Frequently Asked Questions
FAQs at a Glance:
Can the Principal Investigator or others in the lab execute the MTA on behalf of UCSD?
Am I required to provide a completed 700-U Conflict of Interest form?
Can a post-doctorate or other lab personnel request the transfer of materials?
Does UCSD require an MTA to be executed in order to transfer materials to my lab?
What are the procedures for Shipping Specimens or Biological Substances
1. What is a Material Transfer Agreement (MTA)?
A Material Transfer Agreement (MTA) is a legal contract that establishes the terms and conditions of the transfer of tangible research materials between the owner and the recipient.
An MTA protects the rights of UC and the providing UCSD researcher, and records the transfer.
An MTA is required by UCSD for any outgoing transfers of:
UCSD-developed materials
UCSD materials that contain components received from external sources (third party materials)
Materials developed exclusively at a company or non-UC facility
Human blood, tissue, and/or plasma harvested at UCSD
An MTA protects UCSD and the UCSD providing scientist against claims that may arise through the recipient’s use of the UCSD material. An MTA also allows the use of the materials to be limited to specific projects and precludes the further transfer of the materials to non-approved recipients. In addition, except for transfers of human stem cells, UCSD policy does not require an MTA to be executed to receive research material.
3. What happens if I don't use an MTA?
If Receiving Materials:
You may be precluded from publishing the results of your research in cases where you received the material directly from a colleague or other source without obtaining authorized permission from the entity that owns the material.
You may be subject to personal liability if you use materials from a colleague or other source without obtaining authorized permission from the entity.
If Sending Material:
You may lose control over the material developed and its research use. The recipient will have no legal restrictions on further transferring the material to other institutions (whether non-profit or for-profit) or to other researchers. As well, the recipient or others may publish on the material before you do.
You may cause yourself and the University of California to be liable for penalties or legal action arising from such transfer. If you transfer a research material that is governed by an existing agreement that restricts further transfer of the material, you may cause the University of California to be in violation (breach) of the existing agreement and expose UC and yourself to penalties or legal action.
You may be subject to personal liability if, for example, you send out human blood or tissue without authorization of UCSD.
4. How long does it take to complete an MTA?
In general, MTAs for receipt of materials from a U.S. government agency or Non-Profit organization are reviewed, processed, signed by UCSD, and forwarded to the provider for countersignature within 1 to 3 working days. The provider usually returns a fully-signed MTA to UCSD within 1 to 30 days. UCSD will forward a copy of the fully-signed MTA to the academic identified on the MTA request form.
MTAs from For-Profit entities or Non-Profit organizations outside the U.S. generally include restrictive terms that must be negotiated before the materials can be transferred. Such MTAs may require extensive document review. UCSD will review the MTA and contact the provider to propose changes within 1 to 10 working days after receipt of the request form. Negotiation time varies from 1 to 60 days. In some cases additional time may be necessary.
5. What type of materials can be sent or received?
Material Transfer Agreements are used to transfer a variety of material used in scientific research, including, but not limited to;
Reagents
Cell lines
Plasmids
Vectors
Chemical compounds
Software
Databases
Gene chips
Devices
6. Why does it take so long to negotiate the MTA?
The time required to negotiate MTA terms is generally subject to several factors; the value and novelty of the material to be transferred, the complexity and number of terms to be negotiated, and the responsiveness of the entity providing or receiving the materials.
If you are requesting the transfer of "state-of-the-art" materials, the MTA is more likely to include restrictive terms. If this is the case, the terms of the MTA may require significant negotiation before the materials can be transferred.
In addition, delays in negotiation may also be caused by the number and complexity of changes to the MTA terms and conditions. Since an MTA is a legally binding agreement, changes frequently require extensive review and careful consideration by the provider and/or recipient. Also, when UCSD materials contain materials obtained from third parties, the time taken to obtain permission to transfer the materials can be significant.
7. Can the Principal Investigator or others in the lab execute the MTA on behalf of UCSD?
Under UCSD policy, only an authorized official may negotiate and execute Material Transfer Agreements. This is very important to be aware of since an unauthorized employee who executes an MTA can be held personally liable if a lawsuit results from the transfer of the materials.
8. I do not intend to make any inventions, why can't UCSD just accept the invention terms in the agreement?
Since materials transferred under MTAs are generally used in basic research directed toward gaining a fuller understanding of the subject under study, a particular result and/or invention may not be foreseen or identified at the beginning of the research.
This means that if UCSD agrees to assign ownership of the invention, and an invention results from the research, the investigator-inventor would be unable to use the invention in his/her future research without the consent from the owner. This would have major implications on use of related data for other research. Additionally, if the investigator-inventor used government funds to conduct research with the transferred materials, UCSD could jeopardize its ability to receive government agency funding for future research.
In addition, agreeing to invention terms that do not comply with UCSD policy could subject UCSD to legal action from its investigators and others, and jeopardize UCSD's tax exempt status under the Tax Reform Act.
9. I will not develop anything that has market, i.e. commercial value. Why does UCSD need to negotiate intellectual property terms?
UCSD does not require that an MTA include intellectual property terms. In fact, except for human stem cells, UCSD does not require an MTA to receive research materials; however the entity transferring the material to UCSD almost always requests that a formal MTA document be signed by an authorized official of UCSD, and that such intellectual property terms are included.
So in cases when the company's MTA includes intellectual property terms that are overly broad, UCSD must contact the company to negotiate terms acceptable under UCSD policy.
10. Am I required to provide a completed 700-U Conflict of Interest form?
The required Material Transfer form for sending or receiving material includes a question which asks about your financial relationship with the entity. If your response is "Yes" additional paperwork, 700-U and Addendum, will need to be completed for Conflict of Interest review.
For the Conflict of Interest 700-U form, click here.
For the Conflict of Interest Addendum, click here.
11. Can a post-doctorate or other lab personnel request the transfer of materials?
Since the academic in charge of the laboratory is responsible for the laboratory, only he/she can request/authorize the transfer of materials.
12. Does UCSD require an MTA to be executed for incoming transfers of research materials to my lab?
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Except for the transfer of human embryonic cells, UCSD policy does not require an MTA to be executed to receive research materials. However, if you wish to receive animals, human tissue or blood, or if the materials being transferred are otherwise subject to Environment, Health & Safety approval; such as a request to transfer viruses, prions, recombinant DNA and other such biohazardous materials, or you have a financial relationship with the entity providing the materials, you must obtain approval from the appropriate IRB prior to receiving the materials.
13. I am a UCSD/VA Joint Appointee. Can I submit material transfer requests to UCSD for review and processing?
If the requested materials will be used in UCSD space, the appropriate Material Transfer Process Form must be submitted to UCSD.
If the requested materials will be used in VA space, then the material transfer request must be submitted to the administrative officer of VA Research Services.
UCSD and the VA are separate legal entities. As such, each entity is responsible to execute agreements for activities conducted at its facilities.
14. What are the procedures for Shipping Specimens or Biological Substances?
Specimens and/or biological substances (human or animal) resulting from medical practice and research are considered a threat to the public health. Even though the threat may be negligible; such substances are still subject to regulations governing transport of hazardous materials under U.S. Department of Transportation (FAA) and Air Transportation Association (ATA) regulations. Prior to shipping any such material, contact the UCSD Shipping Coordinator at 858-534-7467, ext. 244. Please Note: Failure to properly package, mark, label, or document the materials for shipping may result in substantial fines by the FAA or ATA.
For further detailed information, click here.
15. I am transferring human tissue, blood, or plasma to a site participating in a multi-site clinical study. Do I need to have an MTA in place before the transfer?
No, a separate MTA is not required for the transfer, provided that the transfer is for routine testing of the tissue, blood or plasma in connection with the clinical trial.
Please Note: If the material provided by UCSD is to be used by the receiving organization for its own research, an MTA is then required for the purpose of such research.
