Transformative R01 Program

Frequently Asked Questions

A. Scope and Intent of the T-R01 Program

1. Why has the Roadmap established the T-R01 Program?
A major goal of the NIH is to foster bold and creative investigator-initiated research. The NIH has created the Transformative Research Projects Program (T-R01) to facilitate the submission and support of exceptionally innovative, high risk, original and/or unconventional research that has the potential to create new or challenge existing scientific paradigms. The T-R01 program will be piloting novel approaches to peer review and program management to facilitate identification and support of out of the box thinking, unproven concepts and truly transformative ideas.

2. What distinguishes an NIH T-R01 Award from a standard R01?
The T-R01 program is different in several ways. First, it is designed to support high risk research that will create new or challenge existing paradigms. It is expected that T-R01 projects will reflect an exceptional level of creativity in proposing bold and highly innovative new approaches to fundamental problems. Anticipated research outcomes must have a major impact on broad, important problems in biomedical and/or behavioral research. While research areas of particular interest are outlined in the FOA (http://grants.nih.gov/grants/guide/rfa-files/RFA-RM-08-029.html), proposals from any/all areas of science relevant to the NIH mission will be considered in the T-R01 program (http://www.nih.gov/about/almanac/).

Second, the application is highly abbreviated, with page limitations in the biosketch and research design sections. The heart of the proposal will be contained in the Research Design and Methods section of the PHS 398, and will be limited to 8 pages in length. Within these limitations, applicants must be able to present a strong and compelling case for the need to establish or overturn an existing paradigm, the innovation or novelty associated with the rationale or approach, and the breadth of the study’s potential impact.

Third, new procedures for evaluating applications will be piloted under the T-R01 initiative that are distinct from the traditional NIH peer review process. A multi-tiered review will be conducted by the Center for Scientific Review (http://www.csr.nih.gov) in an effort to determine the potential of the project to make seminal contributions toward solving important biomedical or behavioral research problems. Biomedical and behavioral research is defined broadly in this program as encompassing scientific investigations in the biological, behavioral, clinical, social, physical, chemical, computational, engineering, and mathematical sciences.

3. What issues should be considered when thinking about a T-R01 application?

Is the topic exciting and interesting? Would someone outside of the field agree?
Is the project focused on creating or challenging a central paradigm?
Is the rationale and/or approach clearly novel and innovative?
If the studies succeed, would there be radical changes in the field?
If the studies succeed, would there be a profound impact in other scientific areas?
Based on the approach and effort required, will conclusive results be obtained by the end of the project period?
Is this really a new idea? Is it substantially different from mainstream research?

4. T-R01 Awards are meant to support new and novel research directions that create or challenge paradigms. 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 of interest. Successful T-R01 applicants are expected to conduct innovative studies addressing current paradigms in biomedical or behavioral sciences. It is expected 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 disciplines targeted for emphasis under the T-R01 program?
The NIH encourages T-R01 applications from scientists from all disciplines relevant to the NIH mission, including the biological, behavioral, clinical, social, physical, chemical, computational, engineering, and mathematical sciences (see: http://www.nih.gov/about/almanac/).

6. Can someone at NIH review my idea and let me know if it is a good fit for the T-R01 program?
Questions about the scope and intent of the T-R01 program should be directed to Kristin Abraham, Ph.D. in the NIH Office of the Director – OPASI at (301) 594- 8190 or at T_R01@mail.nih.gov. Email inquires are strongly preferred.

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B. General Questions

1. How many awards will be made in 2009?
The NIH expects to make as many as 60 awards, depending on budget requests and the availability of funds.

2. What budget and project period should I request?
Budgets should be well justified and commensurate with project needs over a five-year project period. Well justified requests for support of larger programs (up to $25 million total costs per year for 5 years) may be proposed. Because the T-R01 FOA specifies that budgets up to $25 million total costs per year may be requested, prior NIH approval will not be required for submission of proposals with budgets exceeding 500K direct costs.

3. Do T-R01s include indirect costs?
Yes. In addition to the direct costs, applicable facilities and administrative costs will be allowed.

4. 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.

5. What post-award requirements must I fulfill?
You will be required to submit an annual report as per standard NIH reporting requirements (Non-Competing Continuation Grant Progress Report (PHS 2590) and financial statements as required in the NIH Grants Policy Statement. In addition, you will be required to participate in an annual meeting in Bethesda, MD. Finally, to help the NIH evaluate this program, you may be contacted periodically to report on your latest research efforts.

6. May two or more scientists apply as a team for a T-R01 Award?
Yes. Multi-PI applications and applications from multi- or inter-disciplinary teams are encouraged.

7. 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 create or challenge fundamental scientific paradigms.

8. If my T-R01 application is not funded, will I have an opportunity to revise and resubmit?
No. However, you may submit a new proposal in future T-R01 competitions, or you may be able to incorporate some elements of your T-R01 proposal into one aim of a conventional R01 or R21 application.

9. How will the program be administered?
T-R01 awards will be administered by NIH IC staff on behalf of the NIH Office of the Director.

10. Will the T-R01 program be repeated in 2010?
NIH hopes to announce the T-R01 program again next year if funds are available. To be notified of T-R01 and other NIH Roadmap news, register for the NIH Roadmap LISTSERV at http://list.nih.gov/cgi-bin/wa?SUBED1=nihroadmap-l&A=1

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C. Eligibility

1. Are individuals at all stages of their careers eligible?
Yes, individuals at all career stages are eligible to apply for T-R01s. 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/orfor-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 Program (IRP), are eligible for this award.

4. Are scientists in the NIH Intramural Program eligible?
No.

5. I am currently a postdoctoral fellow. Am I eligible to apply for a T-R01 Award?
Applicants must be able to show concrete evidence for their claim of innovativeness and potential to conduct ground-breaking independent research. This could be very difficult for a postdoctoral fellow who has never conducted independent research. In addition, like all NIH grants, the T-R01 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 T-R01 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 T-R01 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. T-R01 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 T-R01 project proposes an incremental advance in existing studies or a significant departure from existing work. Applicants must also provide compelling justification for the advantage of using the T-R01 Award review process rather than standard peer review. In general, projects that are appropriate for more traditional grant mechanisms are not appropriate for T-R01 award applications.

7. I have a EUREKA application under review. Can I submit the same project to the T-R01 program?
NIH policy does not allow multiple submissions of essentially the same project. EUREKA grants, like T-R01 Awards, are meant to support unusually innovative research, and applications to both programs for the same project are therefore not permitted, since they would constitute multiple submissions. More broadly, funding for the same project may not be sought through multiple submissions to the T-R01 Award program and any other award program targeting unusually innovative research.

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D. 2009 Application Process

1. How does the content of a T-R01 application differ from the content of a conventional R01 application?

	T-R01	Conventional R01
Biosketch	Publications that illustrate innovation and significance of past accomplishments	Most recent publications
Research plan	Respond to questions about the challenge, potential impact, and appropriateness for the T-R01 program	Describe specific aims, background, significance, preliminary studies, and provide experimental details
Timeline	Required	Not required
Appendix	Not allowed	Allowed

2. How does the format of a T-R01 application differ from the format of a conventional R01 application?

	T-R01	Conventional R01
Budget	Modular or categorical. No limits up to maximum funds available for the program as a whole. No prior approvals required for budgets requesting more than $500 K DC per year; however, requests in excess of $250K DC in any year require detailed budgets and compelling justification.	Modular or categorical. No limits except for requirement for institute approval if requesting more than $500K DC in any year
Term	5 years maximum	5 years maximum
Biosketch	Limited to two pages. Publications limited to 10 or fewer items	No limit on number of references, other than the biosketch page limit
Research plan	8 page limit	25 page limit
Aims and description of research	Approach limited to five pages; generally one aim	Generally multiple aims
Literature cited	One page limit	No page limits
Cover letter	Allowed	Allowed

3. What are the dates for submission of 2009 applications?
The application may be submitted to Grants.gov beginning December 29, 2008 and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization), January 29, 2009. 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 T-R01 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 T-R01 application. If you have preliminary data, it should be VERY briefly summarized in the approach section of the research plan, which is limited to five pages. Also keep in mind that if the preliminary data suggests that success is certain, this may be an indication that the project is not new, exceptionally innovative or high risk.

6. Do I need advance permission to submit a T-R01 application that exceeds $500K in direct costs?
No, the NIH policy for submission of applications with budget requests exceeding $500K direct costs does not apply to RFAs, including the Transformative R01 RFA (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.

7. Given the two page limitation in the biosketch, may I truncate the author lists in individual citations?
Yes, if a single citation exceeds 5 authors you have the option of using the designation “et al.” This exception to full author listing is valid ONLY for T-R01 proposals.

8. Are biosketches for co-PIs and co-Investigators subject to the two page limitations?
Yes, all biosketches submitted under the T-R01 initiative should conform to the same form and format.

9. Should current and prior support information be provided in the limited biosketch?
Yes, but information should be limited to those activities that are most directly related to the proposal. An exhaustive encyclopedic presentation of current and prior funding histories is not required in the application, but will instead be requested post-review by NIH staff as part of the Just-In-Time process.

10. 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.

11. 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.

12. 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.

13. 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).

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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 eight-page proposal replace the traditional “Research Plan” (with “Specific Aims”) or is it to be submitted in addition to that section?
The eight-page research plan replaces the traditional 25-page “Research Plan” section required for most other NIH grant applications. Specific Aims, Background & Significance, and Preliminary Studies sections are omitted. The instructions for preparing a T-R01 application are very 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. Literature citations are limited to one page and do not count against the 8-page limitation for the Research Plan. 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 eight page limit of the research plan.

5. Where do I submit the various required sections of the application?

Abstract – upload on 424 R&R Other Project Information Component form where indicated.
Project Narrative – upload on 424 R&R Other Project Information form where indicated.
Budget and Budget Justification – upload on 424 R&R Budget Component forms where indicated.
Research Plan (limit, eight pages) – upload as a single pdf under PHS 398 Specific Research Plan Attachment #5 (Research Design and Methods). Attachments for Specific Aims, Background & Significance and Preliminary Studies are omitted under the T-R01 FOA.
Literature Cited (limit, one page) – upload under PHS 398 Specific Research Plan where indicated (Bibliography & References Cited).

6. May I include additional information in an appendix?
No, all information submitted for review must be included in the allowed sections of the application and comply with page limitations. Appendices will not be accepted.

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F. 2009 Evaluation and Selection of Awards

1. How will T-R01 applications be reviewed?
Applications will be reviewed by NIH staff for completeness and then by a multi-disciplinary group of scientific experts convened by the Center for Scientific Review (CSR) in accordance with NIH peer review procedures and using review criteria outlined in the FOA. Significance, innovation and transformative potential will be the primary determinants of scientific merit. Applications will be reviewed in special study sections with other T-R01 applications, not with conventional R01 applications. The review panels will be looking for convincing evidence that the project has the potential to transform and significantly impact important paradigms in biomedical or behavioral research. They will also assess whether there is compelling justification for use of the T-R01 program review process as opposed to standard peer review.

2. When will my application be reviewed, and by whom?
Questions about review should be directed to the scientific review officer (SRO) assigned to the application.

3. Will I have an opportunity to submit an update before my application is reviewed?
No. Supplemental updates will not be accepted.

4. Will T-R01 applications be reviewed by experts in my field?
The T-R01 review process will use a panel with broad expertise to assess transformative potential, innovation and significance, and subject-matter experts to 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 timeline and at the 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 competing T-R01 applications?
The primary review consideration will be the potential of the project to have a major impact on important scientific paradigms. 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 judged to have transformative potential and high significance will receive a brief resume of the review panel discussion. Summary statements will contain descriptions of the process used to evaluate the application and the result of that evaluation. Those applications judged as nonresponsive to the FOA due to a perceived lack of transformative potential or significance will not receive review comments.

8. How will awards be selected for funding?
The NIH Director will make the final selection of awards based on review recommendations and programmatic considerations.

9. When will the 2009 awardees be notified?
Awardees will be notified of review outcomes in August 2009. The earliest anticipated award start date will be September 1, 2009.

10. Can the decision of the review panel be appealed?
No. There is no appeal process

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This page last reviewed: January 22, 2009