What is it? Why is it important?

Upon destruction of Biological Material (BM) its biological properties become destroyed in an irreversible way.

 

Situations where BM become destroyed include:

  • Equipment failure (e.g. freezer failure with irreversible damage to biosamples)
  • Loss of biological specimen associated data needed for the evaluation of analytical results
  • The surpassing of biological specimen expiration date or retention time
  • Unmet biological specimen quality requirements (e.g. biological specimen contamination, erroneous sample identification, damaged containers)
  • Withdrawal of donor consent

 

Withdrawal of consent from donors of Biological Material (BM) participating in a study or research project requires that:

  • No further BM (from the date of withdrawal) is collected from participants
  • Upon final data analysis, BM and HrPD is anonymized

More

The anonymisation of BM and HrPD requires:

  • For the anonymisation procedure to be submitted and approved by EC
  • The donor does not dissent to the anonymisation. This might be important as information might become available that could potentially be of health interest or benefit to a donor

What do I need to do?

Define destruction procedures of BM in an SOP and train applicable staff.

 

In order to describe destruction procedures find out about:

  • Legal requirements for destruction or anonymisation of BM and HrPD
  • BM destruction procedures at your institution, including:
    • Special requirements needed for the destruction of biohazard material
    • Responsibilities of collaborating partners such as the logistic and transport department
  • Who is the responsible destruction institution (e.g. either internally at your institution or through an external service provider)
  • If the destruction institution is in possession of the required destruction certificate(s)
  • How the destruction institution can certify the destruction of BM

 

Requirements needed to ensure destruction traceability includes:

  • A list of biological specimens destined for destruction. Include specimen identification details
  • The reason for destruction
  • Date of destruction and responsible destruction institution or staff
  • If applicable, a destruction certificate

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.

Swiss Law

ClinO – see in particular articles

  • Art. 7 Information given to participants
  • Art. 9 Consequences of revocation of consent

HRO – see in particular articles

  • Art. 8 Information given to participants
  • Art. 10 Consequences of revocation of consent
Abbreviations
  • BM – Biological Material
  • ClinO – Clinical Trials Ordinance
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • HRO – Human Research Ordinance
  • HrPD – Health Related Personal Data
  • SBP – Swiss Biobanking Platform
  • SOP – Standard Operating Procedures
Completion ↦ Biobanking ↦ Leftover Biological Material ↦ Destruction
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 ↦ Destruction

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