NIH Funding Opportunities

Recovery Act 2009 Limited Competition: AHRQ Clinical and Health Outcomes Initiative in Comparative Effectiveness (CHOICE) Grants (R01)

Agency for Healthcare Research and Quality (AHRQ)

Deadline:  December 16, 2009

 AHRQ seeks research grant applications for projects in the area of comparative effectiveness research to respond to the American Recovery & Reinvestment Act of 2009.  In its Report to the President and Congress, the Federal Coordinating Council for Comparative Effectiveness Research defines comparative effectiveness research (CER) as “the conduct and synthesis of research comparing the benefits and harms of different interventions and strategies to prevent, diagnose, treat and monitor health conditions in ‘real world’ settings.”  Both the Institute of Medicine report on Initial National Priorities on Comparative Effectiveness Research and the earlier Congressional Budget Office report on Research on Comparative Effectiveness of Medical Treatment have adopted similar definitions.  These definitions allow comparative effectiveness studies to be approached with the comparison of similar treatments, such as competing drugs, or analyzing very different approaches, such as surgery and drug therapy. In this FOA, AHRQ has operationalized the definition of CER with the additional specification that evaluation of treatments includes any potential medical intervention under consideration, whether prognostic, preventive, diagnostic, therapeutic, or palliative.

 In FY 2010, AHRQ intends to support research grants focusing on comparative effectiveness of different clinical treatments and services, as authorized by Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act (MMA), Pub. L. No. 108-173.  See 42 U.S.C. 299b-7.  The intent of these research project grants is to support research focusing on the generation and translation of new scientific evidence and analytic tools in an accelerated format and the integration of evidence into practice and decision-making in the health care system.  AHRQ is especially interested in studies that include under represented and AHRQ priority populations such that potential clinical heterogeneities and population subgroups are considered in study design and proposed methodologies, and that subgroup analyses can be performed and research results and findings are relevant for all populations.  Applicant’s specific plans for inclusion of priority populations will be evaluated by the scientific review committee and will be a component of the assigned priority score.

Specifically, the goal of this FOA is to request applications for large projects in comparative effectiveness aimed at generating new knowledge to help inform decision making in priority areas of clinical care. The impact of these studies should have a high likelihood of creating major advancements in clinical care. Emphasis will be placed on applications that define important research gaps and design a study to provide actionable results.  Applications that include study aims to address the outcomes and effectiveness of assessments across population subgroups often underrepresented in medical research are expected. Priority populations include but are not limited to racial and ethnic minorities, persons with disabilities, children, elderly, patients with multiple and chronic conditions, and disadvantaged and/or under represented populations for the specific condition being studied.  Priority conditions important to the Medicare, Medicaid, and CHIP programs and mandated by the MMA section 1013 are of special interest.  The current list of priority conditions includes:

·       Arthritis and non-traumatic joint disorders

·       Cancer

·       Cardiovascular disease, including stroke and hypertension

·       Dementia, including Alzheimer's disease

·       Depression and other mental health disorders

·       Developmental delays, attention-deficit hyperactivity disorder and autism

·       Diabetes mellitus

·       Functional limitations and disability

·       Infectious diseases including HIV/AIDS

·       Obesity

·       Peptic ulcer disease and dyspepsia

·       Pregnancy including pre-term birth

·       Pulmonary disease/asthma

·       Substance abuse

The clinical emphasis of the application should be to develop new scientific evidence that fills important knowledge gaps and to generate critical insights on the clinical effectiveness and comparative clinical effectiveness of health care interventions. These interventions could include medical tests, devices, procedures, therapeutics, or behavioral and counseling interventions.  For studies in which randomized controlled trials may not be feasible or timely, or would raise ethical concerns that are difficult to address, novel or alternative study designs should be proposed, with the emphasis on prospective data collection as appropriate.  Such clinical research projects also need to be informed by the information needs and inputs from various stakeholders (e.g., policy-makers, clinicians, and patients) to ensure the most appropriate outcome measures for assessing the effectiveness of the interventions and outcomes of importance to stakeholders are included in the study. 

In general, it is expected that proposed projects submitted under this FOA will:

·       Have significant stakeholder inputs in research study questions, execution, and translation to ensure that there is a ready audience for research findings and that the findings can be adequately incorporated into clinical decision making;

·       Be directly applicable to a real-world clinical decision for which new knowledge would help the public, patients, clinicians, or policy makers make better decisions;

·       Be grounded in sound scientific methodology and informed by prior research;

·       Evaluate alternative options for a specific clinical management decision point for either one of the priority conditions, or if another condition, then with a rationale for why this research represents a priority;

·       Evaluate subgroups including racial and ethnic minorities and other disparate and often under represented patient (e.g., elderly, children, etc.) populations;

·       Be prospective and longitudinal in nature.  Observational designs (e.g. prospective cohort studies) or interventional studies (e.g. randomized clinical trials, cluster-randomized trials, pragmatic clinical trials) are acceptable as long as the design is commensurate with the evidentiary needs;

·       Measure the spectrum of outcomes including both short-term and longer-term benefits as well as harms;

·       Measure outcomes relevant to the patient, e.g. mortality, morbidity, health and functional status.

 

ARRA Administrative Supplements and Competitive Revisions:
Clarifications on Programmatic Limitations and use of Modular Budgets
(NOT-OD-09-079)
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-079.html

In March, the NIH announced the availability of funds under ARRA for project expansions via competitive revisions (NOT-OD-09-058) and administrative supplements (NOT-OD-09-056), including administrative supplements providing summer research experiences for students and science educators (NOT-OD-09-060). This Notice serves to clarify that requests in response to the Notices cited above may be made in excess of programmatic cost limitations or ceilings associated with a program or activity code (e.g., direct costs stipulated for Small Research Grants [R03], Exploratory/Developmental Grants [R21]).  If a project was previously funded under a program or activity code with budget limitations or ceilings, these limitations or ceilings are not applicable to ARRA competitive revision and/or administrative supplement requests. Note: All budget requests must be commensurate with the scope of the programmatic request and will be subject to a cost analysis prior to award.  In addition, budgets submitted in competing revisions will be subject to the peer review.

Concerning modular budgets and competitive revision applications, the modular grant concept applies.  Therefore, for electronic submissions, budget requests for competitive revisions equal to or less than $250,000 direct costs per year must still use a modular budget component; requests over $250,000 direct costs per year must use the detailed budget component.  (For paper PHS 398 applications (e.g., P01), a detailed budget is always required.) Please note the flexibility to switch from a modular to a detailed budget is only available for those Funding Opportunity Announcements (FOAs) where both the detailed budget and modular budget components are part of the application package.  (For FOAs where only the modular budget component is available (e.g., SC1, SC2, SC3) competitive revisions will be submitted using the modular format for no more than $250,000 direct costs per year.) Note that this flexibility to switch from a modular budget to a detailed budget only applies to ARRA competing revision requests and is not a change in our general practice. Institutions and Project Directors/Principal Investigators should be aware that they will receive a validation warning when submitting a competitive revision through Grants.gov if the parent application was submitted using a modular budget and they are now submitting a detailed budget.  The warning will read:  “The parent grant for this revision uses the modular format; in most cases, this application must be submitted with a modular budget.  If the budget caps permitted by the FOA exceed the modular limit of $250k, the application must be submitted with a detailed budget”.  Please disregard this warning.  It will not affect submission of the application through Grants.gov.  Inquiries: GrantsInfo@mail.nih.gov.

Recovery Act of 2009: NIH Award Terms and Additional
Information for Recipients Receiving Recovery Act Grant Funding
(NOT-OD-09-080)
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-080.html

ARRA requires recipients to separately account for, track, monitor, report on, provide for audit of, and closeout of all grant funding provided under the ARRA. NIH, in accordance with the Department of Health and Human Services (HHS) guidance, is implementing a number of unique business processes to accommodate the separation of ARRA funding from funding provided under the standard NIH Appropriation. This Notice is designed to explain these new business processes and alert grantees to the steps they must take to successfully administer ARRA awards. The information at this link applies to all Notice of Awards (NoAs) issued with ARRA funding.

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NIH Grant Announcements

Recovery Act Funds for Administrative Supplements (NOT-OD-09-056)

Deadline: Applications may be submitted throughout FY2009 and FY2010. 
However, note that some NIH ICs may have specific deadlines for submission of administrative supplements as listed on their own Web sites: http://grants.nih.gov/recovery/ic_supp.html.

The National Institutes of Health (NIH) announces the opportunity for investigators and United States institutions/organizations with active NIH Research Grants to request administrative supplements for the purpose accelerating the tempo of scientific research on active grants. Support for these supplements will come from funds provided to NIH through the American Recovery and Reinvestment Act of 2009 (“Recovery Act” or “ARRA”), Public Law 111-5.  Consistent with the intent of the Recovery Act, the purpose of this program is to promote job creation and economic development along with accelerating the pace and achievement of scientific research. 

In addition, Recovery Act funds allocated to NIH specifically for comparative effectiveness research (CER) may be available to support supplements.  Projects receiving these funds will need to meet this definition of CER: “a rigorous evaluation of the impact of different options that are available for treating a given medical condition for a particular set of patients. Such a study may compare similar treatments, such as competing drugs, or it may analyze very different approaches, such as surgery and drug therapy.” Such research may include the development and use of clinical registries, clinical data networks, and other forms of electronic health data that can be used to generate or obtain outcomes data as they apply to CER. For further information: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-056.html

Recovery Act Funds for Administrative Supplements Providing Summer
Research Experiences for Students and Science Educators (NOT-OD-09-060)

Deadline: Applications may be submitted throughout FY2009 and FY2010. However, note that some NIH ICs may have specific deadlines for submission of administrative supplements as listed on their own Web sites: http://grants.nih.gov/recovery/ic_supp.html.

The National Institutes of Health (NIH) announces the opportunity for investigators and United States institutions/organizations with active NIH Research Grants to request administrative supplements for the purpose of promoting job creation, economic development, and accelerating the pace and achievement of scientific research. These supplements will also encourage students to seriously pursue research careers in the health related sciences, as well as provide elementary, middle school, and high school teachers, community college faculty, and faculty from non-research intensive institutions with short term research experiences in NIH-funded laboratories. For further information: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-060.html

Phased Innovation Award Program for AIDS Vaccine Research

The National Institute of Allergy and Infectious Diseases invites R21/R33 research proposals for the Phased Innovation Award Program for AIDS Vaccine Research. Prospective applicants should propose prophylactic vaccine research projects that are innovative, novel, may be high risk/high impact, and that exhibit the potential to advance AIDS prophylactic vaccine design or evaluation. Eligibility is unrestricted. Standard R 21/R33 submission dates and guidelines apply. More information regarding PA-09-119 is available at: http://grants.nih.gov/grants/guide/pa-files/PA-09-119.html.

Research on Clinical Decision Making in People with or at Risk for Life-Threatening Illness

The National Institute of Nursing Research and the National Cancer Institute invite R01 proposals for research on clinical decision making in people with or at risk for life-threatening illness. These illnesses are ones that almost always lead to death in a fairly short period of time if left untreated, but may be chronic - or even cured - if dealt with early in the disease process. Eligibility is unrestricted. Standard R01 submission dates and guidelines apply. More information regarding PA-09-122 is available at: http://grants.nih.gov/grants/guide/pa-files/PA-09-122.html.