Department of Health
and Human Services (HHS)
and Human Services (HHS)
EXPIRED
National Institute of Neurological Disorders and Stroke (NINDS)
Reissue of RFA-NS-19-037
July 18, 2024 - Notice to Allow Requests for Budget Increases for NINDS Research Program Award (R35). See Notice NOT-NS-24-124
May 6, 2021 - This RFA has been reissued as RFA-NS-21-020.
July 7, 2020 - Notice of Change to Key Dates for RFA-NS-20-030. See Notice NOT-NS-20-092.
July 26, 2019- Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research. See Notice NOT-OD-19-128August 23, 2019- Clarifying Competing Application Instructions and Notice of Publication of Frequently Asked Questions (FAQs) Regarding Proposed Human Fetal Tissue Research. See Notice NOT-OD-19-137
None
93.853
The purpose of the NINDS Research Program Award (RPA) is to provide longer-term support and increased freedom and flexibility to Program Directors (PDs)/Principal Investigators (PIs) to allow them to redirect their time away from the administrative burden of writing and managing multiple grant applications and towards engaging in the lab. This RPA affords investigators at most career stages the opportunity to advance their long-term research goals, rigorously explore exciting research opportunities, and mentor trainees, which support and align with the mission of NINDS. RPAs will support the overall research programs of NINDS-funded investigators for up to 8 years, at a level commensurate with a PD/PI’s recent NINDS support (Part 2, Section II). This greater funding stability will provide eligible investigators increased security, allowing them to undertake research projects that require a longer timeframe or to embark upon research that breaks new ground. Research activities outside of the NINDS mission, or traditionally supported by another NIH Institute or Center, will not be considered through this program.
Benefits of the RPA include:
A more stable funding environment, facilitating the pursuit of longer-term research goals;
Flexible funding, enabling investigators to pursue research opportunities as they arise, not tied to specific aims;
Reduced time spent writing grant applications and managing multiple grant awards, allowing investigators to spend more time conducting and overseeing research; and
More time for PDs/PIs to mentor and train individuals in their laboratories.
Enhancing the diversity and inclusiveness of the neuroscience and biomedical research workforce will enhance our overall creativity and ability to expand fundamental knowledge about the brain and nervous system and contribute to reducing the burden of neurological disease. The RPA is a signature program for NINDS, as such NINDS strives to ensure it reflects our commitment to diversity. As scientific progress accelerates by leveraging a broad range of experiences, NINDS strongly encourages women and individuals from diverse backgrounds (including nationally underrepresented groups) to apply.
July 21, 2020
August 14, 2020
No late applications will be accepted for this Funding Opportunity Announcement.
All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).
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.
New Date August 15, 2020 per issuance of NOT-NS-20-092. (Original Expiration Date: August 01, 2020 )
Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.
Applications that do not comply with these instructions may be delayed or not accepted for review.
Overview
Most grant awards are limited to 2-5 years and are intended to support individual projects, rather than the overall research program of an investigator's laboratory or research group. Due in part to these constraints, many PD/PIs spend a considerable portion of their time writing grant applications rather than performing and overseeing research and directly mentoring trainees in their laboratories. The NINDS RPA is a different approach that aims to support the NINDS-related research of an investigator's laboratoryor research group for a sustained period. The award is intended to increase funding stability, reduce the time investigators spend writing grant applications, and facilitate a more flexible research environment. This should allow for increased time for investigators to be directly involved in the research in their laboratories, fostering more creative and/or long-term research goals, enabling more engagement with trainees, and assuring a high level of rigor and attention to experimental design all of which contribute to advancing the mission of NINDS.
Because the RPA is intended to support most, if not all, of the NINDS-related research in an investigator's laboratory, investigators receiving an RPA must relinquish their other NINDS research grants, with a limited number of exceptions (see below). PD/PIs can retain non-overlapping grant support from other NIH ICs, provided they remain able to maintain the required level of effort on the RPA (see below). The funding that PDs/PIs receive from leading or participating in NINDS multiple-PD/PI research grants, program project grants, and/or Center grants will also be incorporated into the RPA, but the investigators will be expected to continue the collaboration with support from RPA.
By replacing all or most of an investigator's NINDS funding, the research supported by an RPA should be the major focus of the investigator’s laboratory or research group. Therefore, the PD/PI must devote at least 6 person months (i.e., the equivalent of 50% effort on a full-year appointment, 66.67% on a 9-month appointment, or 100% on a 6-month appointment) to the RPA throughout the duration of the award period. Applications from PD/PIs committing less than the required amount will not be accepted. When applicable, PDs/PIs will be expected to renegotiate their time and effort on other non-NINDS awards in order to accommodate the level of effort required by the RPA.
The budget for the RPA will be set at a fixed level that is generally commensurate with the PD/PIs funding over the prior four years. No RPA budget will exceed $750K direct costs (DC) per year, and no RPA will be awarded for less than $350K direct cost (DC). Applicants should refer to Section II, Award Budget for detailed guidance on preparing their budget. When considering an RPA application, investigators should balance this funding limitation against the benefits of the RPA, which include:
It is important to note: the goal of the RPA mechanism is not to expand an investigator's current level of NINDS funding. However, NINDS acknowledges that there are circumstances where a flat budget may limit the ability of productive research programs, particularly for those investigators with limited external sources of funding, to capitalize on new and emerging scientific opportunities. Furthermore, NINDS recognizes that the research programs of investigators earlier in their career may require additional funding as their programs mature. Therefore, NINDS offers supplemental funding for PDs/PIs to request budget increases at the five-year administrative review when it is scientifically well-justified.
As part of the consolidation of an investigator’s NINDS research into the RPA, institutions will be required to relinquish their financial interests in current NINDS-funded research grants where the applicant investigator is listed as a PD/PI (e.g. research project grants (RPGs), P01s, P50 and other Center awards [including leads on subprojects/project leaders]). A limited number of goal-directed activities, shown below, are not subject to consolidation into the RPA. An RPA recipient would remain eligible to apply for these types of activities:
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.
Need help determining whether you are doing a clinical trial?
NINDS intends to commit $20 million in FY 2021 to fund up to 30 awards. NINDS will seek to ensure that RPA awards are diverse not only with respect to scientific approach and area of study, but also with respect to investigator background and career stage.
Applicants may request up to a maximum of $750,000 direct costs per year; however, the requested RPA budget must be commensurate with the investigator's recent level of NINDS support. That level of support must be calculated using the average direct cost total for the 4 most recent years (i.e. 2016 - 2019 or 2017 - 2020, whichever is greater) from all awarded NINDS research grants of the type that will be folded into the R35 award; it should not include funding that is exempt from R35 fold in (see Section 1, Overview). Calculations should use awarded direct costs (including administrative cuts), and in the case of MPD/MPI awards or multi-component grants/cooperative agreements, should only include the amount of the total award that is attributable to the applicant PD/PI. Moreover, in the case of multi-component grants/cooperative agreements, the budget should not incorporate funds attributable to cores, as these funds will not be folded into the RPA. Please note that pending support should not be considered when developing an RPA budget, even if such applications should get funded between the R35 submission and award. Although the RPA mechanism is not intended to support the expansion of an investigator's current level of NINDS funding, RPAs will be awarded for no less than $350K DC. Barring this exception, only in rare and extremely well-justified circumstances (e.g. an investigator is still within the growth phase of their careers) will awards exceed the most recent 4-year funded average of NINDS grants subject to be folded in. Applications submitted with budgets of more than 20% over the 4 year average described above will be considered non-compliant to this FOA and will be withdrawn prior to review. PDs/PIs are encouraged to discuss their proposed budgets / projects with NINDS program staff prior to submission and should provide detailed evidence supporting their proposed request in the budget justification section (e.g. table calculating 4-year average of direct costs, including grant numbers with awarded direct costs for each year; for example, see https://www.ninds.nih.gov/Funding/About-Funding/Research-Program-Award-R35). Year one of the R35 award will be offset by any funds disbursed in the same FY from awards that will be folded into the RPA.
The maximum project period is 8 years.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Governments
Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
Eligibility to apply to this FOA is limited to PDs/PIs who meet all the following criteria:
PDs/PIs who have had at least one of the following types of active NINDS grants in each of the past 5 years (that is FY16-20), with no more than one of those years in a no cost extension: R00, R01, R37, R56, DP1, DP2.
PDs/PIs whose 4-year NINDS funding history is limited to a single MPI or multi-component grant are not eligible to apply.
The research supported by an RPA should be the major focus of the investigator’s laboratory or research group. Therefore, the PD/PI must devote at least 6 person months (i.e., the equivalent of 50% effort on a full-year appointment, 66.67% on a 9-month appointment, or 100% on a 6-month appointment) to the RPA throughout the duration of the award period.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
Although 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.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to:
Anna Taylor, Ph.D.
Telephone: 301-827-3565
Fax: 301-402-4370
Email: anna.taylor@nih.gov
Bibliography: Each application must include a comprehensive PD/PI publication list (Bibliography) from 2016 to the present, attached as a document under Other Attachments . In this section, applicants should include: 1) a thorough listing of publications (separating out research articles from review articles and commentaries) since 2016 to clearly document the PD/PI’s recent research trajectory, 2) provide a brief, half page, paragraph highlighting the rigor in these publications, and 3) proactively identify and address any papers retracted during this time frame.
Mentoring & Service: NINDS places a high value on training and mentorship and has described characteristics that define outstanding mentorship. In this section, applicants should include a document under Other Attachments : 1) a description of their commitment and dedication to superior mentorship and training in neuroscience research (e.g. Landis award), 2) a comprehensive list of Mentoring and Service, highlighting the PD/PI’s commitment to inclusive excellence including training of individuals from groups that are underrepresented in biomedicine (NOT-OD-20-031), and3) a description of significant contributions of service to the research community (e.g. study section service).
Biographical Sketch:
A biosketch should only be provided for the PD/PI and in rare cases, for co-investigators receiving financial support from the RPA.
The RPA is intended for investigators at most career stages with track records of research achievement and productivity commensurate with career stage and significant life events (e.g. childbirth, family care, serious illness or disability, military service). NINDS strongly encourages women and individuals from diverse backgrounds (including nationally underrepresented groups) to apply. The PD/PI should address these considerations as well as the other RPA-specific elements of the Investigator Review Criterion within the Biosketch.
Current & Pending Support:
This attachment is required. For the PD/PI only, use the SF424 R&R Current and Pending Support instructions as modified here. To minimize redundancy, grants and other support reported in the Current and Pending Support section can be simply listed by grant numbers or other relevant identifiers (for other types of support). Do not list Total Costs for the Entire Project Period; instead list Annual Direct Costs allocated to the R35 PD's/PI's laboratory, only. List the PD's/PI's effort on each support mechanism in person-months.
All sources of support including foreign support should be reported. List NINDS grants first, followed by other NIH grants, followed by other sources of support.
Include all current (FY2020) and pending (FY2021) support (including subcontracted support) for the PD/PI (even if they receive no salary support from the project(s)) for ongoing projects and pending applications.
Reviewers will be instructed not to consider concurrent submission of applications to other organizations that are not components of NIH or the Public Health Service.
All instructions in the SF424 (R&R) Application Guide must be followed.
While a 10-year R&R Detailed Budget form is provided in the application package, applicants may not request more than 8 years of support. PDs/PIs should provide in the budget justification, detailed evidence supporting their proposed request (e.g. table calculating 4-year average of direct costs, including grant numbers with awarded direct costs for each year; for example see https://www.ninds.nih.gov/Funding/About-Funding/Research-Program-Award-R35. Calculations should use awarded direct costs (including administrative cuts), and in the case of MPI/MPD awards or multi-component grants/cooperative agreements, should only include the amount of the total award that is attributable to the applicant PD/PI. Moreover, in the case of multi-component grants/cooperative agreements, the budget should not incorporate funds attributable to cores, as these funds will not be folded into the RPA. Applicants must commit at least 6 person months (i.e., the equivalent of 50% effort on for a full-year appointment, 66.67% on a 9-month appointment, or 100% on a 6-month appointment) throughout the duration of the RPA period. Applications from PD/PIs committing less than 6 person months for the duration of the award will not be accepted.
Specific Aims: Specific Aims should not be submitted.
Research Strategy: Upload the Research Strategy as a single attachment containing the following information. Note, material covered in the Biosketch should not be repeated.
1) General background regarding the area(s) of research proposed and key gaps in our understanding or challenges that need to be addressed. Describe in broad terms the scientific question (s) that you will address and their importance.
2) Description of your recent research advances and how you will leverage them in your proposed research program. Describe progress during the previous five years and include evidence and examples of your conduct of rigorous research and transparent reporting. Explain how you will leverage your recent contributions (e.g., novel ideas, accomplishments, experience, sustained productivity, etc.) into the new approaches proposed in your research program. Discuss the reasons and likelihood that you will continue to generate important scientific advances throughout the proposed research program.
3) Overview of proposed research program. Describe, in general terms, the overall vision, conceptual framework and planned strategies for advancing and sustaining the proposed research program for the next eight years. Identify the key questions or challenges you plan to address and the general approaches and tools that might be used to address them. Discuss the importance of the research question, and how the research, if successful, would affect current understanding of the problem being addressed and/or advance the field of study. Include plans for transparent reporting, addressing resource/data sharing as appropriate and consistent with achieving the goals of the program and consideration of sex and other biological variables in the research program.
The proposed research can be either a continuation of your previous or current work or involve a new line of investigation. Given that the RPA may be used to consolidate funding from multiple projects, into a single award, there is no obligation to develop a single, unifying theme. If the planned research program diverges significantly from your past/current work, explain your rationale for the changes and describe your ability to undertake this new direction. A detailed experimental plan is not expected, nor is preliminary data required. Figures can be used sparingly to highlight critical pieces of data and/or to provide a high-level summary of the overall research program. Although the proposed direction of the research program will be considered in review, if new opportunities or directions arise during the course of the research, you will have the flexibility to change course and pursue them. Whether the program is an extension of current work or a new line of investigation, describe how the flexibility, level of effort, and longer-term funding offered by the RPA will benefit your research program.
Letters of Support: The application must include a letter from the institution's Authorized Organizational Official (AOR) indicating that they are aware of and accept the condition that other NINDS research awards must be relinquished as a condition of receiving a RPA (as described in Part 2, Section I), and providing a statement that if chosen to receive an award, the PD/PI must devote at least 6 person months (i.e., the equivalent of 50% effort on for a full-year appointment, 66.67% on a 9-month appointment, or 100% on a 6-month appointment) to the RPA throughout the duration of the award period.
The following modifications also apply:
All applications, regardless of the amount of direct costs requested for any one year, should include a Data Sharing Plan.
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
It is anticipated that the terms of award will include, but not be limited to, the following:
A permanent change of PD/PI will not be allowed under the RPA. A temporary change may be allowed with prior approval under circumstances such as sabbatical leave, medical conditions, disability, or personal or family situations.
Transfer of an RPA to a foreign institution will not be allowed. Addition of a foreign component, including a significant new foreign collaboration requires prior approval.
It is expected that the RPA will replace current NINDS funding of the laboratory. Institutions will be required to relinquish their interests in current NINDS-funded research grants where the applicant investigator is listed as the PD/PI or project lead on e.g. research project grants (RPGs), P01s, P50 and other Center awards [including Leads on subprojects] or proportional interest in awards where the applicant is one of a multiple PI team (MPI), with the exceptions of those indicated in Part 2, Section I of this FOA. The initial budget period of the RPA and timing of the award will be negotiated so that a smooth transition of support takes place.
It is expected that the PD/PI will renegotiate effort on other grants, if necessary, to permit required effort on the RPA. Note that a change in effort of more than 25% may require programmatic approval from other NIH ICs. A temporary reduction in effort may be approved under circumstances such as medical conditions, disability, or personal or family situations.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
In addition, for applications involving clinical trials:
A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.
For this particular announcement, note the following:
An RPA is intended to support most of the NINDS-related research in an investigator's laboratory or research group for a sustained period of time, facilitating increased funding stability, reduced administrative burden, and a more flexible research environment enabling more ambitious, creative and/or long-term research. RPA applicants are expected to provide an overview of their proposed research program, the scientific questions or challenges they intend to address and a general description of approaches and tools that might be used to address them.
Accordingly, reviewers will emphasize the following:
Reviewers will consider each of the review criteria below in the determination of scientific merit but will assign only a single overall impact score. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Does the research program address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the overall goals of the research program are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will obtaining answers to the scientific questions posed change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Specific to this FOA: Does the proposed research program address a problem that is sufficiently comprehensive and substantial to be appropriate for long-term pursuit? Is the proposed research program adequately broad and does it have potential to move the field forward?
In addition, for applications involving clinical trials
Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?
Is the PD/PI, collaborators, and other researchers well suited to the project? If the PD/PI is in the early stages of an independent career , do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? MPI applications and applications from ESIs are not permitted.
Specific to this FOA: Does the PD/PI have a track record of productivity in recent years of having substantial impact in the proposed field of study appropriate for the applicant’s stage of career? Critical life events such as family care responsibilities, serious illness or disability, or military service should be taken into account. Has the PD/PI shown evidence of being adaptable, able to recognize new opportunities and explore new areas of scientific inquiry, and open to the use of new tools, technologies, and strategies, as appropriate? Is it anticipated that the PD/PI's research productivity and contributions to science will continue at the same high caliber? Does the PD/PI have a record of conducting rigorous, reproducible, and transparent research? Has the PD/PI proposed an appropriate commitment of time and effort for the proposed work? Does the PD/PI have a record of professional service, including evidence of high-quality mentorship of undergraduate, graduate, or medical students, postdoctoral or clinical fellows, or junior faculty? Does the PD/PI have a record of training individuals from diverse, underrepresented populations?
In addition, for applications involving clinical trials
With regard to the proposed leadership for the project, does the PD/PI and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Does he/she have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Specific to this FOA: Does the PD/PI have a track record of creativity and innovation? Will the increased stability and flexibility of the RPA mechanism enable continued high innovation or more innovative and adventurous approaches to the scientific issues described in the application?
In addition, for applications involving clinical trials
Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the overall goals of the research program? Has the investigator included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Has the investigator presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Has the investigator presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
Specific to this FOA: Will the proposed research benefit from the unique features of the R35's long term and flexible approach to funding? Does the PD/PI provide strong evidence that the research program will evolve appropriately as the work is performed? Will the funding stability and flexibility of the RPA allow the PD/PI to pursue highly impactful, longer-term research that may be more difficult to pursue through other grant mechanisms? Is there a sound basis for the proposed level of effort?
In addition, for applications involving clinical trials
Does the application adequately address the following, if applicable
Study Design
Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?
Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?
Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?
Data Management and Statistical Analysis
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
In addition, for applications involving clinical trials
If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?
Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?
If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial
If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?
Study Timeline
Specific to applications involving clinical trials
Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?
Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?
For research that involves human subjects but does not involve one of thecategories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Not Applicable
Not Applicable
Not Applicable
Not Applicable
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the Scientific Review Branch, NINDS in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
Applications will be assigned
to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the
National Advisory Neurological Disorders and Stroke Council
The following will be considered in making funding decisions:
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
It is anticipated that the terms of award will include, but not be limited to, the following:
Six months prior to the end of the -05 budget period, the following should be submitted concurrently with the year four RPPR in order to request the three additional years of funding: 1. A letter co-signed by the Business Official and Principal Investigator requesting an additional three years of support; and 2. A one to two page description of the overall research accomplishments during the previous 4.5 years that justifies continuation of the research program for the final three years. Further details may be provided in the NOA.
Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.
ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm
Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols. Data and Safety
Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).
Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.
HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.
Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
a) Under Section 6.2 B.1 What are the major goals of the project? Note that the goals of the program of research supported by the RPA are broader than the specific aims of a single project and should be appropriately described. In addition to the scientific goals, describe the goals of enhanced mentoring of trainees and other research personnel that this award facilitates. If the goals of the RPA have changed, complete section B.1.a. Provide a rationale for the changes in the context of the originally proposed research program and further contributions to the field, and an explanation of how the research continues to fit within NINDS mission interests.
b) Under Section B.2, in addition to the instructions, emphasize how the work continues to be innovative and of high impact.
c) Under section D.2.c. additional information, indicate if there have been changes in Other Support. In addition to the revised Other Support page, include an explanation of the relationship of the new awards to the activities supported by the RPA.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreementsare required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM)about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings.Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.
Finding Help Online:http://grants.nih.gov/support/(preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email:GrantsInfo@nih.gov(preferred method of contact)
Telephone: 301-945-7573
Grants.gov Customer Support(Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email:support@grants.gov
Anna Taylor, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-827-3565
Email: anna.taylor@nih.gov
Ernest Lyons, Ph. D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9223
Email: LyonsE@ninds.nih.gov
Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)