Biobanks and Data registries
Overview of "data registries, biobanks" and the regulatory requirements
Biobanks
Swiss Biobanking Plattform
The Website Swiss Biobanking Platform (SBP) provides information, guidelines and templates for biobanks. SBP is a nationally coordinated platform for biobanks. It aims to respond to the increasing requests from biomedical researchers regarding quality and the interconnectedness of biobanks for research purposes.
Template of the Swiss Biobanking Platform for the reglement of biobanks. The template is endorsed by swissethics.
Template of the Swiss Biobanking Platform for MTA 2.0 (it consits of the template Master Legal Instrument and the template Project Agreement). For biological material with preanalytical and personal data (associated data).
Template of the Swiss Biobanking Platform for MTA 3.0 (it consits of the template Master Legal Instrument and the template Project Agreement). For biological material with preanalytical and personal data (associated data).
SBP has revised its MTA templates (MTA 1.0 and MTA 2.0) to propose only one single template (MTA 3.0) which now includes different options and guidance depending if you share or not personal data.
swissethics supports the use of the MTA 3.0.
Data registries
Information, guidelines and templates on data registries
Developed by the Swiss Personalised Health Network and endorsed by the Swiss Biobanking Platform and the ETH Domain Strategic Focus Area on Personalised Health and Related Technologies.
Both data and human biological material are addressed in this new version of the Framework.
Health Data Ethics Map and Course
Health Ethics & Policy Lab, ETH Zurich created the Health Data Ethics Map to explore health data ethics responsibilities and rights. The map was created based upon the Swiss Personalized Health Network's «Ethical Framework for Responsible Data Processing in Personalized Health Research.»
Guidelines of the SPHN advisory group on the ethical, legal and social implications (ELSI). These guidelines aim to support researchers with the negotiation of ethically robust, patient privacy conserving and fair conditions for Public-Private-Partnership (PPPs).
Guiding principles of swissethics for registries in human research
Recommendations for health-related registries ANQ, FMH, H+, SAMS and University Medicine Switzerland.
Checklists for health-related registries ANQ, FMH, H+, SAMS and University Medicine Switzerland.
The templates to write the CA, DTUA and DTPA of the Swiss Personalized Health Network (SPHN) are available on the website of the SPHN (click here). Please use the information you find on the website of the SPHN about the different legal agreements necessary to establish research consortia, and data transfer and use in collaborative research projects.
Please contact the Personalized Health Informatics (PHI) Group at dcc@sib.swiss for guidance and support or watch the presentation "Legal agreement for using health-related data in multi-center projects".
The templates CA, DTUA and DTPA are available in English only.
Guideline on the retention period of biological material and personal data of further use projects without the informed consent of the persons concerned (according to Art. 34 HRA)