Set-Up↦Biobanking↦Requirements↦Ethics / Regulatory
What is it? Why is it important?
Initiating a study or research project that involves:
- The collection of Biological Material (BM) from donors
- The further-use of BM and Health-related Personal Data (HrPD) for Research, requires that biobanking procedures are in place in order to comply with ethics (e.g EC), applicable regulatory requirements e.g. HRA, HRO), including relevant standards (e.g. ICH-GCP, ISO norms)
Ethics requirements include that:
- Donors must consent to their BM being used for research purposes. Consent is given within the context of a specific project and/or a broader research framework called "further use"
- Appropriate organizational measures are in place in order to protect the storage of BM and HrPD, which includes:
- Access to required resources and technical equipment (e.g. facilities and materials, equipment maintenance)
- Traceability and documentation of samples and applicable processing operations (e.g. BIMS)
- The prevention of unauthorized or accidental disclosure, alteration, deletion and copying
- Protected access to BM/HrPD (e.g. restricted to study / research staff)
What do I need to do?
Before starting your study or research project, make sure the project complies with ethics, regulatory, and organizational requirements.
Aspects to consider are the:
- Compliance with EC, regulatory requirements (e.g. biobank regulation, donor consent, the database / BIMS, material transfer agreement)
- Definition of sample-workflow processes
- Completion of biobank set-up (e.g. facilities & materials, collection & storage equipment, maintenance & monitoring, freezer emergency plan)
- Implementation of safety measures (e.g. for donors of BM and staff)
- Quality and data integrity assurance (e.g. surveillance of quality indicators, data quality, monitoring, method validation)
For the delegation of tasks and responsibilities (e.g. documented in a staff delegation-log), ensure only to recruit qualified and trained staff.
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 Swiss Biobanking Platform (SBP) can provide you with support on this topic.
Ethics & Legal
- Ethical, legal and professional compliance list for human research biobanks applicable in Switzerland
Swissethics – see in particular
- Templates and Checklists / patient information and declaration of consent
- Further-use of BM and HrPD / Biobanks
- Topics / Biobanks and data registries
Declaration of Taipei – see in particular principles
- 8 – 19 Ethical principles
Declaration of Helsinki – see in particular principles
- 3 - 15 General principles
HRA – see in particular article
- Art. 16 Informed consent
HRO – see in particular article and chapters
- Art. 5 Storage of health-related personal data and biological material
- Chapter 2 Research involving measures for sampling of BM or collection of HrPD from persons
- Chapter 3 Further use of BM and HrPD for research
- Chapter 3, section 2. Informed consent and information