Limited Competition: Enhancing Investments in Comparative Effectiveness Research Resources (R01)
Frequently Asked Questions
The following questions are derived from individual questions submitted to CERDataResourcesFOA@ahrq.hhs.gov about the Request for Applications (RFA) HS-13-011: Limited Competition: Enhancing Investments in Comparative Effectiveness Research Resources (R01) and are shared here for all potential applicants. We encourage applicants to review all replies and to monitor this site for newly added questions and answers.
A. Eligibility/Number of Application Submissions
B. Determining Suitability of the Theme, Projects, or Research Ideas for Submission
C. Formatting, Organization, and Page Limits of Submissions
D. Letters of Intent
Question A1: What organizations are eligible to apply?
Answer A1: Only organizations that currently hold a grant awarded under one of the four Funding Opportunity Announcements (FOAs) listed in Section I of this FOA may submit an application. The four FOAs are:
Recovery Act 2009 Limited Competition: AHRQ Clinical and Health Outcomes Initiative in Comparative Effectiveness (CHOICE) Grants (R01) - RFA-HS-10-003 (see http://grants.nih.gov/grants/guide/rfa-files/RFA-HS-10-003.html)
ARRA-AHRQ Recovery Act 2009 Limited Competition: PROSPECT Studies: Building New Clinical Infrastructure for Comparative Effectiveness Research (R01) - RFA-HS-10-005 (see http://grants.nih.gov/grants/guide/rfa-files/RFA-HS-10-005.html)
ARRA OS Recovery Act 2009 Limited Competition: Enhanced Registries for Quality Improvement and Comparative Effectiveness Research (R01) - RFA-HS-10-020 (see http://grants.nih.gov/grants/guide/rfa-files/RFA-HS-10-020.html)
ARRA OS: Recovery Act 2009 Limited Competition: Scalable Distributed Research Networks for Comparative Effectiveness Research (R01) - RFA-HS-10-015 (see http://grants.nih.gov/grants/guide/rfa-files/RFA-HS-10-015.html)
This FOA is a limited competition. The goal of this FOA is to extend the usefulness of research and clinical infrastructure developed within the four grant programs listed in Section I to answer new research questions in comparative effectiveness. Thus, only those primary recipient institutions that currently hold grants funded under one of the four FOAs listed in Section I of this FOA are eligible to apply.
Question A2: Can eligible organizations that currently hold more than one grant awarded under any of the four FOAs listed in Section I of this FOA submit more than one application?
Answer A2: Yes. Institutions that hold more than one grant funded under one or more of the four FOAs listed in Section I of this FOA may submit one application for each of the current awards.
Question B1: How can applicants determine if their planned approach is a good fit for this FOA?
Answer B1: Applicants are strongly encouraged to read the FOA closely, including its explicitly stated objectives and review criteria; this is the best available guidance to potential applicants about the responsiveness of their planned research. Applicants should be aware that the determination of suitability and responsiveness of applications is within the purview and authority of the Special Emphasis Panel, not AHRQ.
Question B2: Is it suitable for applicants to collect/link specific data elements (e.g., biomarkers, serum porcelain levels) to the current project?
Answer B2: Unfortunately, we are unable to comment on specific aims or proposals. Applicants are strongly encouraged to read the FOA closely, including its explicitly stated objectives and review criteria; this is the best available guidance to potential applicants about the responsiveness of their planned research.
Applicants should be aware that the determination of suitability and responsiveness of applications is within the purview and authority of the Special Emphasis Panel, not AHRQ.
As to whether adding or linking to a specific data element or set of elements fits with the FOA, we refer applicants to Section I, Objective 1 of the FOA. Please note, applications must meet all three objectives to be considered responsive.
The three objectives of this FOA are to:
1. Enhance existing data infrastructure. To enhance data infrastructure, applicants could propose, for example:
- To collect additional data to supplement the current data infrastructure. These additional data could comprise additional collection of new data elements for current study participants and/or recruit additional participants to fulfill a need specifically identified by a stakeholder, e.g. to evaluate heterogeneity or expand findings in an underrepresented subgroup for which the study is currently underpowered. Since the FOA covers infrastructure and not research, data collection to enhance infrastructure for future research to address research questions is allowable, but the FOA does not cover research to evaluate the questions.
- To collect longer-term follow-up data on current participants to ascertain the impact of CER interventions on meaningful patient–centered outcomes. Additional longitudinal data may overcome the limitation of analysis of short duration outcomes imposed by the limited time-frame of the original studies, should potential users of these data for decision making require longer-term outcomes.
- To link existing data to external data, allowing innovative analytic methods to address new stakeholder-relevant questions.
- To validate newly created research tools and software for CER or PCOR in different patient populations and/or extend the applicability of these tools to new populations.
2. Enhance stakeholder engagement to understand their needs. To enhance stakeholder engagement, the applicants could add to diversity and number of existing stakeholders, increase intensity of engagement and explicitly ask questions to better understand their needs. This is necessary to move the data infrastructure to a model that moves towards economic sustainability of the research infrastructure by being useful for clinical practice and/or quality improvement. Expanding the multi-functional capability of the infrastructure to meet the needs of diverse stakeholders will support long-term stakeholder participation and the ultimate sustainability of the infrastructure. The infrastructure capability to address research questions includes clinical effectiveness and comparative clinical effectiveness of health care interventions for prognostic, preventive, diagnostic, therapeutic, or palliative purposes, and the interventions could include drugs, devices, surgical procedures, behavioral, or health system interventions.
3. Assess the capability of the data infrastructure to meet stakeholder needs. The resources for this FOA will not allow for the conduct of a research study. Applications that propose the conduct of research will not undergo peer review or be considered for funding. However, pilot projects to test the completeness and accuracy of the infrastructure in order to ascertain the validity of the infrastructure will be helpful in evaluating and planning for future use and development of the infrastructure as a resource for CER or PCOR to meet stakeholder needs. The pilot study will not be a research study, i.e. the aim of the pilot study is to evaluate the capability of the resources for conduct of future research to answer the relevant research questions guiding infrastructure development rather than to answer these research questions. In order to test that capability, it is important to know whether the infrastructure can collect or is collecting relevant and valid data. Examples of evaluating the capability of the infrastructure include, but are not limited to evaluation of: the diverse patient subgroups that are included in the network; the linkages between different databases (e.g. diagnostic, pharmacy, claims, EHRs); the ease of extracting information from these databases; the completeness and accuracy of the data elements; the analytic and clinical utility of the data elements; the details on the clinical interventions available in the infrastructure (e.g. the types of devices used in procedures or the types of patient-reported outcomes collected); and the governance and policy structures established to comply with relevant regulations. Applicants should not budget more than 20% of total grant funds for the pilot projects.
Applications that address development of infrastructure in the absence of improved stakeholder engagement or assessing the capability to answer an explicit and relevant research question will be deemed non-responsive and will not undergo review. The conduct of the proposed project should guide the opportunities to improve the chance for sustainability of the current research infrastructure. Thus, as part of the project plan, the application must delineate a process to enhance the sustainability of the resource. This process could consider, for future research purposes, issues such as maintenance of the research infrastructure (including personnel and data repositories), establishing or maintaining data linkages and data infrastructure, researcher access to and interface with data resources, and data reporting.
Question B3: Can applicants discuss the scientific and research aspects of their proposals with AHRQ over the phone?
Answer B3: AHRQ appreciates all expressions of interest from prospective applicants. Applicants should read the FOA closely, including its review criteria; this is the best available guidance to potential applicants about the responsiveness of their planned research.
Applicants who have specific questions after reviewing the FOA can Email their questions to CERDataResourcesFOA@ahrq.hhs.gov. For reasons of equity and consistency, AHRQ scientific staff responds in writing to all inquiries. Wherever it is possible and appropriate, AHRQ will clarify common areas of uncertainty in a written and generalized format that is applicable for dissemination to other potential applicants, such as frequently asked questions. Telephone counseling on potential study ideas is discouraged in order to be equitable and avoid potential misdirection of applicants.
Question C1: Are applications allowed to have appendices?
Answer C1: Applications may include an appendix, but applicants should not use the appendix to circumvent the specific page limit for the Research Strategy component. Applicants should observe the page number limits specified in the FOA. Applications will be rejected if they do not comply with these requirements.
Question C2: Does the 12-page limit for the Research Strategy section of the application include the Specific Aims?
Answer C2: No. The Specific Aims are limited to one page, and that page is separate from the Research Strategy. It does not count toward the 1-page limit.
Question C3: Can the tables and figures be in a smaller font size?
Answer C3: Yes. A font size smaller than 11-point font may be used for figures, graphs, diagrams, charts, tables, figure legends, and footnotes; however, the font type must follow the font typeface requirement (Palatino, Georgia, Arial, or Helvetica) and be readily legible.
Question C4: Is there a page limit for the appendix?
Answer C4: The FOA does not restrict the number of pages in the appendix, stating only that applicants should not use the appendix to circumvent the page limit of the Research Plan.
Question C5: Should applications include a 1-page introduction?
Answer C5: Applications for this FOA are considered new applications, so applicants should not submit a 1-page introduction. Applicants will find that they do not have the ability to submit an introduction in the SF 424 form. The FOA includes text about an introduction page; however, this text was part of a template for revised or resubmitted applications, and does not apply to this particular FOA.
Question D1: What specific information should be in the letter of intent? Is there a particular format or length?
Answer D1: As stated in the FOA, the letter of intent allows AHRQ staff to estimate the potential peer review workload and plan the review accordingly (that is, anticipate the nature of reviewer expertise that will be required). Prospective applicants may submit a letter of intent that includes an acknowledgement of interest in this funding opportunity and the following information:
- Descriptive title of proposed research
- Name(s), address(es), and telephone number(s) of the PD/PI
- Names of other key personnel
- Participating institution(s)
- Number and title of this funding opportunity
This letter of intent is not required, is not binding, and is not considered in the review of subsequent applications. AHRQ requests that letters of intent for this FOA be Emailed to CERDataResourcesFOA@ahrq.hhs.gov by June 7, 2013.
Question E1: Can part of the proposed budget be used to sustain current ARRA-funded activities that are part of the electronic clinical data infrastructure (as opposed to engaging stakeholders and conducting pilot assessments)?
Answer E1: The FOA allows support of infrastructure that is directly related to stakeholder engagement. The FOA also requests the conduct of pilot projects to assess the capability of the infrastructure to meet the future research needs of stakeholders. Any infrastructure support that is not related to stakeholder engagement or to pilot projects will be considered outside the scope of the FOA.
Question E2: Can applications include costs for meetings, such as travel, lodging, fees for the venue, and audiovisual equipment?
Answer E2: AHRQ policy prohibits the use of grant funds to pay for food-related costs, except when meal expenses are part of the per diem allowance for travel related to the performance of the grant.
Other costs, such as travel, lodging, fees for the venue, and equipment are allowed as long as they are justified, reasonable, and allocable to the grant. From a programmatic standpoint, the application should provide a rationale for the meeting that supports the objectives of the FOA.