Strategies to Leverage Research Funding Guiding DOD's Peer Reviewed Medical Research Programs (2004) / Chapter Skim
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4 Assessment of Alternative Sources and Mechanisms of Nonfederal Support
4 Assessment of Alternative Sources and Mechanisms of Nonfederal Support
Pages 71-90
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From page 71... ...
The committee then discussed the impact of the second approach -- the development of collaborations, or partnerships, with nonfederal funders such as companies, foundations, and states -- on CDMRP and those who might participate in these partnerships with the program. POTENTIAL ADVANTAGES AND DISADVANTAGES OF COST SHARING AND MATCHING REQUIREMENTS Mandatory cost-sharing or matching requirements have a number of potential advantages and disadvantages for funders and grantees.
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. Other programs, such as the California Breast Cancer Research Program (see Appendix A)
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From page 73... ...
For example, the Arkansas Research Matching Fund states that its purpose is "[t] o raise the national ranking of Arkansas' research performance and to be competitive in our economic and educational endeavors by investing in research and research infrastructure" (Arkansas Science and Technology Authority, 2000)
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, NSF can require cost sharing when we believe there is tangible benefit to the award recipient(s) (normally beyond the immediate term or scope of the NSF-supported activity)
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From page 75... ...
. On December 28, 2000, in response to a 1999 report of the National Science and Technology Council, Renewing the Government-University Partnership, the President issued Executive Order 13185, "To Strengthen the Federal GovernmentUniversity Research Partnership." The Executive Order presented a list of principles, one of which was that "Agency cost-sharing policies and practices must be transparent." DOD responded by drafting a policy, Cost Sharing in DOD Research Programs Using Assistance Instruments, as part of the DOD series of administrative instruction.1 The instruction, which has not been formally issued, said that while DOD does not have a general requirement of cost sharing in its research grant programs, program offices could use cost sharing in individual programs on a case-by-case basis if they follow procedures to ensure that its use is appropriate.2 Inappropriate use of cost-sharing requirements could be unfair to 1See www.acq.osd.mil/ddre/research/draftcostsharing.pdf.
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From page 76... ...
Guidance for the Preparation and Submission of Unsolicited Proposals says: By statute, cost sharing is usually required on contracts for basic or applied research projects resulting from unsolicited proposals However, colleges and universities need not propose cost sharing since their activities generally do not produce benefits that can be measured as having significance apart from the benefit intrinsic in conducting research for NASA.4 NASA grants and cooperative agreements do not require cost sharing by institutions of higher education, hospitals, or other nonprofit organizations, and it is only required of commercial firms if they are "expected to receive substantial compensating benefits for performance of the work."5 3"The only exception to this policy would be unusual situations where there is a reasonable probability of a potential commercial application related to the research and development effort." 4National Aeronautics and Space Administration. Guidance for the Preparation and Submission of Unsolicited Proposals.
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From page 77... ...
However, subsequent phases of those pro grams, which provide the performer with present or future economic benefits through commercialization, will require some form of cost-sharing or cost participation.6 In conclusion, although matching fund requirements at first glance appear to be a good way to leverage funds, for several reasons they may not in fact expand the amount of research conducted in a particular area. First, matching funds may be diverted from other research projects, and some highly promising research may go unfunded because of a lack of matching funds, or the match itself may reduce the total number of projects and therefore the number of ideas that are funded.
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Public-private partnerships (PPPs) have been growing rapidly in the international sector, facilitated by several large foundations with an interest in international health, such as the Wellcome Trust and the Bill and Melinda Gates Foundation.
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Collaborating companies will want off-setting compensation, such as faster or more extensive access to research results, or a larger share in the intellectual property rights resulting from the research. · Universities in geographic regions that are already institutionally rich with R&D organizations and related functions will have a competitive advantage in forming research funding collaborations.
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Called the Avon Foundation-NCI "Progress for Patients" Awards for Early Phase Clinical Interventions in Breast Cancer, the program is intended to provide a rapid means to support novel and promising Phase I and II clinical trials and studies focusing on risk assessment or validation of biomarkers in human subjects (NCI Avon, 2003)
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The risks of collaborations for for-profit firms include those of losing proprietary information and gaining incomplete intellectual property rights when new technologies are developed jointly. Firms also have to worry about recouping their investments, given that industrial research generally proceeds over a much shorter period than does academic research.
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From page 82... ...
Although foundations and charities do fund basic and exploratory research, and should be encouraged to collaborate, they have relatively few resources compared with industry or the federal government. The easiest way to maximize nonfederal funding would be to change program priorities to emphasize the development and testing of diagnostics, therapeutics, medical devices, and other efforts to develop commercial products.
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In 1994, NIH issued guidelines on Developing Sponsored Research Agreements: Considerations for Recipients of NIH Research Grants and Contracts, which were intended to provide Recipients with issues and points to consider in developing spon sored research agreements with commercial entities, where such agreements may include research activities which are fully or partially funded by NIH. The intent is to assist recipients in ensuring that these agreements comply with the requirements of the Bayh-Dole Act and NIH funding agreements while uphold ing basic principles of academic freedom.8 These guidelines focus on the preservation of academic freedom, the timely dissemination of research results, and permissible amounts of private support both absolutely and as a percentage of the recipient's total research funding.
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CHANGES IN FEDERAL LAWS AND REGULATIONS REQUIRED BY ALTERNATIVE FUNDING SOURCES AND MECHANISMS DOD has the authority to award grants, cooperative agreements, and contracts to for-profit enterprises, states, and consortia as well as to universities and other nonprofit research institutions. It also has the authority to require cost sharing on grants, cooperative agreements, and contracts, at least to the extent that the other party or parties are expected to benefit.
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From page 85... ...
. Unlike NIH, CDC, or NSF, however, DOD has special authority to make awards that are not subject to conditions that apply to federal grants, cooperative agreements, and contracts, such as Bayh-Dole intellectual property provisions, and this authority could be delegated to CDMRP to make it easier to co-fund projects with for-profit firms that have technologies of interest to CDMRP.11 Gift Authority One mechanism for securing nonfederal funding for CDMRP would be to accept voluntary contributions from foundations, companies, state governments, and other funders of medical research to enlarge a specific CDMRP grant program.
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Such "other transactions" are exempt from the usual controls and oversight mechanisms set forth in acquisition statutes and the Federal Acquisition Regulation and from laws applying only to contracts, grants, and cooperative agreements. Under this authority, DOD has established
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The TIA per mitted Motorola to use its existing accounting systems, which were not compliant with the Federal Acquisition Regulation, and to negotiate other rights important to the company, including alternate dispute resolution procedures, intellectual prop erty rights less stringent than the requirements of the Bayh-Dole Act, and foreign access to technology. In return, Motorola paid $1.5 million of the $4.9 million cost of the project.a a "Annual Report on Cooperative Agreements and Other Transactions Entered into during FY2001 under 10 USC 2371." See www.acq.osd.mil/dpap/Docs/FY01RPT.doc.
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Rick Atkins, President and CEO, National Prostate Cancer Coalition, at the workshop held by the Committee on Alternative Funding Strategies for DOD's Peer Reviewed Medical Research Programs. National Academies, Washington, DC, April 26.
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2004. Presentation by Ann Kolker, Executive Director, Ovarian Cancer National Alliance, at the workshop held by the Committee on Alternative Funding Strategies for DOD's Peer Reviewed Medical Research Programs.
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2004. Presentation by Fran Visco, President, National Breast Cancer Coalition, at the workshop held by the Committee on Alternative Funding Strategies for DOD's Peer Reviewed Medical Research Programs.
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