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2015 Frequently Asked Questions

A. SCOPE AND INTENT OF THE NIH TRANSFORMATIVE RESEARCH AWARDS INITIATIVE

  1. Why has the Common Fund established the NIH Transformative Research Awards?
  2. What distinguishes an NIH Transformative Research Award from a standard R01?
  3. What distinguishes an NIH Transformative Research Award from an NIH Pioneer Award?
  4. What issues should be considered when thinking about a Transformative Research Award application?
  5. Transformative Research 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?”
  6. Are there particular disciplines targeted for emphasis under the Transformative Research Awards initiative?
  7. Are applications proposing clinical research appropriate for this initiative?
  8. Can someone at NIH review my idea and let me know if it is a good fit for the Transformative Research Awards initiative?

B. General Questions

  1. How many awards will be made in 2015?
  2. Is a letter of intent (LOI) required to apply for this award?
  3. What budget and project period should I request?
  4. Do I need NIH approval before submitting a budget exceeding $500K in annual direct costs?
  5. Do Transformative Research Awards include indirect costs?
  6. How much time/effort are recipients expected to devote?
  7. What post-award requirements must I fulfill?
  8. May two or more scientists apply as a team for a Transformative Research Award?
  9. Will technology development be allowed or just hypothesis-driven research?
  10. If my Common Fund Transformative Research Awards application is not funded, will I have an opportunity to revise and resubmit?
  11. How will the program be administered?
  12. Will the Transformative Research Award program be repeated in 2016?

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 Transformative Research Award?
  6. Can the same project be submitted to two programs at the same time? While my Transformative Research 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 Transformative Research Award?

D. 2015 Application Process

  1. How does the content of a Transformative Research Awards application differ from the content of a conventional R01 application?
  2. How does the format of a Transformative Research Awards application differ from the format of a conventional R01 application?
  3. Do I need to submit a Specific Aims page?
  4. What are the dates for submission of 2015 applications?
  5. Do I need to include preliminary data in my Transformative Research Awards application?
  6. Should I include preliminary data, if I have any?
  7. Is there a limit to the number of applications that can be submitted by an individual or an institution?
  8. What must be done before I submit an application to Grants.gov?
  9. Where can I find help registering for Grants.gov?
  10. Where can I find help in submitting my application to Grants.gov?
  11. 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. In my proposal, may I include citations to key publications? If so, what is the appropriate format?
  3. In my application, may I include figures and illustrations?
  4. Where do I submit the various required sections of the application?
  5. May I include additional information in an appendix?

F. 2015 Evaluation and Selection of Awards

  1. How will Transformative Research Awards 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 Transformative Research Awards 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 2015 awardees be notified?
  10. Can the decision of the review panel be appealed?
  11. What is the success rate of applications for the Transformative Research Award Initiative?

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A. Scope and Intent of the Transformative Research Awards Initiative

1. Why has the Common Fund established the NIH Transformative Research Awards initiative?

 

The NIH Transformative Research Awards initiative has been established to support exceptionally innovative, high risk, and/or unconventional research projects that have the potential to create or overturn fundamental paradigms or otherwise have unusually broad impact. Such projects, due to their inherent risk, may be more difficult to support using a standard NIH R01 grant, but due to their potential impact, may merit pursuing.

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

The NIH Transformative Research Award is different in several ways. First, it is designed to support research that will create new or challenge existing paradigms, develop broadly enabling technologies, or lead to major improvements in health through the creation of highly innovative too therapies, diagnostic tools, or preventative research. Given the inherent risks that may be involved in this type of research, such applications may not fare well in standard R01 review.

Second, the special application instructions, as described in the current Funding Opportunity Announcement http://grants.nih.gov/grants/guide/rfa-files/RFA-RM-14-003.html have been designed to focus the applicants' and reviewers' attention more on innovation and potential and less on demonstrations of feasibility. 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. Demonstrations of feasibility through preliminary data are not expected.

Third, procedures for evaluating applications submitted under the Transformative Research Award initiative 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 distinguishes an NIH Transformative Research Award from an NIH Pioneer Award?
 

Though both award initiatives support highly innovative research, the Transformative Research Award initiative allows applications from individuals as well as teams of investigators and permits large direct cost budgets (>$500,000 per year), whereas the Pioneer Award initiative allows applications only from single investigators and has a direct cost budget of $500,000 per year. In addition, the Pioneer Awards allow for more flexibility to change research direction; hence greater emphasis is placed in review on the qualities of the investigator, finalist applicants are interviewed by the peer review panel, and awardees are required to expend at least 51% of their research effort on the Pioneer Award project during the first three years of the award

 

4. What issues should be considered when thinking about an application to the Transformative Research Award initiative?

 

  • Is the topic exciting and interesting? Would someone outside of the field agree?
  • Is the project focused on creating or challenging a central paradigm  developing a broadly useful technology, or on creating radical new approaches to disease diagnosis, treatment, or prevention?
  • Is the rationale for the project compelling?
  • 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?
     

5. Transformative Research 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. Successful applicants are expected to conduct innovative studies that challenge current paradigms or establish new 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.

 

6. Are there particular disciplines targeted for emphasis under the Transformative Research Awards initiative?

The NIH encourages Transformative Research Awards 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/).

 

7. Are applications proposing clinical research appropriate for this initiative?

Yes. Though technical and conceptual risks are expected in highly innovative projects, clinical research also must contend with potential risk to human subjects. Clinical researchers should not be dissuaded from submitting applications as long as rigorous assessment of participant risk/benefit ratios compellingly indicates the ratio to be in favor of the potential benefit. Many of the advances in public health have been achieved through clinical trials, which necessarily involve some risk to participating human subjects. NIH acknowledges the presence of such risk and has established a set of clinical research ethics principles that provides guidance regarding the risk/benefit ratio in clinical research. Applicants proposing clinical research should contact Program Staff at the appropriate component NIH Institute or Center (IC) to ensure that their applications conform to IC-specific policies for clinical research.

 

8. Can someone at NIH review my idea and let me know if it is a good fit for the Transformative Research Awards initiative?

Questions about the scope and intent of the Transformative Research Awards initiative should be directed to Ravi Basavappa, Ph.D. in the NIH Office of the Director at 301-435-7204 or at Transformative_Awards@mail.nih.gov. Email inquiries are strongly preferred. For applications involving clinical research, applicants should contact program staff at the appropriate NIH Institute or Center (IC) to assure compliance with IC-specific policies regarding clinical research. 

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B. General Questions

1. How many awards will be made in 2015?

The NIH Common Fund intends to commit up to $15 million (total costs) in FY2015, 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. In addition, Institutes and Centers of NIH may choose to support particular mission –relevant applications. 

2. Is a letter of intent (LOI) required to apply for this award?

A letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

3. What budget and project period should I request?

Budgets should be well justified and commensurate with project needs over the project period.  Well-justified requests for support of larger research projects may be proposed (up to the amount made available for the entire initiative).  Additionally, requests in excess of $250K in direct costs in any year require detailed (non-modular) budgets in addition to compelling justification. 

4. Do I need NIH approval before submitting a budget exceeding $500K in annual direct costs?

No. Because the Transformative Research Award FOA specifies that large budgets may be requested, prior NIH approval will NOT be required for submission of proposals with budgets exceeding $500K direct costs. 

5. Do Transformative Research Awards include indirect costs?

Yes. In addition to the direct costs, applicable facilities and administrative costs will be allowed.

6. 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.

7. 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 are strongly encouraged 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. 

8. May two or more scientists apply as a team for a Transformative Research Award?

Yes. Multi-PI applications and applications from multi- or inter-disciplinary teams of investigators are particularly encouraged.

9. 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 highly innovative approaches to create or challenge fundamental scientific paradigms, develop broadly enabling technologies, or create radical new approaches to disease diagnosis, therapy, and prevention. 

10. If my application is not funded, will I have an opportunity to revise and resubmit?

Resubmission applications (A1) are not allowed. You may submit substantially the same idea or a refinement of the idea as a new application in response to a subsequent TRA solicitation. Or, you may be able to incorporate some elements of your proposal into a conventional R01 or R21 application. ​

11. How will the program be administered?

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

12. Will the Transformative Research Awards initiative be repeated in 2016?

NIH hopes to announce the Transformative Research Awards initiative again next year if funds are available. To be notified of NIH Common Fund  FOAs and news, register for the NIH Common Fund LISTSERV at https://list.nih.gov/cgi-bin/wa.exe?SUBED1=NIH-OSC-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 to apply.

2. Are foreign institutions eligible?

No.  Foreign institutions and non-domestic components of U.S. organizations are not eligible apply. However, foreign components (such as collaborators) as defined in the NIH Grants Policy Statement are allowed.

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 Transformative Research 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 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.  Individual outstanding, highly innovative early stage and junior investigators may want to consider applying for the NIH Director’s New Innovator or Early Independence Award Programs as appropriate. 

6. Can the same project be submitted to two programs at the same time? While my Transformative Research 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 Transformative Research Award? 

The general policy of the U.S Public Health Service, which includes the NIH, does not allow multiple submissions of essentially the same proposal to any of its components. Transformative Research 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 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 Transformative award applications. 

 

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D. 2015 Application Process

1. How does the content of a NIH Transformative Research Awards application differ from the content of a conventional R01 application?

 

  Transformative Research Awards Conventional R01
Biosketch Publications, patents, or meeting abstracts may be cited which illustrate investigator’s findings of exceptional innovation and significance. Items cited may be annotated to explain significance and/or innovation. Ten items maximum. Suggested maximum of 15 publications.
Research plan Respond to questions about the challenge, potential impact, and appropriateness of proposed research for the Transformative Research Awards initiative 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 Transformative Research Awards application differ from the format of a conventional R01 application?

 

  Transformative Research Awards Conventional R01
Budget

Modular or categorical.

No limits up to maximum funds available for the program as a whole, $15 million for FY2015. No prior approvals required for budgets requesting more than $500K 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 No more than ten items, each of which illustrates innovation and significance of past accomplishments or is project relevant. Annotation permitted to explain innovation and significance represented by item. Item may be publication, patent, or meeting abstract. This modified format applies to PIs only. Biosketches for other personnel/collaborators may be in the standard format. Suggested maximum of 15 publications.
Specific Aims Used to address Challenge/Innovation/Impact and Rationale (no listing of specific objectives expected) Used to list specific objectives of project
Research Strategy

Maximum length is 12 pages: 
Recommended lengths: (a) Approach -- ten pages; (c) appropriateness for Transformative Program -- 1 page; (d) Timeline -- one page

12 page limit, which includes preliminary data and details of experimental design
Aims and description of research Generally one overarching aim. Generally multiple aims
Literature cited No page limits No page limits
Cover letter Allowed Allowed

 

3. Do I need to submit a Specific Aims page?

Yes. However, as indicated in the FOA, this should be used to address the Challenge/Innovation/Impact and Rationale Topics and not primarily to list specific objectives of the research.

4. What are the dates for submission of 2015 applications?

The application may be submitted to Grants.gov beginning September 10, 2014 and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization), October 10, 2014. Application materials will not be accepted after that time and applications that are not complete will not be evaluated.

5. Do I need to include preliminary data in my Transformative Research Awards application?

No. Reviewers will focus on the challenge and approach to judge innovation, novelty, impact and technical merit. 

6. Should I include preliminary data, if I have any?

Preliminary data may 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 Awards application. If you have preliminary data, they should be briefly summarized in Research Strategy section of the application. 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. 

7. 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. 

8. 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/. Both the institution and the applicant must also complete a one-time registration in the NIH eRA Commons at https://public.era.nih.gov 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. 

9. 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.  You can also find help at the iPortal, which displays the top 10 requested help topics (FAQs), searchable knowledge base, self service ticketing and ticket status, and live web chat (available 7:00 A.M. - 9:00 P.M. ET).

10. 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.  You can also find help at the iPortal, which displays the top 10 requested help topics (FAQs), searchable knowledge base, self service ticketing and ticket status, and live web chat (available 7:00 A.M. - 9:00 P.M. ET).

11. Where can I find help in registering for the eRA Commons?

Step-by-step directions for registering with eRA Commons are available at http://era.nih.gov/commons/faq_commons.cfm#II3.  For questions regarding the Commons registration process, contact the NIH eRA Commons help desk at phone: 866-504-9552 (Toll Free); 301- 451-5939 (TTY) business hours Monday–Friday, 7:00 a.m.–8:00 p.m. (Eastern Standard Time).  Alternatively, you may email commons@od.nih.gov and a customer service representative will be in contact with you.

 

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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. 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. The citations may be in any format and there is no page limit.

3. In my application, may I include figures and illustrations?

Yes, you may include figures and illustrations within the page limit of the research plan. Do not include links to websites for further information, or animations.

4. 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, 4 pages) and selected ongoing and completed research projects where indicated.
  • Budget and Budget Justification – upload on 424 R&R Budget Component forms where indicated.
  • Specific Aims (limit, one page) – upload under PHS 398 Research Plan Component where indicated, as directed in the FOA.
  • Research Plan – upload under PHS 398 Research Plan Component where indicated, as directed in the FOA.
  • Bibliography & References Cited – upload under Other Project Information Component where indicated (Bibliography & References Cited).
     

5. 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. 2015 Evaluation and Selection of Awards

1. How will Transformative Research Award applications be reviewed?

Applications will be reviewed by NIH Division of Receipt and Referral staff for completeness and responsiveness. All applications determined to be complete and responsive will be reviewed in a multi-phase process by an “Editorial Board “ comprised of 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. All applications received in response to this FOA will be reviewed in a single special study section. 

2. When will my application be reviewed, and by whom?

Questions about review should be directed to the Scientific Review Officer managing the review (Dr. John Bowers, email: bowersj@csr.nih.gov; telephone: 301-435-1725. 

3. Will I have an opportunity to submit an update before my application is reviewed?

No. Updates will not be accepted unless they are to inform of unforeseen events (such as natural disasters) that will have a substantial impact on the ability to execute the proposed research.

4. Will Transformative Research Awards 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 Awards 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?

Applications judged to have transformative potential and high significance by the review panel will receive critiques by individual subject matter experts and will receive a brief resume and summary of discussion if discussed by the panel. In the multi-phase review process used, the subject matter experts will not be members of the review panel. Applications judged by the review panel to not be among the most meritorious will NOT receive evaluation by subject matter experts and will receive summary statements that provide a description of the review process.

8. How will awards be selected for funding?

The Director of the Division of Program Coordination, Planning, and Strategic Initiatives will make the final funding decisions based the results of initial peer review, the recommendations of the Council of Councils, which provides the second level of review, and consultations with IC Directors. The individual ICs may be funding most of the Transformative Research Award in the years after the first year of the award.

9. When will the 2015 awardees be notified?

Awardees will be notified of review outcomes in June 2015, and funding decisions in August 2015. The earliest anticipated award start date will be August 2015. 

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

No. There is no appeal process.

11. What is the success rate of applications for the Transformative Research Award Initiative?

Information about success rates for NIH grant applications can be found through the NIH Research Portfolio Online Reporting Tools (RePORT) website at http://report.nih.gov/success_rates/index.aspx.

 

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