AHRQ Mentored Clinical Scientists Comparative Effectiveness Development Award

Questions and Answers

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The following are responses to frequently-asked questions received in response to the solicitation. This list will be updated once or twice weekly as needed:

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Program Scope/Focus/Application Preparation

Question 1: Is AHRQ looking for training programs that offer a wide variety of CER experiences, or could the design/approach be more focused?

Answer 1: It may be appropriate to focus the design/approach of the program to fit the strengths experiences of the applicant institution/faculty mentors. The particular focus would need to be explained, supported, and adequately justified in the application.

Question 2: There are several places in the RFA that stakeholder group input is mentioned. I was wondering what form this input was being envisioned? Does the K12 program have to use the AHRQ Stakeholder group or the expectation is that local groups are to be formed that will provide stakeholder input?

Answer 2: The FOA notes that applications must demonstrate active involvement of stakeholders to ensure that the research is responsive to stakeholder needs and how the stakeholders will use the information in their decision-making. The definition of what constitutes a stakeholder and the manner/format in which stakeholder involvement is provided to the program is not specified by AHRQ. Applicants need to define and justify who their stakeholders are and how their input will be obtained.

Question 3: Is it expected that applicants will propose only one cohort of K-12 recipients for 3 years of funding? Is there a possibility of competitive renewal after the three year cycle?

Answer 3: Yes, it is expected that applicants will propose only one cohort of K-12 scholars for 3 years of funding. We have no plans at this time regarding any possibility for competitive renewal at the end of the 3 year cycle for grantees under this award program.

Question 4: Is there a requisite (minimum) number of scholar candidates that can be requested in the application?

Answer 4: A cohort will have a minimum of two scholars.

Question 5: When the grant application is submitted in January, applicants may not know who the precise funded scholars and mentors will be.Can applicants simply list 5 “TBN Mentors” (one for each Scholar) on the budget page and explain this in the budget justification? Also, the RFA states that, for key personnel, “Information should be provided for the PD/PI, Mentors, and internal Advisory Committee members participating in the Program.” That is not a problem at all for the PI/PD or the Advisory Committee (including the external member). However, if specific mentors are not known at the time of the application because specific scholars may not be known at that time, what should be done about the mentors being listed as key personnel on Page 2 of the application.

Answer 5: Applicant can list "TBN mentors" and explain in the budget justification.They can also also include names and biosketches and/or brief blurbs in the text of the application describing potential mentors and their qualifications.

Question 6: What application form should be used?

Answer 6: Applicants must use the 11/07 version of the PHS 398, per instructions noted on the link provided in the FOA application instructions — http://grants.nih.gov/grants/funding/phs398/phs398.html

Question 7: Should we use the PHS 398 budget forms or the Institutional Training Substitute budget forms?

Answer 7: Applicants should use the standard budget forms of the 398.

Question 8: Please clarify who needs a letter of support. The application will be processed through our university. However, our university has a large Clinical and Translational Science Institute (CTSI) grant from NIH, which includes many external institutional partners (e.g., other universities) in addition to our own university. Even though all are members of the CTSI should we include letters of support from each organization?

Answer 8: The RFA provides a description of the information that should be documented in letters of support. It is up to the applicant organization to determine and define the nature of participating and/or supporting entities for their proposed program and for whom they deem it is relevant to provide letters of support.

Question 9: In describing our mentor's CER research base for the K12 we would like to be able to highlight some of our prior publications but are uncertain where to include these citations. There is no instruction regarding the “Literature Cited”. Please advise.

Answer 9: The page limitations for The Clinical Research Career Development Program (must not exceed 25 pages, including any tables or charts) described in the FOA apply to Items 2-5 of the Research Plan in the instructions for the PHS 398. The application should be organized as per the PHS 398 instructions with the specific additional information as detailed in the FOA. The other items from the Research Plan should still be included as appropriate, and do not count toward the 25 page limitation noted above.

Institution, PI/PD and Scholar Eligibility/Candidate Selection

Question 10: What does the term “limited” signify in the title of the announcement?

Answer 10: If your institution meets the eligibility requirements and fits with the research objectives outlined in the announcement, you are eligible to apply.

Question 11: The RFA says "Proposed mentors must have an AHRQ, NIH, or other equivalent large research grant or contract (e.g. R01)..." Does this require that the mentor be a PI/PD of the relevant grant, or could Co-Investigators also qualify? Are R21s included — do they count as large? Are large foundation grants (multi-year, similar scale as R01) included?

Answer 11: Language related to having a grant, means someone has to be a PI/PD on the large grant. If the R21 exceeds $100,000 annually for more than one-year (in direct costs), it is considered large. Large foundation grants (multi-year, similar scale as R01) are included.

Question 12: We are considering developing residency fellowship program with a focus on translational research. If we include 3 years worth of 75% effort for the research mentoring and projects within the residency/fellowship structure would this be considered as responsive to the RFA?

Do K12 scholars need to have faculty appointments, or can they be appointed as post-graduate fellows (e.g., post-MD and/or post-PhD)?

Answer 12: For the K12 program, a scholar candidate must have a “full time” appointment at the academic institution that is the applicant institution at the time of the award. With respect to levels of prior research experience, candidates should resemble those candidates supported by the individual mentored Clinical Scientist Development (K08) or the Mentored Research Scientist Development Award (K01) described at http://www.ahrq.gov/fund/training/rsrchtng.htm#MRSDA. Each institution determines the appointment status of an individual. Generally, however, applicants for Career Development awards, hold a full-time faculty or research appointment at the institution. Candidates must be able to commit a minimum of 9 person-months (75% of full-time professional effort) conducting research career development activities associated with this award for a consecutive three-year period of time. The remaining 3 months (25% effort) can be divided among other research, clinical, and teaching activities only if these activities are consistent with the goals of the Award, i.e., the candidate's development into an independent investigator. Career development funds do not support clinical training. In addition, these programs must be focused in the area of Comparative Effectiveness Research.

Question 13: The RFA indicates that a candidate for appointment as a scholar on this award may not simultaneously submit or have an application pending for an AHRQ/NIH career award (e.g., K08, K23). Does this mean that a scholar cannot have such a K award application pending at the time of their appointment on the K12, or does this mean that he/she cannot submit an individual K award application at any time during his/her support through the K12?

Answer 13: A candidate for the K12 award may not simultaneously submit, be on,or have pending an application for any other AHRQ or NIH career award (e.g., K01, K07, K08, K18, K22, K23, K24, K25, K99) or any PHS award that duplicates any of the provisions of the K12 award. AHRQ needs to discuss and develop its policy with regard to whether a scholar appointed to a K12 can submit an individual mentored career development application to AHRQ for activation after completion of the appointment on a K12 or similar institutional career development grant. Scholars appointed to AHRQ's K12 and applying for an NIH individual mentored career development grant upon completion of training on AHRQ's K12 grant would need to adhere to the policies of individual NIH Institutes.

Question 14: Since there is only one cohort of scholars, is it appropriate for us to select them before the application so that we can include details of their qualifications and plans? Or, should we present a larger slate of candidates (with less detail) and a selection process? Or, as is usual in K12 awards, just a description of the pool in general and a selection process?

Answer 14: Both options are included. As the FOA notes, "Applicants must describe a recruitment plan that includes a strategy for recruiting candidates. The plan should address the depth and diversity of the applicant pool, including those underrepresented in health services research. These individuals may include underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research. The plan should demonstrate that a sufficient cadre of potential scholars is available to ensure that all requested positions will be filled by July 1, 2010 and that all of the scholars will commit to full, three-year term appointments. To the extent possible the plan should list and briefly describe specific potential candidates, and their research interests." Applicants can include specific names of and plans for candidates for scholar appointments selected before the application is submitted.

Appointment Periods

Question 15: Can the potential start dates for faculty scholars be 9/1/10 or later? Will the end date for the award then be 8/30/13? If the start date is later, will the end date be later as well?

Answer 15: We are hoping to be able to have the start dates for faculty scholars to occur as early as July 1, 2010 and as late as September 30, 2010. Ideally, we would want the end dates for the K12 faculty scholars to be the last day of the grant award, but are flexible so long as the end date occurs prior to October 1, 2013.

Allowable Costs

Question 16: Does the 90K in maximum annual salary support for the faculty member include fringe benefits?

Answer 16: Fringe benefits will be included in addition to the 90K salary.

Question 17: Can Assistant Program Director and Administrative Assistant costs be covered under the grant?

Answer 17: An Assistant Program Director is not included as an allowable cost. Limited administrative and clerical salary costs associated distinctly with the program that are not normally provided by the applicant institution may be direct charges to the grant only when specifically identified, reasonable, and justified.

Question 18: Is it reasonable to use grant support to enhance or develop one or more methodological emphases area, such as supporting biostatisticians to create seminars or courses on methods for analyzing observational data?

Answer 18: No. Grant support can only be used to cover expenses delineated in the RFA.

Question 19: Will faculty supported by the grants be able to apply funds to their own research?

Answer 19: The K12 includes some allowable costs for PD/PI salary and for faculty mentoring, not for the conduct of their research. For each appointed K12 scholar, AHRQ will allow up to $25,000 annually for their research-related costs — examples include consultants, supplies, equipment, technical personnel, data, travel, and statistical services, and other program-related expenses. These costs must be justified as specifically required by the proposed program and must not duplicate items generally available at or through the grantee institution. K12 Scholars should be strongly encouraged also to apply for independent research grant support (e.g., R01, R21, R03) by the end of their third year appointment.

Question 20: Does the $5,000 for mentor support need to go toward their salary support or can it be used to provide mentors with other research support (e.g., research assistant) instead?

Answer 20: The $5,000 needs to go to salary support/fringe benefits since the announcement specifically states so in the following statement — "Salary and fringe benefit support for mentors cannot exceed $5,000 annually per scholar."

Question 21: We are using the NIH salary cap for PD/PI salary calculations but wanted to know if you are aware that based on this, 10% of the PD/PI salary plus fringe will exceed the grant maximum allowable amount of $25,000 per year for PD/PI support.

Answer 21: Although 10% of the salary, plus fringe benefits, may exceed $25,000, the FOA notes that "support for the PD/PI may be requested but may not exceed $25,000 annually, including fringe benefits." The PD/PD is still expected to devote the required time commitment.

Question 22: The RFA does not mention anything about the tuition. Can we budget tuition as an allowable expense over and above the $25,000 annually approved for research related costs?

Answer 22: No. For each appointed K12 scholar, AHRQ will allow up to $25,000 annually for their research-related costs — examples include consultants, supplies, equipment, technical personnel, data, travel, and statistical services, and other program-related expenses. If tuition is a program-related expense, it may be included and justified within the $25,000 allowable cost.

Tables and Appendices

Question 23: Are there required tables for the application similar to those used for the T32 NRSA Institutional Training Grant applications?

Answer 23: There are no required tables. Note that the content component of the "Clinical Research Career Development Program" in the application must not exceed 25 pages, including any tables or charts.

Question 24: Could you clarify what materials are required to be included in the appendices? Can curricula be included?

Answer 24: There are no required appendices. Also, note that appendices cannot be used to circumvent the page limitations. An application that does not observe the required page limitations may be delayed in the review process and may not be reviewed. Letters of support and consortium/contractual arrangements should not be included in appendices. Any appendix materials you choose to provide must follow the guidance for appendix materials provided for the instructions in the PHS 398.

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Current as of January 15, 2009