What is it? Why is it important?

The declaration of Taipei covers ethical principles in human research related to the use of health databases and biobanks. It includes research that involves:

  • The further-use of identifiable health-related personal data, and/or
  • Identifiable biological material

The declaration:

  • Applies to research beyond individual patient care
  • Is in concordance with the Declaration of Helsinki by providing additional principles on health databases and biobanks (e.g. the collection, storage, and use of identifiable data and biological material)
  • Provides ethical guidelines regarding the governance of biobanks and health databases, with the aim to protect participants and their data
  • Aims to protect the dignity, autonomy, privacy, and confidentiality of research participants
  • Requires research to contribute to the benefit of society, in particular public health objectives
  • Is not legally binding


A health database is a repository used to collect, organise, and store information on individuals and populations (e.g. demographics, diagnostics, medical treatment, genetic information).

A biobank is a collection of biological material including any associated data.

With biological material, one refers to a chemical substance present or produced in a living individual. A sample can provide both biological information and genetic data.

What do I need to do?

As a SP-INV and Site-INV familiarise yourself with the declaration.

Ensure participants:

  • Are adequately informed about the multiple and infinite use of their data and/or biological material
  • Freely provide consent in accordance with the Declaration of Helsinki
  • Know about their right to withdraw consent for their data to be collected and used for research
  • Know about their right to request information regarding their collected data
  • Can trust that their data and biological material are handled and stored in a manner that guarantees their confidentiality

To promote quality and reliability, make sure the governance of your biobank (with its database) complies with the principles of Taipei.


Governance is the organisation and set-up of a health database and/or biobank to ensure that:

  • Individual rights prevail over the interest of stakeholders and science
  • Relevant information is made available to the public
  • The custodian of the health database and biobank:
    • Consults and engages with individuals and their communities
    • Is accessible and responsive to all stakeholders

The declaration primarily addresses physicians, but encourages others using data or biological material from health databases and biobanks to adopt its principles.

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic


The World Medical Association – see in particular

  • Declaration of Taipei: research on health databases, big data and biobanks
  • Medical Ethics: Declaration of Helsinki - Medical research involving human subjects

PMID: 33324212 - Publication

  • Linking the declarations of Helsinki and of Taipei: Critical challenges of future-oriented research ethics
  • CTU – Clinical Trials Unit
  • Site-INV – Site Investigator
  • PMID – PubMed Identifier
  • SP-INV – Sponsor-Investigator
  • WMA – World Medical Association
Basic ↦ Ethics and Laws ↦ Principles of Ethics Research ↦ Declaration of Taipei

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Quality and Risk
Set-Up Drug or Device
Set-Up Biobanking

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Completion Biobanking
Current Path (click to copy): Basic ↦ Ethics and Laws ↦ Principles of Ethics Research ↦ Declaration of Taipei

Please note: the Easy-GCS tool is currently under construction.