Industrial Contracts Office
1705 El Camino Real
Palo Alto, CA 94306
ico@stanford.edu

FOR RESEARCHERS – FAQs

Material Transfer Agreements FAQs

What is an MTA?

MTA stands for Material Transfer Agreement.  An MTA is used to effect the transfer of research materials from one entity to another.  The materials may range from biological materials to chemical compounds to certain equipment.

When an MTA is needed

An MTA is used in two instances:
  1. When you are receiving material at Stanford from another entity that requires an agreement.  Sometimes, the entity sending out the material will agree to use the SLA or UBMTA.  Sometimes the sender prefers its own MTA; or,
  2. When you are transferring (nonhuman) material from Stanford to another entity.  Stanford does not require MTAs for transfers of nonhuman material from Stanford labs, but if you would like to put one in place, you may use the standard Outgoing MTA template for Industry or the SLA or UBMTA for transfers to non-profits. For CIRM-funded materials, researchers should use the standard Stanford Outgoing CIRM MTA for Industry or for Nonprofit. Transfer of human tissue requires a different agreement.

What process do I need to follow if I have an MTA?

Incoming: Please have the PI complete and submit the MTA eRouting form or complete and sign the Incoming MTA Routing Form and email or fax it to our office, along with any other related information.  Some entities will send an MTA to you directly – if so, please forward it to us.  After we have reviewed the Routing Form and the MTA, we will contact you to let you know if we need further information, if we need to negotiate the MTA terms, or if we can sign as is.

Outgoing: You are welcome to use the standard Outgoing MTA for Industry or for Non-Profit Organizations on our website for transfers that do not involve human tissues. For CIRM-funded material, you're encouraged to use the standard Stanford Outgoing CIRM MTA for Industry or for Nonprofit. If you find that these documents need to be edited or do not fit your needs, please contact us and we will help you create an outgoing MTA that works for you.

Outgoing human tissues:  Please complete and submit the Human Tissue Agreement Routing Form.  ICO will use a Human Tissue Agreement for this transfer. Please note that you do not need an MTA for transfers from your lab to outside entities, unless the transfer involves human tissues or you want to transfer materials you’ve received from outside Stanford.

What do I need to consider when I receive research materials?

Use of certain materials requires compliance with federal laws and Stanford policies. If your research will involve material that is …
  1. Obtained from a living person: Requires Human Subjects Panels (IRB) approval.  Please provide us with a copy of your IRB approval or exemption letter and send Stanford’s IRB Office a copy of the Provider’s IRB letter, if applicable.
  2. Human embryonic/fetal/adult stem cells: Requires Stem Cell Research Oversight (SCRO) approval.  Please contact SCRO to submit your protocol.
  3. A live animal or material used in a live animal:  Requires Laboratory Animals (A-PLAC) subjects approval.  Please provide your A-PLAC protocol number.
  4. Radiological Hazard (EH&S): Requires EH&S approval.  Please provide your CRA/SMH number.
  5. rDNA, infectious or biohazardous material:  Requires Biosafety (EH&S) Panel training and approval.  Please provide your APB number, attach a copy of a map and/or description of the agent requested, and a reference for the agent (if available). This information will help facilitate Biosafety review.

Is there any other information I need to provide to ICO if I have an incoming MTA?

Yes!  We need to know what funding you will use to support your research using the material.  This information enables us to ensure that there are no conflicts between rights the University may grant to your funder and rights the University may grant to the provider of the material. We also need to know about potential or actual conflicts of interest, such as ownership of stock in, membership on the board of, or gifts from, the company that is providing you the material.

Who can sign an MTA?

ICO has signature authority on behalf of Stanford to sign MTAs.  PIs also sign incoming MTAs to acknowledge that they have read, understood and will uphold their obligations under the agreement. When PIs send out materials from their laboratories to other non-profit research institutions (except for human tissues, human stem cells and CIRM-funded materials), they may personally sign the outgoing MTA (if they use one); ICO does not need to sign.

How can I speed up processing of my incoming MTA?

ICO’s goal is to provide the Stanford community quick and easy processing of MTAs.  However, our office receives over 450 MTAs per year – that’s nearly 2 per business day!  For each MTA, ICO must check that the terms of the agreement are consistent with university policy, compliance regulations are adhered to, and any conflicts of interest are reviewed and approved before the agreement takes effect.  Generally, we are able to finalize MTAs from non-profit entities faster than MTAs from for-profit entities, because for-profit agreements often contain more terms that require negotiations.  To help us expedite processing of your MTA, please fill out the MTA eRouting form or Incoming MTA Routing Form completely.  Anything unusual about the material or the agreement should be noted.  Finally, please provide contact information for the provider. 

Who should I contact if I have questions about my MTA?

Please feel free to call us at 650-723-0651, or email us at ico@stanford.edu.  You may check the status of your MTA on the web through our Contracts Connection. (Please contact us if you’d like access.)  We look forward to hearing from you!

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Human Tissue Transfer Agreements

 

I’m only sending aggregate patient data - do I need a Human Tissue Transfer Agreement?

A Human Tissue Transfer Agreement is not required when the transfer involves only de-identified data.

What if I’m providing human specimens to a colleague(s) for a second clinical opinion or to share a unique case?

A Human Tissue Transfer Agreement is not required - this is considered a part of clinical care.

What if I’m providing human specimens to a colleague(s) for patient diagnosis/clinical purposes?

A Human Tissue Transfer Agreement is not required.

I’m paying a third party to analyze some samples as a service and not for the third party’s research purposes.  Do I need a Human Tissue Transfer Agreement?

No.

What if I will be providing human tissues to the clinical research/trial sponsor?

A Human Tissue Transfer Agreement is not required if the transfer is clearly addressed in the clinical research/trial agreement.  If the transfer is not addressed in the existing agreement, a Human Tissue Transfer Agreement is needed, unless the Recipient prefers to amend the existing agreement.

Can I charge a fee for providing human samples that I have banked/collected over time?

You may be reimbursed solely for expenses you will incur in preparing and shipping the human samples.

I’ve been approached by a Company to collect human specimens from a specific population of patients for the Company’s research purposes in which I will be participating.  Is this considered sponsored research or should I transfer the specimens under a Human Tissue Transfer Agreement and just charge a flat fee?

This would be considered sponsored research and not a service to the Company.  Stanford does not enter into fee-for-service agreements where the fee is the purchase of human specimens and the service is the procurement and sale of human specimens and there is no research content on the part of the Stanford faculty.

A Company has asked me to collect human specimens for the Company’s research purposes.  I will collect the samples but will not participate in the research.  Should I transfer the specimens under a Human Tissue Transfer Agreement and just charge a flat fee?

No. Unless there is an approved scientific justification for Stanford researchers, the transfer of human tissue/blood to a for-profit company for its research purposes, with or without a fee, is not allowed.

Who should I contact if I have questions about my Human Tissue Transfer Agreement?

Please feel free to call us at 650-723-0651, or email us at ico@stanford.edu.  You may check the status of your agreement on the web through our Contracts Connection (please contact us if you’d like to receive access).  We look forward to hearing from you!

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Sponsored Research Agreements

What is a Sponsored Research Agreement (SRA)?

An SRA is used when a company provides funding to Stanford for a particular researcher to pursue a particular area of research during a specified timeframe. 

When do I need an SRA?

ICO negotiates these agreements when a company provides funding to the university for a specific project and expects intellectual property rights or detailed reports from the research.  If a company provides funding without expecting anything in return, it is not a sponsored research arrangement, but a gift.

What process do I need to follow if I have an SRA?

Please complete and sign the PDRF and submit it to the Office of Sponsored Research (OSR), along with a statement of work and a budget.  All SRAs go through OSR; however, the SRAs with companies are negotiated by ICO as they often contain intellectual property terms.  OSR will forward the SU-42, statement of work, and budget to our office.  After we have reviewed the documents, we will contact you to let you know if we need further information.  We will contact the company to negotiate the terms of the SRA.

What do I need to consider when I use certain materials in my research?

Use of certain materials requires compliance with federal and Stanford regulations.If the material is …
  1. Obtained from a living person: Requires Human Subjects Panel (IRB) approval.  Please provide us with a copy of your IRB approval or exemption letter and send Stanford’s IRB Office a copy of the Provider’s IRB letter, if applicable.
  2. Human embryonic/fetal/adult stem cells: Requires Stem Cell Research Oversight (SCRO) approval.  Please contact SCRO to submit your protocol.
  3. A live animal or material used in a live animal:  Requires Laboratory Animals (A-PLAC)  subjects approval.  Please provide your A-PLAC protocol number.
  4. Radiological Hazard (EH&S): Requires EH&S approval.  Please provide your CRA/SMH number.
  5. rDNA, infectious or biohazardous material:  Requires Biosafety (EH&S) Panel training and approval.  Please provide your APB number, attach a copy of a map and/or description of the agent requested, and a reference for the agent (if available). This information will help facilitate Biosafety review.

Is there any other information I need to provide to OSR and ICO if I have an SRA?

Yes!  We need to know if you have any other funding you will be using to support your research.  This information enables us to ensure that there are no conflicts between rights the University may have granted to your existing funder and rights the University may grant to the company.We also need to know about potential or actual conflicts of interest, such as ownership of stock in, membership on the board of, or gifts from the company that is funding you.

Who can sign an SRA?

ICO has signature authority on behalf of The Board of Trustees of the Leland Stanford Junior University to sign SRAs.  PIs also sign to acknowledge that they understand and will abide by the agreement.

How can I speed up processing of my SRA?

ICO’s goal is to provide the Stanford community timely processing of SRAs.  However, our office handles many SRAs and negotiations, especially of intellectual property terms, can be long and complex.  For each SRA, ICO must check that the terms of the agreement are consistent with university policy, compliance regulations are adhered to, and any conflicts of interest are reviewed and approved before the agreement takes effect.  To help us expedite processing of your SRA, please fill out the SU-42 completely and provide us with complete statements of work and budgets. 

Who should I contact if I have questions about my SRA?

Please feel free to call us at 650-723-0651, or email us at ico@stanford.edu.  You may check the status of your SRA on the web through our Contracts Connection (please contact us if you’d like to receive access).  We look forward to hearing from you!

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Confidentiality Agreements

Does Stanford sign NDAs with a third party for its researchers?
No.  Stanford does not sign NDAs on behalf of its researchers because the university does not have the resources to keep confidential information that only a few people receive.  For more information, see:  Confidentiality Agreements.
Are Stanford employees required to sign NDAs as a condition of their employment at Stanford?
No.  Stanford does not require its employees to sign NDAs.  Stanford is a research institution that does not generate confidential information.
Is there anyone at Stanford who can review my NDA before I sign it?
Stanford’s Office of Sponsored Research (OSR) and ICO can review your NDA.  However, the NDA is between you and the third party, so OSR and ICO will not sign it on behalf of Stanford.
If I sign the NDA, am I liable if something goes wrong?
Yes.  Please make sure to carefully read the NDA and make sure you can comply with its terms before you sign. 
Who should I contact if I have questions about my NDA?
Please feel free to call us at 650-723-0651, or email us at ico@stanford.edu.  We look forward to hearing from you!
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