What is it? Why is it important?

Upon study completion and the analysis of the study Biological Material (BM), potential amounts of BM might remain unused in the biobank.

 

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:

More

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

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

SBP Documents

Material Transfer Agreement 3.0

  • Introduction
  • Master Legal Instrument

SBP-NExT - An interactive tool dedicated to Biobanks and Researchers

Swiss Law

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
Abbreviations
  • BM – Biological Material
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • HRA – Human Research Act
  • HRO – Human Research Ordinance
  • HrPD – Health Related Personal Data
  • SBP – Swiss Biobanking Platform
Completion ↦ Biobanking ↦ Leftover Biological Material ↦ For Further-Use
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
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 Protocol
Conduct Statistics
Conduct Drug or Device
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Current Path (click to copy): Completion ↦ Biobanking ↦ Leftover Biological Material ↦ For Further-Use

Please note: the Easy-GCS tool is currently under construction.