FOR RESEARCH ADMINISTRATORS – 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:
- When a researcher is 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,
- When a researcher is transferring (nonhuman) material from Stanford to another entity. Stanford does not require MTAs for transfers of nonhuman material that is not funded by CIRM from Stanford labs, but if the researcher would like to put one in place, she may use the standard Outgoing MTA template for Industry or the SLA or UBMTA for transfers to non-profits. CIRM-funded material requires a slightly different MTA depending on if the recipient is industry or nonprofit. If the CIRM-funded material is going to industry, this MTA should be used. If the CIRM-funded material is going to a nonprofit, this MTA should be used. Transfer of human tissue requires a different agreement.
- How are MTAs processed?
- 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 the researcher directly – if so, please have the researcher forward it to us. After we have reviewed the Routing Form and the MTA, we will contact the researcher if we need further information, if we need to negotiate the MTA terms, or if we can sign as is.
Outgoing: Researchers are welcome to use the standard Stanford Outgoing MTA for Industry or for Non-Profit Organizations on our website for transfers that do not involve human tissues. For CIRM-funded materials, researchers should use the standard Stanford Outgoing CIRM MTA for Industry or for Nonprofit. If the researcher finds that these documents need to be edited or do not fit his/her needs, s/he can contact us and we will help create an outgoing MTA that works.
Outgoing human tissues: The researcher needs to complete and submit the Human Tissue Agreement Routing Form. ICO will use a Human Tissue Agreement for this transfer. Please note that a researcher does not need an MTA for transfers from the lab to outside entities, unless the transfer involves human tissues or materials received from outside Stanford.
- 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.
- Who should I contact if I have questions about an MTA?
- Please feel free to call us at 650-723-0651, or email us at firstname.lastname@example.org. You may check the status of an 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
- The PI is only sending aggregate patient data – does s/he need a Human Tissue Transfer Agreement?
- A Human Tissue Transfer Agreement is not required when the transfer involves only de-identified data.
- What if the PI is 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 the PI is providing human specimens to a colleague(s) for patient diagnosis/clinical purposes?
- A Human Tissue Transfer Agreement is not required.
- The PI is paying a third party to analyze some samples as a service and not for the third party’s research purposes. Does s/he need a Human Tissue Transfer Agreement?
- What if the PI 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 the PI charge a fee for providing human samples that have been banked/collected over time?
- The PI may be reimbursed solely for expenses incurred in preparing and shipping the human samples.
- The PI has been approached by a Company to collect human specimens from a specific population of patients for the Company’s research purposes in which the PI will be participating. Is this considered sponsored research or should the PI 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 the PI to collect human specimens for the Company’s research purposes. The PI will collect the samples but will not participate in the research. Should the PI 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 a Human Tissue Transfer Agreement?
- Please feel free to call us at 650-723-0651, or email us at email@example.com. You may check the status of an 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 is an SRA needed?
- 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.
- How are SRAs processed?
- The PI needs to complete and sign the SU-42 form 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 the PI if we need further information. We will contact the company to negotiate the terms of the SRA.
- 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.
- Who should I contact if I have questions about an SRA?
- Please feel free to call us at 650-723-0651, or email us at firstname.lastname@example.org. You may check the status of an 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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- 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 a researcher’s NDA before s/he signs it?
- Stanford’s Office of Sponsored Research (OSR) and ICO can review NDAs. However, the NDA is between the researcher and the third party, so OSR and ICO will not sign it on behalf of Stanford.
- If the researcher signs the NDA, is s/he liable if something goes wrong?
- Yes. The PI should carefully read the NDA and make sure s/he can comply with its terms before signing.
- Who should I contact if I have questions about a NDA?
- Please feel free to call us at 650-723-0651, or email us at email@example.com. We look forward to hearing from you!
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