Tissue Compliance Circulars

Issue 02/2024

Attention to clinical laboratories: Do you know that appropriate consent must be obtained before clinical human tissue specimens can be supplied for research?
1. Why is appropriate consent required for the supply of de-identified human tissue for research
2. Requirements to be fulfiled prior to the release of tissue
(Released 28 Feb 2024)

Issue 01/2024

TCC Requirements for Industry-Sponsored Studies
Addressing FAQs on human tissue management for industry-sponsored studies:
1. Tissue samples stored for a few hours in the institution's freezer; should a tissue bank be set up for this temporary storage?
2. How should temporarily stored samples be managed - records to be maintained and scope of monitoring. Introduction to PCT 1505-04 NHG Tissue Banking Activities Monitoring Plan Template
3. Who can perform tissue bank / tissue collection monitoring

(Released 16 Jan 2024)

Issue 03/2023

Human Tissue Framework (HTF) Practicum Course. Register your interest by 16 August 2023.
1. Link for registration
2. Held via zoom on 30 August 2023
(Released 10 Jul 2023)

Issue 02/2023

NHG Tissue Bank Monitoring Framework
1. Types of monitoring activities within the NHG Tissue Bank Monitoring Framework (i.e. SIV, SMV, Annual Tissue Banking Activity Self-Assessment (TASA))
2. Scope of the NHG Tissue Bank Monitoring Framework
3. How should monitoring activities be documented - PCT 1502-01 NHG Tissue Bank Review Checklist
4. New/Updated resources
a) PCT 1505-04 NHG Tissue Banking Activities Monitoring Plan Template
b) PCT 1501-B04 Quality Management of Tissue Banks and Tissue Collections
c) PCT 1504-08 Tissue Banking Activity Self-Assessment Form (TASAF)
(Released 29 May 2023)

Issue 01/2023

New to Tissue Banking Activities? In NHG, you must complete the Human Tissue Framework (HTF) Course before commencing tissue banking activities
1. Who should complete the HTF Course
2. What to expect from the HTF Course
3. When should the HTF Course be completed
4. How to access the HTF Course
(Released 6 Feb 2023)

Issue 06/2022

Which application form should you use? – Tissue Bank Application Form or Tissue Collection Application Form?
1. Information on which Tissue Application Form to use under different scenarios
2. Announcement on new resource: NHG Investigator's Manual Chapter 9 - Tissue Repository
3. Announcement on updated resources
a) 1703-01 TB application form
b) 1703-03 TB amendment form
c) 1703-04 TC amendment form
d) 1703-07 Declaration of LHBM
e) 1703-09 TC status report form
f) 1704-05 ICF for donation of biological material
(Released 6 Dec 2022)

Issue 05/2022

Non-Compliance Case Study: Storage of Leftover Tissue Without Consent
1. Case study of non-compliance that was observed at a  TQM on-site audit on 23 Aug 2022.
a) Non-compliance from TB-2021-002
b) There was a transfer in custodianship of tissues from the study team PI to the TB custodian. Custodian did not check through the ICFs nor verify and track the consent restrictions of each sample received till much later. It was noted that there leftover blood specimens from a donor were stored without appropriate consent.
c) Introduction to the 1504-09 Tissue Handover Form to document transfer of custodianship

2. Announcement that the 1703-02 Tissue Collection Form has been updated
(Released 29 Sep 2022)

Issue 04/2022

Human Tissue Framework (HTF) Practicum Course. Register your interest by 16 September 2022.
1. Introduction to the HTF Practicum Course
2. Link for registration
3. Held via zoom on 30 September 2022
(Released 4 Aug 2022)

Issue 03/2022

Documenting Right to Meet HBRA 37(9)
1. Implications of HBRA 37(9)
2. Scenarios where HBRA 37(9) is applicable/not applicable
3. Introduction ot 1505-03 Letter of Undertaking for Leftover Tissues Template to comply with HBRA 37(9)
4. Reminder that appropriate consent must be obtained from donors before supplying leftover diagnostic tissue
5. Reminder on the Human Tissue Framework Forum
(Released 13 Jun 2022)

Issue 02/2022

Attention: Updates to the NHG Policy for Tissue Banks
1. 4 key updates to the policy dated 11Feb2022
2. Reminder to register with NHG TCC if researcher is involved in tissue banking activities
3. Annoucement that HTF Minimum Training Requirements will be extended to SAF staff/doctors appointed in NHG
(Released 29 Mar 2022)

Issue 01/2022

Non-Compliance Case Study: Storage of Leftover Tissue Without Appropraite Consent
Case study of non-compliance that was observed at a TQM remote audit on 30 Sep 2021.
a) Non-compliance from TB-2019-002 at KTPH
b) Donor autonomy was neglected
c) Storage without appropriate consent
(Released 3 Feb 2022)

Issue 04/2021

For ongoing studies planning to store leftover tissue for future research, please ensure your ICF is HBRA 12(2) compliant.
1. For study team members who intend to store leftover tissue for future research, instructions were given to check through all ICF versions used for consenting donors since 01 Nov 2019 to ensure that ICF used is 12(2) compliant.
2. Researchers were also reminded to destroy any leftover tissue if study had been completed for more than 1 year and appropriate consent had not been obtained for storage for future research.
3. Updates to Resources
a) 1703-01 Tissue Bank / 1703-02 Tissue Collection application form
b) 1703-08 Tissue Bank / 1703-09 Tissue Collection status report form
c) 1704-15 (Optional) ICF for donation of leftover biological samples
(Released 21 Dec 2021)

Issure 03/2021

Human Tissue Framework Forum and New/Updated Resources
1. Human Tissue Framework Forum - Purpose, How to access

2. New/Updated Resourced
a) Overview of Human Tissue Framework Slide Deck
b) Decision Tree Tool on whether activities would be regulated under the HTF
c) HSA Guidance on Consent Requirements for Clinical Trials Involving Collection and Use of Human Tissue Version dared 01 Jul 2021
d) Translated SCF Templates for Donation of Leftover Biological Materials
(Released 30 Aug 2021)

Issue 02/2021

Attention: MOH Update On The Governance Of Leftover Tissue.
Do you have any ongoing studies which mayhave leftover tissue to be used for futureresearch after the study is completed?

If so, in order to use the leftover tissue for future research, you may need to ensure that study participants have been consented with all the HBRA 12(2) elements.
1. Informed consent requirements and whether registration with TCC is required under these 2 scenarios
a) Storage of leftover human tissue for future research not yet approved by IRB
b) Use/storage of leftover tissue for a HBR study that had already been approved by the IRB.

2. Introduction to 2 new resources
a) NHG TR 1704-15 Optional Consent Form For The Donation of Leftover Biological Samples
b) NHG Guidance to Store and Use Leftover Human Tissue for Future Research
(Released 7 Jun 2021)

Issue 01/2021

Attention: MOH Update On The Governance Of Leftover Tissue. Storing Leftover Tissue For Future Research? You May Need NHG TCC's Approval For This
1. Leftover tissue stored for existing IRB-approved Human Biomedical Research (HBR) and own future HBR that has obtained IRB approval would be subject to the requirements of the HBR framework; do not need to be regulated under the HTF.
2. Leftover tissue stored for a future research yet to obtain IRB approval is regulated under the the HTF.
3. Notice for researchers to register with NHG TCC if they have leftover tissue from a completed study and intend to store them for future research yet to obtain IRB approval
4. Registration of Legacy Human Biological Material (LHBM) if the leftover tissue had been collected and made non-identifiable before 01 Nov 2019.
(Released 3 Mar 2021)

Issue 10/2020

Are You Ready For The MOH Tissue Bank Audit?
1. Audit preparation tips
2. Introduction to Custodian Self-Assessment Form and/or Tissue Collection Activity Self-Assesmsent Form.
3. Reminder that PCT SOPs, forms and templates are downloadable from SharePoint.
(Released 14 Dec 2020)

Issue 09/2020

MOH Is Auditing NHG Tissue Banks In January 2021 - What You Need To Know
1. MOH Audit Preparation Timeline
2. MOH Audit Scope
3. How should custodians get ready for the audit
(Released 13 Nov 2020)

Issue 08/2020

1. Researcher A wants to use de-identified leftover biopsy samples for his research.
2. His protocol was approved by the DSRB, together with a waiver of consent.
3. Researcher A approaches Clinical Lab XYZ and requests for de-identified leftover biopsy samples for this study.
4. Clinical Lab XYZ recognizes that de-identified biopsy samples is human tissue. What should clinical lab XYZ do before releasing the de-identified biopsy samples to the researcher?
Responsibilities of the clinical lab before releasing leftover diagnostic tissue for research
1. Register as a TB with NHG TCC
2. Confirm that leftover diagnostic tissue no longer required for therapeutic/diagnostic procedures
3. Obtain documentary evidence on the intended use of tissue
4. Ensure appropriate consent is obtained for the supply of leftover tissue (i.e. HBRA 12(2) compliant)
5. Seek endorsement from ITBC for the release of leftover tissue to the researcher.
(Released 12 Oct 2020)

Issue 07/2020

Do You Have Leftover Human Biological Material After Completing Your Research Project? Do You Intend To Store And Use These Leftovers For Future Research.
1. 2-checkpoint guide to determine if leftover human biological material are regulated under the HTF
2. How to register leftover tissue with NHG TCC
(Released 25 Aug 2020)

Issue 06/2020

Resources For Tissue Donors
1. Tissue Donor Brochure (11 FAQs about tissue donation and checklist of questions for donors to ask during consent taking)
2. 1506-01 Information Sheet on the Management of Incidental Findings
(Released 6 Jul 2020)

Issue 05/2020

Obtaining Consent From Donors Lacking Mental Capacity
1. Circumstances under which tissue may be obtained from persons lacking mental capacity
2. Whom to obtain consent from
3. What would be considered "reasonable effort" to ensure that persons in the previous hierarchy are not available for consent taking.
(Released 3 Jun 2020)

Issue 04/2020

Obtaining Consent From Non-English Speaking Donors
1. Short Consent Form Template
2. Witness Requirement Flowchart - Prescribed witness vs Impartial witness under different scenarios
3. Announcement that HTF Course has been upgraded to include information from the HBR (Tissue Banking) Regulations 2019
(Released 12 May 2020)

Issue 03/2020

Essential Documents For The Tissue Bank
1. What essential documents should be maintained?
2. Where should essential documents be maintained?
3. Tissue Bank File Contents Template
4. Common Essential Documents Errors
5. ALCOA principles
(Released 2 Apr 2020)

Issue 02/2020

Prescribed Witness During Consent Process For Tissue Donation
Prescribed Witness - Who, Why, When?
(Released 25 Feb 2020)

Issue 01/2020

What Is Appropriate Consent Taking With Tissue Donors?
1. Introduction to the 12(2) elements
2. Introduction to the 1704-05 Informed Consent Form for Donation of Biological Material template
3. Use separate ICFs - one for current research, another for collection of additional tissue for future research
4. Submit ICF for tissue donation to TCC, not DSRB.
(Released 21 Jan 2020)

Issue 05/2019

Attention: All Researchers, How Should You Request For Tissue?
1. Tissue specimen request process (endorsement from ITBC)
2. Introduction to the 1504-04 Tissue Specimen Request Form and 1504-05 Specimen Retrieval Form
(Released 24 Dec 2019)

Issue 04/2019

Attention: All Tissue Custodians, When Can You Release Tissue For Research
Responsibilities of the custodian before:
1. Supplying tissue samples for research
2. Exporting tissue from Singapore
(Released 13 Dec 2019)

Issue 03/2019

NHG Is One Tissue Bank
1. NHG TCC governance structure.
2. Roles and responsibilities of NHG Tissue Person-In-Charge (TPIC), NHG TCC, Institutional Tissue Bank Committee (ITBC), TB Custodian
(Released 2 Dec 2019)

Issue 02/2019

HBRA Human Tissue Banking Regulations. Am I Affected? What Do I Need to Do? A 3-step Guide.
1. Definition of human tissue, tissue banking activities and tissue bank.
2. How to register tissue bank (TB) with NHG Tissue Compliance Committee (TCC)
(Released 13 Nov 2019)

Issue 01/2019

Human Tissue Regulations Effected on 01 November 2019
1. Announcement on the activation date of the Human Tissue Framework (HTF)
2. Where to locate the Human Biomedical Reseach (Tissue Banking) Regulations 2019.
(Released 5 Nov 2019)