Activities that take place before, simultaneously with or independently of a proposal being assembled fall into the “pre proposal” phase of the sponsored project lifecycle.
[View Image]CDAs are contracts that govern the disclosure of confidential or proprietary information between parties. Often, a CDA is used to enable parties to evaluate the potential of a proposed collaboration in advance of an MTA or DUA.
MTAs and DUAs are contracts that establish the terms and conditions governing the use of material or data received from (or sent to) an outside entity. The outside entity may be another university, a government agency or other non-profit entity, or a for-profit company. These agreements address important issues such as liability, intellectual property, publication rights and regulatory compliance, among others.
These agreements are negotiated by the Division of Sponsored Programs’ Gray Team on behalf of the university. As with a grant award, a CDA, MTA or DUA is executed between institutions, not individuals. Investigators do not have the authority to sign these agreements on behalf of VCU.
Generally speaking, a DUA is needed any time non-public data is exchanged between entities.* A DUA provides assurances to the institution releasing the data that the data will be protected and will be used only for a specific purpose. This is especially important when the data being exchanged is subject to HIPAA or FERPA regulations.
Certain entities, including NIH and the International Cancer Genome Consortium, require that a DUA be executed before granting a researcher access to their databases. These Data Access Agreements do not require any negotiation, but they do require institutional approval. For this reason, the process for obtaining institutional approval is the same as for other DUAs.
Data Use / Data Access Agreements address issues such as:
*PLEASE NOTE: When a VCU investigator is receiving HIPAA-covered data from the VCU Health System via a Limited Data Set, a different type of DUA is needed. That agreement is executed between the PI and the VCU IRB. It can be found on the VCU IRB website.
Regardless of whether you are sending or receiving data, the process for implementing a DUA is fairly simple. Just submit a DUA Request in RAMS-SPOT to let us know you need an agreement executed, and we’ll take it from there.
The Gray Team in the Division of Sponsored Programs (mtadua@vcu.edu) will draft a preliminary agreement, or review the one sent by the other party, and negotiate acceptable terms directly with the outside entity.
Progress of the review and negotiation can be tracked in RAMS-SPOT. Once the agreement has been signed by both parties and all necessary regulatory approvals are in place, the PI is free to send or receive the data. The final executed agreement will be available in RAMS-SPOT for convenient reference.
IMPORTANT NOTE: VCU cannot sign an agreement in which human subjects data is exchanged until the IRB has approved the protocol associated with that exchange. If the data is deidentified, you will need IRB documentation that the proposed project does not meet the criteria for “human subjects research.” For fastest turn-around, please do not submit a DUA request until you have IRB approval (or are very close to it).
Review by the Division of Sponsored Programs focuses on ensuring that the Terms of the Agreement do not conflict with any state laws, university policies, or other project-related agreements.
The following terms are the most common “problem points” that need to be revised/negotiated with the other party:
Research Data Ownership, Retention, Access, and Security Policy
MTAs are used for a wide variety of research materials, including biological materials (e.g., unique plasmids or viral vectors, cell lines, tissues, and genetically modified animals), unique reagents, chemicals, and engineered materials. Generally speaking, an MTA is needed whenever there is a material transfer that is not covered by any other agreement (e.g., purchase order/procurement, grant award, or sponsored clinical trial). An MTA should be in place BEFORE the transfer happens.
Common instances that require an MTA:
Common instances that do NOT require an MTA:
Generally speaking, it is up to the provider of a material to determine whether an MTA is required, so the examples above are guidelines only.
If you are using materials obtained under an MTA, please review the terms and conditions of that agreement to ensure that VCU does not break its contractual obligations with the other organization. MTAs that involve human or animal research or hazardous materials may require additional approvals before the MTAs are executed and the materials transferred.
Regardless of whether you are sending or receiving materials, the process for implementing an MTA is fairly simple. Just submit an MTA Request to let us know you need an MTA, and we’ll take it from there.
The Gray Team in the Division of Sponsored Programs (mtadua@vcu.edu) will draft a preliminary agreement and/or negotiate acceptable terms directly with the other party. Particular attention is given to any other agreements or approvals associated with the project, to ensure that no terms contradict each other.
Progress of the review and negotiation can be tracked in RAMS-SPOT. The PI may be asked to sign the agreement to document his/her acknowledgement and acceptance of its terms.
Once the agreement has been signed by both parties and all necessary regulatory approvals are in place, the PI is free to send the material to the requesting scientist or to receive the material from the providing entity. The final executed agreement will be loaded into RAMS-SPOT for convenient reference.
Several repositories, such as Addgene and NCI’s Developmental Therapeutics Program, require institutional approval of a standard MTA before the material will be released. Although the agreement will not be negotiated, an MTA Request is still required before the transaction will be approved. After placing an order from such a repository, please send an MTA Request to the Gray Team via the RAMS-SPOT “Submit Document for Review” function. (See instructions above.)
Review by the Division of Sponsored Programs focuses on two general areas:
If the material is human in origin or will be used as part of a human research subjects protocol, we will confirm that the PI has an IRB approval or exemption on record.
If the material will be used in an animal protocol, we will confirm that the PI has IACUC approval.
If the material is biohazardous, we will confirm with Safety & Risk Management that the PI has an updated BioRaft Registration .**
If the material will be received from or shipped to a foreign country, we will confirm that doing so does not violate any Export Control Laws.
** It is critical to ensure that the proposed work has all regulatory approvals in place in advance. The Division of Sponsored Programs cannot sign an MTA for any work that was performed without the necessary approvals.
The following terms are the most common “problem points” that need to be revised/negotiated with the other party:
Kristin Schmidt Berube
Contracts Manager
Division of Sponsored Programs
(804) 828-6772
mtadua@vcu.edu
VCU Limited Submission Compliance Notice
Instructions and screenshots for new limited submission opportunities process
Access limited submission opportunities
Melissa Throckmorton
Director of Research Development and Strategic Projects, Office of the Vice President for Research and Innovation
throckmortms@vcu.edu
(804) 827-1443
Individual PI account needed for access to NSF Fastlane and Research.gov systems.
Associated document/form | NSF account request e-form |
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Responsible VCU unit(s) | PI/Study Staff initiates e-form, Division of Sponsored Programs completes action in sponsor system. |
Individual account needed for role-based access to NIH era Commons systems.
Associated document/form | NIH account request e-form |
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Responsible VCU unit(s) | PI/Study Staff initiates e-form, Division of Sponsored Programs completes action in sponsor system. |
Search for sponsor name in RAMS-SPOT using “%key word.” If sponsor name not listed, indicate “TBD.”
Related VCU systems | RAMS-SPOT [RAMS SPOT get started - funding proposal smart form provides additional guidance.] |
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Responsible VCU unit(s) | PI/Study Staff indicates ‘TBD” in Funding Proposal sponsor field, Division of Sponsored Programs completes request. |
Some sponsors request a letter of intent prior to receipt of a full proposal. If the submission requires Division of Sponsored Programs signature, process LOI as "Pre-proposal" in RAMS-SPOT. LOI may or may not lead to a full proposal.
VCU policy or compliance notice | Office of Sponsored Programs Responsibilities Sponsored Program Proposals: Definitions, Solicitation, Review, Approval and Submission |
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Related VCU systems | RAMS-SPOT [RAMS SPOT get started - funding proposal smart form provides additional guidance.] |
Responsible VCU unit(s) | PI/Study Staff initiates funding proposal in RAMS-SPOT, Division of Sponsored Programs reviews and approves. |
All proposed principal investigators must meet the requirements of the VCU policy or be an approved exception, prior to proposal submission.
Associated document/form | Principal investigator (PI) eligibility exception |
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VCU policy or compliance notice | Principal Investigator Eligibility |
Responsible VCU unit(s) | PI/Study Staff should initiate |
Research development
Contact us
Blue team1
ospblue@vcu.edu
Gold team1
ospgold@vcu.edu
Green team1
ospgreen@vcu.edu
Red team2
ospred@vcu.edu
Gray team3
mtadua@vcu.edu
Post award team4
ospaward@vcu.edu
1 Government and nonprofit-sponsored proposals, administrative actions and agreements;
Team assignments by school/college can be found here
2 Industry-sponsored and non-federal clinical trial proposals, administrative actions and agreements
3 Material transfer agreements, data use agreements and confidentiality nondisclosure agreements
4 Award review, processing and distribution (all funding sources), subaward agreements and modifications (when VCU is PTE) and non-financial closeout