Unfunded Research Agreements

When collaborating with external entities, it's essential for researchers to protect sensitive UCSD information which, if disclosed inappropriately, may jeopardize publications or patent disclosures. A Confidentiality or Non-Disclosure Agreement (interchangeably called a CDA or a NDA) is a crucial tool in this process. In the research context, a CDA is typically used when a Principal Investigator is considering a collaboration with an outside entity and needs to exchange confidential information to assess the potential for a research partnership. The primary goal of a CDA is to safeguard ownership rights and establish clear guidelines for the use and dissemination of confidential information, ensuring that both UCSD’s and the other entity’s interests are protected. By putting a CDA in place, PIs can ensure that their research and intellectual property are secure before sharing sensitive information with potential external partners. 

UCSD CDAs must be executed by a central office with signature authority. OCGA manages CDAs for research and incoming services (UCSD is paid to perform a service) only. 

UCSD Sponsored Projects Office Confidentiality/Non-Disclosure Agreement Template

What is the Non-Negotiable CDA Process?

Effective 09/17/2024, OCGA is excited to roll out a non-negotiable CDA process which aims to get CDAs executed quickly so that PIs and departments may begin discussions and meetings with external entities as soon as possible. This process will use UCSD’s standard research CDA template, which is carefully crafted to ensure compliance with relevant UC policies and regulations while remaining broad enough to address all research contexts. We have successfully used this template with various entities, from other universities to companies. 

To use this process, the PI and department will first need to notify the outside entity of UCSD's requirement to use the standard CDA template without modification, and share a copy of the template. Once the entity has signed the CDA, it can then be uploaded to Kuali Proposal Development (PD). OCGA will review the PD record within 1 business day of receipt. Once the PD record has been fully completed and approved, AND all relevant compliance reviews (such as Export Control reviews) have been completed, OCGA will sign the CDA within 2 business days. 

Why Should I Use the Non-Negotiable CDA Process?

The process will significantly shorten the time it takes to get a CDA signed. While implementing the non-negotiable CDA process will require some initial effort from the Principal Investigator and department, we are confident that it will ultimately streamline the process so that discussions can happen as soon as possible. 

Please note that if the other entity wants to negotiate UCSD’s template or use its own template, the Non-Negotiable CDA Process cannot be used. The department should still submit those agreements to KR PD and OCGA will review and negotiate as needed; however, the short turnaround times will not be feasible due to the required negotiation. 

How do I use the Non-Negotiable CDA Process?

 Please follow these steps to process a non-negotiable research CDA with OCGA: 

1. First confirm that the CDA should be managed by OCGA by reviewing the below decision tree.
   
2. Confirm that it meets all 4 criteria: 
   • Facilitates preliminary discussions for a future research collaboration only
   • No funding, tangible research materials, equipment, software, or data are being transferred
   • No research activities will be performed on the proprietary information exchanged at this time
   • No known COI conflicts between the PI and the outside entity
3. Download a copy of UCSD’s standard CDA template and add the topic of conversation as the Purpose (ex.”gene editing in Alzheimer’s disease”) 
4. Email the template to the other entity, and ask them to review and sign. You can use this email template to do so
5. Once the other entity has signed an unmodified copy, create a KR PD record and upload the partially-signed CDA in the Attachments tab. Be sure to put “NON-NEGOTIABLE CDA” in the Project Title line so that it is promptly identified. This is our only way of identifying a CDA going through this special process
6. OCGA and applicable compliance offices will review
7. Once all compliances AND the PD record are completed and approved, OCGA will countersign the CDA and return a copy to the PI/department. Please note that compliance reviews are managed independently and outside of OCGA’s control.
   
8. Email the fully-signed copy to the other entity, and begin your discussions

Decision Tree

Download the NDA/CDA Decision Tree for larger text

• Office of Innovation and Commercialization
• Procurement
• Health Science Business Contracting
• Office of Clinical Trials Administration

• A Data Use/Transfer Agreement allows one or more party(ies) to provide access to, or transfer of, data to or from a UCSD principal investigator for research purposes
• A mutual DUA can also be negotiated to allow UCSD and the other party(ies) to exchange data
• The DUA will provide appropriate protection of the data from unauthorized disclosure or use, or under applicable laws (such as HIPAA for human subjects data), while still ensuring UCSD’s ability to publish its research results or to share them for academic purposes.
• Data use terms may also be included within a larger agreement context, such as a sponsored or collaborative research agreement, so a DUA is commonly negotiated for “standalone” projects where the primary focus is the data itself

NIH/NCBI dbGaP Data Access Requests:

Effective Jan. 25, 2025, the NIH requires that dbGaP data and all derived data be secured in NIST SP 800-171-compliant systems (see NOT-OD-24-157). This applies to any new or renewed data requests. Please note that the Sponsored Projects Office cannot approve any data requests until your IT environment is compliant. If you are not currently compliant, please reach out to your IT department.

The National Institutes of Health’s National Center for Biotechnology Information (NIH NCBI) advances science and health by providing access to biomedical and genomic information. UCSD researchers who wish to receive data from the dbGaP database are required to submit a Data Access Request through eRA Commons, and the Request must be approved by an authorized SPO Signing Official. After you have completed your application through eRA Commons, please complete and submit this internal form so that the SPO Signing Official can review and approve the request. Be sure to include the NCBI dbGaP project# so that we may locate your request. You will need to complete this internal form every time a Signing Official signature is needed, which can happen at 3 timepoints:

• New
• Renewal
• Close-out

Your eRA Commons application requires you to list an IT Director:

• IT Director for Health Science departments: Kenneth Wottge (wottge@ucsd.edu)
• IT Director for General Campus departments: Arlene Yetnikoff (ayetnikoff@ucsd.edu)

Please note: this internal form should only be used if you are requesting data from the dbGaP database and you do not need to submit a separate KR PD record.

You will need to certify that your current IT environment is compliant with NIST SP 800-171, you will not store or share data outside of the NIST-compliant environment, you will delete all dbGaP data from the environment at conclusion of the project period, and you will be responsible for any additional costs needed to ensure that your IT environment is compliant.

Note: The National Institutes of Health’s Genomic Data Sharing Policy requires broad and responsible sharing of human and non-human genomic data resulting from NIH-funded research. When applicable, PIs are required to submit to the NIH a Genomic Data Sharing (GDS) certification, which must be cross-signed by a SPO Signing Official. NIH GDS certifications are not considered data use/transfer agreements and should not be submitted to Kuali PD.

• When a certification is required at pre-award stage (proposal or Just-In-Time): work with your SPO proposal officer to complete and submit the certification
• When a certification is required at post-award stage: email researchadmin@ucsd.edu. A SPO award officer will reach out to you directly

IRB review and concurrence for the relevant IRB-approved consent form(s) covering the data collection are required. You can submit the request for review to the IRB at irb@ucsd.edu and include the completed (unsigned) NIH GDS certification and the IRB#. After the IRB has provided concurrence, provide this email confirmation to SPO.

An Equipment Loan Agreement is usually an agreement between UCSD and another party that allows that party to loan one or more items of equipment to UCSD for research purposes. 

• Separate equipment loan agreements are generally only negotiated in cases where a company is providing equipment only and no other research support (e.g., no funding).
• If the equipment is being loaned/provided as a part of a research project funded by the party providing the equipment or as part of an unfunded collaboration, the loan terms should be included as part of the research or collaboration agreement.
• Loaned equipment is not automatically covered by the UCSD insurance program, be sure to confirm if and how the loaned equipment will be covered.

A letter of intent (LOI) (sometimes also called a white paper, letter proposal, pre-application, or concept paper) is a short description of the proposed project. The purpose of an LOI is to introduce the proposed project to the potential sponsor and to elicit feedback that will hopefully lead to an invitation to submit a full proposal application. See the Forms page for more information.

Master Agreements are research contracts between a single sponsor and UCSD to cover a multitude, or variety, of research projects at UCSD or within a UCSD Department or Center.

The terms and conditions of the master agreement can govern all UCSD projects with the sponsor; therefore, an agreement does not need to be prepared or negotiated for each project, but a master agreement may require a long time to finalize due to its applicability to undefined research projects.

Once the master agreement is finalized, the sponsor will usually require pre-approval of a UCSD principal investigator’s proposal describing the scope of work and other project-specific aspects such as budget and schedule.

Definition of an MTA

A Material Transfer Agreement (MTA) is a legal contract that establishes terms, conditions, and a record of a transfer of tangible research materials between the owner and a recipient for research purposes and is required for material coming into and going out of UC San Diego.

Examples of tangible research materials:

• Mice
• Plasmids
• Reagents
• Human materials (blood, tissue, etc.)
• Cell lines
• Vectors

Request Kuali Access

• Users will need to request access to Kuali
• Users should request the Department Proposal Creator role

Related Contacts

• Conflict of Interest Office (COI)
• Shipping Specimens or Biological Substances (Hazardous Shipping)
• Office of IRB Administration (OIA)
• Environment, Health & Safety (EH&S)
• Export Control

Addgene Requests

Addgene requests DO NOT require a Kuali record. Use this link to take you to the Addgene Request Form.

Request Process

Step 1. Submit an MTA Record

All material transfer agreements that involve sending or receiving tangible research materials must be submitted through Kuali Research. ADDGENE requests do not require a Kuali record. Use this link to take you to the Addgene Request Form

Providing incorrect or incomplete information may cause delays.

Step 2. MTA requests are routed to either the SPO or OIC depending on the type of request. 

Step 3. Negotiation time

The terms of an MTA must be developed and carefully negotiated to maintain our legal obligations as a public university and to ensure we follow UC policy in alignment with Principles Regarding Future Research Results. Negotiation time will vary based on:

• Sufficient and detailed information provided in the Kuali record
• Type of material being transferred
• Value and novelty of the material (e.g. "state-of-the-art" materials may include more restrictive terms)
• Complexity of the terms

Step 4. Execution of Agreement

Once negotiation is finalized the MTA will be signed by the authorized representatives. 

Only the SPO and OIC have the delegated authority to sign MTAs on behalf of UC San Diego.

 For Reimbursements of Materials

Reimbursements are not facilitated for the outgoing transfer of human biological materials under an MTA.

For other types of material for which you would like to be reimbursed when sending out materials under an MTA, select “Yes” to the following MTA question:

"For UCSD developed or managed material, are there costs associated with the transfer that you would like reimbursed to your lab (excluding reimbursements for shipping)?"

Mutant Mouse Resource & Research Centers

The Mutant Mouse Resource & Research Centers (MMRRC)  function as a single repository resource with an Informatics, Coordination and Service Center (ICSC) and four regional distribution facilities:

• The Jackson Laboratory
• University of California, Davis
• University of Missouri
• University of North Carolina, Chapel Hill

Instructions for receiving MMRRC mice:

1. Lab contacts MMRRC (mmrrc.org) and places order.     
2. MMRRC will send a link to the online Conditions of Use (COU)  via email.  Note – this email will most likely be sent from Brian Davidson at UC Davis to the UCSD individual placing the order and to UCSD ACP.
3. Lab initiates/submits a KR PD request as a Material Transfer Request (MTA):
   1. The “Sponsor” should be one of the four regional centers (any is acceptable, most often used is UC Davis)
   2. The KR PD record should be completed as for any other MTA request; however, there is no need to upload a draft MTA. In the Unfunded Agreement Questionnaire, when asked about a draft agreement, select “online” and note that you have an email with the link and will forward it to the MTA Help Desk, mtahelpdesk@ucsd.edu.
4. SPO will review the KP PD record and request the email from MMRRC with link to online COU be forwarded to the MTA Help Desk, if not already done
5. Once KR PD record is completed by the lab and approved by SPO, the request is assigned to a SPO Officer who will sign the online COU at the link provided via email
6. MMRRC will proceed to work with lab/ACP re shipping materials

Lab Moves

If a PI is moving their lab, either to or from UC San Diego, and they plan to transfer tangible research materials, an MTA(s) will be required. Please contact the MTA Help Desk (MTAHelpDesk@ucsd.edu) as soon as possible for further instructions. This is necessary for the following:

• all parties are appropriately engaged in an effort to facilitate timely action.
• there is institutional knowledge of the transfers to address existing contract obligations.
• PI may continue using the materials at the new institution.

Contact MTAHelpDesk@ucsd.edu to start this process as soon as possible.

Tsien Lab Materials

The Tsien Lab no longer sends out samples directly. All of the Tsien Lab constructs are available either commercially or through Addgene, to non-profit or academic institutions. For more information visit the Tsien Lab website.

All MTAs for Tsien Lab materials are handled by the Office of Innovation and Commercialization (OIC). Email mta@ucsd.edu. 

Addgene Materials

Addgene is a global, nonprofit repository that was created to help scientists share plasmids. To initiate a material transfer to receive plasmids from Addgene, follow the below steps. 

1. Place Addgene order. For more information go to Addgene Ordering Instructions.
   • Addgene sends the standard material transfer agreement to the MTA team automatically.
2. Submit a request to the SPO using the Addgene Request Form
3. The SPO will process your request in the order received.

For depositing plasmids into Addgene, contact OIC at mta@ucsd.edu. For other Addgene questions, contact MTAhelpdesk@ucsd.edu.

Reimbursements for Materials

Reimbursements are not facilitated for the outgoing transfer of human biological materials under an MTA.

For other types of material for which you would like to be reimbursed when sending out materials under an MTA, select “Yes” to the following MTA question:

"For UCSD developed or managed material, are there costs associated with the transfer that you would like reimbursed to your lab (excluding reimbursements for shipping)?" 

Reimbursement Cost versus Total Charges

The reimbursement amount requested by the UCSD investigator will differ from the total cost charged to the Recipient Institution. Total cost may include taxes and associated fees.

Be sure to contact the Office of Innovation and Commercialization (OIC) at mta@ucsd.edu for a comprehensive total cost to provide to the Recipient Institution. 

• Commonly, these are agreements between two or more parties that function as a more formal alternative to a verbal or "handshake" agreement but are not intended to be legally binding.
• In the research community, MOUs often act as a letter of intent to indicate a common interest in pursuing similar research goals or a future partnership; however, such intentions may not have progressed to the point where the parties are prepared to make a formal commitment
• However, depending upon the wording and the intent of the parties, a MOU may have the power of a binding contract.
• “MOU” is also a broad title that is often used by companies or foreign institutions on agreements that UCSD would categorize as a research collaboration or a different type of unfunded agreement (CDA if it permits the transfer of proprietary information, DUA if it contemplates the transfer of data, etc.). In KR PD, the initiator should select the category of unfunded agreement that describes the activity that is taking place, rather than the title of the document, to ensure that appropriate compliance reviews occur
•  Global Initiatives at UC San Diego can process unfunded non-binding MOUs with international institutions and partners. These MOUs cover student, faculty, scholar and staff mobility; joint research projects and publications; special short-term programs, workshops and visits; publications, materials and information exchange. virtual classroom and laboratory programs; and research internships.  These MOUs can also create a framework for exploring deeper areas of collaborations and/ or to co-apply for funding opportunities. If you would like to develop an international partnership, visit the Global Initiatives International MOU and Agreements page to learn more and start the process.

• A Software Licensing Agreement allows for an outside party to provide use of software to UCSD for research purposes, providing both parties mutual benefit from use of software by UCSD.
• Separate software licensing agreements are generally only negotiated in cases where a company is providing software only and no other research support (e.g., no funding).
• If the software is being loaned/provided as a part of a research project funded by the party providing the software or as part of an unfunded collaboration, the licensing terms should be included as part of the research or collaboration agreement.

Note: Agreements may be processed by UCSD Procurement & Contracts if there is a recurring payment to the other party AND the other party is loaning the software to UCSD without requesting any evaluation.

A contract that formally acknowledges the relationship and participation of two or more parties who are submitting a proposal for research funding to an outside sponsor, such as the Federal government.

Establishing the purpose of each party's participation and which of the parties will be primarily responsible for submitting the proposal and receiving the award, and which party will receive a subaward(s) from the party receiving the award.