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Frequently Asked Questions for RM12-023 and RM12-024

 

  1. What is the NIH Common Fund and how is this different than applying for a grant from an individual Institute or Center?
  2. Why does this FOA use the U01 mechanism? How does the U01 compare to the R01?
  3. Should there be an economist on the research team?
  4. What Study Section will review my application?
  5. [For applications that will propose their own advisory board:] Should the application include names of proposed advisory board members or is it best to leave them off so as not to preclude them from being reviewers?
  6. Should I name someone at NIH as our Project Scientist?
  7. What will the Steering Committees do?
  8. Do I need to budget for future activities that the Steering Committee might undertake?
  9. How big should I make the project and how many components should I have?
  10. Will there be a distinct Data Coordination Center for these cooperative agreements?
  11. Are applications with multiple Principal Investigators allowed?
  12. I still have questions—whom should I contact?

 

What is the NIH Common Fund and how is this different than applying for a grant from an individual Institute or Center?
The NIH Common Fund was enacted into law by Congress through the 2006 NIH Reform Act to support transformative cross-cutting, trans-NIH programs. These programs typically involve a series of integrated initiatives that collectively address the goals of the program. Additional information about the Common Fund can be found at http://commonfund.nih.gov/about.

The Health Economics program is one of 28 Common Fund initiatives. The goals of Health Economics are to: (1) build research capacity in health economics such that future NIH-supported research is informed by economic analysis of factors that influence health and the adoption of NIH-supported innovations; (2) identify factors that influence optimal adoption of high-value health technologies; (3) investigate the conditions under which personalized medicine approaches have the greatest likelihood of adding value and determine facilitators and barriers to appropriate adoption; (4) develop one or more products or tools (e.g., syntheses, guidelines, databases) that address the lack of adequate or available data needed to conduct economic analyses that inform the translation of NIH-supported research into practice within the changing context of the health care system.

Funding opportunity announcements (FOAs) for the Health Economics Common Fund program are developed by a Working Group consisting of representatives of multiple Institutes and Centers. The applications are reviewed by a Special Emphasis Panel and considered by the Working Group. Once awards are made, each grant will be assigned a Program Officer from an individual Institute. However, the Common Fund funds the grants. The Health Economics program has several existing funded grants, a list of which can be found at http://commonfund.nih.gov/Healtheconomics/fundedresearch.

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Why does this FOA use the U01 mechanism? How does the U01 compare to the R01?
The U01 or cooperative agreement mechanism is used by many Common Fund Programs. Common Fund programs are designed to be catalytic and achieve a defined set of high impact goals within a limited timeframe. The current U01 FOAs for the Health Economics Common Fund Program are intended to provide generalizable understanding and through synthesis of these efforts to improve the process leading from scientific advances to health improvement. The U01 (a cooperative agreement) is a support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH staff will assist, guide, coordinate, or participate in project activities. NIH staff will not dictate specific details of individual projects, but rather provide a framework through the Steering Committee that can facilitate communication and build synergy among investigators working in this area, with the aim of establishing a solid foundation for development of this field. Each grant will be assigned a Program Officer and a Project Scientist.

Applications for these U01 awards are very similar to R01 applications, and the scope of work should also be similar to what would be proposed for an R01 (subject to the larger objectives of Common Fund initiatives). In particular, the research plan for this U01 application should be the same as for an R01. The budget should include funds for the Principal Investigator to travel to Bethesda, MD to participate in twice yearly Steering Committee meetings.

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Should there be an economist on the research team?
The review criteria for judging investigator(s) in RFA-RM-12-024 include, “Does the project team include extensive and appropriate research expertise in economics and in the aspects of personalized health care or prevention addressed by the project aims?”, so inclusion of one or more project team members with extensive training and/or experience in economics and with a significant role on the research team is well advised. Likewise, RFA-RM-12-023 states that “(p)rojects involving multidisciplinary teams led by a health economist, or with the substantial involvement of a health economist, are encouraged”.

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What Study Section will review my application?
The initial review committee for each RFA will be an ad hoc Scientific Review Committee of outside experts composed by the Center for Scientific Review and will be named after the applications have been submitted. These committees will include experts appropriate for the science in the applications. Applicants will receive a notice through NIH Commons before the committee meets with the exact assignment and date of the meeting. As always, investigators are welcome to submit a cover letter (which the reviewers do not see) listing any needs for particular expertise which they would like to call to the Review Officer’s attention. Guidance on cover letters is available at http://public.csr.nih.gov/ApplicantResources/PlanningWritingSubmitting/Pages/Cover-Letters-Help-Us-Refer-and-Review-Your-Application-.aspx, but note that there will be no choice as to the review group to which the application will be assigned. Second-stage review for applications will be provided by the national advisory council of the NIH Institute or Center of the Program Officer assigned to it.

Prior to review, NIH staff will screen each application for responsiveness to the FOA. This screening is intended to ensure that applications at least minimally address the scientific requirements of the announcement. . Applicants are encouraged to discuss their proposed projects with the Scientific Contact listed in the FOA prior to submission for preliminary feedback regarding responsiveness to the FOA. Reviewers will be briefed on the objectives of the FOA and the goals of the Common Fund program and may provide in their critiques their view of how well the application responds to the FOA.

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[For applications that will propose their own advisory board:] Should the application include names of proposed advisory board members or is it best to leave them off so as not to preclude them from being reviewers?
This decision is left to the applicant. No one who is named in an application could serve as a reviewer for that application. Applicants may prefer to describe the qualifications and expertise of potential advisory board members rather than name individual prospective members. Advisory boards are not required.

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Should I name someone at NIH as our Project Scientist?
No. Applications should not name any NIH staff member for any role (except if NIH intramural scientists are involved as co-investigators, in which case see section IV.6 of the RFA). Each application judged to be responsive to the RFA will be assigned to a Program Officer at NIH before review. After review, the chairs of the Health Economics Working Group will assign a Project Scientist to those applications likely to receive an award. Principal Investigators can certainly make recommendations, but the decision will be made by the chairs.

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What will the Steering Committees do?
The Project Scientist and Steering Committee roles will commence after awards are made. Post-award, the Steering Committee will provide a framework that can facilitate communication and build synergy among investigators working in this area, with the aim of establishing a solid foundation for development of the fields. The Steering Committee will not direct or otherwise influence the details of individual projects. The Steering Committee, consisting of each Principal Investigator and corresponding Project Scientist, will meet twice a year in Bethesda, MD.

Future activities of the Steering Committees, which will cut across individual projects, will be decided by the Steering Committees after the individual awards have been made. These could include methodological or substantive workshops; data harmonization; sharing of resources such as data sets, models and estimation methods; development of new data resources; or small collaborations or exchanges between related projects.

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Do I need to budget for future activities that the Steering Committee might undertake?
The application budget need only include funds for the Principal Investigator or designee to participate in person in meetings of the Steering Committee in Bethesda, Maryland. (Section IV, 2, Content and Form of Application Submission: “Application budgets should include funds for participation of one investigator in twice-yearly 1-day Steering Committee meetings in Bethesda, MD.”)

If funding allows, the Common Fund Health Economics program will fund any truly common activities of the Steering Committee. Except as noted for travel to Steering Committee meetings, the budgets in the applications for the RFAs should only reflect what is needed for the work proposed in the individual application.

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How big should I make the project and how many components should I have?
Budgets are not limited, but as always, proposed budgets “must reflect the actual needs of the proposed project.” The total amount expected to be available for each RFA is $2.7 million for the first year (total costs, both direct and indirect, for all projects) and the hope is to make “six to eight” awards. There is always variation in the size of awards from an RFA; one can propose a complex award on the larger end of the expected range—but the expectation before review is that awards will be approximately the size of an average R01, with scope to match.

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Will there be a distinct Data Coordination Center for these cooperative agreements?
No.

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Are applications with multiple Principal Investigators allowed?
Yes. A justification for a multiple Principal Investigator arrangement is a required part of any such application, and reviewers do consider this. Applicants should pursue this option if—but only if—it makes scientific sense for your project.

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I still have questions—whom should I contact?
Contact John Haaga (HaagaJ@mail.nih.gov) for questions about RM12-023 and Gregory Bloss (Gregory.Bloss@nih.gov) for questions about RM12-024.

 

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