A. Scope and Intent of the Type 1 Diabetes Impact Award Program
1. Why has the Type 1 Diabetes (T1D) Impact Award program been established?
A major goal of the NIH is to foster bold and creative investigator-initiated research. The NIDDK has created the Type 1 Diabetes Impact Award program (DP3) to facilitate the submission, support and review of exceptionally innovative, high risk, original and/or unconventional research that has the potential to provide major advances in type 1 diabetes research.
2. What distinguishes the type of research supported in a T1D Impact Award from a standard R01?
The Type 1 Diabetes Impact Award is different from a standard R01 in several ways: is expected that T1D Impact Award projects will reflect an exceptional level of creativity in proposing bold and highly innovative new approaches to fundamental scientific problems that relate to type 1 diabetes. Anticipated research outcomes must have a major impact on broad, important problems in T1D, or lead to major improvements in health of T1D patients through the development of highly innovative therapies, diagnostic tools, or preventive strategies. The topics of T1D autoimmunity, imaging and biomarker development, diabetic complications, and engineering the artificial pancreas are of high priority, and have been identified in a recent Diabetes Research Strategic Plan as important for propelling progress in type 1 diabetes research (http://diabetesplan.niddk.nih.gov). For more information about these specific topics of interest, see details provided in the FOA (RFA-DK-10-012).
Second, the Research Strategy section of the application is uniquely structured to focus on the project’s potential significance and impact for type 1 diabetes research. While all other sections of the application remain the same as for regular R01s (including Specific Aims, Project Summary/Abstract, Project Narrative, Bibliography and Literature Cited – limit one page, etc.), the heart of the proposal will be contained in the 12-page Research Strategy section of the PHS 398. Within this 12-page limit, applicants must follow precisely the form/format as described in the FOA, with appropriate subheadings and text limits for the 200 word Significance and Impact Statement and Project Description (combined up to 11 pages), Investigator Qualification (one-half page) and suitability for T1D Impact Award program (one-half page). Within this framework, applicants should present a strong and compelling case outlining the need or problem being addressed, the innovation or novelty associated with the project rationale and/or approach, and the breadth of the study’s potential impact.
Third, procedures for evaluating T1D Impact Award applications are distinct from the review process currently being used by the chartered NIH study sections. A multi-tiered editorial-style review will be conducted by the NIDDK Review Branch in an effort to determine the potential of the project to make seminal contributions toward solving important biomedical problems in T1D research.
3. What issues should be considered when thinking about an application to the T1D Impact Award Program?
4. T1D Impact Awards are meant to support new and novel research directions. What is meant by a "new and novel research direction?"
A new and novel research direction is one that is distinct from mainstream research currently or previously conducted by the applicant or by other investigators in the field. Successful applicants are expected to conduct innovative studies addressing current paradigms or obstacles in type 1 diabetes research. It is anticipated that such studies may be associated with a high level of risk. While a new research direction may have as its foundation the applicant’s prior work and expertise, it cannot be an obvious extension of an existing research enterprise. Rather, a new research direction must reflect a fundamental new insight into a problem that may derive from exceptionally innovative approaches and/or from radically unconventional hypotheses.
5. Are there particular scientific disciplines or topics targeted for emphasis under the T1D Impact Award program?
The NIDDK encourages T1D Impact Award project applications from scientists from all relevant disciplines that address fundamental questions or problems in type 1 diabetes research. Applications should be focused in areas of opportunity outlined in the draft diabetes research plan (http://diabetesplan.niddk.nih.gov). While applications in any area relevant to type 1 diabetes will be considered responsive, proposals addressing key questions or concepts in the areas of T1D autoimmunity, imaging and biomarker development, diabetic complications, and engineering the artificial pancreas are particularly encouraged (see the FOA for details).
6. Can someone at NIH review my idea and let me know if it is a good fit for the T1D Impact Award program?
General questions about the scope and intent of the T1D Impact Award solicitation should be directed to Dr. Kristin Abraham (abrahamk@mail.nih.gov).
Questions about potential topics for T1D Impact Award submissions can be directed to NIDDK Program Directors overseeing related portfolios, including:
7. Can this research also be applicable to type 2 diabetes? Can I use animal models of type 2 diabetes or include patients with type 2 diabetes?
Research projects for this FOA do not have to exclusively focus on type 1 diabetes, but can target concepts relevant to both forms of diabetes (type 1 and type 2) if the ideas and/or results are fundamental for advancing type 1 diabetes research. In circumstances where concepts classically associated with type 2 diabetes are examined in the context of type 1 diabetes, strong and compelling justification must be provided explaining how the study would dramatically advance our understanding of type 1 diabetes. In general, animal models to be used should exhibit phenotypes classically associated with type 1 diabetes, but models with related type 2 diabetes phenotypes may be used for specific purposes. For clinical studies, patients with type 1 diabetes must be included. Patients with type 2 diabetes could also be included if their addition was well justified.
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B. General Questions
1. How many awards will be made in 2011?
NIDDK intends to commit approximately $30 million (total costs) in FY2011 to fund 4-12 applications, contingent upon the availability of funds and the submission of a sufficient number of meritorious applications. Applicants may request up to $5 million direct costs to support a project period of 5 years (i.e., up to $1 million direct costs per year). The number of awards will depend on the size and scope of the most meritorious applications.
2. What budget and project period should I request?
Budgets should be commensurate with project needs over a five-year project period. Funds may be requested for personnel, supplies, equipment, subcontracts, and other allowable costs. You should estimate the direct costs for each year and sum them to derive the five-year total. Note that the direct and indirect costs for any subcontract must be included within the direct cost cap ($5 million over five years) for the budget from your institution. Only the five-year total should be requested, and must not add up to more than $5 million direct costs. Budget detail is not required and should not be submitted in the application. A detailed budget will be requested as part of the just-in-time documents and will be reviewed by NIDDK program and grants management staff prior to award.
3. Do I need prior approval to submit a proposal that exceeds $500K direct costs?
No. Because the T1D Impact Award FOA specifies that budgets up to $1 million direct costs per year may be requested, prior NIH approval is not required to submit proposals with budgets exceeding $500K direct costs.
4. Do T1D Impact Awards include indirect costs?
Yes. In addition to the direct costs, applicable facilities and administrative costs will be allowed.
5. How much time/effort are recipients expected to devote?
Principal investigators are expected to devote time commensurate to project needs, and follow general guidelines as for other NIH projects of similar size, complexity, and duration.
6. What post-award requirements must I fulfill?
You will be required to submit an annual report on or before the anniversary of the budget/project period start date of the award as outlined in NIH NOT-OD-11-010 (New Procedures and Instructions for Submitting Annual Progress Reports for Multi-Year Funded (MYF) Awards). In addition, to help the NIDDK evaluate this program, you may be contacted periodically to report on your latest research efforts.
7. May two or more scientists apply as a team for a T1D Impact Award?
Yes. Multi-PI applications and applications from multi- or inter-disciplinary teams are particularly encouraged.
8. Can the T1D Impact Award application include development of a dedicated core?
Support for a core may be included in the T1D Impact Award application if well justified as part of the overall research strategy; however, the DP3 is a research grant mechanism and as such will not generally be used for infrastructure development or support.
9. Can the T1D Impact Award application consist of a P01-style assembly of individual research projects focused on a common theme?
No, the T1D Impact Award should be organized as a single project with unified aims.
10. Will technology development be allowed, or just hypothesis-driven research?
Applications proposing hypothesis-driven research and those proposing the development of new tools and technologies are both encouraged. The focus is on applying creative and innovative approaches to major unsolved problems in type 1 diabetes research.
11. If my T1D Impact Award application is not funded, will I have an opportunity to revise and resubmit?
No. However, you may submit a new proposal in any future competitions, or you may be able to incorporate some elements of your proposal into a conventional R01 or R21 application.
12. Are T1D Impact Awards renewable?
No. Competing renewal applications for a Type 1 Diabetes Impact Award will not be allowed. At the end of the five-year T1D Impact Award project period, awardees are expected to seek support to continue their research through traditional routes, such as submission of an R01 grant application.
13. How will the program be administered?
Awards will be administered by NIDDK staff.
14. Why is the budget request for this grant mechanism different from other NIH grants?
Most other NIH grants require you to request an annual budget, either modular or detailed. For the Type 1 Diabetes Impact Award application, you are asked to request only the total five-year budget. We do not require, and will not accept, budgetary details (See FAQ Section D: Application Process for details.) The Type 1 Diabetes Impact Awards will be funded through the
Special Statutory Funding Program for Type 1 Diabetes Research. As this statutory funding program is scheduled to end at the end of Fiscal Year 2011, T1D Impact awards must be made by the end of the 2011 Fiscal Year.
15. Why are the budget period and project period for this grant mechanism the same?
For most NIH grants, funds are made available to the institution on a yearly basis. For the Type 1 Diabetes Impact Award, NIH will commit all five years of funding for each grant from the FY2011 budget (i.e. multi-year funding). This is an unusual feature for NIH grants, but it will have no effect on your ability to conduct your research.
16. If I receive a T1D Impact Award, will I still be considered a “new investigator” when I apply for my first R01 grant?
No.
17. Will the T1D Impact Award solicitation be repeated in 2011?
Future plans for additional T1D Impact Award solicitations will be contingent on availability of funds.
C. Eligibility
1. Are individuals at all stages of their careers eligible?
Yes, individuals at all career stages are eligible to apply. Women and members of groups underrepresented in biomedical or behavioral research are especially encouraged.
2. Are foreign scientists and institutions eligible?
Yes. However, applications from foreign institutions must comply with all NIH policies concerning grants to foreign (non-U.S.) organizations (for details, see http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260).
3. Are individuals employed by government agencies, non-academic, and/or for-profit organizations eligible?
Individuals from all organizations that can otherwise apply to the NIH for funding and that are willing to abide by the terms and conditions that NIH requires, with the exception of the NIH Intramural Research Program, are eligible for this award.
4. Are scientists in the NIH Intramural Research Program eligible?
No.
5. I am currently a postdoctoral fellow. Am I eligible to apply for a T1D Impact Award?
Applicants must be able to show concrete evidence for their claim of innovativeness and potential to conduct ground-breaking independent research in type 1 diabetes. This could be very difficult for a postdoctoral fellow who has never conducted independent research. In addition, like all NIH grants, the T1D Impact Award is made to institutions on behalf of investigators. Because most institutions will only authorize grant applications from individuals who are independent investigators, this could present an administrative barrier to applying.
6. Can the same project be submitted to two programs at the same time? While my T1D Impact Award application is pending, can I submit the same project for another NIH grant such as an R01? If I have an application pending, can I submit the same project for a T1D Impact Award?
The general policy of the Public Health Service, which includes the NIH, does not allow multiple submissions of essentially the same proposal to any of its components. T1D Impact Awards are meant to support projects that are substantially different from mainstream studies being pursued in the investigator’s lab or elsewhere. Applicants must explicitly address how the proposed research direction will differ from their past or current work and the reviewers will evaluate whether the project proposes an incremental advance in existing studies or a significant departure from existing work. In general, projects that are appropriate for more traditional grant mechanisms are not appropriate for the T1D Impact Award.
D. 2011 Application Process
1. How does the content of a T1D Impact Award application differ from the content of a conventional R01 application?
| T1D Impact Award | Conventional R01 | |
| Introduction | Omit | Include if amended application |
| Budget | Provide only overall total costs for 5 year project period | Modular or categorical |
| Budget Justification | None | SF 424 R&R 4.7.3 Item K |
| Specific Aims | Limited to one page | Limited to one page |
|
Research Strategy (12 pages) |
Describes the Significance and Impact (200 words), the project (including any preliminary studies and experimental details), investigator qualifications, and suitability for T1D Impact Award. | Describe specific aims, background, significance, preliminary studies, and provide experimental details |
| Biosketch | Publications that illustrate innovation and significance of past accomplishments | Most recent publications |
2. How does the format of a T1D Impact Award application differ from the format of a conventional R01 application?
| T1D Impact Award | Conventional R01 | |
| Budget |
No limits up to $1million direct costs
per year No prior approvals required for budget requests exceeding $500K direct costs in any year No modular or categorical budget* *Do not include SF 424 R&R or PHS 398 Budget Component pages. Insert estimated project funding request covering all 5 years in Item 15 of the SF424 R&R Cover Component (4.2). Detailed budgets will be requested as part of "Just-in-Time" (JIT) submissions. |
No limits Prior approvals required for budget requests exceeding $500K direct costs in any year Modular or categorical budgets |
| Budget Justification | None. A brief description of components, personnel, and equipment needs may be provided within the Research Strategy. | Provided with both categorical and modular budgets |
| Terms | 5 years maximum; budget for entire project awarded at inception | 5 years maximum; budget provided in annual increments |
|
Research Strategy (12 pages) |
Contains: (a) 200 word Significance & Impact statement; (b) Project Description (up to 10.5 pages); (c) Investigator Qualifications (1/2 page); and (d) Suitability for T1D Impact Award (1/2 page). |
Contains: (a) Significance; (b) Innovation; (c) Approach. |
| Biosketch | Publications that illustrate innovation and significance of past accomplishments | Most recent publications |
3. What are the dates for submission of 2011 applications?
The application may be submitted to Grants.gov beginning February 11, 2011 and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization), March 11, 2011. Application materials will not be accepted after that time and applications that are not complete will not be evaluated.
4. Do I need to include preliminary data in my T1D Impact Award application?
No. Reviewers will focus on the challenge and approach to judge innovation, novelty, impact, and technical merit.
5. Should I include preliminary data, if I have any?
Yes, if preliminary data will help convince reviewers that the approach is logical and potentially worthwhile. However, be aware that there is no Preliminary Studies section in a T1D Impact Award application. If you have preliminary data, it should be briefly summarized in the Project Description section of the research strategy, which is limited to up to 10.5 pages.
6. Is there a limit to the number of applications that can be submitted by an individual or an institution?
Individuals may submit more than one application, provided each application is scientifically distinct. There is no limit to the number of applications an institution can submit.
7. What must be done before I submit an application to Grants.gov?
It is important that you check immediately with your sponsored research office to determine whether your institution is registered with Grants.gov. Please note that the registration process could take up to two weeks. The institution’s Authorized Organizational Representative (AOR) is responsible for completing the registration process. If your institution is not already registered, it must first register with the Central Contractor Registry (the Credential Provider) at http://www.ccr.gov/ and then with Grants.gov at http://www.grants.gov/GetStarted. Both the institution and the applicant must also complete a one-time registration in the NIH eRA Commons in order to submit applications to NIH. Institutional officials are responsible for registering investigators in the eRA Commons. You should work with your AOR (also known as Signing Official in the eRA Commons) to determine your own institution’s process for registration.
8. Where can I find help registering for Grants.gov?
For help with the Grants.gov registration process, contact Grants.gov customer support at 1-800-518-4726 (Toll Free), Monday–Friday, 7:00 a.m. to 9:00 p.m. (Eastern Standard Time), or at support@grants.gov.
9. Where can I find help in submitting my application to Grants.gov?
For help with the technical aspects of submitting an application to Grants.gov, check the resources available at Grants.gov. If you need assistance, contract Grants.gov customer support at 1-800-518-4726 (Toll Free), Monday through Friday, 7:00 a.m.–9:00 p.m. (Eastern Standard Time), or at support@grants.gov.
10. Where can I find help in registering for the eRA Commons?
Step-by-step directions for registering with eRA Commons are available at
http://commons.era.nih.gov/commons/registration/registrationInstructions.jsp.
For questions regarding the Commons registration process, contact the NIH eRA Commons help desk at phone: 301-402-7469 or 866-504-9552 (Toll Free); 301- 451-5939 (TTY) business hours Monday–Friday, 7:00 a.m.–8:00 p.m. (Eastern Standard Time).
E. Grants.Gov Application Documents
1. What format should I use for the documents submitted with my application to Grants.gov (abstract, biosketch, current research support, research plan)?
All documents must be in PDF format and provided according to instructions outlined in the FOA.
2. Does the 12-page research strategy with its components that are unique to T1D Impact Award applications replace the traditional “Research Strategy” or is it to be submitted in addition to that section?
The 12-page research strategy addressing the four bullet points outlined in the FOA replaces the traditional "Research Strategy" section required for most other NIH grant applications. Instructions for preparing a T1D Impact Award application are different from those for most other NIH grants. Read carefully the application instructions and review criteria in the FOA.
3. In my proposal, may I include citations to key publications? If so, what is the appropriate format?
Yes, you may include citations as a separate PDF (SF 424 R&R Item 4.4.9). Literature citations are limited to one page and do not count against the 12-page limitation for the Research Strategy. The citations may be in any format.
4. In my application, may I include figures and illustrations?
Yes, you may include figures and illustrations within the 12-page limit of the research plan. Do not include links to websites for further information, or animations.
5. Where do I submit the various required sections of the application?
DOCUMENTS TO BE UPLOADED: The following table is a summary of the documents that must be uploaded to the application. Detailed instructions for completing each application component are below.
| Document Name | Form/Field | Special Instructions |
| Project Summary/ Abstract | SF424 R and R Other Project Information Component, Field 7 | Maximum 30 lines of text |
| Project Narrative | SF 424 R and R Other Project Information Component, Field 8 | 2 – 3 sentences maximum |
| Bibliography and References Cited | SF 424 R and R Other Project Information Component, Field 9 | Limit one page |
| Facilities and Other Resources | SF 424 R and R Other Project Information Component, Field 10 | Complete as for regular R01 |
| Biographical Sketch | SF 424 R and R Senior/Key Person Profile, field titled “Attach Biographical Sketch” | Focus on publications that illustrate innovation and significance of past accomplishments |
| List of Current and Pending Research Support | SF424 Senior/Key Person Profile Component | Provide current year direct costs to applicant and percent effort for each project. Include detailed statements verifying no overlap between the T1D Impact Award application and existing or pending support. |
| Specific Aims | PHS 398 Research Plan, Field 2 | Complete as for regular R01 |
| Research Strategy | PHS 398 Research Plan, Field 3 (Research Strategy) | Twelve pages maximum; must include Significance and Impact Statement (200 words); Project Description (up to 10.5 pages); Investigator Qualifications (one-half page); Suitability for T1D Impact Award Program (one-half page). |
| Human and Vertebrate Animal Subjects Plans (If applicable) | PHS 398 Research Plan Component, Fields 6-10 | Complete instructions for the PHS398 Research Plan component are in the SF424 Application Guide, (*pdf), Section I, part 5 (Competing PHS 398 Components) – see page I-109. There are also supplemental instructions for preparing the human subjects plan in Part II of the Application Guide. |
| Multiple PD/PI Leadership Plan, Consortium/Contractual agreements, Letters of Support, Resource Sharing Plans | PHS 398 Research Plan Component, Fields 12-15 | Complete as directed in the PHS 398 Research Plan component of the SF 424 Application Guide, (*pdf) |
6. May I include additional information in an appendix?
Yes, but do not use the appendix to circumvent page limits. Follow all instructions as described in the SF424 Application Guide.
7. May I include experimental approaches in the Human and Vertebrate Animal Subject Plans?
No, you cannot circumvent the page limits by including extensive experimental approaches in these sections.
F. 2011 Evaluation and Selection of Awards
1. How will Type 1 Diabetes Impact Award applications be reviewed?
Applications will be reviewed by NIH staff for completeness and responsiveness and then by a multi-disciplinary group of scientific experts convened by the NIDDK Review Branch in accordance with NIH peer review procedures and using review criteria outlined in the FOA. Applications with the highest merit will be discussed, using significance, innovation, and potential impact as primary determinants of scientific merit. Applications will be reviewed in a special study section using an editorial-board method, not with conventional R01 applications. The review panel will be looking for convincing evidence that the project has the potential to transform and significantly impact important paradigms in type 1 diabetes research.
2. When will my application be reviewed, and by whom?
The reviews will occur during June and July, 2011. Questions about review should be directed to the NIDDK scientific review officer (SRO) assigned to the application.
3. Will I have an opportunity to submit an update before my application is reviewed?
Submission of supplemental updates will be at the discretion of the SRO.
4. Will T1D Impact Award applications be reviewed by experts in my field?
The review process will use a panel with broad expertise to assess potential impact, innovation, and significance; subject-matter experts will judge scientific and technical merit. It is extremely important to keep this review process in mind when describing your project plan; minimize jargon and use language that scientists in other fields can understand.
5. How will reviewers judge the likelihood that the project will be completed during the funding period?
They will look at the project description and percent effort of the PI and other essential personnel. Although the instructions do not specify a minimum percent effort, a low percent effort may raise concerns about whether essential personnel are devoting enough time and attention to the project to adequately pursue the goals in the time allotted.
6. How will the review process accommodate the potential dissimilarity in complexity of T1D Impact Award applications?
The primary review consideration will be the potential of the project to have a major impact on important problems in type 1 diabetes research. Reviewers will judge the project scope and complexity in this context to ensure that the activities proposed are necessary and commensurate with project goals.
7. Will I receive a summary statement or other comments?
Yes, proposals will receive a brief resume of the review panel discussion and critiques from subject-matter experts.
8. How will awards be selected for funding?
The NIH will make the final selection of awards based on review recommendations and programmatic considerations.
9. When will the 2011 awardees be notified?
Awardees will be notified of review outcomes by September 2011. The earliest anticipated award start date will be September 30, 2011.
10. Can the decision of the review panel be appealed?
No. There is no appeal process.
11. When will I be required to provide a detailed budget?
A detailed budget and justification will be requested “Just-in-Time” (JIT) prior to award.