The NIH Director's Transformative Research Award, established in 2009, supports 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.

The NIH Director's 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 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 Notice of Funding Opportunity 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 and extensive data may actually dampen reviewer enthusiasm. Third, procedures for evaluating applications submitted under the NIH Director's Transformative Research Award 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 in an effort to determine the potential of the project to make seminal contributions to NIH-related areas of research. This year, an anonymized review process is being piloted to focus even more on the merit of the idea.

A comparison of all four NIH Director's awards is available online.

The NIH Common Fund intends to commit approximately $8 million to the initiative and make approximately 7 awards. The number of awards is dependent on the size and scope of the most meritorious awards, NIH appropriations, and the submission of a sufficient number of meritorious applications.

In order to support the most innovative and impactful research, the NIH recognizes the need to foster a diverse research workforce across the nation. Applications to this award program should reflect the full diversity of potential PD/PIs, applicant institutions, and research areas relevant to the broad mission of NIH. Researchers from diverse backgrounds (see NOT-OD-20-031), including individuals from underrepresented racial and ethnic groups, individuals with disabilities, individuals from disadvantaged backgrounds, and women are strongly encouraged to work with their institutions to develop applications for this Notice of Funding Opportunity. The primary requirements are that the research be highly innovative and have the potential for unusually broad impact.

Not at all. Applications are welcome in all research areas broadly relevant to the mission of NIH. These areas include, but are not limited to, the behavioral, medical, natural, social, applied, and formal sciences. Research may be basic, translational, or clinical. The Transformative Research Award program makes only a few awards each year. The breadth of NIH’s interest is not fully represented in current or previous awards. Just because your particular area of research is not yet represented doesn’t mean that you shouldn’t apply.

Outstanding research is conducted at a broad spectrum of institutions, and it benefits the national scientific enterprise to support exceptionally innovative and impactful science that represents this breadth. Therefore, this Notice of Funding Opportunity encourages applications from the full range of eligible institutions, including those serving primarily underrepresented groups, those that may be less research-intensive, and from all domestic geographic locations. What we seek for this program are truly great ideas, regardless of where they come from.

Yes, barring any unforeseen circumstances, we anticipate releasing a funding opportunity for the next fiscal year. To receive funding announcements and other High-Risk, High-Reward Research program news, register for our LISTSERV or watch for the announcement on the website.

NIH staff cannot provide comments on specific ideas or plans for individual research grant applications. The external review will evaluate the merit of your application. However, questions about the scope and intent of the NIH Director's Transformative Research Award should be directed to Dr. Trish Labosky in the NIH Office of the Director at Transformative_Awards@mail.nih.gov. 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.

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 to ensure that their applications conform to their policies for clinical research.

• Is the project focused on creating or challenging a central paradigm, developing a broadly useful technology, or 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?

Funding Year	2024
Letter of Intent Due Date	Not applicable
Earliest Submission Date	August 1, 2023
Application Due Date	September 1, 2023
Scientific Merit Review	March 2024
Council of Councils Review	May 2024
Award Notifications	July 2024
Earliest Project Start Date	August 2024

An independent evaluation by the Science and Technology Policy Institute was completed in 2021 and is available on our website. The study concludes that the Transformative Research Award initiative has been effective in supporting unusually innovative and impactful research.

The success rate of Transformative Research Award applications for fiscal years 2018-2022 is 5.8%. The success rate varies depending on the number of applications received, the number and budgets of meritorious applications, and funds available.

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

Yes, individuals at all career stages are eligible to apply.

No, there are no citizenship or residency requirements. Foreign scientists are eligible if apply they apply from a U.S.-based institution.

No, foreign institutions are not eligible. Only institutions in the United States or its territories can apply. For the types of eligible domestic institutions, see the Notice of Funding Opportunity.

No, NIH Intramural scientists are not eligible.

Individuals from all organizations that can otherwise apply for NIH funding and will abide by the terms and conditions, with the exception of the NIH Intramural Program, are eligible for this award.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) is invited to work with their organization to develop an application for support. Like all NIH grants, the NIH Director's 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 postdoctoral fellows. Highly innovative early stage and junior investigators may want to consider applying for the NIH Director’s New Innovator Award or the NIH Director's Early Independence Award as appropriate.

No, there is no limit to the number of applications an institution can submit.

The NIH encourages applications from scientists from all disciplines, including the biological, behavioral, clinical, social, physical, chemical, computational, engineering, and mathematical sciences, who provide evidence of interest in exploring topics of relevance to the NIH mission.

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.

Yes, but all applications must be submitted as “new” applications, regardless of any previous submission to the program. An application must not reference any previous submission or review.

Yes, the award may be transferred to another eligible institution according to the same policies and procedures used for traditional research grants. Awards may not be transferred to foreign institutions.

While you may apply to other funding opportunities while your NIH Director’s Transformative Research Award application is pending, NIH policy prohibits multiple submissions of the same, or essentially the same, project at the same time. You may either submit applications for different projects concurrently or submit the same project again after receiving the summary statement from the first submission.

Yes, you may submit a previously unfunded application as long as the previous study section review is complete and the summary statement has been released. NIH policy does not limit the number of times you can resubmit an application with essentially the same content and scope as an earlier application. However, it would be wise to address reviewer comments and concerns before resubmitting an application.

Applications may be submitted to Grants.gov beginning August 1, 2022 and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the investigator’s institution/organization) on September 1, 2023.

As stated in the Notice of Funding Opportunity, late applications will not be accepted.

No extensions will be given, and late applications will not be accepted. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Because the Transformative Research Award is offered under a new RFA each year, the program does not provide submission extensions. No extensions will be given, and late applications will not be accepted. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. NIH may grant exceptions to the late submission policy under extenuating circumstances, such as natural disasters, which will be announced in a special Notice. See the Application Guide for additional information.

Letters of intent are not required or accepted.

It is important that you immediately check 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 six 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 System for Award Management and then with Grants.gov. Both the institution and the investigator 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.

For help with the Grants.gov registration process, contact Grants.gov customer support at 1-800-518-4726 (Toll Free) or at support@grants.gov.

For help with the technical aspects of submitting to Grants.gov, check the resources available at Grants.gov. If you need assistance, contact Grants.gov customer support at 1-800-518-4726 (Toll Free) or at support@grants.gov.

For questions regarding the eRA Commons registration process, contact the eRA Service Desk at 1-866-504-9552 (Toll Free) or 301-402-7469 from Monday–Friday, 7:00 AM to 8:00 PM (Eastern Time).

All documents must be in PDF format and cannot exceed page limits (if documents exceed page limits, the application will be considered non-responsive and will not be evaluated). Specific formatting instructions for each document are in the SF424 (R&R) Application Guide.

Individuals may submit more than one application, provided each application is scientifically distinct.

There is no limit to the number of applications that an institution can submit.

No, Letters of Reference will not be accepted.

Towards the objective of funding the best possible science, an anonymized review process is being piloted for this program. Therefore, a significant difference is that the Specific Aims and Research Strategy sections of the Research Plan must not contain information that reveals the identify of participating investigators or individuals.
 
Sections of the application not listed below (such as Vertebrate Animals or Human Subjects) must be completed , if applicable, for the Transformative Research Award application and must follow the standard SF424 instructions while keeping in mind that the level of detail available may not be as great as that for a standard R01 given the nature of the Transformative Research Award program.

	Transformative Research Award	Conventional R01
Specific Aims Page	Do not list specific objectives of the proposed research. Instead, describe the overall project and why it is well aligned with the objectives of the Transformative Research Award initiative. The Specific Aims page must not contain any information that reveals the identity of participating investigators or institutions.	State concisely the goals of the proposed research and summarize the expected outcome(s), including the impact that the results of the proposed research will have on the research field(s) involved. List specific objectives.
Research Strategy	Address items of programmatic interest, which focus on significance/breadth of potential impact, exceptional innovation, the logic of the approach, and a timeline. Preliminary data are not required. A detailed experimental plan should not be provided. All other aspects required of conventional R01s, such as addressing rigor, reproducibility, and sex as a biological variable must be followed. The Research Strategy section must not contain any information that would reveal the identity of participating investigators or institutions.	Describe significance, innovation, approach, and preliminary studies. Experimental details are expected.

The Transformative Research Award allows for multiple Principal Investigators (PIs) on an application. PIs lead the project’s scientific development or execution. All team members who meet this definition should be listed as a PI on the application (it is important to note that NIH does not use the term “co-PI,” and it should not be used in your application). One PI will be designated as the “contact” PI and will be the primary contact for all grant-related communication. However, all listed PIs are viewed equally. If you are submitting a multi-PI application, you must include a Multiple PI Leadership Plan in your application. Only investigators designated as PIs on the application are considered Transformative Research awardees and included in program activities (i.e., HRHR Symposium, seminars, etc.) and are featured on the website and in the award announcement (other senior/key personnel are not included). For more information on how to determine the proper designation of team members, see the National Institute of Allergy and Infectious Diseases guide on team roles.

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

No, but if provided, they will be evaluated. Reviewers will focus on the challenge and approach to judge innovation, novelty, impact and technical merit.

Limited preliminary data may help convince reviewers that the approach may be plausible. Also keep in mind that if the preliminary data suggests that success is very likely, this may be an indication that the project is not new, exceptionally innovative, or high-risk and therefore not well suited for the Transformative Research Award initiative.

Yes, you may include references as a separate PDF using the "Bibliography & References Cited" component of the application. The citations in the Specific Aims page and Research Strategy section must be numeric only and correspond to the respective numbered full reference in the Bibliography and References Cited component. The numeric citation is required to comply with the anonymization instructions as described in the RFA.

Yes, you may include figures and illustrations within the page limit of the Research Strategy Plan. Figures and illustrations must comply with anonymization requirements.

No, applications must be self-contained within the specified page limitations and comply with anonymization requirements. Internet website addresses (URLs) may not be used to provide information necessary to the review. However, applicants can cite published articles that include movies or links to movies. We cannot guarantee that reviewers will refer to citations, so any information critical to the evaluation of the research proposal should be included in the essay.

No, all information submitted for review must be included in the allowed sections of the application and comply with page limitations. The standard NIH Appendix policy applies.

No, we cannot accept any additional data after an application has been submitted. Only information allowed by NIH post submission policy will be accepted.

Only materials allowed by NIH post submission policy are allowed.

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 NIH Director's Transformative Research Award solicitation. If you do submit again, the application must not reference any previous submission or review.

An overview of the anonymized review process is included in the Transformative Research Award Application and Award Guide, and an explanation of its purpose discussed in a blog article by Mike Lauer (Deputy Director for Extramural Research). A third-party evaluation of the anonymized review process is ongoing, but a report on the first year of anonymized review is posted on the website.

All applicants should carefully read and follow instructions outlined in the Notice of Funding Opportunity for anonymization requirements. To help applicants screen their Specific Aims page and Research Strategy essay for potential anonymization violations, the NIH Center for Scientific Review created the TRA Anonymization Check (TRAAC) tool. TRAAC scans documents for items that could violate anonymization requirements, such as names of individuals or institutions, honors and awards, hyperlinks, references, and other identifiable text. Potential violations are highlighted in the document and returned to the user for their reference. TRAAC is a screening tool meant to provide general guidance only. It cannot infer meaning or comprehend complex references. Anonymization instructions in the Notice of Funding Opportunity take precedence over any information provided by TRAAC and should be referred to for complete and comprehensive directions. TRAAC does not provide an ultimate, definitive judgement on anonymization. It is designed to err on the side of false positives and so may flag terms that do not breach anonymity and can be retained in the text. The responsibility for the text to include is borne by the PI(s). All submitted applications will be screened by NIH staff and are subject to withdrawal if not responsive to the Notice of Funding Opportunity instructions.

All anonymization requirements outlined in the Notice of Funding Opportunity must be followed. You cannot include any information that could be used to reasonably infer the identity of any participating individuals or institutions. Tools, methods, technology, and published findings should be stated without naming any developer, researcher, or institution (numbered citations can be used for attribution). If a tool, method, technology, or finding is commonly used and known and would not reveal the identity of any project participant, it can be named. If naming a tool, method, technology, or piece of knowledge would lead to reasonable inference of project participants, try to describe what it does or accomplishes without naming it. Don’t include details that could lead to the identification of project participants. Applicants are encouraged to check their Specific Aims page and Research Strategy essay for anonymization violations with the TRA Anonymization Check (TRAAC) tool. TRAAC scans documents for items that could violate anonymization requirements, such as names of individuals or institutions, honors and awards, hyperlinks, references, and other identifiable text. Potential violations are highlighted in the document and returned to the user for their reference. TRAAC is a screening tool meant to provide general guidance only. It cannot infer meaning or comprehend complex references. Anonymization instructions in the Notice of Funding Opportunity take precedence over any information provided by TRAAC and should be referred to for complete and comprehensive directions. TRAAC does not provide an ultimate, definitive judgement on anonymization. It is designed to err on the side of false positives and so may flag terms that do not breach anonymity and can be retained in the text. The responsibility for the text to include is borne by the PI(s). All submitted applications will be screened by NIH staff and are subject to withdrawal if not responsive to the Notice of Funding Opportunity instructions.

Yes. All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing (DMS) Plan. See Notice OD-22-198, DMS website, and DMS FAQ page for more information.

Yes. All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing (DMS) Plan. See Notice OD-22-198, DMS website, and DMS FAQ page for more information.

No. For proposed studies of human genomic data subject to the GDS Policy, applicants should complete the DMS Plan anticipating sharing according to the criteria in the Institutional Certification.

Yes. There are sample plans available on the DMS website.

DMS Plans should be included within the “Other Plan(s)” field on the PHS 398 Research Plan Form as indicated in the Application Instructions. See the DMS website for more details on developing and formatting Plans.

Additional funds can be requested to support Data Sharing and Management Plans. See Part F in the Data Sharing and Management website.

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 $250,000 in direct costs in any year require detailed (non-modular) budgets in addition to compelling justification.

No, because the NIH Director's Transformative Research Award RFA specifies that large budgets may be requested, prior NIH approval will NOT be required for submission of proposals with budgets exceeding $500,000 in direct costs.

Yes, in addition to the direct costs, applicable facilities and administrative costs (indirect costs) are allowed and will be determined at the time of award based on the institution's negotiated rate.

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.

Applications will be reviewed by NIH 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 funding opportunity announcement. Significance, innovation, and transformative potential will be the primary determinants of scientific merit. All applications received in response to the funding opportunity announcement will be reviewed in a single special study section.
 
For this review, an anonymized review process will be used in which the identity of the investigators and institutions is withheld until the last stage of review. In the first stage, the peer review panel will use the anonymized Specific Aims pages to identify a subset of applications with the most transformative potential. In the second stage, this subset of applications will be evaluated by "Mail Reviewers," who will use the anonymized Specific Aims pages and anonymized Research Strategy components to provide feedback on the significance, innovation and approach. In the third stage, the peer review panel, informed by the Mail Reviews, will prioritize the applications to be discussed; then, after having access to the complete applications, will finalize the applications to be discussed and discuss and score these in a panel meeting. All criteria will be assessed in the scoring by the panel. All other applications will be considered as "Not Discussed". See the Application & Award Guide for more information.

A Working Group in the Advisory Committee to the Director evaluated the Common Fund High-Risk High-Reward Research Program. The Working Group presented its findings and recommendations in June 2019. The Working Group found that the program was effective in supporting innovative and impactful research and that, overall, women and underrepresented groups were not adversely affected by the review process. It found, however, the applicant pool had limited diversity. The Working Group recommended that anonymized review be piloted to help improve applicant diversity at both the investigator and institution level. The anonymized review is being piloted with the Transformative Research Award initiative.

Because the Transformative Research Award is piloting an anonymized review process, all submitted applications will be assigned to temporary dummy accounts so no identifying information is available to reviewers during the anonymized review process. That means your application will not be linked to or show up in your eRA Commons account, and you will not receive application status updates until the anonymized portion of the review is complete. Contact NIH staff directly for updates on your application. Once the anonymized review portion is complete, the applications will once again be available through eCommons.

The Scientific Merit Review will begin in the autumn and conclude in early spring by peer reviewers as described in Q&A 1 in this section. The Advisory Council Review by the Council of Councils will be in May. The names and affiliations of reviewers will be posted on the NIH Director's Transformative Research website. Questions about the review should be directed to the Scientific Review Officer Dr. James Li at jamesli2@nih.gov.

Only information allowed by NIH post submission policy will be accepted.

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.

No, you should not name specific reviewers for your application. Applications will be evaluated for scientific and technical merit by appropriate Scientific Review Groups convened by the Center for Scientific Review.

They will look at the timeline and at the effort commitment of the PI and other essential personnel. Although the instructions do not specify a minimum effort, a low level of committed 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.

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.

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 that discusses and scores the applications. 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 but not evaluative comments.

The Director of the Division of Program Coordination, Planning, and Strategic Initiatives in the Office of the Director, NIH, will make the final funding decisions based the results of initial peer review, the recommendations of the Council level of review, programmatic considerations, availability of funds, and consultations with IC Directors.

Awardees will be notified in the summer. New awardees are expected to attend the High-Risk, High-Reward Research Symposium to be held the following summer.

No, there is no appeal process.

Although there are no stipulations on the research agenda, you will be required to submit a two- to five-page annual report of your activities during the year and are expected to participate in an annual High-Risk, High-Reward Research Symposium in Bethesda, MD. In addition, to help the NIH evaluate this program, you may be contacted periodically for at least five years and asked to report on your latest research efforts.

Awards will be administered by an NIH Institute/Center best matching the proposal topic. However, Dr. Trish Labosky from the Office of the Director will also serve as a program officer to coordinate administration of all NIH Director's Transformative Research Awards.

As described in the Notice of Award posted in your NIH Commons account, a progress report is due annually on October 1.

Yes, please be sure to identify yourself as an NIH Director’s Transformative Research Award recipient in journal articles, oral or poster presentations, news releases, interviews with reporters, and other communications related to your research funded by this program. Although citing NIH support is always important, it is even more so in the case of the NIH Director's Transformative Research Award, which is a component of the NIH Common Fund. In journal articles, please cite the grant number as well as the name of the program. An example of how this might be worded is, "This work was funded by the National Institutes of Health through the NIH Director’s Transformative Research Award, R01-IC######."

Yes, please notify us at Transformative_Awards@mail.nih.gov of any significant publications or media coverage so we can highlight you and your research on our website.

As required by Federal legislation, the NIH Public Access Policy requires NIH funded scientists to submit final peer-reviewed journal manuscripts that arise from NIH funds to PubMed Central. Please visit the NIH Public Access site for additional information about the process of submitting your accepted publications.

Yes, as an awardee, you are expected to attend the annual High-Risk, High-Reward Research Symposium held in Bethesda, Maryland, typically in the summer.

No, these awards are intended to provide funds to initiate important new directions in research over a five-year time frame.

Yes, you may request a no-cost extension for a NIH Director's Transformative Research Award as described here.

Yes, the award may be transferred to another eligible institution according to the same policies and procedures used for traditional research grants. Awards may not be transferred to foreign institutions.