Concept↦Biobanking↦Regulatory Requirements↦Material Transfer Agreement
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
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.
SOPs, Forms and Templates – see in particular
- Shipping log
- Material Transfer Agreement 3.0
- Master legal document
- Project agreement
Swissethics – see in particular
- Topic/ Biobanks and data registries (Material transfer agreement)
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