5
Findings and Recommendations

The Congressionally Directed Medical Research Programs (CDMRP) are a set of research funding initiatives on prevalent cancers and other diseases that have been administered by the U.S. Army Medical Research and Materiel Command (USAMRMC) of the Department of Defense (DOD) since 1992. The effort does not contribute directly to the principal medical mission of DOD, which is to prevent and treat war-related illnesses and wounds, but the work is relevant to the department’s responsibility for the underlying health of military personnel and their dependents.

CDMRP is a small piece of the very large federal budget for national defense, which is under great strain because of current operations in Iraq and Afghanistan, as well as increased efforts to counter terrorism in other parts of the world. In response to a congressionally directed request by the DOD, the Institute of Medicine (IOM) formed a committee to report on the possibilities of augmenting the funding of CDMRP from nonfederal sources, identify mechanisms that could be used to leverage such funding, assess the impacts of alternative nonfederal sources and mechanisms of funding on CDMRP, and identify any legal or regulatory barriers to leveraging nonfederal funding. This committee did not formally evaluate the performance and results of CDMRP.

In forming its conclusions, the Committee on Alternative Funding Strategies for DOD’s Peer Reviewed Medical Research Programs relied on the information gathered during the workshop, during conversations with CDMRP staff and stakeholders, and from the scientific literature addressing issues related to the funding of medical research. Because the literature on the benefits and costs of different research support mechanisms or the effects of leveraging of federal research and



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Strategies to Leverage Research Funding: Guiding Dod’s Peer Reviewed Medical Research Programs 5 Findings and Recommendations The Congressionally Directed Medical Research Programs (CDMRP) are a set of research funding initiatives on prevalent cancers and other diseases that have been administered by the U.S. Army Medical Research and Materiel Command (USAMRMC) of the Department of Defense (DOD) since 1992. The effort does not contribute directly to the principal medical mission of DOD, which is to prevent and treat war-related illnesses and wounds, but the work is relevant to the department’s responsibility for the underlying health of military personnel and their dependents. CDMRP is a small piece of the very large federal budget for national defense, which is under great strain because of current operations in Iraq and Afghanistan, as well as increased efforts to counter terrorism in other parts of the world. In response to a congressionally directed request by the DOD, the Institute of Medicine (IOM) formed a committee to report on the possibilities of augmenting the funding of CDMRP from nonfederal sources, identify mechanisms that could be used to leverage such funding, assess the impacts of alternative nonfederal sources and mechanisms of funding on CDMRP, and identify any legal or regulatory barriers to leveraging nonfederal funding. This committee did not formally evaluate the performance and results of CDMRP. In forming its conclusions, the Committee on Alternative Funding Strategies for DOD’s Peer Reviewed Medical Research Programs relied on the information gathered during the workshop, during conversations with CDMRP staff and stakeholders, and from the scientific literature addressing issues related to the funding of medical research. Because the literature on the benefits and costs of different research support mechanisms or the effects of leveraging of federal research and

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Strategies to Leverage Research Funding: Guiding Dod’s Peer Reviewed Medical Research Programs development (R&D) funding is sparse, this information was supplemented by committee members’ judgment and experience as seekers of funding, recipients of governmental and private-sector research support, proposal reviewers, and managers of research programs. This report addresses the question of whether it is possible and desirable to augment the appropriated dollars for CDMRP with funding from other sources. The answer to the of whether it is possible rests on an analysis of nonfederal sources of funding and mechanisms that may be available to access them, as well as potential impediments to that process. The answer to whether it is desirable rests on an analysis of how these other sources and funding mechanisms might affect the goals and effectiveness of CDMRP. Desirability also depends on how “augmentation” is defined. Augmentation of funding that increases public health, for example, by creating a critical mass of knowledge or skills, or by joining complementary resources that are needed to solve a problem, or by enabling results that would not otherwise be possible, is more desirable than augmentation that only serves to extend program funds, especially if the additional funds are not newly applied to biomedical research and are simply shifted from other biomedical research uses. CDMRP occupies a niche in the spectrum of federally-funded medical research: it emphasizes high-risk exploratory research and new ideas by supporting projects that have little or no preliminary data and new investigators without an established track record in research. Based on testimony from program officials, grantees, and members of the advocacy community presented at an April 2004 workshop (see Appendix C for workshop agenda and participants) and an evaluation conducted by an earlier committee of the Institute of Medicine (IOM, 1997), the program appears to be well-run, supports high-quality research, and contributes to research progress in its areas of focus. It also concentrates its resources on research mechanisms that complement rather than duplicate the research approaches of the major funders of medical research in the United States, such as industry and the National Institutes of Health (NIH). CDMRP’s strategy of focusing on support of exploratory research, new investigators, and innovative approaches affects the prospects for outside funding. Funding of such work is generally and properly regarded as a function of the federal government, making up for market failures that result in private-sector underinvestment in these vital areas. Nonfederal funders—particularly philanthropic organizations and state governments—are unlikely sources. Given the disparity between the amount of federal resources relative to nonfederal resources, they have little motivation to provide funds unless they expect to leverage federal dollars for their priorities or they would like the federal program to pay for the application, peer review, and grants management processes. Leveraging of nonfederal funds would happen most easily for certain types of research that are not the main focus of CDMRP and that are already supported

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Strategies to Leverage Research Funding: Guiding Dod’s Peer Reviewed Medical Research Programs by major funders of medical research. This includes later-stage research with applications that are likely to become commercially viable or possibly training or infrastructure grants. The possibility of co-funding from industry, the largest nonfederal funder of biomedical research, is least likely for early-stage exploratory research, which is one of the most important foci of CDMRP. The committee concludes that CDMRP should pursue leveraging where it is appropriate, especially if it promises to leverage research results. Later-stage research initiatives, such as clinical research and clinical trials, are probably most appealing to other funders, although any initiative of possible interest to other funders might be pursued. Leveraging would be facilitated if Congress granted the authority and means for the program to solicit and use outside funds for extramural awards. If private co-funding and other collaborations with CDMRP grow, there would have to be some changes in the way the program is currently run. For example, the potential risks inherent in public-private collaborations would need to be anticipated and addressed. Peer review of developmental research would need to involve a different set of experts than those who review exploratory research, for example, scientists who have successfully developed products and have some experience with identifying promising projects. If CDMRP shifted emphasis from exploratory research to early-stage development of diagnostics; drugs, vaccines, and other therapeutics; and medical devices and other products, it would be in a better position to attract funds from venture capital and biotechnology and pharmaceutical companies. In accord with federal policy, however, this shift should be based on scientific grounds, not just to extend program funds. It should also consider the support that industry and other federal agencies already give to the development and testing of diagnostics, therapeutics, medical devices, and other efforts to develop commercial products and weigh that against the need for more high-risk/high-gain exploratory research to understand better the diseases addressed by CDMRP and identify potential points of intervention for preventing and treating them. The committee was charged with assessing alternative nonfederal sources of support. It did not, therefore, consider some alternatives for leveraging CDMRP funds. For example, the committee did not assess how CDMRP might achieve greater progress in research by leveraging the resources of NIH and other federal biomedical research programs or by working out a more productive division of labor among the federal agencies that have similar program goals. The committee also did not look at the extent to which program rules and procedures could be revised to reduce the administrative burden on applicants and awardees and free additional time and other resources for research at applicant institutions—important issues that would need to be addressed elsewhere.

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Strategies to Leverage Research Funding: Guiding Dod’s Peer Reviewed Medical Research Programs Recommendation 1: Facilitate Collaboration When Appropriate Findings. The majority of funding of biomedical research comes from industry and is not readily accessible to a program such as CDMRP. Experience with cost sharing in other federal basic research programs shows that requiring recipients to provide significant percentages of the cost of projects to augment federal funds imposes additional expenses on both the recipient and the funder. This requirement also can have unintended—and often undesired—consequences (such as discouraging the submission of outstanding proposals from researchers at institutions with limited means) and may not substantially increase the total amount of funding in an area of research (or may redirect it from other important uses). Cost sharing is most appropriate when the co-funder receives a tangible benefit, and this is much more likely to happen in later-stage research or infrastructure projects rather than in basic and exploratory research. Yet CDMRP’s greatest strength has been its support of new ideas and new investigators, where cost sharing beyond the provision of facilities and equipment is least justified. The experience of federal R&D funding agencies with voluntary public-private collaborations generally has been positive, although collaborations must be individually negotiated, which can add significant costs to a project and increase the time it takes for the research to begin. Appendix A includes a number of examples in which foundations, companies, and state governments have partnered with federal agencies to fund a research project or program. In some cases, the nonfederal supporters of research have contributed dollars to the federal agency to use in funding research grants. In other cases, the nonfederal funding is not commingled with federal funds per se but is instead coordinated with them. For example, the federal and nonfederal collaborators fund different parts of an overall program or the nonfederal organization provides supplementary funding to a federal recipient. In some cases, a foundation or voluntary health agency funds applications that fall just below the pay line for federal grant programs, which saves them the costs of soliciting and reviewing proposals. Recommendation 1. CDMRP should facilitate collaborative arrangements for funding research when collaboration would be beneficial and appropriate—for example, when it would achieve greater results through synergy or economies of scale or critical mass—but CDMRP should not expect such arrangements to augment significantly overall program funding. Opportunities for collaboration with other sponsors of biomedical R&D should be encouraged, not to stretch program funds, but to achieve program goals that could not be met otherwise. For example, increased funding might allow attainment of a critical mass in an area that no single funder could achieve, the development of a shared infrastructure, or the creation of a synergistic effect through the interactions of the different collaborators. In some cases, solving a

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Strategies to Leverage Research Funding: Guiding Dod’s Peer Reviewed Medical Research Programs particular problem may require interdependent inputs from more than one entity. Such collaborations generally will be targeted and time-limited, although they may be repeated or continued when each participant perceives it to be beneficial. CDMRP should experiment with award mechanisms that facilitate collaborative R&D arrangements among academic institutions, industry, philanthropies, state governments, and/or other supporters of research, as has been done in the Breast Cancer Research Program with Collaborative-Clinical Translational Research Awards and Biotechnology Clinical Partnerships. These awards require collaborations to perform clinical trials, in the first case, between community-based oncology practices, the private sector, and academic centers, and in the second case, between a biotechnology company and an academic institution or health care organization. In addition, CDMRP should, through its inclusive planning process, develop programs that outside funders would be willing to help fund (see Recommendation 2, below). An alternative would be for CDMRP to approach nonfederal funders to explore the possibility that they might fund projects that receive high scores but that cannot be funded by CDMRP. This reliance on the CDMRP application and review process would save the nonfederal funders administrative costs. Recommendation 2: Provide DOD with Gift Authority Finding. Some federal agencies, such as NIH and the Centers for Disease Control and Prevention (CDC), have the authority to accept gifts for specified purposes and have foundations that can solicit private funds for their programs. Under current law and regulations, however, the Army is only allowed to accept private donations in its Army General Gift Fund for certain purposes (e.g., to benefit a school, hospital, library, museum, cemetery, or similar Army institution or organization), which do not include augmenting the funding of an extramural grant program such as CDMRP. Unlike some of these other federal research agencies, neither CDMRP nor its parent organization, USAMRMC, has the authority to receive outside funds to augment its budget for extramural awards. Even if it had such authority, it could not be used actively, as it is not legal for federal employees to seek funds from private sources. The Henry M. Jackson Foundation for the Advancement of Military Medicine was established to be the recipient of funding for medical research and education projects from other federal and nonfederal sources, but only on behalf of the faculty of the Uniformed Services University of the Health Sciences, researchers at Walter Reed Army Institute of Research, and other intramural DOD researchers. The Jackson Foundation does not fund extramural research. Nonfederal funders also may contribute funds to the Defense Cooperation Account (DCA), but Congress must appropriate these funds and authorize their use for a specific purpose, and donors are asked not to designate the intended use of their contributions to DCA. If Congress wishes CDMRP to draw on founda-

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Strategies to Leverage Research Funding: Guiding Dod’s Peer Reviewed Medical Research Programs tions and private donors, it needs to provide the authority to receive gifts to support research administered by CDMRP or in collaboration with CDMRP. Recommendation 2. Congress should provide the CDMRP with authority to: a. receive gifts and donations from individuals, companies, foundations, and other organizations for the support of research grants and contracts awarded by CDMRP, and b. charter a nonprofit foundation with authority to solicit and transfer nonfederal funds for the support of research grants and contracts awarded by CDMRP. Gift authority might be granted to the Secretary of Defense, the Service Secretaries, or the Commander of USAMRMC, as long as it is delegated to the CDMRP program. A nonprofit foundation with the mission of assisting CDMRP or USAMRMC could be modeled after the Foundation for the National Institutes of Health or the CDC Foundation. Alternatively, the mission of the Henry M. Jackson Foundation could be expanded to include fundraising for CDMRP or USAMRMC extramural research programs. Based on the experience of similar foundations for other agencies, however, expectations of substantial donations to such a foundation should be modest. Congress also would have to provide for the additional costs of establishing and maintaining the foundation. Recommendation 3: Limit Cost-Sharing/Matching Requirements Finding. Cost-sharing and matching requirements do not always advance research goals. Usually, cost-shared funds do not expand the total funding provided for research. Rather, they involve the rechanneling of existing funding streams. In addition, cost-sharing requirements can impose additional administrative costs on both recipients and funders. Recipients must spend time seeking these sharing funds (or divert their own dollars from other uses), managing the relationships with donors, and documenting that the cost sharing was obtained and used properly. Funding agencies must ensure that the cost sharing was actually provided by all partners. Cost-sharing requirements thus generate additional administrative costs for all concerned. However, cost sharing makes sense where the extra costs are more than offset by additional benefits resulting from the partnership, such as when research results have foreseeable commercial applications. Recommendation 3. CDMRP should not impose cost-sharing or matching fund requirements beyond those currently required, except when a tangible benefit to the award recipient is anticipated beyond the immediate term or scope of CDMRP-supported activity (for example, funding of instruments and facilities).

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Strategies to Leverage Research Funding: Guiding Dod’s Peer Reviewed Medical Research Programs Care should be taken to see that cost sharing does not divert funds from other desirable activities, such as other research projects that would have been funded by those dollars. CDMRP should not let expectations of increased nonfederal funding shift the program’s scientific priorities away from its focus on innovative exploratory research, research into disease prevention and causation, and epidemiological studies. Recommendation 4: Issue Guidelines for Collaboration Finding. Research on university-industry and government-industry partnerships and similar collaborations has identified a number of potential benefits and costs that result from these relationships. The benefits generally take the form of induced private investment in developing research results into commercial goods and services, but these benefits do not necessarily require co-funding or formal matching requirements. The costs can include the imposition of secrecy on the scientific process, the occurrence of delays and bias in the reporting of research results, the shifting of research priorities toward near-term development rather than long-term research, and the possibility of financial conflicts of interest for both research institutions and individual researchers. Although collaborations with outside funders would be a useful adjunct to CDMRP efforts, their benefits should outweigh the additional costs involved, and the primacy of scientific excellence and program relevance can and should be maintained. Any pressure to shift program priorities away from basic exploratory research in order to maximize outside funding should be resisted. CDMRP policies and procedures regarding the protection of human subjects in research and avoidance of conflicts of interest should, of course, be rigorously applied. Recommendation 4. DOD should issue guidelines for collaboration with the private sector, paying special attention to the potential impact of research collaborations with nonfederal funders on (a) program costs; (b) the integrity of the peer review process; (c) program priorities; (d) perceived and actual conflicts of interest; (e) openness in scientific communication; and (f) other issues that may arise in federal-private co-funding arrangements. Other research funding agencies have issued guidelines governing public-private collaborations, which could serve as models for DOD guidelines. The guidelines of NIH and CDC were described in Chapter 4. They focus on such issues as potential conflicts of interest that must be identified and addressed; intellectual property rights; the timely publication of research results; and the maintenance of academic freedom, and they contain suggestions of ways for avoiding or managing them.

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Strategies to Leverage Research Funding: Guiding Dod’s Peer Reviewed Medical Research Programs REFERENCE IOM (Institute of Medicine). 1997. A Review of the Department of Defense’s Program for Breast Cancer Research. Washington, DC: National Academy Press.