subjects must include all HBRA 12(2) elements	If researchers still require the tissues for analysis, even after IRB’s acknowledgment of study closure, such tissues could be retained and used within 12 months of IRB acknowledgment for study closure. After which, the tissues should be discarded, transferred to a tissue bank or an IRB approved study or registered with the NHG TCC.

Scenarios

ICF Requirements for leftover tissue to be used in future research

Is registration as a tissue bank with the Tissue Compliance Committee (TCC) Required?

You have completed your studies, and have some leftover human tissue. These tissue were collected before 1 Nov 2019.

The ICF used to consent the donors of such tissue must at least have HBRA 12(2)(a), 12(2)(f) and 12(2)(i) elements.

Yes. Your tissue must be registered with TCC.

Please submit the TCC tissue bank application form.

Otherwise, if the tissue had been made non-identifiable prior to 1 Nov 2019, you can submit using the Legacy Human Biological Materials Declaration form instead.

You have completed your studies, and have some leftover human tissue.These tissue were collected from or after 1 Nov 2019.

The ICF used to consent the donors of such tissue must have all HBRA 12(2) elements.

Yes. Your tissue must be registered with TCC.

Please submit the TCC tissue bank application form.

You have an ongoing study, and intend to store leftover tissue for future unspecified research.

The ICF that you use to consent current subjects must include all HBRA 12(2) elements

If researchers still require the tissues for analysis, even after IRB’s acknowledgment of study closure, such tissues could be retained and used within 12 months of IRB acknowledgment for study closure. After which, the tissues should be discarded, transferred to a tissue bank or an IRB approved study or registered with the NHG TCC.

The above requirements will not apply to leftover tissue stored for future research that has received IRB approval. This is because such future research demonstrates clear research intent that can be governed under the Human Biomedical Research (HBR) Framework. Hence, HTF requirements need not apply.

You may refer to the following resources (Restricted: NHG Intranet access required) for more details.

NHG Governance Structure for Human Tissues

NHG is registered under MOH as a single "Mothership" Tissue Bank. Under this governance structure, each NHG institution has established an Institutional Tissue Bank Committee (ITBC) to oversee institutional-level tissue banking activities. Learn more about the NHG Tissue Governance Framework here.

About NHG Tissue Compliance Committee (TCC)

The NHG Tissue Compliance Committee (TCC) was formed to advise on the set up, conduct and monitoring of institutional human tissue banks.

The TCC is chaired by A/Prof Leong Khai Pang (Senior Consultant, TTSH) and comprises representatives from each NHG institution.

Contact Information

For any enquiries, please contact the NHG TCC Secretariat at NHGTCCSecretariat@nhg.com.sg