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Researchers FAQs

A. HBRA Consent

B. Human Biological Materials/Human Tissues

​After you have obtained broad consent for the leftover tissues, you may carry on with your research and the leftover tissues will be transferred to the Tissue Bank after the study. There is also a possibility that there will be no leftovers to transfer, that is also fine. Please contact the Tissue Bank that you are using for the workflow and charging matters.

​If you are supplying leftover samples to your own HBR Study B, you need not be subjected to HTF. If you are supplying to other studies, you are a tissue bank. A tissue bank will be required to be registered OR you can come under the oversight of an existing tissue bank to facilitate the downstream research. For release of tissues to Study B, the tissue bank will need to sight the IRB approval/exemption and have mechanisms of tracking for the release of tissues. The duties of tissue bank will need to be fulfilled.

The collection, storage and supply of tissues is deemed as a Research Tissue Bank (HTF framework):
- Samples collected prospectively will be stored for possible future research, shared by multiple investigators or distributed to other projects/researchers.
- Leftover research samples collected during an IRB approved protocol intended to be stored for possible future research after the study is closed or to be shared across various investigators/projects (e.g. Study A passing tissues to Study B).
 
A tissue bank should be registered OR you can come under the oversight of an existing tissue bank to facilitate the downstream research.

Yes. HBRA compliant consent (ie. consent form containing all essential elements according to HBRA) needs to be obtained for use of these discarded tissues in research.

​Yes, you will need to obtain HBRA compliant broad consent (containing all HBRA required consent elements) for use of these tissues/biological materials for future research, even though the materials are collected from HSA-regulated trial.

Since you are operating under your current IRB-approved project , the PI should ensure that identifying information of the tissue samples are masked before releasing them externally and that there is documentation (eg. Material Transfer Agreement (MTA)) in place. You will be excluded from the HTF framework as you are operating within your current approved HBR.
 
If your protocol has provisions for storing the samples for future research, you can then use a broad consent form. It is important for the PI to discuss with the external collaborator who is the custodian of the tissues because the responsibility of the Tissue banking activities lies with the custodian. The PI may still be responsible for the Tissue Banking activities even though tissues are stored externally.
 
If the external collaborator is responsible for Tissue Banking for future research, then the control and supervision on the tissue banking matters will be from the non-SingHealth tissue bank. Note that Tissue Banking will have to be performed through a registered Tissue Bank.

​No, the HBRA First Schedule defines such materials as Human Biological Materials excluded from definition of Human Tissue. These will not be subject to the consent requirements for removal, donation or use of human tissue from a tissue donor under HBRA Section 12 (2), and also not fall under the scope of the duties of a tissue bank under HBRA Section 35.

Even though consent meeting the elements of HBRA is not required, investigators should ensure that subjects have consented for use of their non-tissue samples for future research.

C. Research Data

​No. The record linkage key still resides in the same team. Research is still considered as working with individually identifiable information if the record linkage key is still accessible by the study team. For a research to be considered as working with de-identified information, the record linkage key must be held by a trusted third party.

It is important to know whether your study team is able to handle/access to individually identifiable data/Human Biological Materials (HBM).
E.g. Subjects have given consent for study team to use their information in an individually identifiable manner.
E.g. Waiver of consent granted by the IRB to use the information in an individually identifiable manner.
 
In your own HBR in which informed consent is obtained for use of individually identifiable information, it is not necessary to go through a third party de-identification process. In this scenario, investigators can work with individually identified health information.
 
However, HBRA requires “Every person who has obtained individually‑identifiable information or human biological material for the purposes of human biomedical research must take all reasonable steps and safeguards against loss or unauthorized access”. Investigators will need to ensure that the data sent is not identifiable to the party outside (eg. send in a coded manner) and the linkage key will be kept with the investigator.
 
The de-identification process (where the third party holds the linkage keys and study team does not have access to it) is necessary if the study team does not have the approval/not authorized to use the data/HBM in an individually identifiable manner.
A clinical database (individually identifiable) can be used for patient care and management purposes but not for research as consent for research has not been obtained. No IRB approval is required for use in patient care and management.
 
If there is an intent to use the clinical database (individually identifiable) for research, application to the IRB with consent from the subjects OR application for a waiver of consent in order to use the database in the individually identifiable manner (High Bar waiver criteria must be met if data was obtained or compiled after 1 Nov 2017). Alternatively, the third party de-identification process can be used to render the database non-identifiable to be used in research.

D. Others

​Service Improvement and Quality Assurance projects do not need to be submitted to CIRB unless the projects subject the participants to additional risk or burden beyond the usual clinical practice. When publishing QA/QI study or clinical audit, the project should not be described as research and the publisher should be informed of the nature of the project accordingly.

​No, NEHR is NOT to be used for research. Please be reminded that NEHR can only be used for clinical care. Any use of NEHR will need to be reported as a Protocol Non-Compliance to CIRB and Suspected Contravention to MOH.