Recovery Act Limited Competition Comparative Effectiveness Research on Upper Endoscopy in Gastroesophageal Reflux Disease, Eradication Methods for Methicillin Resistant Staphylococcus aureus and Dementia Detection and Management Strategies (RC4) | Apply Online

Opportunity Summary:

The National Institutes of Health (NIH) released this Recovery Act funding opportunity to jump start preliminary comparative effectiveness research (CER) in a few specific, high priority clinical areas where stronger evidence was considered overdue. The program is funded through the American Recovery and Reinvestment Act of 2009 (ARRA), and it is framed as a limited competition intended to move quickly and generate useful, near term information for patients, clinicians, and health systems. A key point is that NIH is not looking for large, definitive, multi year phase III style trials here. Instead, the agency describes the projects as large pilot or preliminary studies that can test feasibility, refine study designs, generate early comparative results, and set the stage for later, more conclusive CER.

The announcement focuses on three targeted topics: (1) the use of upper endoscopy in gastroesophageal reflux disease (GERD), (2) methods to eradicate methicillin resistant Staphylococcus aureus (MRSA), and (3) strategies for dementia detection and management. Within each topic, the intent is to compare real world alternatives that clinicians and patients actually face, rather than testing an intervention against placebo in an artificial setting. NIH states that the CER definition should follow the Federal Coordinating Council definition (as referenced in the FOA), which generally emphasizes comparing benefits and harms of different interventions and strategies in typical practice to inform decision making.

The funding mechanism is the RC4, an ARRA specific NIH grant mechanism created for Recovery Act research support. Total funding planned under the FOA is $15 million, divided evenly across the three topic areas (about $5 million per topic). NIH anticipated making roughly 4 to 6 awards per topic area in fiscal year 2010, depending on the number of applications received, their quality, and the availability of funds. Individual project budgets are capped at $1.25 million in total costs for the entire project, and the project period cannot exceed three years. There is no cost sharing or matching requirement, which lowers the barrier for organizations that might not have discretionary funds to contribute.

Eligibility is broad and includes many types of U.S. organizations that can conduct applied health research. Eligible applicants listed include state, county, and city or township governments; special district governments; public and state controlled institutions of higher education; private institutions of higher education; independent school districts; public housing authorities and Indian housing authorities; federally recognized tribal governments and other tribal organizations; small businesses and other for profit organizations; and nonprofit organizations (including both 501(c)(3) and certain non 501(c)(3) entities). The FOA also explicitly notes additional eligible groups such as Alaska Native and Native Hawaiian Serving Institutions, Hispanic Serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith based or community based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions. This wide eligibility reflects the practical nature of CER, where useful studies often require access to health systems, community settings, or large patient populations rather than only traditional academic laboratories.

In terms of timing and administrative details, the opportunity is listed as a discretionary grant under a health related Recovery Act funding activity category, with CFDA number 93.701 (Trans NIH Recovery Act Research Support). It was posted on December 28, 2009, and the application due date was February 26, 2010, with an archive date of March 29, 2010. The funding opportunity number is RFA OD 10 008, and NIH is the sponsoring agency. Applicants were directed to the full announcement on the NIH grants site for complete requirements and instructions. For technical issues accessing or linking to the announcement, NIH provided an Office of Extramural Research (OER) webmaster contact (FBOWebmaster@OD.NIH.GOV).

Overall, this FOA is best understood as a time limited Recovery Act initiative meant to produce practical, decision relevant evidence in three specific clinical problem areas. It funds well scoped, comparatively oriented studies that can be completed within three years and within a $1.25 million total cost cap, with the expectation that results will help guide future, larger CER investments and improve real world clinical decision making in GERD endoscopy use, MRSA eradication approaches, and dementia detection and management strategies.

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