What is it? Why is it important?
- The further-use of identifiable health-related personal data, and/or
- The further-use of identifiable biological material
- 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?
- Are adequately informed about the multiple and infinite use of their study 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
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
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch
The World Medical Association – see in particular
- Declaration of Taipei: Research on health databases, big data and biobanks
- Declaration of Helsinki: Ethical Principles for Medical Research involving Human Subjects
PMID: 33324212 - Publication
- Linking the declarations of Helsinki and of Taipei: Critical challenges of future-oriented research ethics