What is it? Why is it important?

Health care providers gather health information to support on-going patient care. The Declaration of Taipei provides ethical principles for:

  • The collection, storage and use of Biological Material (BM) and Health-Related Personal Data (HrPD) beyond individual patient care
  • The deployment and use of health databases and biobanks including its governance

 

Based on the Declaration:

  • A health database is a system for collecting, organizing and storing health information
  • A biobank is a collection of BM and associated data
  • BM is a sample obtained from an individual human being, living or deceased, which can provide biological and genetic information about that individual

More

The declaration of Taipei works in accordance with the Declaration of Helsinki, which lays down ethical principles for:

  • Medical research involving human subjects
  • Means used to obtain IC from participants with the aim to use their identifiable BM/HrPD
  • The protection of research participants regarding their dignity, autonomy, privacy, and confidentiality (e.g. data protection law)

What do I need to do?

Make yourself familiar with the Declaration of Taipei and its ethical principles to ensure that:

  • Health databases and biobanks used in research contribute to the benefit of society and its public health objectives
  • EC approval is received prior to using BM/HRpD for research
  • The dignity, autonomy, privacy and confidentiality of research participants are respected
  • Participants who consent to their BM/HrPD being used for research are adequately informed (e.g. purpose, rights, data protection, risks, data transfer)

 

In order to foster public trust and quality assurance, the Declaration offers important principles needed for the governance of health databases and biobanks.

Where can I get help?

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

The Swiss Biobanking Platform (SBP) can provide you with support on this topic.

SBP Documents

General

  • Biobank Regulation

References

Declaration of Taipei – see in particular principles

  • 8 – 19 Ethical principles

Declaration of Helsinki – see in particular principles

  • 3 - 15 General principles
Abbreviations
  • BM – Biological Material
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • HrPD – Health-Related Personal Data
  • IC – Informed Consent Form
  • SBP – Swiss Biobanking Platform
Basic ↦ Biobanking ↦ Ethics Principles ↦ Declaration of Taipei
Study
Basic

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Statistic Methodology
Concept Drug or Device
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Statistic Methodology
Set-Up Quality and Risk
Set-Up Drug or Device
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Statistic Methodology
Conduct Drug or Device
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistic Methodology
Completion Drug or Device
Current Path (click to copy): Basic ↦ Biobanking ↦ Ethics Principles ↦ Declaration of Taipei

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