What is it? Why is it important?
Leftover BM can serve for “Further-Use” purposes, where alternative researchers are given access to the BM. These are research projects that make “Further-Use” of already collected:
- Biological Material (BM)
- Health-related personal data (HrPD)
Specific requirements apply for the “Further-Use” of BM in alternative research projects, such as to only share leftover BM:
- From donors that agree that their BM can be used for further research projects (e.g. documented in the ICF)
- That is coded or anonymised. Donor confidentiality must be protected at all times
- That is based on an agreement that specifies the conditions under which the BM can be used for further research (e.g. Material Transfer Agreement)
Researchers planning a research project with “Further-Use” BM must submit the project to EC for approval. Reasons include that leftover BM will be used in projects outside the scope of the study protocol under which the BM was collected
What do I need to do?
Set-up a request process for alternative researchers wanting to access leftover BM from your study. Still, reaching out to the research community can be difficult. It is therefore highly recommended to join the NExT for biobanks platform managed by the Swiss Biobanking Platform (SBP).
Through NExT the SBP:
- Gives visibility to your biobank and samples
- Interconnects with the research community
- Networks with biobanks nationally
By joining the NExT you become connected with researchers and partner biobanks. You can:
- Choose which Biological Material / biological Specimens to share
- Decide with whom to share
- Acknowledge researchers sharing requirements
- Fully control the agreement terms
In order to ensure the quality of shared BM, the SBP requires you to obtain at least one SBP Quality Label (SBP-Labels). With a SBP-Label your biobank will be included on the NExT platform and become visible to potential researchers.
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.
Material Transfer Agreement 3.0
- Master Legal Instrument
SBP-NExT - An interactive tool dedicated to Biobanks and Researchers
HRA – see in particular article
- Art 32 Further Use of Biological Material and Health-Related Personal Data for Research
HRO – see in particular chapter, articles and section
- Chapter 3 Further Use of Biological Material and Health-related Personal Data for Research
- Art. 24 Definition of further use
- Art. 25-27 Anonymisation, coding, breaking the code
- Section 2 IC procedures