Governance structures for biobanks 

Table Of Contents

Overview  #

Effective governance is fundamental to ensuring that biobanks operate in an ethical, lawful, transparent and trustworthy manner. Governance extends beyond compliance with legal requirements. It provides the framework through which decisions are made, responsibilities are allocated, risks are managed, and accountability is maintained throughout the biobank lifecycle. 

A well-designed governance framework helps to balance the interests of participants, researchers, healthcare professionals, institutions, funders, regulators and society. It promotes responsible stewardship of biological samples and associated data, facilitates high-quality research, protects participants’ rights and interests, and helps maintain public trust. 

There is no single governance model suitable for every biobank. Governance arrangements should be proportionate to the size, purpose, complexity and risks associated with the biobank, while remaining sufficiently flexible to evolve as scientific, legal and societal expectations change. 

Why governance matters  #

Good governance helps a biobank to: 

  • ensure compliance with applicable legal and ethical requirements; 
  • protect participants’ rights, welfare and privacy; 
  • demonstrate transparency and accountability; 
  • support responsible sharing of samples and data; 
  • promote fairness in access decisions; 
  • manage conflicts of interest; 
  • oversee emerging ethical, legal and societal issues; 
  • manage risks throughout the biobank lifecycle; 
  • foster public confidence and social licence; 
  • ensure the long-term sustainability of the biobank. 

Governance should not be viewed as a one-time exercise established during the creation of a biobank. Rather, it is a continuous process requiring regular review and adaptation. 

Principles of good governance  #

Although governance structures vary, effective governance is generally underpinned by several common principles: 

  • Accountability: roles, responsibilities and decision-making authority should be clearly defined. Individuals and committees should be accountable for their decisions and actions. 
  • Transparency: participants and other stakeholders should understand how the biobank operates, how decisions are made, who can access samples and data, and what safeguards are in place. 
  • Participant-centred governance: participants should be recognised as partners in research. Governance should respect their rights, preferences and reasonable expectations and include mechanisms for meaningful participant and public involvement where appropriate. 
  • Independence: important oversight functions should be sufficiently independent from day-to-day management to ensure objective decision-making. 
  • Proportionality: governance measures should reflect the nature, scale and risks of the biobank without creating unnecessary administrative burdens. 
  • Adaptability: governance should evolve alongside scientific developments, new technologies, changes in legislation and societal expectations. 

Typical governance structures  #

While governance arrangements differ between institutions and countries, many biobanks include several complementary governance bodies. 

  1. Governing Board or Steering Committee: The governing board provides strategic oversight of the biobank. Typical responsibilities include: 
  • setting strategic direction; 
  • approving governance policies; 
  • overseeing financial sustainability; 
  • monitoring performance; 
  • ensuring compliance with legal and ethical obligations; 
  • reviewing significant risks; 
  • overseeing relationships with partner organisations. 

Membership commonly includes institutional representatives, scientific leaders and, increasingly, independent members or public representatives. 

  1. Data and Biospecimen Access Committee (DAC): A Data and Biospecimen Access Committee (DAC) reviews requests from researchers seeking access to samples and data. The committee helps ensure that access decisions are fair, transparent and consistent with: 
  • participant consent; 
  • applicable legislation; 
  • ethical approvals; 
  • governance policies; 
  • the objectives of the biobank. 

Typical considerations include: 

  • scientific merit; 
  • ethical acceptability; 
  • legal compliance; 
  • proportionality of requested materials; 
  • data protection safeguards; 
  • benefit to research; 
  • participant protections. 

Access decisions should be documented and subject to appropriate oversight. 

  1. Ethics Advisory Group: Some larger biobanks establish ethics advisory groups to consider complex ethical issues that may arise during operation. 

Examples include: 

  • return of individual research results; 
  • incidental findings; 
  • recruitment of vulnerable populations; 
  • international data sharing; 
  • commercial partnerships; 
  • emerging technologies such as artificial intelligence. 

These committees typically provide advice rather than replacing formal Research Ethics Committee review. 

  1. Participant and Public Involvement (PPI): Increasingly, biobanks include participants or members of the public within governance structures. 

Public involvement can improve: 

  • transparency; 
  • accountability; 
  • public trust; 
  • policy development; 
  • participant communications; 
  • access governance. 

PPI may involve representation on governance committees, dedicated advisory panels, community advisory boards or consultation exercises. 

Meaningful involvement requires adequate support, training and opportunities for genuine participation. 

  1. Operational governance: In addition to governance committees, biobanks require clear operational governance arrangements. 

These commonly include: 

  • governance policies; 
  • standard operating procedures (SOPs); 
  • quality management systems; 
  • data protection procedures; 
  • records management; 
  • incident reporting procedures; 
  • audit programmes; 
  • risk management frameworks; 
  • training programmes. 

Operational governance ensures that strategic decisions are implemented consistently throughout the organisation. 

Governance as an evolving process  #

Governance should not remain static. Biobanks operate within rapidly changing scientific, technological and regulatory environments. New genomic technologies, artificial intelligence, international data sharing, evolving participant expectations and changes in legislation may all require governance arrangements to be updated. 

Regular governance reviews, periodic policy revisions, stakeholder engagement and ongoing monitoring of emerging risks can help ensure that governance remains effective over time. 

Ultimately, effective governance enables biobanks to fulfil their scientific objectives while protecting participants, maintaining public trust and ensuring that valuable biological resources are managed responsibly for the benefit of society. 

Practical tips  #

When establishing or reviewing a governance framework, consider the following questions: 

  • Are governance roles and responsibilities clearly defined? 
  • Are decision-making processes transparent and documented? 
  • Does the governance structure include independent oversight? 
  • Are participants or members of the public meaningfully involved? 
  • Is there a clear process for reviewing access requests? 
  • Are governance policies regularly reviewed and updated? 
  • Are emerging ethical, legal and technological issues actively monitored? 
  • Is governance proportionate to the size and risks of the biobank? 
  • Is there an effective system for identifying and managing risks? 
  • Does the governance framework support long-term sustainability and public trust? 

Legal and ethical international and EU sources about governance of biobanks  #

International Sources  #

            European Union  #

            • GDPR – Regulation (EU) 2016/679: it is central to the governance of biobanks where biological samples are linked to identifiable or identifiable personal data. 
            • European Health Data Space (EHDS): it is increasingly relevant to biobank governance because it creates a European framework for the use and exchange of electronic health data, including for secondary research purposes. 

                BBMRI-ERIC Resources  #

                Relevant Literature  #

                • European Commission: Directorate-General for Research and Innovation, Biobanks for Europe – A challenge for governance, Publications Office, 2012, https://data.europa.eu/doi/10.2777/68942 
                • Gottweis H, Zatloukal K. Biobank governance: trends and perspectives. Pathobiology. 2007;74(4):206-11. doi: 10.1159/000104446. PMID: 17709961. 
                • Gottweis H, Petersen A (eds.), Biobanks. Governance in Comparative Perspective, 2008, Routledge   
                • Gille, F., Vayena, E. & Blasimme, A. Future-proofing biobanks’ governance. Eur J Hum Genet 28, 989–996 (2020). https://doi.org/10.1038/s41431-020-0646-4 
                • Iacomussi S., The governance of biobanks in the digital society, Aranzadi La Ley, 2026 

                ELSI, gdpr
                Updated on 25 August, 2026