SingHealth Research Tissue Banking Governance

SingHealth Research Tissue Banking Framework

The framework ensures that the SingHealth Research Tissue banks (i) remain faithful to its purpose, encouraging trust between stakeholders; (ii) be guided by a set of overarching principles when making decisions including being transparent, consistent, accountable and fair; (iii) be adaptable over time.

The framework addresses:

1) SingHealth Research Tissue Banks Structure

Each research tissue bank has a defined organizational structure for daily management and oversight of its policies. Each bank is also governed by its own executive or steering committee. This committee will provide supervision and oversight on the release of human biological material (HBM) to the researcher.

2) Proper Conduct of Tissue Banking Activities

The cluster policies defining best practices for tissue banking activities have been developed. The policies and guidance documents are developed in the context of a QMS, which includes document version control. All biobanks will act in accordance with HBRA, PDPA and other relevant guidelines and maintain strict measures to protect confidentiality, ensuring that data and human biological material (HBM) are coded, linked and stored to high standards of security. The same protection will be extended under agreement for any handling or analysis of data or human biological material by third parties engaged to provide services.

Each research tissue bank is expected to develop a list of essential standards (refer to figure), including the research tissue bank access policy, de-identification policy and procedures describing process of re-identifying participants.

The primary research tissue bank is responsible for providing supervision and oversight to the satellite and sub-satellite banks. The split of responsibilities between primary tissue bank and its satellite and sub-satellite banks will be defined.

3) Compliance Monitoring

• A cluster-wide tissue banking quality management policy has been developed to guide the research tissue banks. It defines the biobank’s governance structure and responsibilities, retention policy, storage policy, ethical issues including information on protection of confidentiality and privacy of participants, informed consent, return of incidental findings.
• Scheduled internal audits will be implemented to ensure HTF compliance and that the policies and procedures are followed.
• Risk-based monitoring of tissue banking activities for research will be conducted in accordance with protocols.
• A workflow for management of noncompliance issues and untoward occurrence will be established.

4) Researcher – responsible conduct of tissue banking

• Everyone involved in tissue banking activities takes on self-accountability in following the law and the principles of good practice relating to ethics, science, information, integrity and safety.
• Everyone involved in tissue banking have a duty to ensure that they and those they manage are appropriately qualified, both by education /training and experience, for the role they play.
• Everyone should ensure appropriate informed consent taking from research participants or donors prior to collection of human biological material. •