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A sponsored award binds Yale to a set of specific terms and conditions and may involve a related reciprocal transfer of something of value to the sponsor. A gift is any item of value given to Yale by a donor who expects nothing significant of value in return, other than recognition and disposition of the gift in accordance with the donor’s wishes. The proper classification of external funding is important for tax purposes as well as internal policies. For more information, refer to Procedure 1304 PR.02: Distinguishing Between Gifts and Sponsored Awards.
No. The contract is between Yale and the corporate sponsor. The Principal Investigator should sign the contract only to signify that s/he acknowledges and understands their obligations under the contract and agrees to use reasonable efforts to uphold their obligations as a faculty member of Yale. NO faculty or staff member should sign any contract document unless instructed to do so by their OSP representative.
The standard policy is that Yale owns intellectual property (IP) created under contracts for sponsored research. This is consistent with federal research funding laws.
Indemnification is a contractual agreement to reimburse someone for specific losses. Indemnification arises in contracts for sponsored research, clinical studies, material transfer agreements, and licensing of intellectual property. Generally, a sponsor should agree to defend and indemnify Yale from claims or liabilities arising from the sponsor’s use of that which Yale produces, such as the research, intellectual property, and/or data that arises from the research.
No. While sponsors have the right to review the proposed publication in order to ensure that no confidential or patentable information is disclosed without their approval, sponsors do not have the authority to restrict publication. Freedom to publish is essential to the fulfillment of Yale’s academic mission to disseminate the findings of research. Yale reserves for the Principal Investigator in research agreements the sole and exclusive right to freely publish scientific findings resulting from the Principal Investigators research. Please review the Section II: University Policy on Freedom of Expression in the Faculty Handbook for more information.
All Incoming MTAs for Yale investigators to receive materials from academic, governmental, non-profit institutions and for-profit companies, and those Outgoing MTAs to provide Yale materials to academic, governmental, and non-profit institutions are reviewed, negotiated, and signed by the OSP MTA team. Outgoing MTAs to provide Yale materials to commercial and for-profit institutions are negotiated by Yale Ventures. Inquiries should be addressed to firstname.lastname@example.org.
F&A costs at Yale are part of the true costs of research that must be fully reimbursed by the Sponsor. F&A costs are neither “profit” nor a “tax”. Commercial sponsors are well aware of these costs; analogous costs of the Sponsors are generally higher than F&A costs at the University. Acceptance of a Sponsored Research Agreement without full compensation of the University’s F&A costs places Yale at risk by providing research for amounts lower that its true costs so in essence, the University is subsidizing a for-profit commercial organization, a violation of IRS regulations. In addition, use of F&A rates lower than those charged to the federal government may be seen as benefiting private companies at the expense of the government.
Please contact your OSP Contract Manager as he or she will be able to provide such backup documentation.
Yes. Please ensure that all Informed Consent documents are provided to your OSP Contract Manager for approval prior to submission to the Sponsor or IRB to ensure that Subject Injury Terms are consistent with the negotiated terms of the CTA. OSP will assist in the negotiation of this section directly with the sponsor if necessary.
No. Please note that Yale guidelines do not allow for the purchase of investigational devices, which includes FDA-approved devices being used in an IDE trial for an indication for which the device has not been formally approved. Devices must either be provided by the Sponsor at no cost, or fully reimbursable under the study subject’s insurance, contingent on terms in the CTA to ensure the Sponsor’s responsibility for all uncovered costs. Any exception to this must be managed through your GCA Contract Manager by means of a special wavier to be used in exceptional cases. In no case should the study sponsor ever work independently with YNHH to negotiate separate agreements for investigational devices.
All research contracts with the exception of CDAs, DUAs, and MTAs Please contact your OSP Contract Manager with any questions about your specific contract.