What is it? Why is it important?

A Material Transfer Agreement (MTA) is a legally binding agreement governing the transfer of Biological Material (BM) and Health-related Personal Data (HrPD).

 

The transfer is set between two parties where the recipient intends to use the BM/HrPD for research purposes. The recipient must guarantee that the:

  • Transferred BM/HrPD will solely be used for research. The planned research project must be clearly described in the MTA
  • Storage of BM/HrPD must comply with data protection, ethics (e.g. EC, Decl. of Taipei), regulatory (e.g. HRA), and quality requirements

 

The MTA document defines:

  • Provider and recipient respective rights and responsibilities, regarding the use of transferred BM & HrPD
  • Data protection and data confidentiality aspects
  • In the event of a publication the intellectual property rights

What do I need to do?

For recipients that meet transfer requirements, set-up a MTA that includes a description of:

  • The planned research project and responsible project leader (e.g. provided by recipient)
  • Participant consent and rights
  • Transferred BM including relevant HrPD (e.g. plasma or serum from cancer patients, biopsies of patients with melanoma)
  • BM distribution procedures (e.g. shipment using a courier service, including temperature monitoring and leak-proof packaging)
  • Recipient storage and security measures preventing BM degradation or loss (e.g. locked freezers, restricted access, temperature surveillance and freezer emergency plan)
  • Intellectual property rights (e.g. result ownership rights obtained from BM analysis)
  • Result disclosure agreements (e.g. the biobank retains the right to co-authorship and the right to review any document prior to publication)
  • Fees and liability
  • Expiration and termination of the agreement

 

Prepare the signature page and submit this MTA to the institution’s legal department for review and approval.

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

SOPs, Forms and Templates – see in particular

  • Shipping log
  • Material Transfer Agreement 3.0
  • Introduction
  • Master legal document
  • Project agreement

External Links

Swissethics – see in particular

  • Topic/ Biobanks and data registries (Material transfer agreement)

References

IATA – see in particular

  • IATA Manuals

LTrV/OTrA – see in particular

  • Transport by air ordinance

SDR-ARD – see in particular

  • Transport by road ordinance

ISO 20387:2018 Biotechnology - Biobanking (access liable to cost) - General Requirements for Biobanking – see in particular section

  • 7.3 Reception and distribution of biological material and associated data
Abbreviations
  • BM – Biological Material
  • CTU _ Clinical Trials Unit
  • EC – Ethics Committee
  • HRA – Human Research Act
  • HrPD – Health-related Persona Data
  • IATA – International Air Transport Association
  • IP – Intellectual Property
  • LTrV/OTrA – Verordnung über den Lufttransport / Ordonnance sut le Transport aérien / Ordinanza sul trasporto aereo
  • MTA – Material Transfer Agreement
  • SBP – Swiss Biobanking Platform
  • SDR-ADR – Ordinance on the Road of Dangerous Goods by Road- European Agreement concerning the International Carriage of Dangerous Goods by Road
  • SOP – Standard Operating Procedures
Concept ↦ Biobanking ↦ Regulatory Requirements ↦ Material Transfer Agreement
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): Concept ↦ Biobanking ↦ Regulatory Requirements ↦ Material Transfer Agreement

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