A. Scope and Intent of the Common Fund Transformative Research Projects Program (R01)

1. Why has the Common Fund established the Common Fund Transformative Research Project Program?
2. What distinguishes an NIH Common Fund Transformative Research Project Award from a standard R01?
3. What issues should be considered when thinking about a T-R01 application?
4. Common Fund Transformative Research Project 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?”
5. Are there particular disciplines targeted for emphasis under the Common Fund Transformative Research Project program?
6. Can someone at NIH review my idea and let me know if it is a good fit for the Common Fund Transformative Research Project program?

B. General Questions

1. How many awards will be made in 2011?
2. What budget and project period should I request?
3. Do Common Fund Transformative Research Project awards include indirect costs?
4. How much time/effort are recipients expected to devote?
5. What post-award requirements must I fulfill?
6. May two or more scientists apply as a team for a Common Fund Transformative Research Project Award
7. Will technology development be allowed, or just hypothesis-driven research?
8. If my Common Fund Transformative Research Project application is not funded, will I have an opportunity to revise and resubmit?
9. How will the program be administered?
10. Will the Common Fund Transformative Research Project program be repeated in 2012?

C. Eligibility

1. Are individuals at all stages of their careers eligible
2. Are foreign scientists and institutions eligible?
3. Are individuals employed by government agencies, non-academic, and/or for-profit organizations eligible?
4. Are scientists in the NIH Intramural Program eligible?
5. I am currently a postdoctoral fellow. Am I eligible to apply for a Common Fund Transformative Research Project Award?
6. Can the same project be submitted to two programs at the same time? While my Common Fund Transformative Research Project 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 Common Fund Transformative Research Project?
7. I have a EUREKA application under review. Can I submit the same project to the Common Fund Transformative Research Project program?

D. 2011 Application Process

1. How does the content of a Common Fund Transformative Research Project application differ from the content of a conventional R01 application?
2. How does the format of a Transformative Research Project application differ from the format of a conventional R01 application?
3. What are the dates for submission of 2011 applications?
4. Do I need to include preliminary data in my Transformative Research Project application?
5. Should I include preliminary data, if I have any?
6. Is there a limit to the number of applications that can be submitted by an individual or an institution
7. What must be done before I submit an application to Grants.gov?
8. Where can I find help registering for Grants.gov?
9. Where can I find help in submitting my application to Grants.gov?
10. Where can I find help in registering for the eRA Commons?

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)?
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?
3. In my proposal, may I include citations to key publications? If so, what is the appropriate format?
4. In my application, may I include figures and illustrations?
5. Where do I submit the various required sections of the application?
6. May I include additional information in an appendix?

F. 2011 Evaluation and Selection of Awards

1. How will Common Fund Transformative Research Project applications be reviewed?
2. When will my application be reviewed, and by whom?
3. Will I have an opportunity to submit an update before my application is reviewed?
4. Will Common Fund Transformative Research Project applications be reviewed by experts in my field?
5. How will reviewers judge the likelihood that the project will be completed during the funding period?
6. How will the review process accommodate the potential dissimilarity in complexity of competing Transformative Program applications?
7. Will I receive a summary statement or other comments?
8. How will awards be selected for funding?
9. When will the 2011 awardees be notified?
10. Can the decision of the review panel be appealed?

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A. Scope and Intent of the Transformative Research Projects Program

1. Why has the Common Fund established the Transformative Research Projects Program?

2. What distinguishes an NIH Common Fund Transformative Research Project Award from a standard R01?

The Common Fund Transformative Research 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 Transformative 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, or lead to major improvements in health through the development of highly innovative therapies, diagnostic tools, or preventive strategies. Proposals from any/all areas of science relevant to the NIH mission will be considered for support under the Common Fund Transformative Research Projects 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 12 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, procedures for evaluating applications submitted under the Common Fund Transformative Research are distinct from the review process currently being used by the chartered NIH study sections. 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 an application to the Common Fund Transformative Research Program?

• 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. Transformative Research Project 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 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 Common Fund Transformative Research Project program?

The NIH encourages Common Fund Transformative Research project 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 Transformative Research Projects program?
Questions about the scope and intent of the T-R01 program should be directed to Ravi Basavappa, Ph.D. in the NIH Office of the Director at 301-435-7204 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 2011?

The NIH common fund intends to commit up to $25 million (total costs) in FY2011, contingent upon the availability of funds and the submission of a sufficient number of meritorious applications. Applicants may request up to the amount of funding provided for the program as a whole. The number of awards will depend on the size and scope of the most meritorious applications; however, up to one third of the budget will be reserved projects exceeding $1 million dollars in direct costs.

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 Transformative Research Program 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 Transformative Research Project Awards 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 Transformative Research Project  Award?

Yes. Multi-PI applications and applications from multi- or inter-disciplinary teams are particularly 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 Transformative Research Project application is not funded, will I have an opportunity to revise and resubmit?

No. However, you may submit a new proposal in future Transformative Program competitions, or you may be able to incorporate some elements of your proposal into one aim of a conventional R01 or R21 application.

9. How will the program be administered?

Awards will be administered by NIH IC staff on behalf of the NIH Office of the Director.

10. Will the Common Fund Transformative Research Projects program be repeated in 2011?

NIH hopes to announce the T-R01 program again next year if funds are available. To be notified of T-R01 and other NIH Common Fund news, register for the NIH Roadmap LISTSERV at https://list.nih.gov/cgi-bin/wa.exe?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. 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 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 Common Fund Transformative Research Project  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 Transformative Research Project 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 Common Fund Transformative Research Project 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 Transformative Research Project 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. Transformative Research Project 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. Applicants must also provide compelling justification for the advantage of using the Common Fund Transformative Research Award review process rather than standard peer review. In general, projects that are appropriate for more traditional grant mechanisms are not appropriate for Common Fund Transformative award applications.

7. I have a EUREKA application under review. Can I submit the same project to the Common Fund Transformative Research Projects program?

NIH policy does not allow multiple submissions of essentially the same project. EUREKA grants, like Common Fund Transformative 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 Common Fund Transformative Award program and any other award program targeting unusually innovative research.

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D. 2011 Application Process

1. How does the content of a Common Fund Transformative Research Project application differ from the content of a conventional R01 application?

	Roadmap Transformative Research Project	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 Transformative Research Projects 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 Common Fund Transformative Research Project application differ from the format of a conventional R01 application?

	Roadmap Transformative Research Project	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	12 page limit. The 12 page Research plan for the Transformative Projects Program consists of: (a) a 200 word Challenge, innovation & Impact statement; Rationale (1 page); (b) Approach (10 pages); (c) appropriateness for Transformative Program (one-half page); (d) Timeline (one-half page).	12 page limit
Aims and description of research	Approach limited to ten 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 2011 applications?

The application may be submitted to Grants.gov beginning September 27, 2010 and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization), October 27, 2010.  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 Transformative Research Project 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 Transformative Research Project application. If you have preliminary data, it should be VERY briefly summarized in the approach section of the research plan, which is limited to ten 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. 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).

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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 twelve-page proposal replace the traditional “Research Plan or is it to be submitted in addition to that section?

The twelve-page research plan replaces the traditional “Research Plan” section required for most other NIH grant applications. The instructions for preparing a Transformative Research Project 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 12-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 twelve 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?

• Abstract – upload on 424 R&R Other Project Information Component form where indicated.
• Biographical Sketch (limit, 2 pages) and Current & Pending Support - upload on 424 R&R Senior/Key Person Profile Component forms where indicated.
• Budget and Budget Justification – upload on 424 R&R Budget Component forms where indicated.
• Research Plan (limit, 12 pages) – upload under PHS 398 Specific Research Plan where indicated -as directed in the 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. 2011 Evaluation and Selection of Awards

1. How will Common Fund  Transformative Research Project 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 Common Fund Transformative Program 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 Common Fund Transformative Research 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 Transformative Research Project applications be reviewed by experts in my field?

The 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 Transformative Research Project 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 2011 awardees be notified?

Awardees will be notified of review outcomes in June 2011. The earliest anticipated award start date will be July 1, 2011.

10. Can the decision of the review panel be appealed?

No. There is no appeal process.

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