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Support for research will include the awarding of additional peer-reviewed grants for projects that are deemed likely to make substantial progress within 2 years, targeted supplements to current grants, and new types of activities, such as a challenge-grant program. In March 2009, about $1 billion was made available for revisions of existing competitive grant applications and administrative supplements, including $21 million for those used to fund summer research experiences for students and science educators. The NIH also announced that it had designated "at least" $200 million of the stimulus money to fund 200 or more grants in specific challenge areas (comparative-effectiveness research, clinical research, genomics, information technology for processing health care data, regenerative medicine, stem-cell research, and nine others) that "focus on specific knowledge gaps, scientific opportunities, new technologies, data generation, or research methods that would benefit from an influx of funds."2 Applications are due in late April; the "earliest anticipated start date" is the end of September. About $60 million is to be made available to fund between 40 and 50 grants addressing the heterogeneity of autism spectrum disorders, and another $200 million will support research and research infrastructure "grand opportunities" with the expectation of continued NIH funding beyond 2 years. With regard to research involving human stem cells, on March 9, 2009, President Barack Obama issued an executive order that reversed Bush administration policies limiting the funding and conduct of such research. The NIH has until early July to finalize new guidelines, after which recovery-act funds should become available.
The NIH's research-project grant, more commonly known as "R01," is the agency's original grant mechanism and the largest category of funding as measured by the number of grants and their value; such grants can be initiated by investigators or submitted in response to a program or request for applications. The number of new and continuing R01 grants was 7211 in 2003 but has subsequently decreased; in 2008, 5886 such grants were awarded (see Figure 2A). The total amount awarded has remained under $2.5 billion a year (see Figure 2B). In 2008, the success rate for new R01 grants, defined as the number of applications awarded as a percentage of those reviewed, was 19%, as compared with 25.5% in 1999 and a low of 16.3% in 2006. Although the NIH has yet to state how many additional R01 grants it will fund with stimulus money, the number should be substantial.
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The recovery-act timetable raises practical issues, and more are likely to emerge in the months ahead. For example, it is often not feasible to design, fund, conduct, and complete certain types of research within 2 years — such as a clinical trial comparing the effectiveness of treatments. After a grant is funded, it may take time to hire the people who are needed to carry out the work. Fellows and postdoctoral researchers often have commitments that extend through the end of the academic year in June. The challenges may be greatest for grants funded late in 2009 or in 2010. It is also uncertain how flexible the federal government will be with regard to allowances for spending stimulus money after September 2010, so that work can be completed.
Whereas the stimulus funds are a one-time infusion of money equivalent to about a third of the NIH annual budget, the extent to which the overall budget will continue to increase has yet to be confirmed. If Congress does not substantially increase the NIH budget by fiscal year 2011 — to a level closer to $40 billion than $30 billion per year — many investigators and others who will gain employment because of recovery-act funds may lose their funding at the end of fiscal year 2010. However, if Congress builds on recovery-act funding, allocates additional resources to the NIH, and ensures a continuing real growth rate after adjustment for inflation, biomedical research may be placed on a firmer financial footing.3,4
Each week, the DHHS provides a list of "appropriations, obligations, and disbursements" under the recovery act, along with activities and planned actions (www.hhs.gov/recovery/reports/index.html). As of late March 2009, the NIH had not obligated or disbursed any money. Already, September 2010, the end of next fiscal year, is just 18 months away. The NIH should be very busy.
Source Information
Dr. Steinbrook (rsteinbrook{at}attglobal.net) is a national correspondent for the Journal.
References
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