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AHRQ Clinical and Health Outcomes Initiative in Comparative Effectiveness (CHOICE) Grants

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Questions and Answers


The following questions and answers feature responses from the Agency for Healthcare Research and Quality (AHRQ) to questions submitted on or before October 23, 2009, to CHOICEgrants@ahrq.hhs.gov regarding the Agency's funding opportunity announcement (FOA), RFA-HS-10-003: Recovery Act 2009 Limited Competition: AHRQ Clinical and Health Outcomes Initiative in Comparative Effectiveness (CHOICE) Grants (R01). Select to access the FOA.


Is my proposed topic of interest to AHRQ?

The goal of this FOA is to request applications for large projects in comparative effectiveness aimed at generating new knowledge to help inform decisionmaking 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 under-represented in medical research are expected.

To satisfactorily meet these goals, more than one treatment approach for the condition of interest must be compared in the study design consistent with the definition of comparative effectiveness provided in the FOA. With respect to the methodological approaches of the studies, it is expected that the study design will be prospective and longitudinal in nature. Observational designs (e.g., prospective cohort studies) and interventional studies (e.g., randomized clinical trials, cluster-randomized trials, pragmatic clinical trials) are both acceptable as long as the design is commensurate with the evidentiary needs.

The applicant should demonstrate how the results of the study will fill existing research gaps and create a major advancement in clinical care. Sources from which the research gaps can be identified are listed in the FOA. Evidence gaps for these populations should be explicitly identified in the application.

In addition to priority conditions, the study should consider the needs of both genders, racial and ethnic minorities, socioeconomic groups, the elderly, others with special health care needs (and subgroups), and others that are not adequately represented in clinical studies in the research area.

When considering the conditions, reviewers will consider if the proposed condition to be studied is a priority condition of the Effective Health Care Program or that evidence has been provided by the applicant to demonstrate that the topic is of high importance for study.

The importance of your proposed topic and study design needs to be discussed in light of all these factors described in the FOA.

Is the patient group proposed for study responsive to the FOA?

The populations to be studied and their conditions are both important in this FOA.

For the populations, 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. The 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. Priority populations include but are not limited to racial and ethnic minorities, persons with disabilities, children, elderly, patients with multiple and chronic conditions and special health care needs, and disadvantaged and/or under-represented populations for the specific condition being studied.

For the conditions, reviewers will consider if the proposed condition to be studied is a priority condition of the Effective Health Care Program.

The priority conditions are:

  • Arthritis and nontraumatic 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 preterm birth.
  • Pulmonary disease/asthma.
  • Substance abuse.

If not a priority conditon, evidence should be provided to demonstrate that the topic is of high importance for study. Factors to be considered include:

  1. Burden of disease, including severity, incidence and/or prevalence, or relevance of organizational/financial suggestions of research to the general population and/or AHRQ's priority populations, including racial and ethnic minority populations.
  2. Controversy or uncertainty about the topic or limited scientific data to support clinical decisionmaking.
  3. Total costs associated with a condition, procedure, treatment, or technology, whether due to the number of people needing care, the unit cost of care, or indirect costs.
  4. Potential impact for reducing clinically significant variations in the prevention, diagnosis, treatment, or management of a disease or condition, or in the use of a procedure or technology.
  5. Potential impact for informing and for improving patient and/or professional decision-making, improving health outcomes, and/or reducing costs.
  6. Relevance to the needs of the Medicare, Medicaid, the Children's Health Insurance Program (CHIP), and other Federal health care programs.
  7. Addresses need or gap unlikely to be addressed through other organizations.
  8. Potential for multiplicative effect (e.g., lays foundation for future comparative effectiveness research (CER), such as data infrastructure and methods development and training, or generates additional investment outside government).

What types of interventions are within the scope of this funding opportunity announcement?

AHRQ seeks research grant applications for projects in the area of comparative effectiveness research. The Federal Coordinating Council for Comparative Effectiveness Research defines comparative effectiveness research 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 Initial National Priorities on Comparative Effectiveness Research and the earlier Congressional Budget Office report Research on Comparative Effectiveness of Medical Treatments 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 the 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.

As noted above, the FOA defines comparative effectiveness research to include interventions and strategies to prevent, diagnose, treat, and monitor health conditions in 'real world' settings. The inclusion of usual care as a comparator intervention should be justified by the nature of the research questions, the standard of current practice, and the explicitly defined elements or attributes of what such care constitutes, and how it is consistently applied and measured across study settings. Further, though the FOA places emphasis on assessing the comparative effectiveness of clinical interventions, it does not restrict studies that also aim to include the examination of the broader system interventions and how care is delivered. Applications proposing to include the assessment of complex interventions where broad strategies on the delivery and management of care are employed should note their conceptual, theoretical, and measurement challenges and address in the proposed study plans how such challenges are to be handled and how the studies and their findings would be applicable beyond the particular study settings.

What outcomes should be used to measure effectiveness?

The FOA provides general guidance regarding outcomes to be included in the study design. In general, it is expected that proposed projects submitted under this FOA will measure the spectrum of outcomes, including both short-term and longer term benefits as well as harms, and will measure outcomes relevant to the patient, e.g, mortality, morbidity, health, and functional status. Clinical research projects need to be informed by the information needs and inputs from various stakeholders (e.g., policymakers, 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. The review criteria also note that the study section will consider whether the selected study outcomes are appropriate and if relevant patient-centered outcomes are included.

What types of studies are of interest?

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 decisionmaking.
  • Be directly applicable to a real-world clinical decision for which new knowledge would help the public, patients, clinicians, or policymakers 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 populations (e.g., elderly, children).
  • 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.

What types of study designs will be considered?

Regardless of topic, the study design should address evidence gaps for AHRQ priority populations and populations under-represented in research on the specific condition being studied. Evidence gaps for these populations should be explicitly identified in the application. Innovative study designs with aims related to various fundamental challenges in outcomes and effectiveness research in real-world clinical settings, e.g., patient and clinician preferences, integration of research and practice both in terms of workflow and data management in electronic medical records (EMR) as well as non-EMR environment, are also strongly encouraged.

Examples of potential projects include, but are not limited, to:

  • Prospective and longitudinal cohort studies of the effectiveness and comparative effectiveness of health care treatments and services, including pharmaceuticals, diagnostics, devices, procedures, and other types of interventions or combinations of these interventions.
  • Cluster-randomized or randomized clinical trials of the effectiveness and comparative effectiveness of important new or existing health care technologies. These trials should be widely inclusive of both patients and health systems to adequately reflect health care in the general population.
  • Assessment of the effectiveness and comparative effectiveness of health care treatments for common, high-cost conditions in the elderly, women, and in various racial or ethnic minority groups, as well as those with multiple comorbidities.
  • Assessment of the effectiveness and comparative effectiveness of interventions unique to children or treatments that are commonly administered to children but have been evaluated for safety and effectiveness only in adult populations.
  • Prospective studies that explore outcomes of pharmacogenetic testing in guiding selection of therapeutic interventions.
  • Prospective evaluation of the long-term outcomes of new imaging technologies to diagnose or monitor a priority condition.

Is a retrospective study using an existing database within the scope of this FOA?

The primary objective of this FOA is to request large projects in comparative effectiveness in priority areas of clinical care. The FOA, while emphasizing and encouraging studies that are prospective in nature, does not preclude particular methodological approaches or study designs the investigators deem to be the most appropriate for their proposed research question that have a high likelihood of generating new knowledge to help inform decisionmaking. Investigators also are reminded that AHRQ continues to support and welcome innovative research applications employing broad arrays of methods to examine the effectiveness of existing and emerging health care services through a range of standing program announcements (PAs) and specific requests for applications (RFAs). In addition to the CHOICE FOA, investigators are encouraged to review and consider many funding opportunities that can be found at http://www.ahrq.gov/fund/grantix.htm.

Are projects with methodological aims responsive to the FOA?

The FOA explicitly stipulates that the primary locus of the proposed research projects must focus tightly on the study of comparative effectiveness and may also include methodological inquires as part of the secondary study aims. While not required in this FOA, AHRQ encourages the inclusion of secondary study aims that develop and validate methods to inform future comparative effectiveness research. The FOA considers methodological projects only in the context of secondary aims, and they could include, for example: a) use and evaluation of novel data collection methods, such as distributed research networks; b) use and comparison of innovative analytic techniques; c) use of modeling to predict longer term outcomes than the study duration permits; or d) use of innovative recruitment techniques to assure adequate representation of disadvantaged and/or under-represented populations in a prospective sample. For applications that include methodological aims, the goals should be to advance study designs and methods to fill specific knowledge gaps and to enhance the consistency, applicability, and generalizability of the comparative effectiveness study.

With how many organizations is an applicant expected to collaborate?

The only collaboration described in the FOA is with stakeholders such as the public, patients, providers, policymakers, and groups that are traditionally under-represented in the research enterprise. The PD/PI (project director/principal investigator) should demonstrate that the project is applicable to problems important to stakeholders by providing specific and detailed plans to solicit stakeholder input during the research process or letters of support from stakeholder groups representing multiple perspectives. No requirements for multicenter trials or other research collaboration are specified in the FOA.

The FOA does encourage applicants to collaborate with institutions well versed in comparative effectiveness methodologies or with research centers and integrated health care delivery systems capable of performing accelerated clinical effectiveness and outcomes research and the translation and dissemination of evidentiary information for health care decisionmaking. Existing examples of such AHRQ networks include the Evidence-based Practice Centers (EPCs), the Developing Evidence to Inform Decisions about Effectiveness (DEcIDE) network, the Centers for Education & Research on Therapeutics (CERTs), the John M. Eisenberg Clinical Decisions and Communications Science Center, Primary Care-Based Research Network (PBRN), Accelerating Change and Transformation in Organizations and Networks (ACTION), and the HIV Research Network. A listing of these research networks can be found at the AHRQ's Effective Health Care Program Web site (http://effectivehealthcare.ahrq.gov/index.cfm/who-is-involved-in-the-effective-health-care-program1/). Affiliation with an AHRQ-funded network is not required; these are mentioned to applicants as examples only.

What are the review criteria? How will individual criteria be considered?

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with standard AHRQ peer review procedures that are described in 42 CFR Part 67, Subpart A. Incomplete and/or nonresponsive applications or applications not following instructions given in this FOA will not be reviewed. The following information is taken directly from the FOA.

As part of the initial merit review, all applications will:

  • Undergo a selection process in which only those applications deemed to have the highest scientific merit will be discussed and assigned a priority score.
  • Receive a written critique.

In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application.

  • Significance.
  • Approach.
  • Innovation.
  • Investigators.
  • Environment.
  • Budget.

Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a meritorious priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: Does this study address an important problem (e.g., areas of crucial evidence gaps, or areas of controversy or high variation in clinical care)? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventive interventions that drive this field? Is the population selected for study important, and will disproportionately affected subpopulations or previously under-represented populations be included in sufficient numbers to allow subpopulation analysis? If the aims of the application are achieved, how will it fill an important gap in scientific knowledge or clinical practice? How will important health care decisionmaking be better informed? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventive interventions that drive this field?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Are the selected study outcomes appropriate and do they include relevant patient-centered outcomes? Are the interventions selected for comparison the most appropriate and relevant to decisionmakers? Will the study design provide sufficiently strong evidence to achieve the study aims and adequately inform clinical decisionmaking?

Innovation: Is the project original and innovative? For example, does the project challenge existing paradigms or clinical practice, address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches or methodologies, tools, or technologies for this area?

Investigators: Are the PD/PI and other key personnel appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level(s) of the principal investigator(s) and other researchers? Do the PD/PI and investigative team bring complementary and integrated expertise to the project (if applicable)?

Environment: Do(es) the scientific environment(s) in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment(s) or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

Budget: Is the proposed budget reasonable, and is the requested period of support appropriate in relation to the proposed research? Are excess funds requested for equipment that has broad use at the institution beyond the proposed study?

In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score:

Stakeholder involvement: Has the PD/PI consulted with or described a plan to involve key stakeholders in the research? Stakeholders may include decisionmakers such as the public, patients, providers, policymakers, and groups that are traditionally under-represented in the research enterprise. Has the PD/PI demonstrated that the project is applicable to problems important to stakeholders? This evidence may include specific and detailed plans to solicit stakeholder input during the research process or letters of support from stakeholder groups representing multiple perspectives.

Translation: Has the PD/PI described a plan to disseminate the results of the study? Do these plans consider targeted dissemination plans to reach racial and ethnic minorities as well as other groups where there are disparities in health care and for whom the results are directly applicable? How will the results of the work be presented to stakeholders in a structure that can be immediately incorporated to inform their health care decisionmaking? How will successful implementation be measured?

Degree of responsiveness: How well does the application address the purpose and objectives of this FOA? How responsive is the application to the special eligibility criteria, including the project requirements, noted in the FOA? Is the proposed condition to be studied a priority condition of the Effective Health Care Program? If not, has evidence been provided to demonstrate that the topic is of high importance for study?

Inclusion: Is the plan adequate to address the needs of both genders, racial and ethnic minorities, socioeconomic groups, the elderly, others with special health care needs (and subgroups), and others that are not adequately represented in clinical studies in the research area. Are both genders and racial and ethnic minorities, socioeconomic position, elderly, others with special health care needs (and subgroups) included and are subgroup analyses planned? Are special populations under-represented in research on the condition of interest identified and included, and are subgroup analyses planned? Has adequate attention been paid to under-represented and AHRQ priority populations (see above discussion on Priority Populations in section IV.6 Other Submission Requirements, and inclusion criteria included in section VIII of Required Federal Citations, below.) [In FOA.]

Protection of human subjects from research risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. See the Human Subjects Sections of the PHS398 Research Plan component of the SF424 (R&R). [In FOA.]

Privacy and security protections for patients: The resources and processes to be used to address privacy and security issues in the development and implementation of the intervention will be assessed.

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:

  • Scientific merit of the proposed project as determined by peer review.
  • Availability of funds.
  • Responsiveness to goals and objectives of the FOA.
  • Relevance to program priorities.
  • Programmatic balance.
  • Portfolio balance within AHRQ and DHHS.

Applications that include a significant focus on under-represented and priority populations such that these populations are included in primary analyses will undergo discussion at scientific peer review and will be assigned a priority score. Special consideration will be applied to those applications whose plans on inclusion of priority populations are deemed acceptable by the scientific review committee (25 priority score points will be adjusted from the final average priority score).

Will new researcher status be considered?

As stated in the FOA, the only review criteria considered by the review team with respect to the PD/PI nomination are: Are the PD/PI and other key personnel appropriately trained and well suited to carry out the work? Is the work proposed appropriate to the experience level(s) of the principal investigator(s) and other researchers? Do the PD/PI and investigative team bring complementary and integrated expertise to the project (if applicable)?

New investigators are not given special status during the review and they will not have different paylines. The FOA does encourage applicants to collaborate with institutions well versed in comparative effectiveness methodologies or with research centers and integrated health care delivery systems capable of performing accelerated clinical effectiveness and outcomes research and the translation and dissemination of evidentiary information for health care decisionmaking. Existing examples of such AHRQ networks include the Evidence-based Practice Centers (EPCs), the Developing Evidence to Inform Decisions about Effectiveness (DEcIDE) network, the Centers for Education & Research on Therapeutics (CERTs), the John M. Eisenberg Clinical Decisions and Communications Science Center, Primary Care-Based Research Network (PBRN), Accelerating Change and Transformation in Organizations and Networks (ACTION), and the HIV Research Network. A listing of these research networks can be found at the AHRQ's Effective Health Care Program Web site (http://www.effectivehealthcare.ahrq.gov/index.cfm/who-is-involved-in-the-effective-health-care-program1/). Affiliation with an AHRQ-funded network is not required; these are mentioned to applicants as examples only.

Am I eligible to apply for this funding?

As stated in the FOA, you may submit an application(s) if your domestic (U.S,) institution/organization has any of the following characteristics:

  • Public or nonprofit private institution, such as a university, college, or a faith-based or community-based organization.
  • Units of local or State government.
  • Eligible agencies of the Federal Government.
  • Indian/Native American Tribal Government (federally recognized).
  • Indian/Native American Tribal Government (other than federally recognized).
  • Indian/Native American Tribally Designated Organizations.

The U.S, institution/organization must be located in the 50 States or in the territories and possessions of the United States, Commonwealth of Puerto Rico, Trust Territory of the Pacific Islands, or District of Columbia. Foreign organizations/institutions are not permitted as the applicant organization but may participate in projects as members of consortia or as subcontractors. Applications submitted by for-profit organizations will not be reviewed, but for-profit organizations may participate in projects as members of consortia or as subcontractors. Organizations described in section 501(c) 4 of the Internal Revenue Code that engage in lobbying are not eligible.

Can more than one application be submitted from a single institution?

The FOA states that applicants may submit more than one application, provided each application is scientifically distinct. The FOA is silent on the number of applications that can be submitted from a single institution; thus there is no restriction.

Are multiple PIs allowed on the application?

The FOA clearly states that only one PD/PI may be designated on the application. AHRQ grants policy does not allow or recognize the multiple PIs grant application format at the present time. Additional senior investigators are welcome to lend their expertise as it benefits the project, but they must be officially designated as associate investigators on the application.

How do I obtain and submit an application?

As stated in the FOA, applications submitted in response to this funding opportunity announcement for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide. Specific information and instructions on accessing and submitting the electronic applications can be located in Section IV of the FOA (http://grants.nih.gov/grants/guide/rfa-files/RFA-HS-10-003.html#SectionIV). Answers to frequently asked questions on how to prepare an electronic application may also be accessed at http://era.nih.gov/ElectronicReceipt/faq_prepare_app.htm#1

Will an application be considered as a resubmission from a different FOA at a different agency?

An application will not be considered as a resubmission from a different FOA. An application previously submitted to and reviewed by another agency can be submitted under this FOA as a new application. As a new application, responses to comments from a previous peer review should not be included in a separate section but can be incorporated into the study design as appropriate. Investigators are reminded that the goal of this FOA and the criteria used to review it likely are different from those of other FOAs, and as such, investigators should ensure that their applications are responsive to this particular FOA.

How can I get more information about this opportunity?

Please direct your questions about general FOA issues, including information on the inclusion of priority populations, to CHOICEgrants@ahrq.hhs.gov. Due to staffing resource constraints, all scientific/research (program-related) inquiries pertaining to general FOA issues must be submitted by e-mail and will only be answered via e-mail. Please note that AHRQ staff cannot provide individual information that is not publicly available in the FOA or in an otherwise publicly released notice to correct or clarify information contained in the FOA.

Will there be a technical assistance call?

We will not offer a technical assistance call for this FOA. As stated in the FOA, a compilation of questions and answers will be posted at http://www.ahrq.gov/fund/grantix.htm on or shortly after November 2, 2009, and will include replies to inquiries received by CHOICEgrants@ahrq.hhs.gov on or before October 23, 2009

Is a letter of intent required? What information should it contain? When is it due?

As stated in the FOA, a letter of intent is not required, is not binding, and is not considered in the review of a subsequent application. However, these letters are administratively very helpful because they allow AHRQ staff to estimate the potential peer review workload and plan the review (e.g., anticipate the nature of reviewer expertise to be required).

The letter of intent should include the following:

  • An acknowledgement of interest in this funding opportunity. (Please refer to the number and title of this funding opportunity.)
  • A few comments on the subject of the proposed research.
  • Background expertise of key personnel.
  • The nature and role of participating institutions.
  • Name and e-mail address of the principal investigator.

The letter of intent should be sent electronically, with a subject line of "Letter of Intent CHOICEgrants," to: CHOICEgrants@ahrq.hhs.gov.

The deadline for receipt is November 18, 2009, but letters can be submitted immediately.

Is the CHOICE FOA the American Recovery and Reinvestment Act (ARRA) initiative intended to fund the development of national databases or registries?

AHRQ has announced our Intent to Publish Grant and Contract Solicitations for Comparative Effectiveness Research (CER) Projects with Funds from the American Recovery and Reinvestment Act (ARRA) at http://grants.nih.gov/grants/guide/notice-files/NOT-HS-09-009.html. That statement includes mention of $48 million for the establishment or enhancement of national patient registries that can be used for researching the longitudinal effects of different interventions and collecting data on under-represented populations. This is a different effort than the current CHOICE FOA. The development of patient registries and databases FOA, as stipulated in the Intent to Publish Notice (NOT-HS-09-009), is ongoing. Until the specific solicitations are published, AHRQ cannot provide additional information on their contents. Please sign up to receive updates about AHRQ's Effective Health Care Program and future FOAs at https://subscriptions.ahrq.gov/service/multi_subscribe.html?code=USAHRQ

Do you anticipate that funding might be available through this RFA in the future?

Funding for this FOA was made available through the American Recovery and Reinvestment Act of 2009. This was a one-time investment of funds in comparative effectiveness research. As a result, this is a one-time-only solicitation. We will not accept future applications after the December 16, 2009, deadline. That also means that resubmissions and renewals will not be accepted.

Investigators also are reminded that AHRQ continues to support and welcome innovative research applications employing a broad array of methods to examine the effectiveness of existing and emerging health care services through a range of standing program announcements and specific requests for applications. In addition to the CHOICE FOA, investigators are encouraged to review and consider many funding opportunities that can be found at http://www.ahrq.gov/fund/grantix.htm.

Would much smaller research applications, but otherwise consistent with the FOA, be considered responsive?

The goal of this particular FOA is to request applications for large projects, up to $10 million over 3 years, in comparative effectiveness aimed at generating new knowledge to help inform decisionmaking in priority areas of clinical care. Though the FOA did not explicitly preclude the submission of applications with variable scopes and sizes, research applications that are substantially smaller (e.g., in the range of $1.5 - $3.0 million over 3 years, similar to those under the usual AHRQ research grants programs) do not reflect the intent of this FOA.

Funding for this FOA was made available through the American Recovery and Reinvestment Act of 2009. This was a one-time investment of funds in comparative effectiveness research. Investigators also are reminded that AHRQ continues to support and welcome innovative research applications employing a broad array of methods to examine the effectiveness of existing and emerging health care services through a range of standing program announcements and specific requests for applications. In addition to the CHOICE FOA, investigators are encouraged to review and consider many funding opportunities that can be found at http://www.ahrq.gov/fund/grantix.htm.

Update as of 12/1/09

Does an intervention have to be proven in the disparity population under study before being included in an effectiveness study, or is the general population sufficient?

One of the goals of the FOA is to establish comparative effectiveness for existing interventions in previously under-represented population subgroups. As such, studies designed to address and assess the generalizability and/or heterogeneity of treatment effects across different populations of interest and the disparity population are within the scope of the FOA. It should also be noted that one of the stated FOA review criteria is that the population selected for study is important and that disproportionately affected subpopulations or previously under-represented populations will be included in sufficient numbers to allow subpopulation analysis.

Can two different applications on a similar topic be considered simultaneously by two different agencies?

The investigators are advised to ensure that applications submitted to different U.S. Public Health Service agencies for review and funding consideration have distinctly different study scopes and research questions. The applications should also explicitly address how the two studies have separate aims and involve different research capacity and resources, and they should adequately justify the budgetary requirements and implications. If the two applications are different, you do not need to withdraw a previously submitted application. If the two proposals are substantially equivalent, then only one application should be submitted for consideration.

Are cost-effectiveness questions appropriate for secondary aims of the CHOICE Grants?

Regarding the issue of economic analysis and costs, the FOA does not explicitly preclude the inclusion of economic analysis as part of the overall study design, nor does it preclude the inclusion of costs as part of the outcomes measures. The applicants are advised to provide adequate scientific justification for the proposed analytical approaches and the outcomes of importance, and how the proposed secondary study aims and outcomes contribute to and are tightly related to the primary objective of the comparative effectiveness study.

Is capitation payment per patient enrolled a permissible budgetary arrangement in lieu of consortia/subcontract arrangements to support the effort of individual clinical centers participating in a research network?

Appropriate budgeting of such costs depends on the specifics of individual study configurations, governance structure, and research activities. If these sites are involved in carrying out programmatic activity, the agreements would be considered consortia agreements and individual agreements would be needed. If, however, the applicant institution is procuring goods or services or prescribed activities from these sites, these agreements would most likely be considered subcontracts and you would follow your institution's established procurement policy to establish the subcontract(s). Please be sure to consult with your sponsored programs office for institutional guidance.

Because AHRQ normally does not see capitation payments in AHRQ grant application requests, this may be an issue of concern during the peer review of your application submission. Keep in mind that all costs requested in grant applications must be fully justified and supported and must meet four tests in determining the allowability of costs (i.e., reasonableness, allocability, consistency, and conformance). These four tests apply regardless of whether the particular category of costs is one specified in the cost principles or one governed by other terms and conditions of the award. These tests also apply regardless of whether costs are treated as direct costs or indirect costs. The fact that a proposed cost is awarded as requested by an applicant does not indicate a determination of allowability (http://www.dhhs.gov/grantsnet/docs/HHSGPS_107.doc#_Toc155580209). (Microsoft® Word® files can be viewed with the free Word® Viewer. Exit Disclaimer).

Can I submit an application for a study period longer than 3 years if I include a letter of support from another organization that will support funding in the subsequent years of the project?

The FOA states that applications with project periods that exceed 3 years, total costs in any one year that exceed $4 million, or budgets that exceed $10 million in total costs over the project period will not be reviewed. It is advisable to describe the proposed study in phases in terms of followup periods and to describe the related study and analytical plans per hypotheses and protocols with variable followup lengths. This facilitates review of the study as a viable 3-year project and any additional plans and resources available (e.g., additional external third-party funding) as enabling the longer term followup and outcomes.

It should also be noted that the FOA suggested that, contingent upon the availability of funds, a limited competition solicitation may be announced in fiscal year 2012 for selected projects awarded under this current FOA to support followup studies (e.g., longitudinal outcomes).

What supporting information should be included in the application, and what can be submitted later under just-in-time procedures?

AHRQ uses just-in-time procedures, which allow limited information (e.g., a budget justification and a biographical sketch) to be submitted with the applications. Later, if the application is under consideration for funding, AHRQ staff will request the additional information needed before a notice of grant award is issued. For example, just-in-time procedures allow an applicant to defer certification of institutional review board (IRB) approval of the project's proposed use of human subjects and evidence of compliance with the requirement for education in the protection of human research participants until after completion of the application's peer review and just prior to funding.

For multicenter studies, a complete subaward/consortium budget component (including the budget justification section) should be completed by each consortium grantee organization. Separate budgets are required only for subawardee/consortium organizations that perform a substantive portion of the project. This information is required in the SF424 (R&R) application form and is not considered just-in-time information. Supporting letters from the site investigators at these collaborating institutions may be submitted with the application, and full letters of intent may be submitted later as just-in-time information.

What is the difference between Senior/Key Personnel and Other Significant Contributors in an application?

Senior/Key Personnel are defined as all individuals who contribute in a substantive, meaningful way to the scientific development or execution of the project, whether or not salaries are requested. Consultants should be included if they meet this definition.

Other Significant Contributors are individuals who have committed to contribute to the scientific development or execution of the project but are not committing any specified measurable effort (in person months) to the project. These individuals are typically presented at "effort of zero person months" or "as needed." (Individuals with measurable effort cannot be listed as Other Significant Contributors.) Consultants should be included if they meet this definition. Other Significant Contributors should include their biosketches.

The measurable effort to be contributed is one of the key features distinguishing Key Personnel from Other Significant Contributors on the application.

Current as of December 2009

 

The information on this page is archived and provided for reference purposes only.

 

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